COLD CHAIN VALIDATION

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 What is Cold Chain
Major Sectors
Cold chain in Pharmaceutical Sector

Cold chain in Food Sector

Temperature monitoring

Major Sectors
Some Facts

Content Benefits & Demands

Challenges & Risks

Maintaining Consistent Quality

Why Autocal

In transit Solution

Temperature Monitoring Device

Cold chain uses across the world

Indian Cold chain Market Scenario

Market Dynamics: Bio Pharma & Associated Logistics
Market Dynamics: Growth in Retail & Food Service

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What is Cold Chain
Cold chains are universally uses in the food, pharmaceutical and some chemical shipments.
The cold chain is a logistical system which manages temperature, often between 2o to 8o
Celsius. It is a series of distribution activities which continuously maintain this temperature in Temperature
order to protect the temperature-sensitive cargo from manufacture to the point of consumption. Control
Unique to fresh produce cargoes, the cold chain requires to additionally maintain product Transportation
specific environment parameters which include air quality levels (carbon dioxide, oxygen,
humidity and others) which makes this the most complicated cold chain to operate.
Security Inventory
It is important for every cold storage to have a refrigerant, a valve, a vapour barrier and insulation
during the cargo shipping, leakages may occur from the containers and when this happens, the
temperature may increase which can lead to spoilage as well. In order to avoid such kind of
problems, the containers have to be filled with insulators. Logistics
Packaging Temperature
Control
Warehousing
TEMPERATURE
COLD CHAIN Information
LOGISTICS CONTROL Management
LOGISTICS
(REFRIGERATION)

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Major Sectors:
Food and Beverages, Bio-Pharmaceutical
 Immunization well-known and effective methods of preventing childhood diseases.
 India has one of the largest UIP (Universal Immunization Programme) in the world.
 Under UIP, all the children in the entire country are protected against the 6 deadly Vaccine Preventable Diseases (VPD)
 Services provided district hospitals, community health centers (CHC), primary health centers (PHC) and sub-centers.
 Important elements for improving the immunization is cold chain and vaccine logistics management which is backbone of immunization programme.
 It is a universal fact that all vaccines are sensitive to heat & light and some are sensitive to freezing
 A vaccine must have two characteristics, one is safety and other is potency
 vaccines loose their potency if they are not stored or transported at an appropriate temperature and condition

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Cold chain in Pharmaceutical Sector

Vaccine Manufacturer
Pharmaceutical
Vaccine

International/ National Airports Biotech

Primary Vaccine Store

Vaccines
Intermediate Vaccine Store

Health Centre Blood Products

Health Post

Clinical Trials
Child And Mother

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Cold Chain in Food Sector

Fruits & Vegetables Farm (Point of Harvest)

Pre-cooling
Meat

Cold Storage
Fish & Seafood

Packaging & Processing

Dairy Products
Storage/ Distribution

Beverages Retail(Point of Sale)

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Temperature monitoring is important
when shipping cold chain assets -5oC to 50oC 2oC to 8oC
2oC to 8oC
Cold room temperature The outside temperature at the The goods are stored in retail
time of transporting goods fridge at optimum temperature

The goods are stored in a The goods are then stored in

cold storage room for The goods are
distributed to visible cooler for consumer
distribution access.
local stores

-10oC to 50oC 15oC to 25oC 15oC to 25oC

The outside temperature at the The Crusing temperature when The goods are exposed to varying
time of unloading goods. the plan reaches high attitude temperature when the plane is on
tarmac
The goods are shipped from
the cargo hub in trucks and The Cargo is shipped from the
unloaded at the distribution nearest cargo hub.
channel.

