Airex are the largest isolator manufacturer in Japan. A leader in sterile and containment process handling, they provide high performance cleanroom barrier systems including aseptic manufacturing RABS & isolators, transfer chambers and room bio-decontamination equipment.
As early adopters of Protak’s Enzyme Indicator (EI) technology, Airex implemented the use of EIs for verification of H2O2 decontamination processes back in 2016. As such, EIs were used for decontamination process verification at the aseptic manufacturing facility at Nagese Pharmaceuticals. Their use of EIs and subsequent findings were then presented at the 28th ISPE Aseptic Conference in 2019 under title “Construction of Aseptic Containment Facilities and Overcoming Technical Challenges”
Airex and Nagese Pharmeceuticals received keen interest in the unique content of their presentation despite the conference featuring many new technologies such as Cell Therapy and Robotics. The extent of interest received then spurred Airex and Nagese Pharmeceuticals to publish their presentation as a case study titled “Exploration of the latest GMP trends worldwide and leading technologies in aseptic pharmaceutical manufacturing- Attending the 2019 ISPE Aseptic Conference”
In this case study Ken Nagai, Global Business Director at Airex noted how Airex use of Protak Scientific Enzyme Indicator technology enables “efficiency improvement and deep understanding of decontamination by numerically representing the decontamination strength with EIs” (Enzyme Indicators).
Following the implementation deadline of the EU Annex 1 Good Manufacturing Process (GMP) updated requirements, the need to provide improved contamination control strategies as well as increased use of automated bio-decontamination processes has become a key focus.
Annex 1, section 4.22 specifies that “the bio-decontamination process of the interior should be automated, validated and controlled within defined cycle parameters and should include a sporicidal agent in a suitable form (e.g. gaseous or vaporised form). Gloves should be appropriately extended with fingers separated to ensure contact with the agent. Methods used (cleaning and sporicidal bio-decontamination) should render the interior surfaces and critical zone of the isolator free from viable micro-organisms”.
Unlike conventional tools, Enzyme Indicators offer rapid, quantitative feedback in around 60 seconds, per indicator. Due to the speed and quantitative data collection, the technology provides a stronger level of confidence in bio-decontamination process and, consequently, a greater data driven and consistent approach
The following case study, published by Airex and Nagese Pharmeceuticals in 2019 demonstrates this and also demonstrates how our Enzyme Indicators provide significant advantages over traditional validation methods in identifying worse case challenge locations with unstable decontamination and airflow – such as isolator glove areas.
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