The importance of validating bio-decontamination processes in areas such as pharmaceutical and medical device manufacturing is critical to achieve and remain in compliance with regulations. This significantly reduces the risk of costly delays. But what do organisations need to know in order to do this effectively?
Understanding the need for effective bio-decontamination processes
Successful bio-decontamination is not an easy task. There are a number of essential steps that need to be followed and care must be taken to ensure all processes follow the same conditions in order to meet both user and regulatory requirements.
If any of these critical elements are overlooked, validation of bio-decontamination processes may fail, leading to potentially costly delays in manufacturing or the destruction of potentially contaminated products.
What are the considerations for choosing a bio-decontamination method?
For most applications including aseptic pharmaceutical manufacture, healthcare (hospital pharmacies) and original medical equipment manufacture, the use of hydrogen peroxide for bio-decontamination will be the best solution compared to other methods such as ethylene oxide. This offers a number of advantages, including a fast cycle time, effectiveness at low temperature, good material compatibility and safe byproducts.
As well as the decontamination method used, companies also need to make a decision on how to validate these processes. Traditionally, Biological Indicators (BIs) are used as the validation method. However, this validation process can give limited information and cause delays in results. There can also be variation between BIs, even within the same batch, so it is difficult to effectively demonstrate repeatability of a bio-decontamination process using these indicators.
Opting for Enzyme Indicator inclusion can avoid and highlight these issues. This technology delivers much faster, quantitative results, without the risk of introducing viable organisms into your process. Enzyme Indicators provide a smart, safe solution for validation.
What is the difference between bio-decontamination and sterilisation?
While the two terms are sometimes used interchangeably, it is important to remember that bio-decontamination and sterilisation are not the same. While both aim to eliminate microorganisms including bacteria, fungi and viruses from an environment, hydrogen peroxide decontamination is a surface-level activity, as it is unable to penetrate beneath surfaces.
For this reason, the term ‘sterilisation’ should be reserved for penetrative processes such as Steam, Irradiation or Ethylene Oxide, that are able to go beyond a surface and reach, whereas vaporised hydrogen peroxide is more properly considered bio-decontamination.
What are the best practices for successful bio-decontamination?
There are a range of challenges that must be addressed in order to develop and validate a successful bio-decontamination cycle. However, with the right practices – and the right technology, firms can ensure these critical activities are as cost-effective and efficient as possible.
What are the key guidelines for bio-decontamination processes?
Successful bio-decontamination requires a holistic approach that starts with clear initial requirements and design. A key first step in any process is ensuring the specific requirements for the procedure are clearly documented. This should include everything from the materials used in the construction of the isolation chamber to the load configuration specifications.
Ensuring that the chamber is controlled for temperature, relative humidity and relative saturation is vital. Even slight changes in these variables could make the difference between a pass and fail when it comes to validation, and it is easy for users to overlook these aspects at the design phase. If this is the case, it may require a lengthy and costly investigation to pin down the root cause of a bio-decontamination failure.
Validation processes should also be clear and repeatable to guarantee consistent results. This ranges from ensuring indicators are placed at the most appropriate challenge locations to analysing data to identify areas when improvement is needed.
What are the costs associated with bio-decontamination?
Failure to ensure issues such as material compatibility, control of environmental conditions or VHP concentration can all lead to a failure of bio-decontamination validation. In such cases, these can result in a wide range of costs.
In some cases, a validation failure may mean high cost products must be destroyed or recalled. This is a particular risk when using indicators such as BIs, which are inherently variable and require a seven-day incubation period before providing results.
Enzyme Indicators, being non-viable, can be used for continuous process verification (CPV). This can avoid costly down-time in the manufacturing process to allow for re-validation of a bio-decontamination process using BIs which pose a risk of product contamination.
What are the challenges of meeting regulatory requirements?
Updated Annex 1 regulations state that bio-decontamination processes of critical areas such as isolators or cleanrooms should be automated, validated and controlled within defined cycle parameters. As part of this, users are required to fully understand and validate the efficacy of any VHP agent and dispersion system.
Use of Enzyme Indicators during cycle development and qualification allows for greater visibility, through quantitative results, of the efficacy of a cycle at different locations throughout an isolator or cleanroom. It is possible to very quickly map distribution and therefore determine the areas to focus on for improvement.
