DUPONT TECHNICAL REFERENCE GUIDE FOR

MEDICAL AND PHARMACEUTICAL PACKAGING

June 2017
 CONTENTS

SECTION

1
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

2
Why DuPont Tyvek is unique. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
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3
DuPont Tyvek vs. medical-grade papers: a comparison of properties . . . . 9
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4
Compatibility with sterilization methods. . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

5
Performance of DuPont Tyvek after aging . . . . . . . . . . . . . . . . . . . . . . . . . . 21
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6
Guidelines for printing on DuPont Tyvek . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
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7
Processing/troubleshooting guidelines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

7 APPENDICES

A1
Methods for measuring properties. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

A2
Description of sampling plans. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

A3
Guide to some common industry acronyms. . . . . . . . . . . . . . . . . . . . . . . . . . 42

This technical reference guide is published as of June 2017. DuPont reserves the right to modify testing per our change control procedures as
needed to meet customer needs or to improve production control and efficiency.

Contents  2
CONTENTS

LIST OF TABLES

I. Material compatibility with various sterilization methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

II. Strength and barrier properties before and after ethylene oxide (EO) sterilization . . . . . . . . . . . . . . 16

III. Results from tests comparing strength and microbial barrier of DuPont Tyvek ™ ®

medical and pharmaceutical packaging styles both before and after gamma
radiation at various doses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

IV. Results from tests comparing strength and microbial barrier of DuPont Tyvek ™ ®

medical and pharmaceutical packaging styles both before and after electron-beam
radiation at various doses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

V. Physical properties of DuPont Tyvek medical and pharmaceutical packaging

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styles both before and after steam sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

VI. Sample toxicological results for DuPont Tyvek 1073B, ™ ®

Tyvek 1059B and Tyvek 2FS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

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VII. Physical properties of DuPont Tyvek sterilized by ethylene oxide (EO) before
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and after five-year real-time aging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

VIII. Accelerated aging test results for DuPont Tyvek 1073B and Tyvek 1059B . . . . . . . . . . . . . . . . . . . 23
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IX. Accelerated aging test results for DuPont Tyvek 2FS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

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X. Real-time aging test results for DuPont Tyvek 1073B and Tyvek 1059B (metric units) . . . . . . . . . 24
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XI. Real-time aging test results for DuPont Tyvek 1073B and Tyvek 1059B (English units) . . . . . . . . 25
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XII. Seal strength of DuPont Tyvek 1073B after gamma sterilization following
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accelerated and real-time aging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

XIII. Test methods used for measuring material properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Contents - list of tables  3

CONTENTS

LIST OF FIGURES

1. Scanning electron micrographs (SEMs) of DuPont Tyvek . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

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2. Particle penetration of porous sterile barrier materials (ASTM F2638) . . . . . . . . . . . . . . . . . . . . . . . . . 9

3. Particle penetration of DuPont Tyvek medical and pharmaceutical ™ ®

packaging styles (ASTM F2638) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

4. Microbiological barrier testing of sterile barrier materials (ASTM F1608) . . . . . . . . . . . . . . . . . . . . . . 10

5. Elmendorf tear (MD) properties of DuPont Tyvek styles and medical-grade papers ™ ®

(ASTM D1424 and EN 21974) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

6. Spencer puncture properties of DuPont Tyvek styles and medical-grade papers ™ ®

(ASTM D3420, procedure B) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

7. Elongation (MD) properties of DuPont Tyvek styles and medical-grade papers ™ ®

(ASTM D5035 and EN ISO 1924-2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

8. Hydrostatic head properties of DuPont Tyvek styles and medical-grade papers ™ ®

(AATCC TM 127 and EN 20811) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

9. Particle generation properties of DuPont Tyvek styles and medical-grade papers . . . . . . . . . . . . . 14

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10. Ethylene oxide (EO) residual concentration in porous sterile barrier materials after
sterilization and aeration for 6, 12, 24 and 48 hours . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

11. Results of shrinkage tests conducted on DuPont Tyvek 1073B, Tyvek 1059B and ™ ® ®

Tyvek 2FS after steam sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

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12. Pictorial representation of DuPont Tyvek during package opening . . . . . . . . . . . . . . . . . . . . . . . . . . 31

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13. Pictorial representation of DuPont Tyvek during opening at an extreme angle . . . . . . . . . . . . . . . . 31

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14. Micrograph of folded DuPont Tyvek showing sheet separation, a phenomenon

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that does not compromise the integrity of the package . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

15. Channel in seal determined during dye penetration testing (ASTM F1929:2003) . . . . . . . . . . . . . . . 32

16. Wicking occurs when dye is left too long in the pouch during ASTM F1929:2003 testing . . . . . . . . 32

17. Prediction of fiber tear based on lid alignment on tray . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

18. Multiple cavity thermoform with “skirt” seal or gap between sealed areas . . . . . . . . . . . . . . . . . . . . 35

19. DuPont sealing experiment to test the effect of lid placement on fiber tear . . . . . . . . . . . . . . . . . . . . 36

20. Results of improper lid placement during DuPont sealing experiment . . . . . . . . . . . . . . . . . . . . . . . . 36

Contents - list of figures  4

 INTRODUCTION

DuPont Tyvek for medical and pharmaceutical LEARN MORE ABOUT

™ ®

packaging delivers trusted protection

THE SCIENCE OF PROTECTION
Since its introduction to the industry in 1972,
DuPont™ Tyvek® brand protective material has
WITH DUPONT TYVEK ™ ®

1
been recognized as a standard of excellence for sterile The unique structure of Tyvek® gives it inherent
medical packaging. Tyvek® earned this distinction advantages over other materials, including:
because it provides a higher degree of microbial barrier
and puncture protection for medical devices and supplies Outstanding resistance to microbial penetration
than other porous materials used for sterile packaging Microbial barrier test data consistently prove that Tyvek®
applications. The unique structure of Tyvek® gives it holds out bacterial spores and test particles better than
inherent advantages over other materials. other porous packaging materials—even under the most
rigorous conditions. In addition, a long-term shelf-life
Helping speed up your compliance process study proved conclusively that Tyvek® can maintain
In this guide you will find extensive compliance data sterility for at least five years if package integrity is not
established by the DuPont network of regulatory affairs compromised. The photomicrographs shown here
experts to help you develop and validate the most illustrate how bacteria are trapped on the filament
appropriate solutions with Tyvek®. This will allow you surfaces of Tyvek®.
to meet worldwide regulations and packaging standards,
while accelerating your product regulatory submissions Significantly reduced risk of package failure
and certifications. The tough, continuous fibers of Tyvek® help protect
package integrity from both product breakthrough inside
Providing packaging science support and rough handling outside. Tyvek® is so tough, it resists
DuPont Packaging Engineers are available globally to punctures—even from the irregular or sharp edges of
support you with knowledge about materials, packaging many surgical devices. Compared to medical-grade papers,
design and processing to help optimize performance and Tyvek® has superior tear strength and puncture resistance.
total cost as well as to ease implementation.

Microbes trapped on filament surfaces of Tyvek® (500x magnification) Cross-sectional view of Tyvek® (500x magnification)

Figure 1. Scanning electron micrographs (SEMs) of DuPont Tyvek . ™ ®

The unique structure of Tyvek , which creates a tortuous path with substantial lateral movement, results in superior microbial
®

barrier protection.

Section 1  Introduction  5
 INTRODUCTION

What’s more, because it is breathable, DuPont™ Tyvek® AT THE FOREFRONT OF

minimizes the formation of condensation due to
temperature extremes that can occur during transport.
TECHNOLOGICAL AND
This breathability also allows medical packages made
with Tyvek® to equilibrate rapidly from the pressure
REGULATORY DEVELOPMENT 1
changes that occur not only during shipping but also An industry and technology leader
in storage environments.
As leaders in the industry, we are dedicated to sharing
information and expertise on topics ranging from industry
Low risk of device contamination standards and regulatory compliance to technical issues
The unique structure of Tyvek® generates very few airborne and quality. We develop and participate in conferences
particles when packages are opened or handled. This clean to help the industry stay on top of standards, regulations
peel minimizes the risk of introducing particulates into and new technologies. In addition, members of our team
a clean environment. regularly participate on activities within:
• ASTM International

Compatibility with a broad range of • International Organization for Standardization (ISO)

sterilization methods • European Committee for Standardization (CEN)

• Association for the Advancement of

Only Tyvek® is compatible with all of the most commonly 

used sterilization methods. No matter which process Medical Instrumentation (AAMI)

you use: ethylene oxide (EO), gamma, electron-beam, • Standardization
 Administration of the
steam (under controlled conditions) or low-temperature People’s Republic of China (SAC)
oxidative sterilization processes, Tyvek® will retain its • Japanese Standards Association ( JSA)
superior protective properties of microbial barrier and • Sterile Barrier Association (SBA)
strength, as well as its color and flexibility.
• Parenteral Drug Association (PDA)

• Healthcare Plastics Recycling Council (HPRC)

Helps you meet your environmental goals

As for ecological responsibility, Tyvek® is an excellent Contact our experts

choice. This lightweight, durable material is an
effective way to conserve resources and demonstrate If you have questions or need additional support with
environmental stewardship. Tyvek® is produced under submission challenges, troubleshooting, analytical services,
verified environmental management policy according as well as packaging and regulatory compliance, contact
to ISO 14001. It can be recycled at local recycling your local DuPont representative.
facilities that accept high-density polyethylene (HDPE)
waste according to local legislation. The items sent
for recycling must not have been in contact with any
hazardous substance.

Section 1  Introduction  6
 WHY DUPONT TYVEK IS UNIQUE
™ ®

The unique structure of DuPont™ Tyvek®—tough, Specification vs. other properties

continuous filaments—creates both a tortuous path for
Specification properties are typical values based on roll
superior microbial barrier and excellent strength properties.
averages, with samples taken uniformly across the sheet.
Made of high-density polyethylene (HDPE), Tyvek® offers Specification properties are controlled to a nominal value
all the best characteristics of paper, film and fabric in one and released within release specifications. The values
material. This unique balance of properties, which cannot for other properties are typical but carry no warranty,
be found in any other material, makes Tyvek® lightweight expressed or implied. For medical and pharmaceutical
yet strong; vapor-permeable, yet moisture- and chemical-
resistant; as well as puncture-, tear- and abrasion-resistant.
packaging, specification properties are basis weight,
Gurley Hill porosity and delamination.
2
Tyvek® is also low-linting, smooth and opaque.
All other properties are the result of keeping the three
Specification properties of Tyvek® styles for medical and specification properties on aim. Sampling plans for both
pharmaceutical packaging applications can be found at the specification properties and for miscellaneous properties
following links. are described in Appendix 2.
Specification Properties of Tyvek® 1073B and 1059B —
A miracle of science from DuPont
English and Metric
The discovery of Tyvek® was a chance occurrence by a
Specification Properties of Tyvek® 2FS™ — English and
DuPont researcher, Jim White, who in 1955 noticed
Metric
white polyethylene fluff coming out of a pipe in a
Miscellaneous properties of Tyvek® styles for medical and DuPont experimental lab. After examining this material,
pharmaceutical packaging applications can be found at the it was found that it had some very interesting properties.
following links. A program to develop the new material was set up,
and a year later DuPont submitted a patent proposal
Miscellaneous Properties of Tyvek® 1073B and 1059B —
for strong yarn linear polyethylene.
English and Metric
The proprietary flash-spinning technology, which is the
Miscellaneous Properties of Tyvek® 2FS™ — English and
basis for what was to become a new engineered sheet
Metric
structure from DuPont, took several more years to
It is important to note that these properties are for perfect. In 1959, a pilot facility was established for trial
uncoated Tyvek® as sold by DuPont. Any downstream applications such as book covers, tags, labels and certain
operations, such as coatings applied by sterile packaging garments. In 1965, the new engineered sheet structure
manufacturers (SPMs), may change these values. was registered under the trademark name Tyvek®, but
it was not until April 1967 that commercial production
A description of the test methods used for these of Tyvek® started.
specification and miscellaneous properties can be found
in Appendix 1.

