TraditionalREF 610312
Industry · Solutions
Microbiology testing for pharmaceutical manufacturing.
Bioburden, environmental monitoring and objectionable-organism testing sit at the centre of pharmaceutical quality — where the standard is compendial method, not a customer specification. We supply the reference media and standards that keep that defensible.
Your testing reality
Pharmaceutical microbiology answers to a different standard than food or beverage QC: compendial method, not a customer or retailer specification. USP, EP and equivalent pharmacopoeial methods define how bioburden, environmental monitoring and objectionable-organism testing are run, and deviation from the specified method is itself a finding.
Environmental monitoring carries continuous weight rather than per-batch weight — cleanroom classification depends on an ongoing programme of settle plates, contact plates and active air sampling, not a single release test. Reference cultures for method validation and positive controls are inseparable from that programme: an EM result is only as defensible as the traceability behind the culture that validated it.
Water systems add a third obligation — pharmaceutical water (purified water, water for injection) carries its own compendial testing requirement, tested on a schedule independent of product release.
- Compendial method, not specification
USP, EP and equivalent pharmacopoeial methods set the standard — deviation from the specified method is itself a finding.
- Continuous EM programme
Cleanroom classification depends on an ongoing schedule of settle plates, contact plates and air sampling, not a single release test.
- Traceable reference cultures
An EM or bioburden result is only as defensible as the traceability behind the culture that validated the method.
What to test for
Bioburden, objectionable organisms and the reference standards a validated method depends on.
The core panelPathogens for safety · indicators for control
- Staphylococcus aureuspathogen
- Escherichia colipathogen
- Pseudomonaspathogen
- Salmonellapathogen
- Total Microbial Countindicator
- Enterobacteriaceaeindicator
- Yeast and Mouldindicator
- Coliformindicator
Methods for your operation
Compendial method defines the workflow; reference standards make it defensible.
- Traditional · ISO/USPFor compendial bioburden and EM
Reference culture media manufactured to compendial (USP/EP-aligned) formulations for bioburden and environmental monitoring.
- RapidFor routine EM screening
Ready-to-use contact plates and settle plates sized for a continuous environmental monitoring schedule.
- Molecular · PCRFor objectionable-organism confirmation
Real-time PCR for rapid, high-specificity confirmation of objectionable organisms flagged in routine testing.
Products for pharmaceutical plants
A representative selection across the core panel. The full range is available in the catalogue.
Results that
withstand scrutiny.
Every product is supplied against recognised methods and validation — culture media according to ISO methods, rapid media plates with AOAC certifications, and world renowned reference materials with documented traceability — dispatched by an SFDA-licensed company. Suitable for use in ISO/IEC 17025 accredited laboratories.
Laboratory-ready traceabilitySuitable for ISO/IEC 17025 accredited workflows.
Independent method validationAOAC-certified rapid media plates for routine testing.
Licensed Saudi supplyProducts dispatched through an SFDA-licensed company.
Sourced from the brands your methods are built on.
Building or upgrading your testing programme?
Tell us your product lines and the organisms you're required to test — we'll recommend methods and respond with pricing, availability and lead time.