Validated Cold Chain Packaging for Pharmaceutical Industry
Validated cold chain packaging is a vital component in storing and transporting temperature-sensitive products, such as pharmaceuticals and certain types of food (such as meal kit delivery or frozen meats and seafood). This type of packaging has been scientifically tested and proven to maintain a specific temperature range for a certain period, ensuring the safety and efficacy of the products.
It is important to understand that the validation process involves testing the packaging under various conditions, such as different temperatures, durations, and environmental factors. The testing process is usually done in a controlled laboratory setting and the results are used to create a temperature profile. The profile is then used to ensure that the packaging maintains the required temperature range during transportation and storage.
The packaging materials used can vary depending on the product and the required temperature range. Some common materials include insulated coolers, gel packs, and PCMs. The packaging must also protect the products from external factors such as light and moisture.
In the pharmaceutical industry, temperature-controlled packaging is crucial for maintaining the potency and safety of vaccines and biologics, which are often sensitive to temperature changes. In the food industry, temperature-regulated packaging is essential for maintaining the freshness and safety of frozen foods, dairy, and meats.
To ensure the packaging system is functioning properly, it is important to monitor the temperature during transportation and storage. This can be done using data loggers, which are small devices that can be placed inside the packaging to record the temperature. The data from the loggers can then be analyzed to ensure that the packaging has maintained the required temperature range. It is important to use packaging materials and methods that have been scientifically tested and proven to maintain a specific temperature range for a certain period of time.
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TempAid Cold Chain Solutions
40 Years Experience
TempAid™, a division of Rapid Aid Corp., manufactures a complete line of cold chain solutions designed for optimal temperature stability in the food, pharmaceutical, and laboratory sectors. As part of the Rapid Aid brand, the company has been delivering solutions to the market since 1975. The company has the capacity and manufacturing capability to deliver hundreds of millions of units per year.
What does it take to validate cold chain packaging?
To qualify as validated, materials and methods must undergo a series of rigorous scientific tests to prove their ability to maintain a specific temperature range for a certain period of time. These tests must be conducted under simulated transportation and storage conditions, and the results must be consistent and reproducible.
The packaging must also be able to withstand the rigors of transportation and storage, such as vibration, shock, and changes in temperature and humidity. Additionally, the packaging must be able to protect the products from external factors, such as light and moisture.
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To ensure the safety and efficacy of these products, it is important to use packaging materials and methods that have been scientifically tested and proven to maintain a specific temperature range for a certain period. Contact TempAid today to request a free sample.