Pharmaceutical Microbiology Testing, Sterility Testing, Total Viable Count, Preservative Efficacy Testing, Absence of Specific Pathogens

Pharmaceutical Microbiology Testing

Sterility Testing
Total Viable Count
Absence of Specific Pathogens
Preservative Efficacy Testing
Bacterial Endotoxin Testing

With over 30 years experience in pharmaceutical microbiology testing, Tepnel Pharmaceutical Services offers a range of microbiology testing services which span the drug development pipeline including amongst many: total viable count, absence of, preservative efficacy testing, endotoxin testing and sterility testing services.

New non-sterile harmonised methods now available

Tepnel Pharmaceutical Services is now able to offer the harmonised methods for non-sterile pharmaceutical microbiology testing, making it quicker, more cost effective and easier for manufacturers of non-sterile monograph or non-monograph products to comply with the new regulations for European, US and Japanese Pharmacopoeias.

What are the benefits?

Standardises your testing regime
In some instances, sample quantities are reduced
Eliminates the need, costs and time of duplicate testing
Improved microbiological testing
Harmonised Tests include sterility testing, absence of, total viable count, preservative efficicacy testing

These new methods are fully established at Tepnel Pharmaceutical Services. All work undertaken is performed under our GxP quality umbrella and complies with current Good Manufacturing Practice (cGMP). In order to maintain compliance, please contact us for a proposal on +44 (0)1506 424270 or email pharmaservices@gen-probe.com

Other Pharmaceutical Microbiology Services

Specialist Microbiological method development and validation (sterile and non-sterile products)
Sterility Testing using isolator technology with VHP sterilisation
Bacterial Endotoxin (LAL) Testing - Gel Clot/Kinetic Turbidimetric & Chromogenic
Bioburden analysis - Absence of & Total Viable Counts
Microbial identification - DNA/API System & API lab software
Preservative Efficacy Testing
Microbiological antibiotic assay to Ph.Eur and USP
Environmental Monitoring Services
Stability testing support for API and finished products
Ph.Eur., USP and JP Pharmacopoeia testing plus TGA, CFR guidelines, in-house and customer-specified methods
Consultancy services including QP release testing service

Gen-Probe Life Sciences Ltd.
Tepnel Pharmaceutical Services
Appleton Place
Appleton Parkway
Livingston
West Lothian. EH54 7EZ
Tel: +44 (0)1506 424270
Email: pharmaservices@gen-probe.com