Temperature mapping studies are conducted to provide documentation and control of temperature distribution for transport or storage areas. This helps manufacturers, distributors and transporters of pharmaceutical, biotechnological and other temperature sensitive products protect their value by identifying potential environmental control problems before products are affected. Inadequately controlled environments can lead to ineffective or spoiled products.
Cryopak offers complete mapping services to cold chain logistics companies, distributors and manufacturers. We conduct mapping studies that reduce costs and satisfy the most demanding regulations. As regulators increase their emphasis on GMP requirements, the definitive method to demonstrate that all controlled storage equipment or storage areas stay within the specified limits is through a thorough temperature mapping study.
Our regulatory compliance engineers provide expertise in protocol development, datacollection and technical report writing.