Assuring Sterility, Stability

 and Regulatory Confidence

Pure water is, to put it simply, vital, in pharmaceutical and biopharmaceutical manufacturing. Even the slightest deviation in water quality can risk contamination, product instability, and compliance failure. Impurities or incorrect moisture levels can compromise sterility, reduce shelf life, and degrade the therapeutic efficacy of your product. These risks are not just operational. There is potential for commercial, regulatory, and reputational harm.

The Eurofins BioPharma Product Testing (BPT) network of laboratories provides a comprehensive range of pharmaceutical water testing services designed to protect your process and maintain your regulatory compliance.

Our laboratories perform pharmaceutical water analysis in line with European, U.S., and international pharmacopeial standards (Ph. Eur., USP, JP), offering chemical analysis, physio-chemical analysis, microbiological, and quantitative endotoxin testing for all types of pharmaceutical water and steam samples:

  • Compendial analysis for bulk purified water (PW)/water for injection (WFI) and other grades 
  • Non-compendial chemical analysis of samples from water systems 
  • Non-compendial microbiological analysis of samples from water systems 

Our experts use validated methods and cutting-edge instrumentation to deliver consistent, conclusive results. We support everything from routine monitoring to complex troubleshooting, providing data essential for you to resolve issues quickly and limit impact on production.

Because laboratory water is essential to development and manufacturing, we prioritise responsiveness and reliability with pick-up service and fast, accurate measurement and support that goes beyond analysis.

Eurofins BPT is more than a laboratory provider. We are a partner committed to precision, speed, and uncompromising quality in pharmaceutical water testing, supporting you to deliver safe, effective treatments to patients. 

Services

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Pharmaceutical water testing

Compliant with GMP requirements 

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Water for injection, purified water, and highly purified water (HPW) analysis

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Total organic carbon (TOC), conductivity, nitrates, heavy metals, and microbial limits testing

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On-site system qualification

Including sampling points and distribution loops 

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System suitability testing

For TOC and conductivity measurements 

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Specified organisms

pathogens such as coliforms, E.coli, pseudomonas species, etc.

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Isolate identification to species level

Bacterial and fungal

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Endotoxin analysis

Gel clot, kinetic turbidimetric and kinetic chromogenic

microbiology

Environmental monitoring

Incubation and reporting 

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Expert consultation

On water system design, sampling, and deviation investigation 

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Client site-based training

For water sampling/aseptic technique 

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Harmonised services

through our global network of GMP-compliant laboratories 

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Quick turnaround times

that do not compromise on data integrity