Page 32 - GMP for warehouse

GMP Training – GMP for Warehouse by www.gmpsop.com

Protecting sensitive materials

Many companies (particularly companies manufacturing biologicals and
vaccines) handle, store, and transport temperature-sensitive raw materials and
finished products. The protection of temperature-sensitive products is critical to
their effectiveness and safety.

Products can be degraded by excessive heat, moisture, light or repeated

freeze/thawing cycles.

STATUS LABELS

Freezers
Frozen materials are usually stable at -20°C and below,
though some materials require freezing at -80°C. If the
temperature rises, it will probably do so slowly over
several hours. Once the temperature rises above a
certain point, some to the frozen materials will start to

deteriorate or degrade. There must be a written action
plan that includes a contingency for relocation if the
temperature continues to rise.

Automatic defrost refrigerators
Some cold storage refrigerators have an automatic

nightly defrost cycle, these refrigerators may not be
suitable, as many frozen products can partially melt
then re-freeze, causing them to deteriorate and
degrade.

Heat and moisture
Almost all medicinal products are sensitive to heat and
will degrade at higher temperatures. Some products will
degrade at room temperature, while others can

withstand temperatures above 30°C for prolonged

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