Tepnel is at the forefront of Microbiological analysis and offers access to industry experienced staff as well as cutting edge technology in the battle against the ever intrusive microbe.
Our Approach/Services
The Microbiology Group has extensive experience in performing microbiological analysis on behalf of the pharmaceutical, biotechnology and healthcare industries. All work undertaken at Tepnel is performed under our GxP quality umbrella and complies with current Good Manufacturing Practice(cGMP).
Our range of microbiological services includes:
Method development & Validation
- Microbiological method development and validation (sterile and non-sterile products)
Sterile & Non-Sterile Testing
- Sterility Testing using isolator technology with gaseous sterilisation
- Membrane Filtration
- Direct Inoculation
- Bacterial Endotoxin (LAL) Testing
- Gel Clot
- Kinetic Turbidimetric with 21CFR Part 11 compliant software
- Kinetic Chromogenic with 21CFR Part 11 compliant software
- Microbial identification:
- DNA
- API System
- API lab Software
- Bioburden Analysis (Total Viable Counts & Absence of Specific Pathogens)
- Micro-organism Identification
- Disinfectant Efficacy to EN standards
- Preservative Efficacy Testing
- Microbiological antibiotic assay to Ph.Eur and USP
Monitoring and Stability
- Environmental Monitoring Services
- Stability testing including storage facilities conforming to ICH guidelines (25°C/60%RH, 30°C/60%RH & 40°C/75%RH with continuous monitoring, data security & 24hr call out)
- Ph.Eur., USP and JP Pharmacopoeia testing plus TGA, CFR guidelines, in-house and customer-specified methods
- Consultancy services including QP release testing service
Contact Us:
For further information please contact Andy Maitland, Business Development Manager,
Mobile: 07879 417942
Email: amaitland@tepnelscientific.com
