Search results
Results from the WOW.Com Content Network
ISO 11737 Sterilization of medical devices – Microbiological methods ISO 11737-1:2006 Part 1: Determination of a population of microorganisms on products; ISO 11737-2:2009 Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process; ISO/IEC 11756:1999 Information technology - Programming ...
Ethylene oxide treatment is the most common chemical sterilization method, used for approximately 70% of total sterilizations, and for over 50% of all disposable medical devices. [ 26 ] [ 27 ] Ethylene oxide treatment is generally carried out between 30 and 60 °C (86 and 140 °F) with relative humidity above 30% and a gas concentration between ...
The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide ...
Sterile dental instruments from hospital central supply (barcoded label indicating sterilization date, expiry date and contents). The central sterile services department (CSSD), also called sterile processing department (SPD), sterile processing, central supply department (CSD), or central supply, is an integrated place in hospitals and other health care facilities that performs sterilization ...
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.
In microbiology, in the context of a sterilization procedure, the D-value or decimal reduction time (or decimal reduction dose) is the time (or dose of an antimicrobial drug) required, at a given condition (e.g. temperature) or set of conditions, to achieve a one-log reduction, that is, to kill 90% of relevant microorganisms. [1]
Anprolene is a registered trade name for ethylene oxide that belongs to Andersen Sterilizers.. Harold Willids Andersen invented Anprolene in 1967 and used plastic bags and small ampoules, hence, substantially less ethylene oxide (EtO) than traditional chamber type sterilizers which employ tanks of EtO.
Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation. [ 1 ]