Section 2  Why DuPont Tyvek is unique  7

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 WHY DUPONT TYVEK IS UNIQUE
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Flash-spinning and bonding process

Tyvek® is formed by a fully integrated process using

continuous and very fine filaments (having an average
diameter of 4 µ) of HDPE that are randomly distributed
and non-directional. (For purposes of comparison,
a human hair is approximately 75 µ in cross section.)
These filaments are first flashspun, then laid as a web on
a moving belt before being bonded together. By varying
the flash-spinning and bonding process conditions,
2
DuPont can engineer the sheet properties to meet
specific market needs.
Tyvek® for medical and pharmaceutical packaging
applications is neither corona treated nor anti-stat treated
because these treatments may compromise the barrier
characteristics of Tyvek®. The styles of Tyvek® designed for
use in medical and pharmaceutical packaging applications
are: Tyvek® 1073B, Tyvek® 1059B and Tyvek® 2FS™. These
styles are manufactured to rigorous quality standards to
meet the unique requirements for medical and
pharmaceutical packaging applications.

Section 2  Why DuPont Tyvek is unique  8

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 DUPONT TYVEK VS. MEDICAL-GRADE PAPERS: A COMPARISON OF PROPERTIES
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DuPont™ Tyvek® offers an optimum balance of microbial Excellent barrier to microbial penetration
penetration resistance, tear strength, puncture resistance
The number-one priority in selecting packaging materials
and clean peel, as well as compatibility with all of the
for medical devices is the ability of the package to
most commonly used sterilization methods, including:
maintain sterility from the point of sterilization until the
ethylene oxide (EO), gamma, electron-beam, steam
product is opened for use. Even under the most rigorous
(under controlled conditions) and low-temperature
conditions in highly contaminated environments, Tyvek®
oxidative sterilization processes.
is highly resistant to penetration by bacterial spores and
The secret to the superior performance of Tyvek® is that other contaminating microorganisms.
it’s not a paper, but rather a sheet of flashspun and bonded
Particulate and bacteriological tests clearly demonstrate
high-density polyethylene (HDPE) filaments. Continuous
that Tyvek® outperforms other commercially available
strands of very fine, interconnected filaments are randomly
porous packaging materials, including medical-grade
oriented and bonded together by heat and pressure during
manufacture. The result is a tough, durable sheet structure
papers (Figures 2 through 4). Comprehensive shelf-life
studies have shown that Tyvek® can maintain sterility for
3
that provides a unique combination of physical properties
at least five years if package integrity is not compromised.
that no other sterile packaging material can match.
(See Section 5, “Performance of DuPont™ Tyvek® after
Tyvek® has become a standard of excellence against which Aging,” for details.)
other sterile packaging materials are judged. Tyvek®
consistently outperforms medical-grade papers in tests
for microbial barrier, tear and puncture resistance, liquid
resistance, and particle generation (Figures 2 through 9).

20 
40# uncoated paper
18 
 
16 synthetic
fiber-reinforced paper
14  
 
% Penetration

12  70# coated paper


 
10 

 55# coated paper
8  
 
6
 DuPont Tyvek 1073B
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


4 ▲

DuPont Tyvek 1059B
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2

▲ ▲  
▲ 
▲  ▲ DuPont Tyvek 2FS
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0   
0 5 10 15 20 25

Face Velocity, cm/min

Figure 2. Particle penetration of porous sterile barrier materials (ASTM F2638).

ASTM F2638 Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a
Surrogate Microbial Barrier measures the ability of a porous substrate to prevent particle penetration, which is highly correlated
to microbiological spore penetration. All materials have a face velocity where maximum percent particle penetration occurs (pMax).
The lower the percent penetration, the better the performance.

Section 3  DuPont Tyvek vs. medical-grade papers  9

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 DUPONT TYVEK VS. MEDICAL-GRADE PAPERS: A COMPARISON OF PROPERTIES
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0.5

0.4  ▲


DuPont Tyvek 1073B
™ ®
% Penetration

0.3
▲
 DuPont Tyvek 1059B
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▲ 
0.2
DuPont Tyvek 2FS
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▲ 

0.1
   3

▲
▲ 
0
0 5 10 15 20 25 30

Face Velocity, cm/min

Figure 3. Particle penetration of DuPont Tyvek medical and pharmaceutical packaging styles (ASTM F2638).
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The percent penetration as a function of face velocity for Tyvek 1073B, Tyvek 1059B and Tyvek 2FS demonstrates that these
® ® ® TM

Tyvek medical and pharmaceutical packaging styles all have a pMax of less than 0.5%. It is important to note the scale difference
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of the Y-axis compared to Figure 2. The pMax of other porous sterile barrier materials ranges from 8% to approximately 18%.

LRV
6

5
5.2
4
4.7

3
3.2
1.7–2.9
2

1
1.3
0
Tyvek 1073B
®
Tyvek 1059B
®
Tyvek 2FS
® ™
medical-grade papers synthetic fiber-
(uncoated) (uncoated) (uncoated) (coated & uncoated) reinforced paper

Figure 4. Microbiological barrier testing of sterile barrier materials (ASTM F1608).

ASTM F1608, Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method), measures the
ability of porous sterile barrier materials to prevent bacterial spore penetration. A completely impermeable control sample (microbial
penetration is zero) is challenged with one million or 106 colony forming units (cfu). The number of cfu 106 has a log10 value of 6.
If a sample challenged in the same way as the control allows 10 cfu (log 10=1) to penetrate, then its log reduction value (LRV) is 5
(6–1=5). Therefore, the higher the LRV, the more resistant the packaging is to microorganisms.

Section 3  DuPont Tyvek vs. medical-grade papers  10

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 DUPONT TYVEK VS. MEDICAL-GRADE PAPERS: A COMPARISON OF PROPERTIES
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Superior tear strength and puncture resistance during rough handling. Compared to medical-grade
papers, Tyvek® provides superior puncture resistance
The tough, continuous filaments of DuPont™ Tyvek®
and tear strength, which means that Tyvek® does not
protect your package from product breakthrough and
puncture easily and tears do not readily propagate
also from penetration by an object outside the packaging
if a package is nicked.

lbƒ (N)
1.0 (4.4)

0.8 (3.6)

0.6 (2.7) 0.7

(3.3) 0.6 0.6

3
(2.8) (2.7)
0.4 (1.8)
0.09–0.21
(0.4–0.9)
0.2 (0.9) 0.34
(1.5)

0 (0)
Tyvek 1073B
®
Tyvek 1059B
®
Tyvek 2FS
® ™
medical-grade papers synthetic fiber-
(uncoated) (uncoated) (uncoated) (coated & uncoated) reinforced paper

Figure 5. Elmendorf tear (MD) properties of DuPont Tyvek styles and medical-grade papers (ASTM D1424 and EN 21974).
™ ®

This test measures the force required to propagate an initiated tear from a cut or a nick. MD signifies machine direction.
The higher the value, the less likely a material will tear under force.

2 2
in.-lbƒ/in. ( J/m )
50 (8756)
50
40 (7000) (8756)

39
30 (5250) (6830)

28
20 (3500) (4903)
3.21–7.79 5.96
(562–1364) (1044)
10 (1750)

0 (0)
Tyvek 1073B
®
Tyvek 1059B
®
Tyvek 2FS
® ™
medical-grade papers synthetic fiber-
(uncoated) (uncoated) (uncoated) (coated & uncoated) reinforced paper

Figure 6. Spencer puncture properties of DuPont Tyvek styles and medical-grade papers (ASTM D3420, procedure B).
™ ®

This test determines the impact resistance of plastic films and packaging materials under conditions that closely approximate the
strain rate that these materials are subject to in the healthcare industry. These results were obtained using a modified Spencer
puncture test apparatus that features a 9⁄ 16-inch (14.3-mm) diameter hemispheric-shaped probe tip and a 6,400-gram pendulum,
which is necessary to puncture tough materials like Tyvek . Results using different test apparatus are not comparable.
®

Section 3  DuPont Tyvek vs. medical-grade papers  11

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 DUPONT TYVEK VS. MEDICAL-GRADE PAPERS: A COMPARISON OF PROPERTIES
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Exceptional resistance to breakage strength of Tyvek®, ensures that form-fill-seal packaging

lines run smoothly and without significant downtime
DuPont™ Tyvek® is an extremely flexible packaging material
due to material web breaks.
that won’t break or tear as easily as medical-grade papers
(Figure 7). This resiliency, combined with the inherent

%
25

20
20
19
15
18

10
3
5
2–3

0
Tyvek 1073B
®
Tyvek 1059B
®
Tyvek 2FS
® ™
medical-grade papers
(uncoated) (uncoated) (uncoated) (coated & uncoated)

Figure 7. Elongation (MD) properties of DuPont Tyvek styles and medical-grade papers (ASTM D5035 and EN ISO 1924-2 @ sample
™ ®

length of 5 in. [13 cm] and rate of extension [ROE] of 2 in./min [5 cm/min]).
Elongation is the measure of the extent a substrate will stretch before it breaks. MD signifies machine direction. The higher the value,
the more a package will stretch before it breaks.

Section 3  DuPont Tyvek vs. medical-grade papers  12

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 DUPONT TYVEK VS. MEDICAL-GRADE PAPERS: A COMPARISON OF PROPERTIES
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Outstanding moisture resistance and moisture Low-temperature oxidative sterilization processes, such
vapor transmission as hydrogen peroxide gas plasma, cannot be used with
cellulosic materials such as medical-grade paper because
Unlike medical-grade paper, DuPont™ Tyvek® has
these materials rapidly interact with the oxidizing agent
outstanding moisture resistance. In fact, water in contact
and its superoxide radicals. This can result in an aborted
with Tyvek® does not wet its surface or spread; it simply
cycle due to inadequate sterilant concentration. Tyvek®
remains as droplets on the surface. That's because Tyvek®
is high-density polyethylene (HDPE) and allows for an
is hydrophobic and does not absorb moisture, giving
effective sterilant concentration to be achieved. Although
it distinct advantages compared to medical-grade paper.
Tyvek® interacts only slightly with these types of sterilants,
For example, when medical-grade paper absorbs moisture, the surface energy is increased. This can cause a lowering
its strength and puncture resistance are reduced. This of the hydrostatic head in industrial applications where
can greatly influence package performance, especially multiple sterilization cycles are validated. The performance
during distribution. In sharp contrast to medical-grade
paper, Tyvek® maintains its superior strength both
of Tyvek® as a sterile barrier is not affected but the liquid
test methods for assessing package integrity (such as dye
3
wet and dry. penetration and water immersion) can produce results that
are different from untreated material.
In addition to its outstanding moisture resistance,
another advantage of Tyvek® is that a high moisture Occasionally, medical device and pharmaceutical packages
vapor transmission rate (MVTR) can be achieved. This are subjected to adverse conditions that allow them to get
is particularly important for the ethylene oxide (EO) wet, such as rain on a loading dock or flooding. When this
sterilization process where water is introduced as a vapor occurs, the time of exposure and severity are not typically
because moisture enhances the effectiveness of EO as a known. Because most device manufacturers label their
sterilant. Because medical-grade paper absorbs moisture packages as “sterile unless opened or damaged,” we believe
vapor, it does not allow for a high MVTR across the water contamination would constitute damage.
material to the package contents.

H2O in. H2O (cm)

60 (153)

58 57 59
50 (127)
(147) (145) (150) 17–54
(44–139)
40 (102)

30 (76)

20 (51)

10 (25)

0 (0)
Tyvek 1073B
®
Tyvek 1059B
®
Tyvek 2FS
® ™
medical-grade papers
(uncoated) (uncoated) (uncoated) (coated & uncoated)

Figure 8. Hydrostatic head properties of DuPont Tyvek styles and medical-grade papers (AATCC TM 127 and EN 20811 @ rate of use
™ ®

of 60 cm H2O/min).
Hydrostatic head is the measure of the pressure required to force three drops of water through a substrate. The higher the value, the
more resistant the package is to water penetration.

