QUALIFICATION REPORT OFDESPENSING BOOTH FOR THE COMPLIANCE OF cGMP

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1.0 Background:
Convell Laboratories was renovated the Dispensing booth of General Tablet. A new
Dispensing booth was purchased for the Dispensing of various kinds of raw material.
The engineering department asked for the qualification of Dispensing booth as per
requirement of cGMP to assurance the cross contamination and other local regulatory
obligations.
1.2 Principle of the booth:
The booth nominally re-cycles 85-90% air & 10-15% of the air is exhausted through
exhaust miniplate HEPA filter. The exhaust/ bleed air is made-up from the front side of
the BOOTH i.e from ground level into the pre-filters.
The down flow air produced within the booth's safe work zone area forces to clean air
over the operator's head and shoulders and downward towards the low-level exhaust
system. The downdraught prevents airborne dusts caused by weighing and Dispensing
operations rising into the operator's breathing zone. The air forced downwards is
extracted at low level into the booth's filtration system where dust particles are
contained at each level of filtration prior to being re-circulated back into the booths' air
stream.
2.0 Objective:

The objectives of this report is

 To verify that the Dispensing booth of General Tablet, supporting utilities installed in
compliance with their installation specifications (IQ).
 To verify that the Dispensing booth of General Tablet , supporting utilities operate in
accordance with their specifications (OQ).
 To verify that the Dispensing booth of General Tablet meeting its predetermined
specifications and quality attributes (PQ).
 To verify the Dispensing booth of General Tablet meets the current Good
Manufacturing Practices (cGMP) requirements.
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3.0 Documentation:

 Approved SOPs and test methods were checked.

 Calibration certificates of components were checked
 Identity number of all the supporting utilities were labeled
 All annexure are attached at the end of this qualification report.

4. Definition

Aerosol generator
Instrument capable of generating particulate matter having appropriate size range (e.g.
0.5, 5 µm to 2 µm) at a constant concentration, which may be produced by thermal,
hydraulic, pneumatic, acoustic or electrostatic means
Airborne particle
Solid or liquid object suspended in air, viable or non-viable, sized (for the purpose of this
part of ISO 14644) between 1 nm and 100.
Particle concentration
Number of individual particles per unit volume of air

Particle size distribution

Cumulative distribution of particle concentration as a function of particle size

Test aerosol
Gaseous suspension of solid and/or liquid particles with known and controlled size
distribution and concentration

Aerosol challenge
Challenging of a filter or an installed filter system by test aerosol

Filter system
System composed of filter, frame and other support system or other housing

Final filter
Filters in a final position before the air enters the clean room
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Installed filter system

Filter system mounted in the ceiling, wall, apparatus or duct

Installed filter system leakage test

Test performed to confirm that the filters are properly installed by verifying that there is
absence of bypass leakage in the installation, and that the filters and the grid system are free
of defects and leaks
Leak
Air filter system² penetration of contaminants that exceed an expected value of downstream
concentration through lack of integrity or defects
Scanning
Method for disclosing leaks in filters and parts of units, whereby the probe inlet of an aerosol
photometer or discrete-particle counter is moved in overlapping strokes across the defined
test area
Supply airflow rate
Air volume supplied into an installation from final filters or air ducts in unit of time.
Total airflow rate
Air volume that passes through a section of an installation in unit of time
Uniformity of airflow
Unidirectional airflow pattern in which the point-to-point readings of velocities are within a
defined percentage of the average airflow velocity

Aerosol photometer
Light-scattering airborne particle mass concentration measuring apparatus, which uses a
forward-scattered light optical chamber to make measurements

5. Cleaning & sanitization of Sampling booth

Dispensing booth was verified for the air flow and HEPA filter leakage test on surfaces.
The Dispensing booth was cleaned and disinfected with commercial Hiclean disinfectant
by trained person according to standard operating procedure (SOP).
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6. Qualification of the Dispensing booth

The qualification of Dispensing booth was divided in to the following three major steps:
6.1 Installation qualification
6.2 Operation qualification
6.3 Performance qualification

6.1 INSTALLATION QUALIFICATION

The following key parameters were checked and all the related documents are attached with
this report. Standard operating procedures were identified and listed. All supporting utilities
were properly connected. All peripherals and electrical were properly connected. All safety
features were checked for safe operation. The following information was verified during I. of
Sampling booth.
A. Equipment identification.
B. Utilities requirement.
C. Major components specifications.
D. Verification of Major components specifications.
E. Standard operating procedures.
A. Equipment Identification
Dispensing booth was fabricated and supplied by M/s Techno Air, Lahore, Pakistan,
This equipment is located in Quarantine area in production department.

Information Description

Manufacturer M/s Techno Air, Lahore, Pakistan

Model No. TS-DS-07
Serial No. ---
Supplier name M/s Technocratic Services
Plot # 763, future colony Mor, Main korangi industrial Area
road, Landhi, Karachi.
Location General tablet

B. Utilities Requirement:
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The following utilities were checked and inspected.

