As professionals in the pharmaceutical and life sciences sectors are well aware, the market is currently struggling with a global supply challenge of Biological Indicators (BIs). BIs are important tools for bio-decontamination validation and their scarcity can lead to delays in validation, disruption to supply chains and greater uncertainty.
What are the causes of this shortage, what are the impacts and how can users mitigate the issues?
Biological Indicators are in high demand in today’s environment, with this set to increase further in the foreseeable future. These insights show this isn’t just limited to manufacturing settings. Growth has been seen in other areas such as bio-decontamination in clinical settings, within hospitals and research laboratories which suppliers are struggling to keep up with.
What does this growing imbalance between supply and demand mean for organisations that are dependent on BIs?
A lack of availability or reduced number of BIs can lead to significant hold-ups in areas such as pharmaceutical manufacturing. With rigorous regulations in this area, companies cannot afford to run the risk of non-compliance if they are unable to demonstrate processes are robust, understood and validated. Therefore, this means equipment for medicinal product manufacture cannot be put into beneficial use.
This can cause higher costs to validation projects execution and, in some cases, entire projects being paused. The knock-on effect for the wider supply chain is also significant, resulting in longer lead times for essential medicinal product or equipment reaching the market.
Despite these challenges, there are alternative options available for companies that require fast, effective bio-decontamination validation. Using Enzyme Indicators (EIs) as a complementary diagnostic tool to BIs can help address many of the issues related to the current challenging situation.
EIs offer more than just a simple pass/fail validation result. They provide an in-depth level of data into the performance of bio-decontamination processes, offering greater insight to help optimise these critical activities.
When used in conjunction with BIs, EIs can expedite validation activities and reduce the number of BIs used, hence reducing BI dependence greatly. This allows companies to maintain compliance and protect their operations whilst building an efficient and resilient validation process. In an environment where BI use alone isn’t sustainable, having other options for these critical activities helps build an efficient and resilient validation process.
Find out more here about how this is being put into practice and click here to watch our latest webinar on how EIs complement BIs.
Read about the advantages and benefits of using our Enzyme Indicators for your H₂O₂ bio-decontamination validation processes.
Biological Indicators vs Enzyme Indicators at a glance.
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