Section 3  DuPont Tyvek vs. medical-grade papers  13

™ ®
 DUPONT TYVEK VS. MEDICAL-GRADE PAPERS: A COMPARISON OF PROPERTIES
™ ®

Clean peel Untorn Tyvek® samples generated fewer particles than

paper across the entire size range from 0.3 µ to 10.0 µ.
Unlike medical-grade paper, which can release a significant
Paper generated 9,000 to 20,000 0.3 µ particles while
number of particulates when a package is opened, the
Tyvek® generated less than 600. Once torn, the number
unique continuous filament structure of DuPont™ Tyvek®
of particles increased for all materials, with paper
results in clean peel and low lint features that minimize the
generating 19,000 to 35,000 0.3 µ particles and Tyvek®
risk of device contamination when packages are opened
generating less than 1,000. This study provides conclusive
or handled. Tests were conducted to measure the quantity
evidence that Tyvek® generates significantly fewer airborne
and size of particles generated by Tyvek® and medical-grade
particulates that could contaminate either the medical
paper both before and after being torn in half (Figure 9).
device or the sterile field.
Untorn After tearing in half

3
35,000 35,000
♦
30,000 30,000

25,000 25,000

20,000 ♦ 20,000

15,000 15,000

10,000 10,000


5,000 5,000
Number of particles

Number of particles

1,000 1,000 ▲

900 900

800 800

700 700
♦ ♦
600 600 
▲

500 500

400 400



300 300
▲
200 200 ▲

100 100

 
0 0
0.3 µ 0.5 µ 1.0 µ 2.0 µ 5.0 µ 10.0 µ 0.3 µ 0.5 µ 1.0 µ 2.0 µ 5.0 µ 10.0 µ

Particle size (microns) Particle size (microns)

 ▲   ♦
DuPont ™
DuPont ™
44# medical- 60# medical- 44# medical-
Tyvek 1073B ®
Tyvek 1059B
®
grade paper grade paper grade paper

Figure 9. Particle generation properties of DuPont Tyvek styles and medical-grade papers (as tested by an internal DuPont protocol).
™ ®

For the particulate generation testing, samples (medical-grade papers, as well as Tyvek 1073B and Tyvek 1059B) were each tumbled ® ®

in a tumbling drum to release particles from the tested materials. The drum was housed in a HEPA filter lab bench. The lab bench
air was filtered with two pre-filters and one HEPA filter. Air was supplied by a blower with a pressure drop across the filters of 0.5 in.
(1.3 cm) of water. Sampling of the number and size of the generated particles was done with a cleanroom monitor coupled to a paper
tape printer. All of the equipment was housed in a temperature-controlled, HEPA-filtered-air cleanroom that had full air exchange
approximately every minute.

Section 3  DuPont Tyvek vs. medical-grade papers  14

™ ®
 COMPATIBILITY WITH STERILIZATION METHODS

Unlike medical-grade papers and films, DuPont™ which is extremely stable when exposed to sterilant gases
Tyvek® offers sterilization compatibility with all of the and high-energy sterilization processes. In addition, Tyvek®
most commonly used methods for sterilizing medical is specially engineered to enable sterilant gases and steam
devices. These include: ethylene oxide (EO), gamma, to penetrate and escape quickly. No matter which of these
electron-beam, steam (under controlled conditions), and sterilization methods is used, Tyvek® will retain its superior
low-temperature oxidative sterilization processes (e.g., protective properties of microbial barrier and strength, as
STERRAD® Sterilization System). That’s because Tyvek® well as its color and flexibility.
is made of 100% high-density polyethylene (HDPE),

Table I. Material compatibility with various sterilization methods

Coated, latex saturated
DuPont Tyvek
™ ®
All film package
medical-grade paper

Ethylene Oxide (EO) Yes Yes No

Gamma Radiation Yes Yes Yes1

Electron-beam Radiation Yes Yes Yes 4

Steam Yes 2 Yes 3 No

STERRAD ®
Yes No No

1. May entrap undesirable odors inside the package.

2. Under controlled conditions (250°F to 260°F [121°C to 127°C] ) at 30 psi for 30 minutes.
3. May become brittle.

Section 4  Compatibility with sterilization methods  15

 COMPATIBILITY WITH STERILIZATION METHODS

Ethylene oxide (EO) and microbial barrier of Tyvek® are maintained after
EO sterilization (Table II). Refer to Section 5,
Ethylene oxide (EO) does not readily adsorb on DuPont™
“Performance of DuPont™ Tyvek® After Aging,”
Tyvek® and is released more rapidly than from cellulosic
for test results after five-year real-time aging.
materials such as medical-grade papers, including synthetic
fiber-reinforced paper (Figure 10). The superior strength

10.0

9.0

8.0

7.0

6.0
EO, ppm

5.0

4.0 4
3.0

2.0

1.0

0
55# synthetic 52# DuPont ™
DuPont ™
DuPont ™
DuPont ™
DuPont™

coated fiber-reinforced coated Tyvek ®

Tyvek ®
Tyvek ®
Tyvek®
Tyvek 2FS
® ™

paper paper paper 1073B 1073B 1059B 1059B (uncoated)

(uncoated) (coated) (uncoated) (coated)

n 6 Hours n 12 Hours n 24 Hours n 48 Hours

Figure 10. Ethylene oxide (EO) residual concentration in porous sterile barrier materials after sterilization and aeration for
6, 12, 24 and 48 hours. The residual analysis was conducted according to ISO 10993-7.

Table II. Strength and barrier properties before and after ethylene oxide (EO) sterilization

Tensile Strength, MD1

Microbial Barrier, LRV2
lbƒ/in. (N/2.54 cm)

unsterilized 44.0 (196) 5.2

DuPont Tyvek 1073B
™ ®

sterilized 46.0 (205) 5.3

unsterilized 37.0 (165) 4.7

DuPont Tyvek 1059B
™ ®

sterilized 35.0 (156) 4.7

unsterilized 31.0 (138) 3.6

DuPont Tyvek 2FS
™ ® ™

sterilized 33.0 (147) 3.3

1. Per ASTM D5035 and EN ISO 1924-2; modified for speed and gauge length.
2. Log Reduction Value (LRV) as tested per ASTM F1608.

Section 4  Compatibility with sterilization methods  16

 COMPATIBILITY WITH STERILIZATION METHODS

Sterilization pouches and rolls intended for the and when packages are opened, Tyvek® maintains its
healthcare sterilization market low-linting performance.
Advanced Sterilization Products (ASP), Division Because Tyvek® is porous, undesirable odors produced
of Ethicon Inc., a Johnson & Johnson company, has by radiation sterilization can be aerated out of the
developed a complete range of self-seal pouches, heat-seal package. Nonporous materials can trap these odors
pouches and heat-seal rolls made with DuPont™ Tyvek® inside the packaging.
4057B for use in the STERRAD® System.
Another advantage of the porous nature of Tyvek® is that
ASP also prints a STERRAD® Chemical Indicator it allows medical packages to equilibrate rapidly from the
on its pouches and rolls to simplify the identification pressure changes that occur during gamma sterilization.
of processed packages. The STERRAD® Sterilization
It’s important to note that although Tyvek® may withstand
process is also used for industrial device sterilization
re-sterilization with either gamma or electron-beam, the
with common package configurations using Tyvek®
device itself may not. If re-sterilization is required, gas
protective material. Caution should be used when
sterilization can also be performed. Tyvek® will remain
choosing methodologies for package integrity testing
flexible after re-sterilization and will continue to provide
after multiple cycles because the water penetration
an excellent microbial barrier.
4
resistance of the material can be altered. For information
about the STERRAD® System, including cycle time and
performance details, visit [Link] Gamma

Radiation sterilization After exposure to gamma radiation up to 100 kGy,

Tyvek® maintains its superior microbial barrier and the
Tyvek® maintains excellent microbial barrier properties impact on strength properties is limited (Table III).
and experiences only slight changes in tensile strength, These properties are also maintained after irradiation
elongation and color when exposed to radiation doses followed by exposure to accelerated and real-time aging
typically used in the medical device industry. Unlike other (Section 5, “Performance of DuPont™ Tyvek® After Aging,”
porous materials, Tyvek® resists post-sterilization brittleness Tables X through XII).

Table III. Results from tests comparing strength and microbial barrier of DuPont Tyvek medical and pharmaceutical packaging
™ ®

styles both before and after gamma radiation at various doses*

Tensile Strength, MD1 Microbial
lbƒ/in. (N/2.54 cm) Barrier, LRV2
unsterilized — 42.0 (187) 5.2
sterilized 25 kGy 39.1 (174) 5.2
30 kGy — 5.3
DuPont Tyvek 1073B
™ ®

50 kGy 35.8 (159) 5.2

60 kGy — 5.4
100 kGy 23.1 (103) 5.1
unsterilized — 36.7 (163) 4.7
sterilized 25 kGy 28.9 (128) 4.7
30 kGy — 5.1
DuPont Tyvek 1059B
™ ®

50 kGy 26.5 (118) 4.1

60 kGy — 4.5
100 kGy 19.1   (85) 4.2
unsterilized — 30.8 (137) 3.6
DuPont Tyvek 2FS
™ ® ™
sterilized 30 kGy 25.1 (112) 3.6
60 kGy 21.2   (94) 3.4
*25 kGy and 30 kGy were single doses; all others were cumulative amounts from double doses (i.e., 50 kGy represents a double dose of 25 kGy, etc.).
1. ASTM D5035 and EN ISO 1924-2; modified for speed and gauge length.
2. Log Reduction Value (LRV) as tested per ASTM F1608.

Section 4  Compatibility with sterilization methods  17

 COMPATIBILITY WITH STERILIZATION METHODS

Electron beam not been conducted. However, we have not seen any
effects other than those shown after gamma radiation
After exposure to electron-beam radiation up to 100 kGy,
and aging (Section 5, “Performance of DuPont™ Tyvek®
DuPont™ Tyvek® maintains its superior microbial barrier
After Aging,” Tables X through XII) because HDPE
and strength properties (Table IV). Specific studies
is radiation stable.
of electron-beam sterilization followed by aging have

Table IV. Results from tests comparing strength and microbial barrier of DuPont Tyvek medical and pharmaceutical packaging
™ ®

styles both before and after electron-beam radiation at various doses*

Tensile Strength, MD1 Microbial
lbƒ/in. (N/2.54 cm) Barrier, LRV2
unsterilized — 42.0 (187) 5.2
sterilized 50 kGy 35.8 (159) 5.2
DuPont Tyvek 1073B
™ ®

100 kGy 21.5   (96) 5.2

unsterilized — 36.7 (163) 4.7

DuPont Tyvek 1059B
™ ® sterilized 50 kGy 30.4 (135) 4.9
100 kGy

*50 kGy was a single dose; 100 kGy was a cumulative amount, representing a double dose of 50 kGy.
21.2   (94) 4.3
4
1. ASTM D5035 and EN ISO 1924-2; modified for speed and gauge length.
2. Log Reduction Value (LRV) as tested per ASTM F1608.

Hydrogen peroxide gas plasma Steam

Based on test data and extensive long-term use, it Tyvek® has been shown to meet packaging criteria
is clear that Tyvek® 4057B is well-suited for use with for steam sterilization under controlled conditions
the STERRAD® Sterilization System from Advanced (250˚F to 260°F [121°C to 127°C] at 30 psi for
Sterilization Products (ASP), Division of Ethicon Inc., 30 minutes). Packaging using Tyvek® for steam
a Johnson & Johnson company. This sterilization method sterilization is commercial at medical device and
uses low-temperature hydrogen peroxide gas plasma pharmaceutical manufacturers.
to enable sterilization of heat-labile devices.
Tyvek® continues to be superior to medical-grade paper
Medical-grade papers, including autoclave paper pouches, when strong, low-linting packaging is required. Tyvek®
are not acceptable for use with the STERRAD® System retains its dimensional stability and integrity—with no
because cellulosic materials neutralize the sterilizing agent. discoloration—when steam sterilized under controlled
Caution should be used when choosing methodologies conditions (250°F to 260°F [121°C to 127°C] at 30 psi for
for package integrity testing after multiple doses of 30 minutes).
low-temperature oxidative sterilization because the
Tensile strength, microbial barrier and Gurley Hill porosity
water resistance of the material can be altered. For more
of Tyvek® are maintained after steam sterilization for 30
information about the STERRAD® Sterilization System,
minutes at temperatures up to 260°F (127°C). (Table V).
visit [Link]
Rigid or semi-rigid trays restrict potential shrinkage and
wrinkling, which can result in a smoother/tighter lid.
Shrinkage of Tyvek® after steam sterilization is less than
1.6% (Table V, Figure 11).

