Sterilization process phases

The sterilization process consists of three phases, as shown in Fig. 2.46 ... 

VII. VALIDATION OF VAPOR PHASE HYDROGEN PEROXIDE STERILIZATION PROCESS... 

Prior to phase I clinical trials, process steps and assays that relate to safety should be validated. For example, sterility assays and sterilization processes must be validated. Cell lines should be qualified prior to any clinical trials, including testing for adventitious agents and identifying and quantifying indigenous virus. Virus clearance steps should be validated, and removal of any potentially toxic or otherwise harmful agents should be validated [41,42],... 

A typical sterilization process with EtO consists of a preconditioning phase, the actual sterilization run, and a period of poststerilization aeration to remove toxic residues, such as EtO, ethylene glycol (formed out of EtO and ambient humidity), and ethylene chlorohydrme (formed out of EtO and materials containing chlorine, such as PVC). In the medical device industry EtO is the most common sterilization method, used for over 70% of total sterilizations and 50% of all disposable medical devices. 

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