A break in the cold chain has several risk factors. None are acceptable when shipping food or pharmaceuticals: microbial growth, reduction of the product’s shelf life, or decrease in the strength or efficacy of medications. These can bring an entire series of health-related risks.
During the cold chain shipping process, stress can damage the packaging and product itself, such as through or temperature. To prevent these risks, various types of solutions are available, such as refrigerated vehicles or the use of isothermal boxes and eutectic plates/gel packs to allow a constant diffusion of cold to maintain uniform temperature levels.
The role of pharmaceutical packaging is to keep the product at a consistent, desired temperature for the duration of its shelf life, from distribution to storage. Thermal testing is an integral part of ensuring products reach their destination intact.
Several organizations and governing bodies and the manufacturers themselves have set guidelines for the handling, shipping, and storage of products. What is not always clear in these guidelines is the testing methods required to meet the guidelines. This is where an international standardization body has an impact.
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The ISTA Lab and Certification Mark
The International Safe Transit Association (ISTA) is one such organization that leads the industry in providing standardized testing methods and lab certifications for both physical and thermal testing of packaging solutions. These test procedures are globally trusted and define how packages should perform to protect their contents under multiple types of conditions.
Lab certification demonstrates a solid commitment to transport packaging professionalism and ensures the laboratory is adequately equipped and maintained to conduct ISTA® package performance testing. TempAid Labs is the only lab in Canada certified by the ISTA as a thermal testing lab.
If desired, packages that are certified can obtain the ISTA Thermal Transport Certification Mark. The mark is registered and can only be printed on certified packages, and it is used by a license agreement and an ISTA member. Retesting is performed to maintain certification whenever there is a change to the manufacturing process or package itself.
ISTA 7E Is the First Global Method for Standardizing Thermal Container Performance
While the ISTA has several standards and testing procedures for different environmental and shipping methods, thermal testing follows a few primary standards.
ISTA Standard 20 is a process standard created by pharma industry experts. The standard sets the minimum requirements for qualifying insulated shippers, including the Standard 7E set of global thermal profiles. These profiles include real-world data to evaluate the effects of external temperature exposures of individually packaged products shipped through parcel delivery systems. Having these profiles allows package qualification to occur faster and assures consistency between different types of packaging systems. Testing to the ISTA 7E standard also meets the compliance recommendations of the Federal Drug Administration and Center for Drug Evaluation and Research.
Labs will also use experimental data collected during summer and winter test campaigns to develop ISTA 7E Heat and Cold Profiles. The thermal lane data was collected during round-trip shipments over 82 different lanes using a parcel service company. This data represents the most comprehensive thermal information about small parcel shipping in the world. This large lane data set provides real-world “what if” simulations of the performance of thermal packaging with actual instances.
When used as an independent standard, they are helpful for comprehensive testing, qualification, and validation of insulated shipper performance.
How We Help Customers Meet ISTA 7E Requirements
TempAid’s in-house, ISTA-certified testing lab is staffed by full-time packaging engineers, including ISTA Certified Thermal Professionals. They have designed and qualified packaging for some of the world’s most essential shipments, including the Covid-19 vaccine. As a certified lab, we can
- Assure your packaging meets industry requirements and maximize your product shelf life with the requisite qualification to support high-value pharmaceutical/biopharmaceutical manufacturers and global regulators.
- Optimize your supply chain using the ISTA 7E Heat and Cold Profiles to ensure the most economical packaging processes, components, and shipping lanes are used.
- Reduce your cost and time-to-revenue by selecting from pre-qualified ISC designs or custom designing platforms to allow your internal resource demands to be kept at a minimum.
What is required of the customer?
Our staff is here to make the testing process go as smoothly as possible.
Typically, you will want to think of the product and package as a single unit. We will provide you with a full proposal, an outline of the testing methodology, and a “checklist” of the needed components. You should be prepared to provide at least three samples to be tested (ISTA recommendation) and any packaging containers used in house.
It is also a good time to document and provide this information before testing if you know your distribution environment well.
Once the above is provided and agreed upon, we follow a testing protocol based on the ISTA lab standard that follows something like this:
- Establish ISTA-based performance criteria.
- The test specimen is preconditioned at precise temperatures.
- Package placed in environmental chamber programmed to run the ISTA temperature test profile with sensors to measure the thermal response.
- The temperature recording are analyzed to determine whether the package performs per the acceptance criteria for the study.
- We provide a detailed, comprehensive testing report outlining the process and outcomes, showing charts of the temperature recordings.
TempAid In-house Capabilities
Meeting the ISTA 7E requirements can be difficult without the proper staff and equipment required to perform adequate testing. However, our approach serves as your in-house testing lab by serving more as a partner than a vendor. Our team works with customers throughout the process to achieve package compliance and provide comprehensive reports after testing completion.
Our lab staff consists of full-time packaging engineers, including ISTA Certified Thermal Professionals. We have several conditioning chambers of various sizes and can test multiple specimens at once to meet fast turnaround times. While we can accommodate almost any package size, .
For more information on the types of ISTA level testing provided at TempAid, contact us.