Section 4  Compatibility with sterilization methods  18

 COMPATIBILITY WITH STERILIZATION METHODS

Table V. Physical properties of DuPont Tyvek medical and pharmaceutical packaging styles both before and after
™ ®

steam sterilization
Tensile Strength, MD1 Microbial Shrinkage Gurley Hill3
lbƒ/in. (N/2.54 cm) Barrier, LRV2 Autoclave, % sec/100 cc
unsterilized — 41.9 (186) 5.2 — 24
sterilized 30 min. 250°F (121°C) 43.1 (192) 4.8 0.5 24
DuPont Tyvek 1073B
™ ®

255˚F (124˚C) 48.4 (215) 4.8 0.3 26

260˚F (127˚C) 48.2 (214) 5.2 1.4 25

unsterilized — 35.2 (157) 4.7 — 19

sterilized 30 min. 250˚F (121˚C) 36.0 (160) 4.7 1.0 21
DuPont Tyvek 1059B
™ ®

255˚F (124˚C) 38.7 (172) 5.1 0.5 34

260˚F (127˚C) 40.2 (179) 4.1 1.5 23

unsterilized — 27.8 (124) 3.6 — 18

sterilized 30 min. 250˚F (121˚C) 26.7 (119) 3.1 0.8 20
DuPont Tyvek 2FS
™ ® ™

255˚F (124˚C) 28.5 (127) 3.1 0.3 20

260˚F (127˚C) 29.1 (129) 3.3 0.9 17

4
1. ASTM D5035 and EN ISO 1924-2; modified for speed and gauge length.
2. Log Reduction Value (LRV) as tested per ASTM F1608.
3. TAPPI T460 and ISO 5636-5.

3.0 
DuPont Tyvek 1073B
™ ®

2.5
▲
DuPont Tyvek 1059B
™ ®
% Shrinkage

2.0

1.5 ▲ 
 DuPont Tyvek 2FS
™ ® ™

1.0 ▲ 

0.5  ▲


0.0
°F 250 255 260
( °C) (121) (124) (127)

Temperature

Figure 11. Results of shrinkage tests conducted on DuPont Tyvek 1073B, Tyvek 1059B and Tyvek 2FS after
™ ® ® ® ™

steam sterilization.

Section 4  Compatibility with sterilization methods  19

 COMPATIBILITY WITH STERILIZATION METHODS

Biocompatibility This testing was also performed on samples of Tyvek®

after exposure to sterilization by EO, gamma and
Biological evaluation of DuPont™ Tyvek® styles for medical
electron-beam sterilization processes and proved that
and pharmaceutical packaging was performed using testing
Tyvek® meets all the acceptable performance criteria
methodologies according to ISO 10993 and United States
(Table VI) after sterilization. The results of the testing
Pharmacopoeia (USP). These styles meet all the acceptable
indicate biocompatibility—even after sterilization.
performance criteria.

Table VI. Sample toxicological results for DuPont Tyvek 1073B, Tyvek 1059B and Tyvek 2FS
™ ® ® ® ™

Ethylene Oxide Gamma Irradiation Electron-beam

Test Performed Unexposed STERRAD ®

(EO) (25 kGy & 50 kGy) (25 kGy & 50 kGy)

Determination of Extractives
Below maximum allowable percentage
from Olefin Polymers1

Hemolysis-Rabbit Blood-ISO2,3 Non-hemolytic

L929 MEM Elution Test-USP4 Non-cytotoxic

4
ISO-Rabbit Pyrogen Test
Non-pyrogenic
(Material Mediated)2,5
Kligman Maximization Test-ISO
Non-allergenic
(CSO and NaCl extracts)2,6

Systemic Injection Test-ISO2,5 No biological reaction

Primary Skin Irritation Test-ISO6 Non-irritant

Short Term Intramuscular

Non-irritant
Implantation Test-ISO (14 and 28 days)7,8

USP Class VI Test9 0% sensitization

Tests were based on the following references:

1. 21 CFR 177. 1520, Olefin Polymers, Federal Register, Title 21, Chapter 1, 1997.
2. Biological Evaluation of Medical Devices-Part 12: Sample Preparation and Reference Materials, EN/ISO 10993-12, 1997.
3. Biological Evaluation of Medical Devices-Part 4: Selection of Tests for Interactions with Blood, ISO 10993-4, 1992.
4. United States Pharmacopoeia 25, National Formulary 20, 2002, <87> Biological Reactivity Tests, In Vitro.
5. Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity, EN/ISO 10993-1995.
6. Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Sensitization, EN/ISO 10993-10, 1996.
7. Biological Evaluation of Medical Devices-Part 6: Tests for Local Effects After Implantation, ISO 10993-6, 1995.
8. ASTM Section 13, Volume 13.01 Medical Devices, Designation: F 981-93, 1994.
9. United States Pharmacopoeia 25, National Formulary 20, 2002, <88> Biological Reactivity Tests, In Vivo.

Section 4  Compatibility with sterilization methods  20

 PERFORMANCE OF DUPONT TYVEK AFTER AGING ™ ®

DuPont™ Tyvek® inherently resists penetration by The results of this study showed that Tyvek® is a remarkably
microorganisms better than other porous packaging reliable microbial barrier. Tyvek® can maintain sterility for at
materials because of its unique structure. Tyvek® is a sheet least five years, providing package integrity is maintained.
structure formed from continuous strands of very fine,
interconnected filaments of high-density polyethylene Summary of the five-year shelf-life test protocol
(HDPE).
These filaments are randomly oriented and bonded together 1. Contents of packages tested for initial sterility
by heat and pressure. This structure also imparts other
Open petri dishes were sealed in special packages, 4.25 in.
important properties for medical packaging, including:
✕ 6.75 in. (10.8 cm ✕ 17.1 cm), designed to simulate actual
strength; resistance to penetration by water; low linting;
disposable medical devices sealed in packages. The package
puncture resistance; and air permeability.
and contents were then sterilized using ethylene oxide (EO).
Tyvek® can provide long-term sterility maintenance of Each package consisted of a lid of Tyvek® sealed to poly-
sterilized and packaged medical devices. The effectiveness PET film.
of Tyvek® in keeping medical devices sterile during storage
To ensure that the petri dish was sterile prior to long-term
has been conclusively demonstrated both by aging studies
shelf storage, samples were randomly tested following the
and by all of the medical devices in the market with
United States Pharmacopoeia (USP) methods for both
five-year—or longer—expiry dates.
anaerobic and aerobic bacteria. An anaerobic chamber
Test methods used to evaluate the microbial barrier was used to test for anaerobic microbial contamination.
properties of Tyvek® include ASTM F2638, ASTM The petri dish was removed from the opened package and
F1608, DuPont Bacterial Test Chamber and others. placed in a sterile bag containing either fluid thioglycolate
Results from both material-based and whole-package culture medium or soybean casein digest broth. This tested
the sterility of the packaged “device” before the multi-year
5
shelf-life studies show:
• Tyvek® holds out bacterial spores, even under the most shelf-life study was started.
rigorous conditions. 2. Stored packages heavily dosed with bacterial spores
• Bacteriological studies clearly prove the outstanding
Packages containing sterile petri dishes were stored on
efficacy of Tyvek® as a bacterial barrier, even after
shelves in cabinets protected from outside contamination
repeated challenges.
and stored under controlled temperature and relative
• Tyvek® maintains sterility even after five years of exposure
humidity. Every four months throughout the entire five
to environments contaminated with microorganisms. years of testing, each package was sprayed with a uniform,
The first DuPont shelf-life studies of Tyvek® were initiated massive dose of Bacillus circulans spores. Actual counts
in 1972 and demonstrated that Tyvek® resisted spore indicated 4,000 to 5,000 spores on each package.
penetration for at least one year under normal conditions. 3. Package sterility checked periodically
To extend that investigation, DuPont initiated a long-term To check sterility, 10 packages were withdrawn randomly
shelf-life study of Tyvek® 1073B and Tyvek® 1059B in 1978. from the storage shelves every six months and the outside
The study was conducted at the DuPont Haskell Laboratory surface of the poly-Mylar® was disinfected. A small hole
for Toxicology. The objective of this program was to see was then made through the poly-Mylar® film and the petri
how well these styles of Tyvek® would resist penetration by dish with a hot, pencil-tip soldering iron. Then, 15 mL of
airborne bacterial spores. This test was designed to have a sterile nutrient agar were injected into the petri dish and
more severe microbial challenge than typical real-world the entry hole was covered with biocidal tape. If any spores
conditions. The samples were challenged repeatedly with had penetrated the lid of Tyvek®, they would have grown
high bio-contamination levels (at ambient temperature on the culture medium after incubation. No spores were
and pressure) for months and years at a time. detected on any samples during the study.

Section 5  Performance of DuPont Tyvek after aging  21

™ ®
 PERFORMANCE OF DUPONT TYVEK AFTER AGING ™ ®

4. Tyvek is inspected for possible bacteria growth

®
Physical properties after aging

The final part of the test procedure determined that the Tyvek® retains its physical properties over time, allowing
packages were indeed challenged with the bacterial spores a package to maintain integrity. The data shown in Tables
on the outside of the lid of DuPont™ Tyvek®. A small VII through XII are for uncoated samples of Tyvek®. It is
swatch of Tyvek® from the package lid was cut out and important to note that any downstream operations, such
placed on an agar medium. After evidence of bacteria as coatings applied by sterile packaging manufacturers
growth, the swatches were examined under a microscope (SPMs), may affect the properties.
and colonies of B. circulans were counted. This acted as a
Table VII shows the physical properties before and after
check for the number of viable spores that were actually
five-year real-time aging of Tyvek® 1073B and Tyvek®
on the surface of Tyvek®. It also ensured that the density of
1059B sterilized by ethylene oxide (EO). Tyvek® 1073B
spores was consistently maintained over the many years of
is the reference product providing the highest level of
the test.
protection for all demanding applications and Tyvek®
1059B is the product providing robust protection for
medium-risk applications.

Table VII. Physical properties of DuPont Tyvek sterilized by ethylene oxide (EO) before and after five-year real-time aging
™ ®

5
DuPont Tyvek 1073B
™ ®
DuPont Tyvek 1059B
™ ®

Property Test Method Units Initial After 5 Years Initial After 5 Years

lbƒ/in. 0.47 0.44 0.45 0.49

Delamination ASTM D2724
(N/2.54 cm) (2) (2) (2) (2)

TAPPI T460 
Gurley Hill Porosity sec/100 cc  37 37 30  28 
ISO 5636-5

Log Reduction
Microbial Barrier Internal DuPont 5.21 unchanged 4.71 unchanged
Value (LRV)

AATCC TM 127 in. H2O 59+ 59+ 59+ 59+

Hydrostatic Head
EN 208112 (cm H2O) (150+) (150+) (150+) (150+)

ASTM D50353 lbƒ/in. 44.0 45.1 36.7 35.9

Tensile Strength, MD
EN ISO 1924-23 (N/2.54 cm) (196) (201) (163) (160)

4 lbƒ/in. 1.53 1.57 1.33 1.44

Seal Strength
(N/2.54 cm) (7) (7) (6) (6)

1. Typical values. ASTM F1608 Standard did not exist so barrier was tested by internal DuPont method similar to the current Standard.
Property remained unchanged after five years.
2. Rate of use: 60 cm H2O/min.
3. Modified for speed and gauge length.
4. Sealing conditions: temperature—290°F (143°C); dwell time—1 second; pressure (seal through the film)—90 psi (621 kPa).

