Absence of Specified Microorganisms Testing

Pharmaceutical grade water, including Purified Water (PW) and Water for Injection (WFI), must comply with the strictest microbiological standards. One of the most critical is the absence of specified microorganisms — ensuring water is free from objectionable organisms that could compromise product quality, patient safety or regulatory compliance.

At Honeyman Laboratories, we carry out absence testing in full alignment with:

  • Ph. Eur. 2.6.13 – Microbiological Examination of Non-Sterile Products: Test for Specified Microorganisms
  • USP <62> – Tests for Specified Microorganisms
  • BP and JP equivalents
  • Which organisms are tested?

    Depending on product type and water use, the following organisms are typically targeted:

  • Escherichia coli – compulsory for PW and WFI in pharmacopoeial monographs
  • Pseudomonas aeruginosa – a key requirement where water is used for topical products or clean utilities
  • Staphylococcus aureus – relevant for non-sterile pharmaceutical preparations
  • Salmonella spp. – objectionable in all oral and topical preparations
  • Candida albicans – included for oral and topical preparations
  • Clostridia – where specifically required
  • Our testing employs validated enrichment broths and selective agar media designed to recover even low numbers of organisms. Incubation is typically 18–72 hours depending on the organism and media, providing reliable detection without unnecessary delay.

    Why is absence testing important?

    Routine total viable count (TVC) monitoring tracks microbial trends in water systems, but it does not confirm the absence of specific objectionable organisms. Absence testing provides assurance that critical pathogens are not present, fulfilling pharmacopoeial requirements and demonstrating control of your water system in line with GMP.

    Why choose Honeyman Laboratories?

  • MHRA-approved, cGMP laboratory with over 30 years’ experience
  • Onsite GMP-trained samplers to ensure correct aseptic sampling and avoid false positives
  • Validated cold-chain transport to maintain sample integrity from your facility to our labs
  • Complete service model – microbiological testing, chemical analysis and water system consultancy through Honeyman Water
  • Regulator-ready reporting – we provide not just results, but full interpretation, corrective action guidance and trend analysis to support inspections
  • Honeyman Laboratories is trusted by leading global pharmaceutical manufacturers to provide accurate, compliant and independent microbiological testing. Whether you need routine compliance checks or bespoke validation protocols, we deliver the reassurance that your pharmaceutical water systems are safe, compliant and inspection-ready.

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