15oC to 25oC -5oC to 50oC

At the time of packaging the goods 2oC to 50oC
The outside temperature when the
are exposed to ambient temperature. The temperature inside the
goods are transported.
storage facility

The goods are manufactured

and processed at optimum The Containers are transported to
temperature The manufactured goods are then The goods are stored inside
the cargo hub for distribution.
stored at the right temperature for refrigerated containers for shipping.
packaging

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Some Facts ……..
 All Vaccines loose their potency due to either exposure to excessive heat (More than +8°C) or excessive cold or light permanently which can not
be regained and the physical appearance of the vaccine may remain unchanged even after it is damaged.
 There is a GROWING international demand for increasingly EXPENSIVE pharma and biopharma products.
 Life-saving products like vaccines ($35 billion market by 2015) are often , requiring temperature-controlled shipping from
manufacturer to end user.
 With growing volume and cost-per-product, by 2014, $16 billion worth of biological and vaccine shipments will require temperature-controlled
rooms during transit.
 The World Health Organization (WHO) reported that as recently as 2005, nearly half of all vaccines were in transit due to poor cold
chain services.
 In a billion-dollar market, wasted product spells dwindling returns, to say nothing of the impact on world health.
 Effective cold chain shipping is therefore critical, particularly as pharma and biopharma cold chain shipments in established and emerging
markets grow dramatically in the coming years.

Freeze sensitive Heat sensitive

vaccines vaccines
 Most sensitive Most sensitive
o BCG (after reconstitution)
o HepB
o OPV
o DPT
o Measles (both before and after
o DT
reconstitution)
o TT
o DPT
o BCG (after reconstitution)
Least sensitive:
o DT
The effect of freezing is not
o TT
cumulative, once frozen it is of no use
o HepB

Least sensitive:
The damage of heat is cumulative and cannot be
reversed by re-freezing the vaccine.

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Benefits & Demands
The cold chain is a well-known method for reducing losses and wastages.

The primary segments of an integrated cold chain, which include;

1) Packing and cooling fresh food products,
2) Food processing (i.e. freezing of certain processed foods,
3) Cold storage (short or long term warehousing of chilled or frozen foods),
4) Distribution (cold transport and temporary warehousing under temperature controlled conditions),
5) Marketing (refrigerated or freezer storage and displays at wholesale markets, retail markets and foodservice operations) can be simple or complex, low
tech or high tech.
Cold chain logistics is the planning and management of the interactions and transitions between these five segments, in order to keep product at their
optimum temperature for maintenance of quality, food safety and prevention of waste and economic losses. Speed is often the key to success when
handling and marketing perishable product.

Benefits:-
 It creates consistent results that the company can rely on.
 It helps earn trust of product to end-users.
 It opens opportunities for powerful business marketing.
 It can boost employees sense of professionalism.
 It can create bigger money-savings.

Demands:-
 India is among the top five emerging pharma markets and has grown at an estimated compound annual growth rate (CAGR) of 13
Percent during the period FY 2009-2013. The Indian pharmaceutical market is poised to grow to 3300 billion by 2020 from the 2009
levels of 756 billion.
 The ever growing pharmaceutical industry is acutely temperature and time sensitive. Cold supply chain acts like a backbone for
pharma industry. It is a big responsibility to have a regulatory supervision and to maintain the efficacy of the drug throughout the
supply chain in order to main the quality of drugs and comply with statutory requirements.

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Challenges & Risks
Challenges:-
 Lack of Road Infrastructure
 Continuity of the cold supply chain
 Uneven distribution of cold chains
 High capital investment
₹.80-90/- sq.ft.($1.6-2.0) against ₹.30/- sq.ft.($ 0.6) in west
 Power supply
-17-18% power deficit
-30% of total expenses against 10% in west
 Management of different temperatures
 Awareness & Mindsets
 Error Irreversibility
Highly temperature sensitive cargo

