Online bioburden and pure water analyser
Leverage your contamination control strategy with the primary validated and 21 CFR part 11 compliant rapid bioburden analysis system.
Efficiency
Get real-time data to ensure the purification, storage and distribution stages are never compromised.
Compliance
We support USP 1231 standard compliance by providing continuous, accurate monitoring at every stage.
Confidence
Get a faster, more reliable way to manage pharmaceutical water quality and compliance.
Challenges in bioburden testing and ultrapure water system maintenance
Pharmaceutical companies struggle with slow and tedious compendial bioburden testing, leading to clearance delays and difficulties in balancing cost and risk in decision making.
Another challenge is maintaining and sanitising ultrapure water treatment systems, which can lead to downtime and raise risks of out-of-spec events, product recalls and reduced asset utilisation in case of contamination or inadequate sanitation.
Ensuring pharmaceutical water quality at every stage
Boost performance and manufacturing
Gain insights into every stage with a solution compliant with EU GMP Annex 1 FDA 21 CFR Part 11 and European Pharmacopoeia standards.
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Replace tedious compendial lab tests with more performant and validated methods.
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Identify critical control points for regular grab sampling campaigns and understand the temporal dynamics of production assets.
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Efficient and effective troubleshooting after an out-of-spec result with a manual grab sampling campaign or online monitoring of a suspicious asset.
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Faster root cause analysis: localise the issue, remediate it and return it to operation.
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Online monitoring of critical treatment barriers and steps (filtration, disinfection, storage) and immediate response to abnormal change.
Gain speed, shrink costs
Make decisions confidently, no longer waiting on lab results. BactoSense PURE provides:
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Unbiased bacterial counts and event-based sampling to act faster.
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Faster release of raw materials and final product.
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Reduce downtime of expensive equipment by speeding up cleaning validation and troubleshooting.
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Optimise sanitation and extend the lifetime of high-value assets to prevent underutilisation.