Isolator Decontamination cycle verification

• Decontamination is function, verify the decontamination process correct or not.
• Different decontamination methods can be used to eliminate bio burden from isolator system and supplies.
• Decontamination purpose chemicals used to treat isolators are Peracetic acid, chlorine dioxide, ozone and hydrogen peroxide (H2O2).
• Decontamination process  inside the temperature of isolator also important, particularly for hydrogen peroxide vapor decontamination.
• Verify the concentration and distribution of the decontamination chemicals. when applied in gaseous or vapor form, the distribution may be evaluated using chemical indicators, spectroscopic methods or electronic sensors.
• Gas and vapor decontamination methods may require fans in the isolator to distribute the chemical evenly.
• If the isolator utilizes a recirculating unidirectional air flow system, distribution fans may not be required, but this should be evaluated on a case-by-case basis.
• Distribution checks are done with the isolator fully loaded with equipment and supplies and setup of these units is defined and documented.
• After decontamination, decontamination agents need to be removed from the isolator. Aeration, open loop and external exhaust system is major role decontamination agents removing process.
• Verification process check the chemical indicators and biological indicators.
• If required after exposure of Biological indicators verify the fraction negative or total kill analysis method. This process at least 3 log reduction kills is conformed in three consecutive validation studies.
• The operator establishes a frequency for re-decontamination of the isolator. The frequency may be as short as a few days on as long several weeks, depending on the maintenance effort. 
• Decontamination agent does not adversely effect on product containers (prove as per validation).
• The ability of the isolator system to maintain an aseptic environment throughout the defined operational period must be validated.
• Microbiology monitoring programme ususally a routine sampling verify the decontamination process.

Related : Isolator Technology