Description Installed Yes. / No.
Clean Air from HVAC Yes. C.
Main Power Supply Yes. Major
Power supply for the weighing Scale Yes
Component’s Specification:
The following Major components were checked and inspected.
Description Specification
Component: Chamber.
Material SS-304
Dimensions (L x W x H): 52”x54”x97” (External)
50”x30”x76” (Internal)
HEPA Filter for exhaust
No. of Filters: One
Media Water proof miro glass fiber
Frame Aluminum
Sealant Urethan
Gasket Neo Double
Size 24”x48”

Test scan @ 0.3µm 99.997%

Air flow 4.5 cmm
Make CTK, Korea

Ceiling Downflow HEPA Filters

No. of Filters: 02
Media Water proof micro glass fiber
Frame Aluminum
Sealant Urethane
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Description Specification
Gasket Neo Double
Size 24”x48”
Test scan @ 0.3µm 99.997%
Face guard Powder coated
Make CTK, Korea

Primary Pad Filters

Location Located directly behind perforated rear wall grilles.
Qty: 2 Nos

Size 592x592x23mm
Efficiency: G4, 90% dust arrestance, synthetic & washable (EN779)
Airflow volume 3600 m3/hr @ initial pressure 40Pa
Make MGT, Turkey

Secondary
Fine-Dust Filter
Location Located directly behind perforated rear wall grilles.
Qty: 3 Nos (6 Pocket/each)
Size 592x592x600mm
Efficiency: F8, (≤90% Em – EN779 Class)
Airflow volume 6800m3/hr @ initial pressure 90Pa
Make MGT, Turkey

SPEED CONTROL Manual Speed Control with dual (Voltage/Amp)

MECHANISM Inverter
Digital Panel and blower Keypad
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speed control button

Inverter model # KP-20IC
Make
Power Supply 3 phase, 50 Hz)
Light Tear drop Tube Fluorescent Ceiling Lights, than 500
lux average level in booth
FAN SYSTEM
Blower Forward-curved, centrifugal direct driven type
blower.
Pressure 700Pa

Noise level maximum average noise level within booth of

80dBA

E. Standard Operating Procedures

S.No Description of SOP Annexure

1. Operation of Sampling Booth Annexure No. 1

2. Cleaning of Sampling Booth Annexure No. 2

3. Preventive Maintenance of Sampling Booth Annexure No. 3

6.2 Operational Qualification

The operational key parameters were verified and all the related calibration
certificates are attached with this report. The functional controls of the Sampling
booth were challenged along with the basic equipment operations. In OQ the
following control functions were checked.
6.2.1 Equipment Control Functions.
6.2.2 Calibration review

6.2.1 Equipment Control Functions:

Test function verifies that all the critical operating functions of the Dispensing booth
are working according to the manufacturer’s specification.
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Dispensing booth Control Functions:

Test Function Specified Observations Remarks

On Switch ON AS Specified OK

Off Switch OFF AS Specified OK

Set the rpm Press green button AS Specified OK

Light ON/ OFF AS Specified OK

6.2.2 Calibration Review

All the calibration certificates (differential pressure) of the Dispensing booth is

attached as annexure no. 4
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6.3 Performance Qualification

Dispensing booth was subjected to the following set of performance tests as given in ISO
14644-3 annex B which given below

6.3.1 Differential pressure

6.3.2 Air Velocity
6.3.3 HEPA Filter Leakage Test

6.3.1 Measurement of differential pressure

 The differential pressure across the HEPA filter was carried out as per test method
that attached as annexure # 5.
 Equipment:

S.No Equipment/ Instruments Model No. Range Resolution

.
1 Magnehelic Gauge DPI-610 0~60 Pascal ±2

 Calibration Review

Equipment/ Calibrating Agency Calibration Date of Calibration due

Instruments (Name & Address) Certificate Calibration Date
Number
Magnehelic Gauge Delta Control 13/11/0481616 20/12/2017 19/12/2018
Engineering Co.

Reviewed & Inspected by:

Name: _________________ Signature: _______________ Date: _____________

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6.3.2 Measurement of Air Velocity of HEPA filters

 Air velocity was carried out as per test method that attached as annexure # 6 and
their results attached as annexure # 6A.
Equipment:

S. No. Equipment/ Model No. Range Resolution

Instruments
1 Velometer VEL-70605210 Multiple ±0.01

 Calibration Review

Equipment/ Calibrating Agency Calibration Date of Calibration

Instruments (Name & Address) Certificate Calibration due Date
Number
Velometer Delta Control 17/12/0133415 20/12/2017 19/12/2018
Engineering Co.

Reviewed & Inspected by:

Name: _________________ Signature: _______________ Date: _____________

Acceptance Criteria:

 0.45 m/s (90 fpm) ± 20%

 Reading will take at 6 inch away from face of HEPA filter.
 The HEPA filter will be changed or adjusted if the velocity fails out range 72- 108 fpm.
6.3.3 HEPA FILTER LEAKAGE TEST

 Booth contains 6 HEPA Filters which installed and design for directional flow.
 HEPA filter leak test was carried out as per ISO Test Method 14644-3 that attached
as annexure # 7.
 The leakage conducted test at rest.
 The result of all the HEPA filters are attached as annexure # 7A

 Equipment
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S. Equipment/ Instruments Model No. Range Resolution

No.
1 Aerosol Photometer DP-3 Multiple 0.001%

 Calibration Review

Process Calibrating Date of Calibration Calibration

Instrumentation Agency (Name & Calibration due date Certificate No
Address)
Aerosol Photometer National 10/06/2018 09/12/2019 403245
1.Ketily,picocamp Institute of
Source Standards and
2.Fluke DMM Technology
3 Flow meter

Reviewed & Inspected by:

Name: _____________ Signature: _____________ Date: _____________

 Acceptance Criteria

 Acceptable filter leak range less than 0.01%

 0.01% leakage to be repair
 Leak are sealed using silicone sealant by caulking 1.5 inches (dimension) around the leak
parallel to the medium and between the separators and smoothed flush with the
separators. The filter is then rechecked for leaks as specified above.
 The extent of filter face obscured at any point by patching material is limited to 5% of
the filter area so that the resulting void in the air stream will be filled in before reaching
the work area. If more is sealed, the filter must be rejected and a new one installe