Proper Storage for Temperature-Sensitive Drug Products

Drug products such as biologics, vaccines and products whose chemical and physio-chemical stability depends on temperature put an added emphasis on pharmaceutical manufacturers to ensure proper handling, storage, transportation and dispensing. Maintaining a secure “cold chain” during the storage, handling and transportation of temperature-sensitive drugs, vaccines and blood products not only assures product quality and integrity for the benefit of the patient, but also helps to keep the manufacturer, hospital, pharmacist, physician and nurse in compliance with various laws, regulations, guidelines and codes.

Cold chain products need to be packed in such a way that ensures that the required temperatures are maintained throughout their labeled shelf-life. Any deviation from the ideal environment can affect safety and jeopardize the drug’s quality, resulting in loss of potency, efficacy, or even the need to discard the product entirely.

Examples of drugs that require refrigeration may include:

• Biologics
• Insulin
• Vaccines
• Products derived from blood or plasma
• Most HIV test kits
• Testing reagents

West’s contract manufacturing group offers drug handling and cold chain solutions for pharmaceutical manufacturers that are looking for a complete integrated approach to device manufacturing and assembly to help ensure that drugs are stored within the desired temperature range throughout the cold chain.

Contact us today to determine how West Contract Manufacturing can support cold chain solutions.