Section 5  Performance of DuPont Tyvek after aging  22

™ ®
 PERFORMANCE OF DUPONT TYVEK AFTER AGING ™ ®

Accelerated aging test protocol After the accelerated aging, the samples were stored
for five years at ambient temperature and humidity.
Samples of DuPont™ Tyvek® 1073B and Tyvek® 1059B
These conditions were chosen before the publication
were aged using the accelerated conditions listed below.
of ASTM F1980-07. The results of these tests are
Samples were rotated through the following cycle six times,
shown in Table VIII.
which is equivalent to six years of aging.
• Two weeks at 130°F (54°C) with a relative humidity

equal to 17%
• Two days at -4°F (-20°C)

• Two weeks at 130°F (54°C) with a relative humidity

between 70% and 80%

Table VIII. Accelerated aging test results for DuPont Tyvek 1073B and Tyvek 1059B
™ ® ®

DuPont Tyvek 1073B

™ ®
DuPont Tyvek 1059B
™ ®

After After
Property Test Method Units Initial 6 Cycles 5 Years Initial 6 Cycles 5 Years

ASTM D50351 lbƒ/in. 42 42 40 37 39 39

Tensile Strength, MD
EN ISO 1924-21 (N/2.54 cm) (187) (187) (178) (165) (174) (174)

1. Modified for speed and gauge length.

5
Tyvek® 2FS™, a product that provides excellent protection to industry norms at that time. In this study, samples of
for form-fill-seal and less-demanding applications, was Tyvek® 2FS™ were aged for 36.5 weeks at 138°F (55°C)
introduced after the accelerated aging tests were conducted and 75% relative humidity. The results of this test are
on Tyvek® 1073B and Tyvek® 1059B. The accelerated shown in Table IX.
aging test conducted on Tyvek® 2FS™ was done according

Table IX. Accelerated aging test results for DuPont Tyvek 2FS
™ ® ™

DuPont Tyvek 2FS

™ ® ™

Property Test Method Units Initial After 36.5 Weeks

ASTM D50351 lbƒ/in. 30.8 30.8

Tensile Strength, MD
EN ISO 1924-21 (N/2.54 cm) (137) (137)

ASTM D50351
Elongation, MD % 17 17
EN ISO 1924-21

Microbial Barrier ASTM F1608 Log Reduction Value (LRV) 3.1 unchanged

1. Modified for speed and gauge length.

Section 5  Performance of DuPont Tyvek after aging  23

™ ®
 PERFORMANCE OF DUPONT TYVEK AFTER AGING ™ ®

Real-time aging test protocol Original properties prior to sterilization are shown to
demonstrate the radiation stability of Tyvek®. Polymers
Samples of DuPont™ Tyvek® 1073B and Tyvek® 1059B were
that are not radiation stable are subject to chain scission
sterilized using gamma and electron-beam and then aged
reactions, which greatly reduce physical properties.
at room temperature for seven years. Both tensile strength
and microbial barrier were tested before and after aging.

Table X. Real-time aging test results for DuPont Tyvek 1073B and Tyvek 1059B (metric units)
™ ® ®

Tensile Strength1, N/2.54 cm

Microbial Barrier, LRV2
MD CD
Gamma Radiation 50 kGy*
Tyvek 1073B
®

Original3 187 213 5.24

Initial 147 175 —
After 7 years 142 148 5.2
Tyvek 1059B
®

Original3 163 178 4.74

Initial 122 138 —
After 7 years 118 127 4.1
Gamma Radiation 100 kGy*
Tyvek 1073B
®

Original3 187 213 5.24

After 7 years
Tyvek 1059B
®
103 130 5.1
5
Original3 163 178 4.74
After 7 years 85 99 4.2
Electron-beam Radiation 50 kGy*
Tyvek 1073B
®

Original3 187 213 5.24

Initial 164 157 —
After 7 years 159 145 5.2
Tyvek 1059B
®

Original3 163 178 4.74

Initial 143 145 —
After 7 years 135 124 4.9
Electron-beam Radiation 100 kGy*
Tyvek 1073B
®

Original3 187 213 5.24

Initial 120 120 —
After 7 years 96 113 5.2
Tyvek 1059B
®

Original3 163 178 4.74

Initial 106 121 —
After 7 years 94 93 4.3
*50 kGy was a single dose; 100 kGy was a cumulative amount, representing a double dose of 50 kGy.
1. ASTM D5035 and EN ISO 1924-2; modified for speed and gauge length.
2. Log Reduction Value (LRV) as tested per ASTM F1608. Note that ASTM F1608 Standard did not exist when the test was initiated,
so barrier for the original value was tested by an internal DuPont method similar to the current Standard.
3. Prior to sterilization.
4. Typical values. ASTM F1608 was not available in 1990 when the test was initiated.

Section 5  Performance of DuPont Tyvek after aging  24

™ ®
 PERFORMANCE OF DUPONT TYVEK AFTER AGING ™ ®

Table XI. Real-time aging test results for DuPont Tyvek 1073B and Tyvek 1059B (English units)
™ ® ®

Tensile Strength1, lbƒ/in.

Microbial Barrier, LRV2
MD CD
Gamma Radiation 50 kGy*
Tyvek 1073B
®

Original3 42 48 5.24
Initial 33 39 —
After 7 years 32 33 5.2
Tyvek 1059B
®

Original3 37 40 4.74
Initial 28 31 —
After 7 years 27 29 4.1
Gamma Radiation 100 kGy*
Tyvek 1073B
®

Original3 42 48 5.24
After 7 years 23 29 5.1
Tyvek 1059B
®

Original3 37 40 4.74
After 7 years 19 22 4.2
Electron-beam Radiation 50 kGy*
Tyvek 1073B
®

Original3 42 48 5.24
Initial 37 35 —
After 7 years
Tyvek 1059B
®
36 33 5.2
5
Original3 37 40 4.74
Initial 32 33 —
After 7 years 30 28 4.9
Electron-beam Radiation 100 kGy*
Tyvek 1073B
®

Original3 42 48 5.24
Initial 27 27 —
After 7 years 22 25 5.2
Tyvek 1059B
®

Original3 37 40 4.74
Initial 24 27 —
After 7 years 21 21 4.3
*50 kGy was a single dose; 100 kGy was a cumulative amount, representing a double dose of 50 kGy.
1. ASTM D5035 and EN ISO 1924-2; modified for speed and gauge length.
2. Log Reduction Value (LRV) as tested per ASTM F1608. Note that ASTM F1608 Standard did not exist when the test was initiated,
so barrier for the original value was tested by an internal DuPont method similar to the current Standard.
3. Prior to sterilization.
4. Typical values. ASTM F1608 was not available in 1990 when the test was initiated.

Section 5  Performance of DuPont Tyvek after aging  25

™ ®
 PERFORMANCE OF DUPONT TYVEK AFTER AGING ™ ®

Accelerated and real-time aging test gamma irradiated (30 kGy) and then stored at 131°F
after gamma sterilization (55°C) and ambient relative humidity for a period of
10 weeks, followed by storage at ambient conditions for
The effect of gamma sterilization and aging on seal strength
five years and then assessed for seal strength according
is negligible (Table XII). Pouches of DuPont™ Tyvek®
to ASTM F88.
1073B and 2.5-mil polyester/polyethylene were

Table XII. Seal strength of DuPont Tyvek 1073B after gamma sterilization following accelerated and real-time aging
™ ®

Seal Strength, lbƒ/in. (N/2.54 cm)

Original 0.915 (4.07)

Sterilized with 30 kGy Gamma 0.949 (4.22)

Accelerated Aging   2 weeks 0.931 (4.14)

  4 weeks 0.856 (3.85)
  6 weeks 0.953 (4.24)
  8 weeks 0.887 (3.95)
10 weeks 0.848 (3.77)

Real-Time Aging 3 years   0.778 (3.46)

Section 5  Performance of DuPont Tyvek after aging  26

™ ®
 GUIDELINES FOR PRINTING ON DUPONT TYVEK ™ ®

Styles of DuPont™ Tyvek® for medical and pharmaceutical Printing plates for flexography
packaging can be printed using standard commercial
Selecting the appropriate type of printing plate is
printing equipment and suitable inks. Because of the unique
dependent upon the nature of the printing job. General
requirements for medical and pharmaceutical packaging,
printing best practices should be followed to optimize the
these styles have no antistatic coating and are not corona
conditions of the pressroom for ultimate performance.
treated. Therefore, special steps must be taken to obtain
Printing variables include the plate, cushion, ink and anilox.
optimum printing results. When printing on Tyvek® medical
As always, it is best to clean the printing plate with 100%
and pharmaceutical packaging styles, we recommend
alcohol prior to inking to enhance ink transfer.
testing before proceeding with production operations.
For printing solids, type and other fine detail-oriented
For additional information about printing on Tyvek®,
images, it is best to use a medium durometer plate.
refer to the DuPont™ Tyvek® Users Manual at
This should be complemented with a medium or firm
[Link].
density cushion. Anilox selection should be based on a
line screen and volume that does not over-ink the plate.
Flexographic printing guidelines
Please seek ink manufacturer’s guidelines for viscosity,
Flexography is the recommended technique for printing pH and other transfer properties that are dependent on
on Tyvek® medical and pharmaceutical packaging styles. your ink application and resistance properties.
For best results, use the smooth side of the sheet. The • Digital Solvent—use DuPont™ Cyrel® DSP or Cyrel® DPL

difference between the rough (“wire”) side and the smooth • Digital FAST—use Cyrel® DFP or Cyrel® DFM
side is minor, but can usually be felt. Rolls supplied directly • Analog—use Cyrel® NOWS or Cyrel® EXL
from DuPont are wound smooth side out. Rolls supplied
from a sterile packaging manufacturer (SPM) may be For images that include fine line screens with dots,
wound differently. Be sure to check with your SPM it is best to use a harder durometer plate. This should
or supplier to determine how your rolls are wound. be complemented with a soft or medium density cushion.
Anilox selection should be based on a line screen
With Tyvek® 2FS™, it is more difficult to feel the difference
volume that does not over-ink the plate. Please see
between the two sides. To help you determine the rough
from the smooth side, a simple six-step procedure has been
manufacturer’s guidelines for viscosity, pH and other
transfer properties that are dependent on your ink
6
developed. For details, refer to Section 7, “Processing/
application and resistance properties.
Troubleshooting Guidelines.” Other important
• Digital Solvent—use DuPont™ Cyrel® DSP or Cyrel® DPR
recommendations are listed here.
• Digital FAST—use Cyrel® DFP or Cyrel® DFR

Press conditions for flexography • Analog—use Cyrel® NOWS or Cyrel® EXL

Ensuring optimum press conditions will help prevent

Inks for flexography
sheet distortion, registration problems in multi-color
work, softening of adhesives and ink pick-off. It is important to not only choose the proper ink for
• Tensions—Keep tensions below 0.75 lb/in. the process, but to verify the suitability of the ink in
(1.3 N/cm) of width. applications where direct contact with the medical
• Temperatures—Maintain web temperatures below device is likely.
• Alcohol-based polyamide inks—These solvent-based inks
175°F (79°C).
• Chilled rolls—Use chilled rolls before windup. typically provide the best adhesion and rub resistance.
Adding microcystalline wax will reduce the offsetting.
• Water-based inks—These inks make it possible to

achieve high-quality results while complying with

environmental regulations.

