LYOPHILIZER QUALIFICATION PDF

Additionally, the chamber must be L stainless steel. The chamber is supplied with clean steam for sterilization.. The clean steam piping must be L stainless steel. Operational Qualification In addition to the common requirements outlined in the "General" section, the OQ protocol will outline the following tests. Shelf temperature accuracy and uniformity testing.

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Additionally, the chamber must be L stainless steel. The chamber is supplied with clean steam for sterilization.. The clean steam piping must be L stainless steel. Operational Qualification In addition to the common requirements outlined in the "General" section, the OQ protocol will outline the following tests.

Shelf temperature accuracy and uniformity testing. Heating rates are for information only. Condenser cooling rates are for information only. The Vacuum System is tested by determining the blank-off pressure, pump ultimate pressure and leak-up rate. Loss of weight from a weighed amount of water in trays is not less than the stated capacity of the condenser.

Silicone levels on swabs in the chamber should not exceed the negative control. Hydrocarbon levels on swabs should not exceed the negative control. Vacuum System The blank-off pressure, pump ultimate pressure and leak-up rate are for baseline purposes only. Condenser Capacity Loss of weight from a weighed amount of water in trays is not less than the stated capacity of the condenser.

Hydrocarbon And Silicone Contamination Silicone levels on swabs should not exceed the negative control. Hydrocarbon levels on swabs should not exceed the negative control NOTE: This procedure must be run after a lyophilization cycle.

Do not use siliconized stoppers in the lyophilizer. Stoppering All vials are stoppered No vials are damaged. Vacuum is maintained in vials. At mid-cycle, the pressure and average temperature of the chamber indicate that the steam is saturated. Do not include the drain in the average temperature calculation. Performance Qualification No water remains in vials or trays after the appropriate freeze drying cycle is performed.

All vials are stoppered No vials are damaged. Vacuum is maintained in the vials, although some percentage failure will occur. Three successful, consecutive, runs are performed. The sterilization cycle provides a minimum cumulative F0 of 12 minutes, at end of cycle dwell, at each thermocouple.

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Water damaged books and documents Lyophilization - Process A freeze dryer consists of three main components: sample chamber, condenser and a vacuum pump system. Depending on what should be dried, the sample chamber that is directly connected to the condenser and vacuum pump is designed with an appropriate number of shelves which can be moved up and down if closing the vials is required. This is called the stoppering arrangement. There are essentially two categories of freeze-dryers: batch and continuous dryers. The benefit of this container is that the product can be easily reconstituted by simply adding liquid. Due to the fact that maintaining a high vacuum is essential for all lyophilization processes, the use of wireless loggers is highly recommended. Continuous freeze dryers are designed for vial drying and complete filling, loading and unloading systems which are integrated in the freeze dryer design.

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