Effective decontamination of cleanroom facilities and other sensitive environments is a critical element in various sectors. Being able to ensure full decontamination of biological pathogens – including bacteria, fungi, spores and virus contaminants – is vital if companies are to remain in compliance with key regulations – including Annex 1.
This is why an effective validation solution to confirm the success or failure of the process is essential, whether in pharmaceutical manufacturing, healthcare facilities, research centres or other life science organisations.
Improving scheduled or routine decontamination of critical areas
Bio-decontamination of environments will need to be conducted as a matter of routine in many facilities, including applications such as medical device manufacturing and pharmaceutical product manufacture. Therefore, steps to ensure these processes are as fast, effective and efficient as possible are essential.
What are the considerations for bio-decontamination?
Typically, a facility – whether a cleanroom, isolator or other enclosed chamber – will be decontaminated using hydrogen peroxide vapour (vH2O2) injected into the target environment. This should be a controlled, consistent and repeatable process in order to minimise efficacy issues.
However, the efficacy of these processes can be affected by a number of variables. For example, even small changes in humidity and temperature can cause wide variations in the efficacy at any given location,resulting in failure of the bio-decontamination process. Organisations that fail to control for these variables may not be able to determine why a certain cycle fails, even if it appears to begin from the same starting conditions.
Other issues include where to best place indicators for validation to ensure the effectiveness of the bio-decontamination procedure is being effectively monitored. Having a clear understanding of these and using a risk-based approach helps minimise the number of indicators used while still having full coverage of the chamber being treated.
What are the risks of not using advanced bio-decontamination validation services?
A failure to adequately bio-decontaminate systems can be very costly. Typically, following cycle development and initial validation (Performance Qualification), cycles are re-qualified annually. A failed re-qualification attempt places any products created in the chamber since the last successful qualification at risk of contamination.
As well as establishing and rectifying the root cause of the failure – a potentially costly and a lengthy exercise in itself – a thorough investigation will be needed to assess the impact on previously manufactured batches. These products should be placed in quarantine and potentially recalled. This can be a hugely costly exercise, both in terms of the financial value of any lost products and extended manufacturing times.
Such events can also lead to long-lasting loss of confidence in, and reputational damage to the manufacturer. Use of advanced bio-decontamination process validation can significantly reduce all these risks.
What are the benefits of bio-decontamination services?
Understanding all these considerations and maintaining regulatory compliance, including the revised Annex 1, can be a tall order for many organisations. Therefore, using a bio-decontamination services consultant can be a great way to address potential issues and develop an effective strategy to ensure these processes can be carried out effectively, and that validation procedures are as fast and informative as possible.
What are the considerations for choosing a bio-decontamination validation service provider?
Companies may opt for a service that simply provides the indicators needed to carry out validation. However, a true partner can offer much more than this. When considering a supplier, you should ask how they will get involved at every stage of the process, from helping to define your requirements and formulating an initial plan all the way through to performance qualification and beyond and maintaining regulatory compliance.
The technology used should also be considered. Traditionally, bio-decontamination processes are validated using Biological Indicators (BIs). However, these offer limited information and take seven days to produce a result. Added to this is that they cannot be taken into live production areas due to the unacceptable risk of product contamination with viable organisms this makes BIs unsuitable for routine processes that require rapid results.
Protak’s Enzyme Indicators, on the other hand, produce quantifiable data that can be used to rapidly optimise processes, as well as offering much faster same-day results – just 60 seconds per indicator. Enzyme Indicators have the added advantage of being non-viable and can therefore be used in routine production for continuous process verification (CPV). This may eventually eliminate the need for annual requalification, which requires costly and lengthy manufacturing shutdowns and loss of production time.
How can partners go beyond bio-decontamination validation technology?
As well as providing the right bio-decontamination equipment and validation technology to give users the answers they need quickly, a good supplier can offer a full range of consultancy services to help improve efficacy and cost-effectiveness.
Among the value-added services that can be offered throughout the bio-decontamination lifecycle are:
- Determining a User Requirements Specification of the bio-decontamination equipment and process that meets the unique needs and objectives of the intended use.
- Design qualification to ensure the equipment and process is fit for purpose and all required documentation is complete and available.
- Risk assessment to identify any particularly challenging areas that require additional focus.
- Load optimisation advice to ensure adequate distribution of vH2O2 across every exposed surface.
- Installation qualification to ensure all assets are delivered, installed and configured to the correct specifications.
- Staff training to equip all operators in the correct use of the bio-decontamination system from loading and testing.
How can bio-decontamination services help ensure Annex 1 compliance?
Recently revised guidelines for Annex 1 have placed a greater focus on more detailed requirements for bio-contamination validation. This means all manufacturers of sterile products employing bio-decontamination must focus on proving these requirements to ensure they remain compliant.
As an example, the regulations have specific requirements for the use of irregular and porous surfaces such as gloves, and it can be difficult to interpret these. Bio-decontamination service providers can assist with this by offering advice and support throughout the process.
This means nothing is overlooked and any particularly challenging aspects are fully evaluated by an outside eye. This ensures bio-decontamination is treated as a holistic process where validation is factored into the strategy right from the start.