Cold Chain Package Testing
Our thermal qualification testing is unmatched. As industry experts, we work with hundreds of companies each year. We are an ISTA-certified testing lab. Our quality system is to ISO-17025. Our lab offers short lead times on scheduling. We quickly write and submit concise reports. Our pricing is affordable and we offer volume discounts.
We can help you realize the benefits of a certified package. We are temperature validation testing experts. If you know what you need, then request a quote from us. If you are unsure, contact us. We thoroughly understand the cold chain package testing standards.
Summary of Cold Chain Regulatory Compliance
Cold chain package testing is the evaluation of a temperature-controlled supply chain. Products that must maintain specific thermal characteristics are evaluated. These products are packaged in special containers to maintain thermal stability. The thermal testing is also called thermal verification and thermal validation.
Cold chain products are most commonly food, pharmaceuticals, chemicals and film. When being transported, these products are often referred to as cold cargo. The objective of the cold chain is to preserve and extend the shelf life of products. It is crucial that these products not experience temperature conditions above or below the acceptable temperature range.
Cold chain logistics include all steps of the transportation. This covers both shipping and storage. Cold chain is a science, technology and process. It is essential to product reliability. One failure in the chain can be catastrophic. That is why every single step needs to be verified.
Temperature Validation Process
The process of temperature validation testing is to identify potential issues prior to the product shipping. To complete the testing, thermocouples are placed on the inside of the package and the outside of the package. The package and product are then exposed to various temperature conditions. These conditions can include extreme hot and cold temperatures. Thermal shock or rapid temperature changes can also be created.
To provide a thorough package validation, temperature mapping can be done. This is especially important for larger packages or pallets of packages. In the case of pallets, thermocouples are placed throughout the pallet. A thermal modeling is conducted by determining if certain pallet positions are more susceptible to out of tolerance conditions. This thermal mapping process is crucial to temperature modeling.
Thermal mapping can vary based on the cold chain segment. For instance, a product might have different packaging based on how it is shipped. It might also have different packaging based on where it is shipped. Lastly, the time of year and climate can create unique package demands. Cold chain modeling is necessary to determine the best materials to use. It also guides how to pack the product.
Each anomaly that occurs needs to be addressed. In the case of food and drugs, the FDA requires all adverse events to be documented and investigated. These failures can have huge impacts on product reliability and usability. Ultimately, this impacts company reputation and sales. A bad package can ruin a great product. Proper packaging is key.
Cold Chain Product Applications
Different products will have different tolerances. As previously mentioned, frozen food is a common product that needs cold chain validation. In the case of frozen food package testing, maintaining a minimum cold temp is the objective. If the product gets colder, the frozen food shipping test is likely still a success. The packaging has met the requirements.
Temperature qualification for pharmaceutical package testing can be more difficult. In the case of pharmaceutical shipping testing, the product cannot get too hot or too cold. Some medicines begin to separate at cold temperatures. This creates a dangerous situation. In the cold chain verification process, there is typically a much tighter tolerance to meet thermal qualification.
With pharmaceutical transport testing, the packaging must often cool but insulate. In warm external conditions, the package must keep the product cool. However, in cold external conditions, the package must provide insulation. It is important for some products to not freeze. This is essential for medicines. The same holds true for many non-frozen foods.
Package testing validation of vaccines is critical. Many vaccines must be stored in a small temperature tolerance. If the vaccine gets too warm, it can become inactivated. This can have deadly outcomes. Likewise, some vaccines cannot get too cold. They can become suspended or separated.
NSF/ANSI 456 Vaccine Storage Unit Testing
Maintaining critical refrigeration and freezer temperatures for vaccines, such as SARS-CoV-2, has created a unique class of storage devices compared to traditional residential and commercial refrigeration units.
The NSF/ANSI 456 certification defines criteria for units used to store vaccines. NSF/ANSI equipment in this type of testing consists of refrigerators, freezers, and combination units. Combination units consist of both refrigeration and freezer units.
For more information on the testing storage units, please follow the link: NSF/ANSI 456 Compliance Testing
Keystone Compliance Cold Chain Package Testing
Our refrigerated package testing capabilities are limitless. We can meet any medical device packaging test requirements. We are also experts in frozen food transport tests. Keystone has dozens of chambers including thermal shock chambers and shakers. This technology also provides Keystone with accelerated aging compliance testing. Furthermore, our fleet of chambers can test any sample size.
Need help developing a scope? We can develop a validation master plan. We can also identify worst case scenarios. We have libraries of standards to choose from. Our data loggers and thermocouple systems are comprehensive. We can test individual packages or packaging systems.
We also have the ability to test seal strength. We have in-house tensile testing. Need a packout with dry ice? No problem. Our accreditation includes food products and drug tests. We also offer expedited testing.
We look forward to working with you to help you certify your packages through our streamlined process. Have a question about cold chain compliance? Contact us and we will determine the best course of action.
For more information on common cold chain compliance-related standards, please follow the links below:
- ASTM D4332: Conditioning Containers, Packages, or Packaging Components for Testing:
- ASTM D6653: Determining the Effects of High Altitude on Packaging Systems by Vacuum Method
- ASTM F2825: Climatic Stressing of Packaging Systems for Single Parcel Delivery
- IEC 60601-1-11 Package Testing
- IEC 60068-2-14 Temperature Testing
- IEC 60068-2-64 Vibration Testing
- ISTA 7D Temperature Validation Package Testing
- ISTA 7E Temperature Validation Package Testing
- NSF/ANSI 456 Compliance Testing of Refrigeration Units