Section 6  Guidelines for printing on DuPont Tyvek   27

™ ®
 GUIDELINES FOR PRINTING ON DUPONT TYVEK ™ ®

Lithographic printing guidelines Inks for lithography

Although flexography is the recommended method for It is important to not only choose the proper ink for
printing on DuPont™ Tyvek® medical and pharmaceutical the process, but to verify the suitability of the ink in
packaging styles, offset lithography can produce acceptable applications where direct contact with the medical
print quality. For best results, use the smooth side of the device is likely. In addition, follow these specific
sheet. Although either side prints well, the smooth side is recommendations for printing on Tyvek® medical
preferred because it makes sheet feeding slightly easier. and pharmaceutical packaging styles.
The difference between the rough (“wire”) side and • Low-solvent-content inks—Use inks with <3% volatile

the smooth side is minor, but can usually be felt. solvent because hydrocarbon solvents found in many
Rolls supplied directly from DuPont are wound litho inks tend to swell and distort Tyvek®. These inks
smooth side out. Rolls supplied from a sterile packaging also release fewer volatile organic compounds (VOCs)
manufacturer (SPM) may be wound differently. Be sure compared to traditional offset inks, reducing the
to check with your SPM or supplier to determine how environmental impact.
• Extra-strong colors—Use extra-strong colors to keep ink
your rolls are wound.
film thickness to a minimum (<0.3 mil [0.008 mm]).
With Tyvek® 2FS™, it is more difficult to feel the This will help minimize sheet distortion and dot gain.
difference between the two sides. To help you • Tint creation—Use opaque white rather than an
determine the rough from the smooth side, a simple
extender when creating tints to minimize the
procedure has been developed. For details, refer to
appearance of fiber swirl.
Section 7, “Processing/Troubleshooting Guidelines.”
• Fountain solution—Maintain fountain solution at
Other important recommendations are listed here.
a minimum level. Either conventional water or alcohol/
water dampening systems can be used. Alcohol substitutes
Offset blankets for lithography
also work well. Do not increase the ink volume if your
Selecting the appropriate type of blanket to use will images appear dull or washed out. Instead, reduce the
depend on whether or not the Tyvek® is coated.
6
amount of dampening solution in the fountain.
• For adhesive-coated Tyvek®—Use conventional offset • Drying—Litho inks dry more slowly on Tyvek® than

blankets of medium hardness. they do on paper, so be sure that pile height does
• For uncoated Tyvek®—Use compressible offset blankets. not exceed 20 in. (0.5 m). Winding the sheets and
maintaining the fountain solution at a pH between
Squeeze recommendation for lithography 4 and 5 can accelerate drying.

Applying an additional 3 mil to 4 mil (0.08 mm to A list of ink manufacturers familiar with the unique
0.10 mm) of squeeze between the blanket and back requirements of printing on Tyvek® medical and
cylinder is required compared to that used for paper of pharmaceutical packaging styles can be obtained
equivalent average thickness. This additional impression, by contacting your regional DuPont representative.
coupled with the compressibility of Tyvek®, compensates
for possible thickness variations of Tyvek®. Special notes for adhesive-coated Tyvek ®

When selecting offset inks, it is important to advise the

ink supplier if the Tyvek® has an adhesive coating because
special ink formulations may be required to prevent ink
set-off to the coated surface. In some cases, printing is done
on the adhesive side. This also should be discussed with
the ink supplier to ensure optimum compatibility between
the ink and the coating.

Section 6  Guidelines for printing on DuPont Tyvek   28

™ ®
 GUIDELINES FOR PRINTING ON DUPONT TYVEK ™ ®

Variable information printing Ink jet printing

The need to print variable information on packages has Tyvek® medical and pharmaceutical packaging styles
resulted in an increased use of electronically controlled have been printed successfully using continuous and
printing processes. These electronic devices can output drop-on-demand ink jet printers. However, because Tyvek®
variable information such as: lot, production date, is made of high-density polyethylene (HDPE) and does
sequential numbering, product codes and bar codes. not absorb moisture, solvent-based inks must be used.
DuPont™ Tyvek® medical and pharmaceutical packaging Most water-based inks are slower drying and tend to
styles are compatible with some of these processes. feather on Tyvek®, resulting in a blurry image. Acceptable
results have also been achieved with ultraviolet (UV)
Thermal transfer printing and change-of-phase inks, which cure almost instantly.
Typically, 200- to 300-dpi print heads are used.
The most common process for printing variable
information is thermal transfer. This process uses heated
Laser (electrostatic) printing
pins to activate a pigmented wax, resin or wax/resin blend
that is carried on a ribbon. The image is created when the Conventional laser printing is not recommended for
molten ink transfers to the substrate. Tyvek® because the high temperatures used to set the toner
distort the Tyvek® during normal printing and will melt
Wax ribbons give the best results for Tyvek® medical and
the Tyvek® if a jam occurs. Cool-process (flash-fusion) laser
pharmaceutical packaging styles (which are not corona
printers are compatible with Tyvek®; however, the toner
treated). The image durability is marginal. If more
transfer efficiency is marginal and the printed image is not
durability is required, a wax/resin blend ribbon should
as sharp as it is with thermal transfer or ink jet printers.
be used. A 90/10 wax/resin blend ribbon yields good
results. This blend ribbon may need to be custom
manufactured because many ribbon manufacturers
only stock 50/50 blend ribbons.
Excellent results in printing alpha-numeric information
have been achieved using 300- to 600-dpi printers. 6
Because of the inherent thickness variability of Tyvek®,
thermal transfer printing on Tyvek® tends to produce
D-C ANSI bar code quality. If a high-density bar code is
needed, or a higher-quality bar-code rating is specified,
a label should be used.

Section 6  Guidelines for printing on DuPont Tyvek   29

™ ®
 PROCESSING/TROUBLESHOOTING GUIDELINES

Heat sealing guidelines Depending on the activation temperature of the sealant,

raising the temperature and lowering the dwell time or
The resultant material bond and seal strength of a heat seal
lowering the temperature and raising the dwell time could
packaging process depends on several factors, including:
produce more consistent seals without transparentizing the
sealing dwell time, sealing temperature, sealing pressure,
DuPont™ Tyvek®. Temperatures must be high enough to
characteristics of the sealant and even the test method used
activate the sealant layer, while not overheating the surface
to measure the seal strength. Seals must be strong enough
of the material and inducing extreme transparentization.
to withstand the rigors of shipping and handling, yet at
the same time facilitate easy access for the end-user to open It is recommended to optimize the heat sealing process
the sterile package using aseptic presentation techniques. using tools such as Design of Experiments. This not only
Optimizing the heat sealing process and consistently results in a heat sealing process that consistently produces
producing packages with the appropriate seal strength acceptable seals, but also can optimize energy output and
is of critical importance because it can have a direct operational throughput and efficiencies.
impact on product efficacy and patient safety. Sealing pressure
Sealing dwell time The third key factor of heat sealing is the pressure at
Sealing dwell time refers to the time the heating which the equipment brings together and holds the two
elements of a packaging process (clamps, plates, bars, materials together to form the seal. It is important to know
etc.) are in direct contact with the substrate(s). It can be the actual pressure the substrates are exposed to because
either one-sided or two-sided heating. The two materials this value is often not equivalent to the input pressure
come together to form a bond or seal. It is important to or the setpoint on the machine controls. There are many
understand how the equipment measures the dwell time techniques to measure sealing pressure—from sensor paper
to determine “true dwell time,” which is when the webs to more sophisticated electronic sensor technologies. For
are actually pressed together. That’s because controls for most heat seal materials, pressure is the least significant
heat sealing equipment vary and cycle time may or may of the three factors required to make a heat seal.
not include travel time for the machine to engage into its Other factors
final closed position. Any variation in the rates of materials
reaching their seal initiation temperature, even by fractions The three main factors for heat sealing—dwell time,
of a second, can have a measureable effect on seal strength. temperature and pressure—can produce significant
variability in seal strength. However, there are other
Sealing temperature factors related to time, temperature and pressure that
The heat sealing process, as previously described, marries
two materials and creates a bond. To achieve this bond,
can also affect heat seals. Some common factors include:
• Variation in platen temperature—“hot spots”
7
one of the materials typically carries a surface sealant layer. or “cold spots”
The heating elements of heat seal packaging equipment • Non-uniform heat transfer due to uneven contact or

are raised to a temperature high enough to either melt or pressure caused by a warped or misaligned platen
activate the sealant. • Material thickness or variation

The primary heat seal factors of time, temperature and To produce uniform seal strengths resulting in clean,
pressure are interactive. A change or tweak in one typically peelable seals that are strong enough to withstand the rigors
requires a change or tweak in one or more of the other encountered during shipping, it is important to develop a
factors. A balance between time, temperature and pressure robust heat sealing process by optimizing the dwell time,
must be met to achieve the desired seal strength and visual temperature and pressure for specific material combinations.
seal transfer.

Section 7  Processing/troubleshooting guidelines  30

 PROCESSING/TROUBLESHOOTING GUIDELINES

Avoiding fold problems The result will be the formation of a delaminated area
along the center line of the sheet of Tyvek®. This is
A sheet of DuPont™ Tyvek® is a monolayer material that
commonly seen when the flexible edge of the pouch seal
is heat treated or bonded on both sides. This treatment
is bent or folded to fit into a shelf carton. With the pouch
makes the exterior less flexible than the interior of the
film on the outside of the bend, all of the force to make the
structure and allows the monolayer material to perform
fold is converted to compression loads on the inner surface
more closely to a multilayer structure (Figure 12).
of the sheet of Tyvek®, which may lead to separation within
the interior of the sheet, commonly referred to as sheet
separation (Figure 14). However, it has been demonstrated
that this phenomenon does not compromise the integrity
of the package.

Figure 12. Pictorial representation of

DuPont Tyvek during package opening.
™ ®

Tyvek , a monolayer material, acts like a multilayer material

®

Figure 14. Micrograph of folded DuPont Tyvek

™ ®

represented by the green/yellow/green layers. showing sheet separation, a phenomenon that

does not compromise the integrity of the package.
When any sheet structure is bent, the outer surface is
placed in tension while the inner surface is placed in Specifically, samples were designed that would allow
compression. The tighter the bend, the greater these a microbial aerosol challenge to be applied to both the
forces become. If these loads become excessive, the sheet of Tyvek® and the seal section containing the
filament structure holding the two layers together delaminated area. The samples were placed in the
will succumb to the forces and the inner surface will apparatus used in the ASTM F1608 and ASTM F2638
buckle inward (Figure 13). microbial barrier tests. No reduction in Log Reduction
Values (LRV) for ASTM F1608 or percent penetration
7
rates for ASTM F2638 was observed.
Sheet separation is typically encountered during the
qualification phase of package testing. During underwater
bubble leak testing (ASTM F2096:2002) a pouch with
sheet separation will produce a stream of air bubbles that
appear to be a channel in the seal. This result requires
additional lab testing to determine if there is truly a
Figure 13. Pictorial representation of channel in the seal or if sheet separation has produced
DuPont Tyvek during opening at an extreme angle.
™ ®
a false positive.
An extreme fold or bend puts the exterior surface in tension
and the interior surface in compression, causing the interior
of the sheet to buckle.

Section 7  Processing/troubleshooting guidelines  31

 PROCESSING/TROUBLESHOOTING GUIDELINES

A dye penetration test (ASTM F1929:2003) is used to

differentiate a channel (Figure 15) from sheet separation.
Lab technicians must follow the ASTM protocol when
performing the test to ensure “wicking” is not produced.
If dye is left too long in the pouch made with DuPont™
Tyvek®, the dye begins to wick through the material
(Figure 16).
Another way to confirm sheet separation vs. a channel is to
reserve the pouches after dye testing, wait until the residual
dye has dried and then peel the pouch open to reveal either
dye in the sealed area, indicating a channel in the seal, or Figure 16. Wicking occurs when dye is left too long
no dye, indicating sheet separation. in the pouch during ASTM F1929:2003 testing.

The best way to avoid sheet separation issues and false

positives is to avoid folding pouches. However, if the
package fold is necessary, opt for a gentle curl instead
of a true fold.
For more information, read “Porous Sterile Barrier
Integrity Testing: Failure Anomalies,” an article that was
published in the January 2006 issue of MD&DI magazine.
This article can be found in the magazine’s online archives
at [Link].

Figure 15. Channel in seal determined during

dye penetration testing (ASTM F1929:2003).

Section 7  Processing/troubleshooting guidelines  32

 PROCESSING/TROUBLESHOOTING GUIDELINES

Determining the rough vs. smooth side of fiber tear/delamination. Typically, rolls of Tyvek® 2FS™
DuPont Tyvek 2FS
™ ® ™
are wound smooth side out when they are shipped.
However, the following steps can be used to verify
When sealing to Tyvek® 2FS™, it is important to always seal
which way the roll is wound.
to the rough side. Sealing to the smooth side will result in

1 4

F old back the edge of the Tyvek® approximately 6 in. (15 cm) Using a felt tip pen or marker, draw a line on one side of the
and crease flat. NOTE: If the roll is wound correctly with the tape, extending the line onto the Tyvek® for easy identification.
smooth side out, the folded area will be the rough side.

