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An autoclave is a machine used to carry out industrial and scientific processes requiring elevated temperature and pressure in relation to ambient pressure and/or temperature. Autoclaves are used before surgical procedures to perform sterilization and in the chemical industry to cure coatings and vulcanize rubber and for hydrothermal synthesis .
This method is a faster process than dry heat sterilization. Steam sterilization is performed using an autoclave, sometimes called a converter or steam sterilizer. The object or liquid is placed in the autoclave chamber, which is then sealed and heated using pressurized steam to a temperature set point for a defined period of time.
Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.
Standards for validation and verification of medical laboratories are outlined in the international standard ISO 15189, in addition to national and regional regulations. [ 1 ] As per United States federal regulations, the following analytical tests need to be done by a medical laboratory that introduces a new testing device:
Moist heat causes destruction of micro-organisms by denaturation of macromolecules, primarily proteins. Destruction of cells by lysis may also play a role. While "sterility" implies the destruction of free-living organisms which may grow within a sample, sterilization does not necessarily entail destruction of infectious matter.
Tyndallization is a process from the nineteenth century for sterilizing substances, usually food, named after its inventor John Tyndall, that can be used to kill heat-resistant endospores.
Data relating to CPP should be recorded, stored, and analyzed by the manufacturer. CPP variables and ranges should be reevaluated after careful analysis of historical CPP data. Identifying CPPs is done in stage one of process validation: process design are an essential part of a manufacturing control strategy.
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) coordinates U.S. federal government evaluation of new, revised, and alternative test methods. Alternative methods are methods for safety testing of chemicals and chemical products that use fewer or no animals or that minimize or prevent animal pain and ...
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