Storage Conditions and Stability of Official Vaccines
Many biological preparations become unstable during storage and thus their safety and efficacy are reduced. Proteins and other macromolecules may be sensitive to heat, light, radiation, and environmental changes, or they may interact with the container materials or other components of the vaccine mixture.
Determining these relationships and optimising stability from the time of
production to administration is an important part of vaccine development. The potency of vaccine may reduce as a function of the time elapsed since production even if optimal conditions are maintained.
The stability of vaccines may undergo significant changes after being exposed to temperature fluctuations during handling or storage. Thus, the ir stability
characteristics should be determined through testing, and the storage and handling conditions should be defined to ensure that minimum standards of potency, identity, and purity continue to be met throughout the shelf-life.