Risks:-

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Maintaining Consistent Quality
When it comes to proper storage and distribution, the right packaging is required not
only to completely seal in temperature-sensitive products and prevent interaction with
potentially contaminating elements but also to maintain the ideal temperature that will
preserve the original quality of the products whilst in transit. Typically, temperature
controlled packaging consists of several items including an outer shipper, inner
polyurethane foam insulated box, gel bricks and gel packs and foam sheets, which
together create a temperature controlled system validated for specific temperatures and
time frames.
For cold chain packaging which is used for drugs and biological elements, insulating
materials are polyurethane and Styrofoam with polyurethane being deemed as the better
option because it can maintain original temperatures for up to 4 days. Meanwhile, for
frozen goods, frozen gel bricks are commonly used to keep the good in the right
temperature throughout transport. As for chilled products, chilled gel packs that are
commonly included in the coolers. All these make sure that the content arrives at its
destination in good condition despite exterior climate. Among the items that require
temperature controlled packaging are the following:
1. Vaccines and serums;
2. Medicines that are still undergoing research and clinical trials, hence, maintaining
their original composition is critical to the successful outcome of the study;
3. Blood samples for transfusion or study. Maintaining ideal cool temperature for them
is crucial because studies show that plasma zinc concentrations increase 6.3 per cent at
1 hour and 40.7 per cent at 24 hours, whereas serum zinc concentrations increased at
0.9 per cent at 1 hour and 12.5 per cent at 24 hours in uncontrolled temperatures;
4. Organs for transplant because they are deprived of oxygen blood supply the moment
they are removed from the donor but placing them in the right temperature controlled
container or packaging automatically restricts the amount of damage that can occur;
5. Biological specimens and certain food products that are frozen, raw and not endemic
to the area;

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Why Autocal
Its a wake-up call to all businesses involved in the cold chain process, not only in the US but all over the world. Indian companies and regulatory bodies
regarded the news as motivation to further persevere in ensuring that the integrity of our cold chain remains intact. Certainly, related agencies made sure
that cold chain validation was a priority in their audit list. The efficacy of many temperature sensitive drugs, medicines and vaccines can be a matter of
life or death if the drugs prove to be ineffective due to them having not been stored or transported under temperature controlled conditions. Besides the
possible tragedies that could stem from products being compromised in storage or in distribution, there are also the other crucial matters of reputation and
liability.
Companies can consult literature on the appropriate legislations, but it would be more prudent to get assistance from industry experts. Cold chain
consultants like Autocal have the knowledge, equipment, and experience necessary to develop, test, and implement cold chain systems for pharmaceutical
and biotech companies. They have the appropriate testing chambers and tools, data-recording equipment, and other related equipment, all calibrated to
pass international standards.
Cold chain specialists are aware that temperature mapping is not the be-all and end-all of the process as it is an indication of the temperature within a
warehouse, fridge or freezer at a particular point in time but it does help to highlight and fix issues. Cold Chain Consultants can help clients in all areas of
cold chain management from meeting regulation requirements and implementing quality management systems to validating and qualifying equipment
and facilities as well as designing and validating cold chain mechanisms. They also advise regarding logistic options and best distribution practices.
If you need proof of your compliance with official standards, Autocal can supply you with all the necessary documentation pertaining to protocol,
validation or qualification reports, engineering reports, as well as packing details vis-a-vis photos and videos.
The protection of regulatory controlled drugs from exposure to unsuitable climatic conditions and the strict adherence to cold chain compliance standards
are duly addressed in legislation in almost all countries. To protect your business, your associates, and your consumers, make sure you undergo
validation.

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In transit Solution
Equipment for vaccine transportation – Cold Box

Every medicine or life saving drug has a different packaging need to keeping them in a
stable environment in transit & it’s a major challenge faced by many pharmaceuticals
companies and testing laboratories. The extreme temperature variances in our country
make it a necessity to have specialized packaging solutions for these drugs. Autocal
provides this isolated container with a tight fitting lid & cooling packs/ icepacks for
maintaining the temperature inside depending on the customer requirements from pickup
to delivery. Temperature control during shipping is critical to prevent any damage to the
biological specimens or pharmaceutical materials, our solutions help in resolving this
issue.
This solution caters for three inner temperature ranges:
• Cold ( +2C to +8C )
• Controlled Ambient ( +15C to +25C )
• Freezing ( -25C to -15C ) / (-60C to -80C)
When required, a data logger can be added to record temperature during shipping.
Customers can check the inner temperature surrounding the payload, at any time
during transportation according to their needs.

