Vacuum system, operation performance evaluation

Performance capabilities and capacities can be evaluated using a separate test for each function of the lyophilizer. These tests focus on the operation of selected subsystems and the capacity for the specific functions during lyophilization. These subsystems include the heat transfer system, condenser, and vacuum system. An overview for testing of each major subsystem is presented in the following sections. Also included are examples and illustrations for performance ranges. These examples, however, do not, reflect the capabilities of a specific lyophilizer, nor are they intended to suggest any industry standard. 

Are there changes in the product (film) that might be due to changes in the vacuum environment The operator s evaluation of film color, reflectance, and uniformity over the fixture can be noted on the process traveler s first check (Sec. 11.4.2). A log of work (work log) performed on the processing system, such as maintenance, cleaning, modification, replacement, etc., including the date and personnel involved, should be kept. These records should be reviewed frequently and discussed with the maintenance/operator persoimel. 

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