2 5

 ut a strip of 1 in. (2.5 cm) wide ARclad® AR-516 tape approximately

C Peel off the strip of tape.
8 in. (20 cm) long. Place it on the “seam” so that approximately

7
1⁄2 in. (1 cm) is on the smooth side and 1⁄2 in. (1 cm) is on the

rough side.

Rough side

Smooth side
3 6

Smooth the tape down by running your finger along the “seam” Look at the adhesive side of the tape and note which half
one or two times. Use moderate pressure. shows evidence of fiber tear. This will be the smooth side.
NOTE: If you have any doubt, take the existing flap and fold it
back on itself approximately 2 in. (5 cm) to create a new “seam.”
Then, repeat steps 2 through 6.

Section 7  Processing/troubleshooting guidelines  33

 PROCESSING/TROUBLESHOOTING GUIDELINES

Fiber tear the bonded Tyvek® surface, could cause fiber tear and/or
delamination during peeling.
Fiber tear results from a delamination of the sheet of
DuPont™ Tyvek®, which is caused by a sharp bend of Tyvek® When forming multiple pouches across the web, tooling
as it is being peeled from the film web. (See “Avoiding should be designed so that an unsealed area of at least
Fold Problems” on page 31 for a description of how this 1 mm resides between adjacent pouches. Singularizing
delamination occurs). To eliminate fiber tear, the first pouches across the web should be performed in unsealed
option is to reduce the seal strength. If this does not areas between pouches. Any edge trim removed from
produce the desired result, you can consider either of outside pouches on the web after sealing should be cut
the following possible solutions: off in an unsealed area.
• Use a more flexible film that will not force Tyvek®

to bend as much when the seal is opened. —OR— Sealing lids to trays
• Use a heavier basis weight of Tyvek® that has a greater
Several factors cause or greatly increase the occurrence
bend radius and a lower tendency to delaminate. of fiber tear when opening lids sealed to either rigid or
flexible thermoformed trays. Eliminating these factors
Cutting and slitting Tyvek ®
can greatly reduce the probability of fiber tear and allow
Blades, cutting wheels and dies need to be maintained for a clean peel opening.
so they are sharp and free of nicks and other imperfections Figure 17 demonstrates various lid placements on a tray and
that could cause rough, irregular cuts. Irregular edge cuts the predicted result after peeling. A leading cause of fiber
could enable films or foils to adhere to filaments from tear is improper lid placement and/or improper lid size.
the center region of the Tyvek® sheet during heat sealing.
This attachment to individual filaments, as opposed to Lids should not be sealed all the way to the edge of
the bonded Tyvek® surface, could cause fiber tear and/or the tray. This could allow adhesive to flow around the
delamination during peeling. edge of the bonded Tyvek® surface and attach to individual
filaments. This attachment to individual filaments, as
Forming pouches
opposed to the bonded Tyvek® surface, could cause fiber
tear and/or delamination during peeling.
Tyvek® should not be sealed all the way to its edge because
this could allow adhesive to flow around the edge of the Additionally, if the edge of the lid has a microscopic nick
bonded Tyvek® surface and attach to individual filaments. or rough cut edge, this can act as an initiation point for
a tear when the lid is peeled.
This attachment to individual filaments, as opposed to
7
 Blue = Tray  White = Lid

Unlikely Fiber Tear Possible Fiber Tear Severe Fiber Tear

Figure 17. Prediction of fiber tear based on lid alignment on tray.

Section 7  Processing/troubleshooting guidelines  34

 PROCESSING/TROUBLESHOOTING GUIDELINES

Tooling should be designed so that an unsealed area of thermoformed tray, the lid overhangs the outer tray edge
at least 1 mm resides between adjacent trays, also known by at least 1 mm.
as a “skirt” (Figure 18), or in the case of an individual

 Forming  Sealing Filling Unsealed gap avoids the risk of delamination

Figure 18. Multiple cavity thermoform with “skirt” seal or gap between sealed areas.

Section 7  Processing/troubleshooting guidelines  35

 PROCESSING/TROUBLESHOOTING GUIDELINES

In an experiment conducted by DuPont, lid placement and the tray. A proper adhesive break leaves the heat seal
was a strong predictor of whether or not the lid would coating on the tray (white witness mark) and allows the lid
experience fiber tear during opening (Figures 19 and 20). to peel cleanly away from the tray. An oversized lid allows
The physics of peeling open a lid from a tray requires an for clean initiation of the peel.
adhesive break of the bond between the heat seal coating

Figure 19. DuPont sealing experiment to test the effect of lid placement on fiber tear.
Proper lid placement with minimum of 1-mm lid overhang all the way around the tray.
All 32 samples showed consistent seal area and no delamination during opening.

Figure 20. Results of improper lid placement during DuPont sealing experiment.
There was no overhang; lid length and width dimensions were equal to the tray seal area dimensions.
A total of 26 out of 32 samples experienced fiber tear ranging from minimal to extreme.

Section 7  Processing/troubleshooting guidelines  36

 METHODS FOR MEASURING PROPERTIES

DuPont uses test methods that are based upon recognized them to work with DuPont™ Tyvek®. Additionally,
industry methodologies (Table XIII). Many of the the use of internal methods based on those of
methods developed to measure properties of porous organizations such as ASTM and ISO allows for
packaging materials were developed for paper. As a result, the assessment of the impact on test results for any
DuPont has modified some of these methods to allow standardized test method modification.

Table XIII. Test methods used for measuring material properties

Comparable DuPont Footnote

Property
Test Method Test Method Number (Deviation from Standard)

ASTM D3776 Modified sample size.

Basis Weight 0010
EN ISO 536 Modified sample size.

TAPPI T460 Modified sample size.

Gurley Hill Porosity 0034
ISO 5636-5 Modified for sealing fluid characteristics.

Delamination ASTM D2724 0005 Modified for speed and gauge length.

TAPPI T425
Opacity 0020
ISO 2471 Modified for different backing standards, area and illumination.

ASTM D1777 7.15 psi, 0.625-in. diameter presser foot.

Thickness
EN 20534, 0027 Surface 2 cm2, pressure 14.5 psi (100 kPa).
(individual)
EN ISO 534

ASTM D5035 Modified for speed and gauge length.

Tensile Strength 0041
EN ISO 1924-2 Modified for speed and gauge length.

ASTM D1424
Elmendorf Tear 0007
EN 21974

AATCC TM 127
Hydrostatic Head 0056
EN 20811 Rate of use: 60 cm H2O/min.

ASTM D774
Mullen Burst 0014
ISO 2758

Bendtsen Air
ISO 5636-3 —
Permeability

ASTM D5035 Modified for speed and gauge length.

Elongation 0041
EN ISO 1924-2 Modified for speed and gauge length.

Spencer Puncture ASTM D3420 1268 Modified for 9⁄16 - in. (14.28-mm) probe.

A1

Appendix 1  Methods for measuring properties  37

 METHODS FOR MEASURING PROPERTIES

Basis weight elongation, which relates to how much energy the substrate
can absorb (i.e., resiliency); and the other is the initial slope
The measure of the weight per unit of area of the
of the stress-strain curve, which relates to how rapidly the
sheet. This is typically expressed in oz/yd2, g/m2, or
substrate elongates when initial forces are applied. This
lb/3,000 ft2 ream. For example, DuPont™ Tyvek®
property is referred to as the initial modulus of the material.
1073B has a basis weight of 2.20 oz/yd2, 74.6 g/m2
Both are important in medical packaging because the first
or 45.8 lb/ream. Reference standards: ASTM D3776
relates to the protective nature of the material and the
and EN ISO 536 (both modified sample size).
second relates to how a package distorts as pressures are
applied. In web-fed equipment, the initial modulus also
Coefficient of friction relates to how much the material resists loss of registration.
The measure of how slippery the surfaces of a substrate Elongation is measured by taking a 1-in. ✕ 8-in. (2.5-cm ✕
are relative to itself or to some other surface, typically 20-cm) strip of product, clamping it so that 5 in. to 6 in.
wood or metal. Tyvek® has a low coefficient of friction. (13 cm to 15 cm) are between the jaws of a tensile tester,
This means that sheets of Tyvek® slide easily over one and then applying force to the ends until the sample breaks.
another and on other surfaces. This is important when Reference standards: ASTM D5035 and EN ISO 1924-2
reams of cut sheets are moved because a sudden stop or (both modified for speed and gauge length).
turn can cause the stack to slide and the ream to collapse.
It is also critical when processing Tyvek® on a form-fill-seal Hydrostatic head
(FFS) machine. DuPont does not typically measure the
The measure of the pressure required to force three drops
coefficient of friction of Tyvek®. For spot checks, we have
of water through a substrate. It is converted to the height
used a slide angle instrument to measure the angle at which
of a column of water, which corresponds to the pressure.
a sample with a 1-lb (0.45-kg) weight will start sliding.
The units are typically inches (in.) or centimeters (cm).
For Tyvek®, this is approximately 18 to 20 degrees. Paper
This property is impacted by the substrate's affinity for
has a 30-degree slide angle.
water. For Tyvek® medical and pharmaceutical packaging
styles, the surface energy is 32 dynes/cm to 25 dynes/cm.
Delamination Reference standards: AATCC TM 127 and EN 20811
The measure of the internal bonding level of a given (rate of use: 60 cm H2O/min.).
substrate. It is the weakest point of any substrate, which
is almost exactly in the middle for Tyvek®. To perform the Microbial barrier
measurement, a split is initiated in a 1-in. (2.5-cm) wide
The measure of the ability of a porous substrate to prevent
sample. This split is the starting point to peel the layers
bacterial spore penetration. One standard test method,
apart. The average force to continue the peel is measured
ASTM F1608, measures the “filtration” efficiency of a
using a tensile tester. The results are given as lbƒ/in. or
substrate to remove spores from an aerosol being forced
N/2.54 cm. Tyvek® medical and pharmaceutical packaging
through the substrate in an air stream.
styles are among the most highly bonded styles of Tyvek®.
This property is very important for process control of A completely impermeable control sample (microbial A1
medical packaging. Reference standard: ASTM D2724 penetration is zero) is challenged with one million or
6 6
(modified for speed and gauge length). 10 colony forming units (cfu). The number of cfu 10
has a log10 value of 6. If a sample challenged in the same
Elongation way as the control allows 10 cfu (log10 10 = 1) to penetrate,
then its log reduction value (LVR) is 5 (6 – 1 = 5).
The measure of the extent a substrate will stretch before Therefore, the higher the LRV, the more resistant the
it breaks. The units are percentage (%) of sample length. packaging is to bacteria and microorganisms. Tyvek® 1073B
Thus, a 10-in. (25-cm) sample of a substrate that has has an LRV of 5.2 and is the best porous substrate available
20% elongation will stretch 2 in. (5 cm) before breaking. for medical packaging.
Two aspects of elongation are important: one is the total