Insulated box with a tight fitting insulated lid suitable for

• Collection & Transportation of small and Large quantities of vaccine during working days to avoid frequent opening of refrigerators;
• Storage of small quantities for emergencies;
• Storage during maintenance periods (cleaning);
• Emergency storage (breakdown of cold chain, power failures).

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Temperature Monitoring Device
Testo 174 T set - Mini Temperature
Temperature Monitoring is a critical part of good storage and handling practice.
AUTOCAL recommends using only a calibrated digital data logger with a current
and valid certificate of calibration testing (also known as a Report of Calibration).
This certificate informs the user of a temperature monitoring device’s level of
accuracy compared to a recognized standard. Calibrated temperature monitoring
devices are required for providers who receive VFC vaccines or other vaccines
purchased with public funds.
Data Logger is used for Monitoring and documentation of the temperature in cold
rooms & storage. It is widely used to monitor temperature in order to protect
sensitive goods in the Food Manufacturing, Food Distribution, Super markets,
Restaurants, Kitchens, Hospitals, Pharmacies, Medical & Pharmaceutical
laboratories. Many foods and drugs have to be stored within a specific cold
temperature range. This can be done in individual cooled store rooms, but also in
specialised cold stores or cold warehouses with high-rack facilities. The temperature
must be continuously documented in all these cold storage facilities, because strict
rules apply to quality management in both the food and drugs industries.
All temperature monitoring devices, through normal use, drift over time, which
affects their accuracy. Because of this, temperature monitoring devices should
undergo periodic calibration testing. Testing should be performed every 1 to 2 years
from the last testing date or according to the manufacturer’s suggested timeline.
AUTOCAL recommends that testing meets standards defined in the Vaccine Storage
and Handling Toolkit. If calibration testing indicates that your temperature
monitoring device is no longer accurate, it should be replaced. Immunization
programs are often excellent resources for information on temperature monitoring
devices.
AUTOCAL recommends a back-up digital data logger for each vaccine storage unit.
Temperature Monitoring Regular temperature monitoring is key to proper cold chain
management. Store frozen vaccines (Varicella, MMRV, and Zoster) in a freezer
between -58°F and +5°F (-50°C and -15°C). Store all other routinely recommended
vaccines in a refrigerator between 35°F and 46°F (2°C and 8°C).
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Cold chain uses across the world

Safe Shelf-life
Secure scales

Europe
North Brand
Reduced
America Advantages:
HACCP
Cold losses:
reduced
Latin Compliant
safe to brand
Chain prices
America

Asia
Pacific Acceptability:
Frozen sea
India food accepted
food

Frozen Frozen Frozen Froze

Processed Processed Processed n
Poultry Fish, Meat Vegetables Ready
Meals

India is still in the early stages of the development of a frozen food market.

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Indian Cold chain Market Scenario
Projected Growth of India Cold Chain Market

 11% of Worlds Total Vegetables

Production is accounted by India alone but
India Share in global vegetable trade is
only 1.7%.

 127 Million Tones of Milk was produced

in 2011-12, but cold storage capacity is
only available for 70,000-80,000 Tonnes
of Milk.

 20% -30% of fish production is annually

wasted in India.

 25,000 unregistered slaughter houses are

present in India, which generally lacks
chilling facilities.

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Market Dynamics:
Bio Pharma & Associated Logistics

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Market Dynamics:
Growth in Retail & Food Service

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We are proud to be associated with….

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 THANK YOU
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Good business relation

For Technical queries:-

Email id: [email protected]
For service related queries
Visit us at www.autocal.net or
get in touch on +91 250 2393 502/3/4

Branches:| Nashik | Pune | Vasai | Goa | Indore |

Hyderabad | Vapi | Vadodara | Sikkim| Baddi |

Providing services for Calibration/Validation/HVAC

(Accredited by NABL as per ISO / IEC 17025: 2005
for high precision calibration in Mechanical [C-0915],
Electro – Technical [C-0916] & Thermal [C-1409] parameters)

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