The new GMP Annex 1, Manufacture of Sterile Products, has been published at the end of August 2022. This new, much more extensive guidance has a chapter dedicated to environmental and process monitoring, as part of Strategic Contamination Control (SCC). Regarding the minimization of pollution risks, the new Annex encourages the inclusion of alternative monitoring systems that are scientifically proven to optimize the detection of environmental pollution.
Protak Scientific’s enzymatic indicators (www.protakscientific.com) are one of these rapid microbiology technologies that serve to detect and quantify any deviation or failure in the VH2O2 biodecontamination process.
The technology is becoming mature and there are already suppliers of isolators using the enzymatic indicators to test their VH2O2 systems as well as multinational companies that routinely use them to monitor their processes. Netsteril has been distributing Protak indicators since 2017 and is a pioneer in Spain in using the technology, both in its biodecontamination services and for the development and validation of VH2O2 cycles.
Enzymatic indicators, with exposure to peroxide, undergo degradation that is measurable and can be correlated with the degree of mortality of a spore population. For the implementation of enzymatic technology, both types of indicators are first used and, after a transition period that will allow the relationship between the two to be determined, the biological ones can be subrogated to the enzymatic ones.