Dryer, qualification

Validation/revalidation of SIP cycle freeze dryer Validation/revalidation for uniformity of heat and chilled temperature distribution in freeze dryer Qualification/requalification of vial washer (specify model) Validation of LAL test... 

Qualification of equipment—The qualification of BPC process equipment including reaction vessels, receivers, crystallizers, centrifuges, dryers, filters, distillation columns, solvent distribution systems, etc. is a well-defined activity. While this equipment is somewhat different in design and operating features, than the dosage form equipment that has been the subject of the majority of papers on the subject, the same general principles apply. Reaction vessels, receivers, and crystallizers differ only minimally from formulation and water for injection tanks. Some BPC dryers are identical to those utilized in tablet departments. Solvent distribution systems are piping systems and may resemble WFI distribution systems. Some pieces of equipment such as distillation columns... 

Although the drying process progresses on the basis of the preprogrammed profile of shelf temperature and chamber pressure with time, there can be variation in terms of temperature within a shelf and across the chamber itself. The mapping of the variation in temperature across the freeze-dryer is an important part of the qualification of a new plant and should be repeated periodically, especially if problems are suspected in coolant flow path etc. 

---