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Monitoring pharmaceutical freeze-drying

The conditions under which pharmaceutical products are freeze dried are subject to strict standards. Satisfying these requirements is crucial for pharmaceutical companies for proving that their products have been safely manufactured and are suitable to be used in patients. In most cases, each freeze dryer manufacturer has its own integrated control system to monitor the freeze drying process, as key parameters that include humidity, temperature and pressure (or vacuum). The system that records the data also independently activates active warnings and alarms if the accepted process parameters are exceeded. These often incorporate a time delay and/or a hysteresis. This activates the alarm once

Lyophilizer Sterilization

A generally recognized acceptable method of sterilizing the lyophilizer is through the use of moist steam under pressure. Sterilization procedures should parallel that of an autoclave, and a typical system should include two independent temperature sensing systems. One would be used to control and record temperatures of the cycle as with sterilizers, and the other would be in the cold spot of the chamber. As with autoclaves, lyophilizers should have drains with atmospheric breaks to prevent back siphonage. Some of the older lyophilizers cannot tolerate steam under pressure, and sterilization is marginal at best. These lyophilizers can only have their inside surfaces wiped with a chemical age

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