Contact us today to find out how we can ensure the reliability and integrity of your packaging system. Cryopak Package Testing Capabilities

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1 ISTA Certified Lab

2 Cryopak offers technical expertise that helps customers ensure a reliable package by providing a wide range of testing capabilities. Cryopak offers quality services for multiple fields including the pharmaceutical, home/personal care, food and consumer goods industries. Cryopak takes great pride in offering exceptional customer service and prompt turnaround time. Contact us today to find out how we can ensure the reliability and integrity of your packaging system. Cryopak Package Testing Capabilities DISTRIBUTION TESTING Distribution Test: ASTM D4169, ASTM D7386, ISTA Series 1, 2 and 3 ASTM D4332 Thermal Conditioning ENVIRONMENTAL CONDITIONING Customer Derived Conditioning ASTM and ISTA Pre-Distribution Test Conditioning Standards ACCELERATED AGING Aging Based on Q10 Theory: ASTMF1980 Dye Leak Testing: ASTMF1929 Vacuum Leak (Flexible Packaging): ASTM D3078 PACKAGE INTEGRITY Vacuum Leak (Rigid Packaging): ASTMD4991 Bubble Leak Testing: ASTM F2096 Visual Inspection: ASTM F1886 PACKAGE STRENGTH Seal Strength Testing: ASTM F88 Burst Strength Testing: ASTMF1140 The above is not a complete list of our testing capabilities. If you require any of these procedures or other additional test methods, please contact us.

3 Distribution Testing During distribution, packages are shaken, tossed, stacked, dropped and exposed to environmental changes. These distribution hazards can potentially cause damage to the product, resulting in costly replacements and can harm your company s credibility. Cryopak performs tests that simulate these distribution hazards in a controlled and repeatable laboratory setting. Cryopak s lab is certified with the International Safe Transit Association. ISTA is an organization that focuses on matters related to responsible transport packaging. ISTA provides standards to optimize packaging systems and provide protocols to simulate expected distribution hazards. ISTA distribution tests can be used to provide engineers with valuable data used to evaluate effectiveness of protective packaging. In addition, Cryopak follows standard with the American Society for Testing and Materials. ASTM devotes major methodologies for package-product performance in distribution: D4169 and D7386. Cryopak staff are highly knowledgeable on all distribution simulation standards and will work with you to design the right series of tests to ensure your product is fully protected from a variety of distribution hazards. Some examples of tests that can be part of a distribution study are as follows: Manual Handling: Simulates drops from specified heights Mechanical Handling: Simulates a truck or forklift in motion Warehouse Stacking: Simulates compressive loads being applied to the shipping unit Vehicle Vibration: Simulates vertical vibration during transportation in a truck Loose Load Vibration: Simulates repetitive shock on the shipping unit Environmental Hazards: Simulates the changing temperatures and humidity that the shipping unit will be exposed to during transit Concentrated Impact: Simulates low-level impacts that the shipping unit will be subjected to during sorting and transit Low Pressure, High Altitude: Simulates the reduction of pressure when a shipping unit is transported by aircraft

4 Environmental Conditioning Temperature and humidity extremes can affect packaging and products. Cryopak s programmable thermal chambers will expose your package and product to a custom or ISTA/ASTM industry standard temperature and humidity profile. Environmentally testing your package and product to worst-case scenario temperature and humidity will allow you to make an informed decision on what packaging to use and verify its effectiveness. ISTA provides standard temperature and humidity test profiles accepted by government and nongovernment organizations worldwide. With the help of Cryopak s engineers, many companies have determined the optimal packaging and transit times for temperaturesensitive product. The performance chart above shows testing data from one of Cryopak s thermal studies. The package (Sample 1) was exposed to elevated temperatures from 25 C to 40 C. During the 96 hour test, the internal temperature of the shipper successfully maintained a controlled temperature between 2 C to 8 C.

5 Accelerated Aging Accelerated aging uses heightened conditioning of heat and humidity to speed up the normal aging process. This test method is accepted by the FDA, the EU and other regulatory bodies to determine shelf life or lifespan when real-time aging data is not yet available. This test will expedite your product to market while real-time aging studies are performed to validate shelf life claims and expiration dates. In addition, accelerated aging will provide an engineer with valuable data on how packaging components and adhesives may breakdown, become brittle or lose bonding capabilities over time. Accelerated aging studies are required for ISO Packaging for Terminally Sterilized Medical Devices. Cryopak Testing Center has multiple constant temperature chambers maintaining different set points that can be utilized for your accelerated aging needs.

6 Package Integrity Integrity testing is essential to determining the sterility of a product and how well the microbial barrier packaging performs. After enduring accelerated aging, environmental stress and/or distribution testing, the packaging is evaluated to determine if it was compromised. These tests ensure that the product will not be damaged under typical distribution hazards. Dye Leak Testing ASTM F1929 A high precision test method that is used for locating package seal defects Vacuum Leak (Flexible and Rigid Packaging) ASTM D3078, ASTM D4991 Uses low air pressure to test the overall package integrity Bubble Leak Testing ASTM F2096 Visual Inspection ASTM F1886 Uses water submersion and air pressure to test for bubbles, which indicate a leak Reveals and documents failuresalong the package surface and seal

7 Package Strength Our fully equipped lab can perform multiple package strength tests which are integral for understanding a package s ability to withstand forces that it may experience. Seal strength testing measures the force it takes to open a package s seal to ensure optimal product safety and customer usability. Burst testing measures a package s ability to withstand internal pressure before failure and exposes weak areas. Seal Strength Testing ASTM F88 Burst Strength Testing ASTM F1140 This test measures the strength of seals in flexible barrier materials. This test determines the ability of packages to withstand internal pressurization. The internal pressure is gradually increased until the package fails, and the peak value is recorded.

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