Cold Chain Testing
Whether you’re shipping vaccines, biologics, or temperature-sensitive medical devices, even minor temperature deviations can severely compromise their safety, quality, and efficacy, leading to issues with texture degradation, changes in physical appearance, and even microbial growth. Cold chain testing is essential to ensure these risks are effectively mitigated. By validating that packaging and storage systems maintain the required temperature range throughout transit, cold chain testing safeguards not only the integrity of your product but also the safety and trust of the end consumer.
What Is Cold Chain Testing?
Maintaining the Quality, Safety, & Efficacy of Your Products
Can your vaccine survive the days-long journey to a hospital or pharmacy? How will your medical device react if exposed to high humidity? What will happen to your perishable food product if truck refrigeration fails? Cold chain testing evaluates the integrity of your packaging materials and procedures for transporting temperature-sensitive products, ensuring your products are maintained within the recommended temperature range throughout storage and distribution.
During cold chain testing, extreme environmental conditions—including temperature variations, shocks, & pressure changes—are simulated in a controlled environment. Following ISTA & ASTM guidelines, and using temperature monitoring devices such as data loggers or temperature indicators, we assess your thermal packaging’s ability to protect your products from damage or degradation.
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Cold Chain Package Testing
Your cold chain packaging must be capable of holding a product’s temperature through its distribution cycle. Whether you’re shipping refrigerated pharmaceuticals and biologics or perishable foods and beverages, our expert team can provide ASTM and ISTA-guided cold chain validation of your thermal transport packaging and temperature control.
Test Methods for Cold Chain Testing
- ASTM D3103 - Thermal Insulation Performance of Distribution Packages
- ASTM D4169 - Performance Testing of Shipping Containers and Systems
- ASTM D4332 - Conditioning Containers, Packages, or Packaging Components for Testing
- ASTM D6653 - Altitude Testing Packaging Systems
- ASTM D7386 - Small Parcel Package Testing
- ISTA 3A - Small Parcel Delivery Systems 150 lb or Less
- ISTA 7D - Thermal Testing Transportation Simulation
- ISTA 7E - Thermal Transport Packaging
More Cold Chain Testing Solutions
What is Thermal Mapping?
An extension of the Good Manufacturing Practice (GMP) environment, thermal mapping evaluates the packaging system used to distribute and ship temperature-sensitive products. This type of testing assesses the packaging’s ability to support the stability of its contained product within the required conditions. Thermal mapping may be used with more cold chain testing and distribution simulation tests. Thermal mapping is offered as part of our wider cold chain testing strategy.
What is a Cold Chain Distribution Strategy?
If your company operates in the medical device, pharmaceutical, or life sciences sectors, having a robust cold chain distribution strategy for each product line is essential. But what is a cold chain distribution strategy? From material sourcing and factory conditions to storage and transportation, a cold chain distribution strategy is your approach to ensuring your product maintains its quality, safety, and efficacy from the point of origin to the final consumer.
There are five key stages to any cold chain distribution strategy, encompassing everything from equipment used to processes maintained:
- Supply Procurement
- Manufacturing
- Storage
- Transportation
- Last-Mile Delivery
Each stage mentioned above should support your cold chain needs. By investing in a cold chain distribution strategy that ensures the cold chain is maintained throughout all of the above stages, your company can unlock new opportunities in innovation, new consumer markets, and new strategies for competitive advantage.
While cold chain logistics can be costly in-house, partnering with a trusted provider can help meet the growing demand and ensure your products are delivered efficiently and effectively. Whether you’re just developing your strategy or seeking third-party insights to enhance an existing plan, Purple Diamond is here to help. Our team can guide you through the complexities of cold chain logistics and provide expert input tailored to your needs.
Ensure Cold Chain Integrity
Ensure your temperature-sensitive products arrive safely and meet the highest standards of quality. Contact us today to validate your packaging, optimize your distribution strategy, and safeguard the integrity of your supply chain.
Why Purple Diamond?
Purple Diamond is proud to be a trusted leader in cold chain validation. Our ISO-accredited laboratories are equipped with advanced technologies and staffed by experts with deep industry knowledge. We rigorously adhere to ISTA, ASTM, and ICH standards, ensuring your thermal packaging meets and exceeds global compliance requirements. At Purple Diamond, we prioritize accuracy, innovation, and reliability, delivering tailored solutions that safeguard the integrity of your temperature-sensitive products throughout their journey.
Accreditations & Affiliations
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Looking for a Packaging Partner?
Whether you’re looking for a team of experts to engineer your new packaging product for optimal sustainability, or seeking a team who can ensure your products stay safe and secure during transport, Purple Diamond can help.