Appendix 1  Methods for measuring properties  38

 METHODS FOR MEASURING PROPERTIES

There are two disadvantages associated with ASTM F1608. increase. This property indicates how a package may perform
The first is that the test method’s air flow rate significantly in environments where pressure changes take place and the
exceeds the air flow rate seen during typical distribution of package balloons or where a force is applied over a relatively
a medical device. The second disadvantage is that it takes a large area, such as when a heavy object is placed on top of a
long time to incubate the spores to get a count of how many lidded tray. Reference standards: ASTM D774 and ISO 2758.
spores penetrated the test material.
Opacity
ASTM F2638 eliminates both of these problems. It’s a
real-time test, eliminating the need to incubate spores. It The measure of how much light passes through a substrate.
functions by counting inert particles as they penetrate the It is a ratio of the reflected light through a sample with
barrier material. More importantly, the air flow rates are a white and a black background. If the reflected light is
close to those experienced during transportation, eliminating the same from both backgrounds, then the opacity is 100%.
the other disadvantage. This test method also varies the A white background without any sample reflects 100%
flow rate and thereby generates a penetration curve. On this of light. A black background has zero reflectance. Opacity
penetration curve, most substrates tested have a maximum. depends on the basis weight and bonding level of Tyvek®.
Therefore, it is possible to report a pMax, which is the Because Tyvek® medical and pharmaceutical packaging styles
maximum penetration for the given substrate. The flow rate are highly bonded, the opacity is relatively low. Opacifiers,
at which the maximum occurs depends on the mass, fiber such as TiO2 used in Tyvek® 2FS™, improve visual appearance
diameter and density of the substrate. and bar code readability. Reference standards: TAPPI T425
and ISO 2471 (modified for different backing standards,
Moisture vapor transmission rate (MVTR) area and illumination).
The measure of the rate at which moisture vapor is Porosity
transmitted through a sample. There are several different
manufacturers of MVTR equipment. It is important to note The measure of the ability of a substrate to permit flow
that MVTR results are highly dependent on the test method of air at a given pressure differential. Two methods are used:
used and the material type. Important variables between Gurley Hill porosity in the United States and Bendtsen air
test methods include: pressure gradient; volume of air space permeability in Europe and most of the rest of the world.
between liquid and sheet sample; temperature; air flow speed The Gurley Hill method measures the time to pass 100 cc
over the sample; and test procedure. Therefore, the results are of air through 1 in.2 (6.45 cm2) of sample at a pressure of
not comparable from one company to another, nor between approximately 5 in. (13 cm) of water. The Bendtsen method
different pieces of equipment. Reference standard: TAPPI measures the actual flow rate of air in mL/min through
T523 (test conditions: 73˚F [23˚C], 85% relative humidity). a 10 cm2 sample at a pressure differential of 1.5 kPa (6 in.
of water). Porosity is important for gas sterilization processes
Mullen burst to ensure that a sufficient amount of sterilant saturates the
package in a short time and that the subsequent flushing
The measure of the ability of a substrate to resist forces
applied uniformly throughout the substrate. It is measured
and aeration of any residuals of the sterilant are efficient.
Porosity also allows the packages to equilibrate rapidly A1
by clamping a sample in a ring stand and expanding a
from the pressure changes that occur in sterilization,
diaphragm under the sample until the sample ruptures in
shipping and storage environments. If any material in
the weakest spot. The pressure in the diaphragm (psi or kPa)
the device develops an odor after gamma radiation, the
is recorded. Because DuPont™ Tyvek® is isotropic (exhibits the
porous material allows the odor to vent so that none is
same value when measured along axes in all directions), it has
evident when the package is opened. Reference standards:
a very high Mullen burst for a low weight material. Mullen
Gurley Hill Porosity: TAPPI T460 (modified sample size)
burst is proportional to the basis weight of the material,
and ISO 5636-5 (modified for sealing fluid characteristics);
the bonding level, and to some extent, the elongation. The
Bendtsen Air Permeability: ISO 5636-3.
Mullen burst value increases as these three property values

Appendix 1  Methods for measuring properties  39

 METHODS FOR MEASURING PROPERTIES

Spencer puncture Thickness

The method for determining the impact resistance The measure of the distance between the upper and lower
of plastic films and packaging materials under conditions surfaces of a substrate. The units of measure are usually
that closely approximate the strain rate that these materials mils, μm or mm. Thickness is measured by placing the
are subject to in the healthcare industry. This property material on a hard, flat surface and then determining
indicates how a package will perform if an object falls the distance from the base by using a presser foot that
on the package or if an object in the package strikes the is parallel to the base and applied to the top surface of
lid. DuPont uses procedure B of ASTM D3420, modified the material. The presser foot is normally circular and
with a 9⁄16-in. (14.3-mm) diameter hemispheric-shaped the pressure applied to the foot depends on the material
probe tip with a 6,400-gram pendulum, which is measured. For Tyvek®, the pressure is 7.15 psi and the foot
necessary to puncture tough materials like DuPont™ diameter is 0.625 in. The measurement corresponds to
Tyvek®. Results using different test apparatus are the highest spot in the area covered by the presser foot.
not comparable. Reference standard: ASTM D3420 The larger the cross-sectional area of the presser foot, the
(modified for 9⁄16-in. [14.28-mm] probe). greater the chance to pick the highest spots on the sheet.
For this reason, the average thickness value measured for
Tear a sheet is lower as the area of the presser foot decreases.
The standard deviation for thickness is approximately
The measure of the ability of a substrate to resist tearing 1 mil (25 µm). Reference standards: ASTM D1777
when a highly localized force is applied. Elmendorf tear (modified to use 7.15 psi, 0.625-in. diameter presser foot,)
measures the energy required to propagate an initiated EN 20534 (modified to use surface 2 cm2, pressure 14.5 psi
tear for a unit distance. The units are lbƒ or Newtons. [100 kPa]) and EN ISO 534.
This property is important because nicks and cuts may
occur at the edge of a lid and could affect its clean peel.
The tear strength of Tyvek® is significantly higher than
that of medical-grade paper. Reference standards: ASTM
D1424 and EN 21974.

Tensile strength

The measure of the ability of a substrate to resist

loads in the plane of the sheet. The units are lbƒ/in.
or N/2.54 cm. Along with elongation, tensile determines
the ability of a material to absorb energy before failure.
Tensile is measured by taking a 1-in. ✕ 8-in. (2.5-cm ✕
20-cm) strip of product, clamping it so that 6 in.
(15 cm) are between the jaws of a tensile tester, and
then applying force to the ends until the sample breaks. A1
Reference standards: ASTM D5035 and EN ISO 1924-2
(both modified for speed and gauge length).

Appendix 1  Methods for measuring properties  40

 DESCRIPTION OF SAMPLING PLANS

Specification Properties Good laboratory practices, such as timely instrument

calibration and measurement control testing, are used
The process of manufacturing DuPont™ Tyvek® requires
to generate laboratory data. The lab data is kept for
strict adherence to good manufacturing practices,
up to 10 years.
ISO 9001 protocol and quality control measures. DuPont
manufactures Tyvek® medical and pharmaceutical packaging
Miscellaneous properties
styles using statistical process control methodology
to control three specification properties: basis weight, DuPont reports miscellaneous physical, mechanical
delamination (i.e., internal bond strength), and Gurley Hill and barrier properties to demonstrate the outstanding
porosity. These properties are controlled to a nominal balance of properties that Tyvek® features. These
value to produce material within specification ranges. miscellaneous properties provide useful information
when comparing Tyvek® to other packaging materials.
Specification properties are reported as a nominal value,
a low value (minimum) and a high value (maximum),
the latter two values representing the specification range Sampling plans for miscellaneous properties
within which product is released. Specification properties Miscellaneous properties represent typical values based
are reviewed periodically (and/or on an as-needed basis) on roll averages, with samples taken at locations and
and are based on process capability, market requirements frequencies comparable to specification properties (unless
and product performance history. Specification properties otherwise noted). Miscellaneous properties are not
are based on roll averages with samples taken uniformly controlled in the process and, therefore, are subject
across the sheet. Routine sampling plans for specification to slight changes from “normal” process drift.
properties are described here. Startup, transitions between
styles of Tyvek® or abnormal situations may require Miscellaneous properties are measured in the laboratory
additional sampling. from samples taken from full width rolls. Laboratory
measurements are made at 6 to 12 approximately equally
Sampling plans for specification properties spaced locations across the roll and averaged to give
“roll averages,” except for thickness, where approximately
Basis weight, delamination and Gurley Hill porosity 112 individual data points are taken at 1-in. (2.54-cm)
measurements are made off-line in the laboratory. intervals. These data points are pooled with individual
Basis weight is also monitored continuously on-line. data points from other rolls and averaged to give an
individual (average) thickness.
Laboratory samples are taken from full-width rolls
typically once or twice per 8-hour shift. Microbial barrier and Moisture Vapor Transmission Rates
(MVTR) are not determined for each roll, but are checked
Basis weight, delamination and Gurley Hill porosity
approximately once per year.
laboratory measurements are made at 12 approximately
equally spaced locations across the roll; numbers are Laboratory data is generated following established
averaged to give “roll averages”—which are compared procedures and guidelines, which include good laboratory
to specifications. Note that laboratory basis weight practices, such as timely instrument calibrations. The lab
measurements may be made at frequencies less than data is kept for up to 10 years.
once or twice per 8-hour shift when the process is
stable—but not less than once per day.
A2
Information in the test method and sampling plan sections of this DuPont Technical Reference Guide for Medical and Pharmaceutical Packaging
is valid as of October 2013. DuPont reserves the right to modify testing per our change control procedures as needed to meet customer needs
or to improve production control and efficiency.

Appendix 2  Description of sampling plans  41

 GUIDE TO SOME COMMON INDUSTRY ACRONYMS

AATCC . . . . . . . A
 merican Association of Textile JAMI. . . . . . . . . . J apan Association for the Advancement
Chemists and Colorists of Medical Instrumentation

AAMI. . . . . . . . . A
 ssociation for the Advancement of JIS . . . . . . . . . . . . Japanese Industrial Standards
Medical Instrumentation
JSA . . . . . . . . . . . Japanese Standards Association
ANSI. . . . . . . . . . American National Standards Institute
LRV . . . . . . . . . . Log Reduction Value
AORN . . . . . . . . A
 ssociation of periOperative
Registered Nurses MD. . . . . . . . . . . Machine Direction

ASQ . . . . . . . . . . A
 merican Society for Quality MDD . . . . . . . . . Medical Device Directive

CAMDI ������������ China Association for Medical MDM . . . . . . . . . Medical Device Manufacturer
Device Industry
MDMA . . . . . . . Medical Device
CD . . . . . . . . . . . C
 ross Direction Manufacturers Association

CEN . . . . . . . . . . E
 uropean Committee for MEDEC . . . . . . . Medical Devices Canada
Standardization
PDA . . . . . . . . . . Parenteral Drug Association
DIN . . . . . . . . . . D
 eutsches Institut fur Normung
(German standards organization) SAC. . . . . . . . . . . S tandardization Administration of the
People’s Republic of China
EDANA . . . . . . . E
 uropean Disposables and
Nonwovens Association SAL . . . . . . . . . . Sterility Assurance Level

EDMA . . . . . . . . European Diagnostic SBA . . . . . . . . . . S terile Barrier Association

Manufacturers Association (formerly ESPA, European
Sterilization Packaging Association)
EN . . . . . . . . . . . European Norm
SEM . . . . . . . . . . Scanning Electron Micrograph
FDA . . . . . . . . . . Food and Drug Administration
SPM . . . . . . . . . . Sterile Packaging Manufacturer
FICCI . . . . . . . . F
 ederation of Indian Chambers of
Commerce and Industry TAG . . . . . . . . . . Technical Advisory Group

HPRC. . . . . . . . . H
 ealthcare Plastics Recycling Council TAPPI . . . . . . . . T
 echnical Association of the
Pulp and Paper Industry
IoPP . . . . . . . . . . Institute of Packaging Professionals
USP . . . . . . . . . . United States Pharmacopoeia
ISO . . . . . . . . . . . I nternational Organization for
Standardization

A3
ISTA . . . . . . . . . . International Safe Transit Association

Appendix 3  Guide to some common industry acronyms  42

 For more information about DuPont™ Tyvek®
for medical and pharmaceutical packaging
and to find out how we can help you with
packaging and regulatory compliance, call us
today at [Link] or visit us at
[Link].
You can also find links to other resources
in your country and information in other
languages at this website.

The English language version of this document is not intended for use in the People’s Republic of China.
For use in the PRC, please refer to the document translated into local language.

This information is based upon technical data that DuPont believes to be reliable. It is subject to revision as additional knowledge and experience are gained. DuPont makes
no guarantee of results and assumes no obligation or liability in connection with this information. It is intended for use by persons having technical skill for evaluation under
their specific end-use conditions at their own discretion and risk. Since conditions of use are outside our control, DUPONT MAKES NO WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING
WITHOUT LIMITATIONS, NO WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE AND ASSUMES NO LIABILITY IN CONNECTION WITH ANY USE OF THIS INFORMATION.
This information is not intended as a license to operate under or a recommendation to infringe any patent or technical information of DuPont or others covering any material or its use.

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