A Contamination Control Strategy (CCS) is a process that all aseptic pharmaceutical manufacturing organisations are required to have in place. It considers every aspect of the manufacturing process, including:
- Microbial contamination
- Sterility assurance
- Cleaning and disinfection
- Chemical and particle contamination
- Any other form of contamination that could arise from damage, distribution issues and environmental fluctuations
The CCS is a vital part of the EU GMP Annex 1 revision and each organisation will have its own put under scrutiny. As such, the importance of quality assurance is paramount. Ultimately, every manufacturer must have a comprehensive, detailed strategy in place.
How Enzyme Indicator technology supports Critical Control Points when implementing Annex 1 Revisions
Sterile manufacturers will be acutely aware of the numerous challenges to bio-decontamination validation that traditional technologies present – from temperature and humidity changes, air flow variation and hydrogen peroxide levels; to load configuration, ‘materials of construction’ and surface irregularities.
Enzyme Indicators can help provide tangible, quantifiable evidence of an effective vaporous bio-decontamination.
The process and stages of cycle development and validation to achieve consistent levels of ‘Log 6 reduction’ of biological kill can often be between 6 to 12 months – from initial engineering to periodic requalification. Traditional bio-decontamination methods such as biological indicators have a high variability and risk of cycle failure and offer no comprehensive, quantifiable understanding of the validation process.
How Protak’s Enzyme Indicator technology helps
Our Enzyme Indicator technology is already helping more than half of the top 20 pharmaceutical manufacturers worldwide. No longer do users need to rely on an initial validation, followed by periodic revalidations, to assess bio-decontamination effectiveness.
Instead, highly detailed information is available in just 60 seconds, with numerical, linear values that allow organisations to see exactly how effective the process was in every single challenge location.
This means users gain a far more comprehensive view of the bio-decontamination process, informed by real-time data across a vast array of challenge points and surface types. Ultimately, this leads to a significantly reduced risk of cycle failure and removes the possibility of false positive results.