Autoclave performance qualification

Steam sterilization validation. All autoclave operations conform to the Master Validation Plan employed at ABC Pharmaceutical Industries. The autoclave has undergone installation qualification, operational qualification, and performance qualification. The autoclave is revalidated on an annual basis. The equipment steam sterilization cycle revalidation data for the autoclave are provided in validated archives. 

The qualification studies conducted indicated that the GMP steam sterilizer (autoclave) performance is satisfactory and in accordance with the operational parameters defined previously. 

Sterilizer parameters are specific to combinations of product, presentation, and autoclave. They must be established empirically. Heat penetration studies done prior to the performance qualification phase of validation serve the purpose of determining the loading patterns, prevacuums, and temperature and pressure settings, etc.which ensure that the sterilization specification is delivered to the product and that it is delivered uniformly throughout the load. 

The sterilization of components and equipment will be validated for each load configuration using the cGMP autoclave. Cycle Development Testing and Performance Qualification Testing will qualify each sterilization process. A separate Performance Qualification and Cycle Development Testing Report will be written for each load configuration. The process will be considered validated when the acceptance criteria is met for three (3) successful consecutive runs. 

Sterilization of chamber and condenser verification of the eight coldest spots within the chamber. These points were then to be used for execution of the performance qualification. Testing was performed using methods similar to those used for an autoclave (2,4,5). 

First part qualification. First part qualification is a process performed the first time a new bonded assembly is manufactured or the first time a new tool is used to manufacture a bonded assembly. First part qualification provides assurance that all of the aspects that control bond assembly quality, such as the design dimensions, detail part manufacturing techniques, tool dimensions, layup procedures and autoclave cure cycle parameters are correct and will produce a bond assembly that meets the engineering requirements. 

Documented evidence is achieved by preparing written validation protocols prior to doing the work, and writing final reports at the completion of the work. Information must be in writing, otherwise it does not exist, according to the FDA. The process equipment used should undergo installation qualification (IQ) and operational qualification (OQ) to establish confidence that the equipment was installed to specification and purpose and is capable of operating within established limits required by the process. Performance characteristics which may be measured could be uniformity of speed for a mixer or the temperature and pressure of an autoclave, for example. 

Operational equipment testing was performed for the vacuum, temperature, and ventilation system, the stoppering function, and the sterilization process. The qualification of the lyophilizer s Sterilization-in-Place (SIP) system is performed similar to an autoclave and uses biological indicators and accumulated lethality (Fq) determination (2,5). 

Some OoA prepregs are already undergoing qualification for aerospace production and have comparable mechanical properties to autoclave-cure systems for primary aircraft structures. Nevertheless, material qualification and the availability of a suite of OoA prepregs are still not at a mature level. To get Federal aviation authority (FAA) approval, a database of performance data from qualification testing is mandatory. Qualification of the... 

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