Pharmaceutical Microbiology Testing Services – Wickham Laboratories
“Wickham Laboratories are familiar with the regulatory expectations of microbiological testing, using industry standard harmonised methods compliant with PH Eur, USP and JP”
Wickham Laboratories undertakes microbiological testing for the pharmaceutical industry by conducting analysis of raw materials, intermediates and final products.
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 support for sterilisation and other processes.
The diverse nature of the pharmaceutical industry means that compliances and regulations require the most up to date legislation.
With over 40 years of experience, our Microbiology department at Wickham Laboratories are familiar with the regulatory expectations of Microbiological Testing, using industry standard harmonised methods compliant with PH Eur, USP and JP.
Routine Quality Control Tests for Microbiological Examination
The Microbiology department at Wickham Laboratories provide 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.
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 on Pharmaceutical Products (Ph.Eur, BP, USP) Validation & analysis available to assess the efficacy of the preservative system across a wide range of product types including, Parenteral, Ophthalmic,Topical or Oral.
Microbial Examination of Non Sterile Products- (Ph.Eur, BP, USP)
- Total viable aerobic counts
- Total viable microbial count
- Yeasts & Mould count
- Tests for specified microorganisms
- Escherichia coli
- Salmonella spp
- Pseudomonas spp
- 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, available for routine quality control and validation.