Microbiology Services - Pharmaceutical Testing

Wickham Laboratories undertakes microbiological testing for the pharmaceutical industry, conducting analysis of a wide variety of pharmaceutical products for batch release into European and International markets.

Data produced by our microbiology department has been used to support license applications in Europe and NDA submissions in the USA.

The microbiology department offers a range of services for the routine quality control, method development and validation of products as well as microbiological testing for the sterilisation and other processes.

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Microbiological Testing Legislation Requirements

The pharmaceutical industry is driven by regulatory pressures and we invest in our quality systems to ensure compliance with GMP, GLP and FDA requirements.

With over 40 years of experience, our microbiology departments at Wickham Laboratories are familiar with the regulatory expectations of microbiological testing, using industry standard harmonised methods compliant with PH Eur, USP and JP.

Sterility Testing (Ph.Eur, BP, USP)

Dedicated clean-room facility (ISO Class 7)
Two Flexible film positive pressure isolators (ISO Class 5)

Membrane filtration methods using the Millipore Steritest^® system
Direct inoculation & sterile fluid pathway testing.

Efficacy of Antimicrobial Preservative in Pharmaceutical Products (Ph.Eur, BP, USP)

Validation & analysis is available to assess the efficacy of the preservative system across a wide range of product types including, Parenteral, Ophthalmic, Topical or Oral.

Routine Quality Control Tests for Microbiological Examination

At Wickham Laboratories Ltd, the microbiology department has extensive expertise in the microbiological testing of different dosage forms, raw materials, intermediates and final products. Using in-house, clients own methods or standard procedures, the department provides a rapid, cost effective service for all your testing requirements.

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Microbial Examination of Non Sterile Products (Ph.Eur, BP, USP)

Total aerobic microbial counts

• Total bacterial count
• Yeasts & Mould count

Tests for specified micro organisms

• Legislation Escherichia coli
• Salmonella spp
• Pseudomonas aeruginosa
• Staphylococcus aureus
• Bile tolerant Gram-negative Bacteria

Bacterial Endotoxin Testing (Ph.Eur, BP, USP)

Gel clot method as an end point assay or semi quantitive titration. Kinetic chromogenic and turbidimetric method are available for routine quality control and validation.

Pharmaceutical Testing - Results and Reporting

Validation and project work may be performed to a protocol and the findings detailed in a final report to GMP. Routine analysis is typically reported on a certificate of analysis. Urgent results may be reported electronically as E-mail, scanned PDF documents or Faxes to speed up the reporting process where required.

Consultancy Support & Advice

In addition to laboratory services mentioned, Wickham Laboratories Ltd offers support and consultancy for;

• Clean rooms
• Water systems
• Microbiological issues

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