Pharmaceutical Microbiology Services
Tepnel operates as a Pharmaceutical Quality Control Laboratory offering a comprehensive range of regulatory compliant (MHRA and FDA) pharmaceutical microbiology testing services that span the drug development pipeline. It is the objective of these suite of testing services to ensure that your product is safe from microbial contamination.
For a variety of reasons, there are a number of problems that can be associated with the microbiological contamination of pharmaceutical products and their ingredients. Therefore, each manufacturer is expected to develop microbial specifications for both their sterile and non-sterile products such that patient safety is ensured throughout the manufacturing process. Our pharmaceutical microbiology laboratories have been involved in sterility testing, detection, isolation, enumeration and identiﬁcation of microorganisms (bacteria, yeast and moulds) testing for bacterial endotoxins and supporting environmental testing of manufacturing facilities for over 25 years.
Our complete range of services include:
- Sterility testing using isolator technology
- Bacterial endotoxin analysis (LAL Testing)
- Bioburden testing – harmonised absence of and total viable counts
- Microbial identification
- Preservative efficacy testing
- Microbiological antibiotic assay
- Environmental monitoring services
- Consultancy services
- Specialist microbiological method development and validation
- Sterile and non-sterile products
Tepnel will work closely with you to determine your raw materials testing and microbiology testing requirements before embarking on any project, ensuring that the appropriate levels of validation of test methods, media and equipment used in methods is built into your testing protocols and specifications.
Sections in Raw Material Testing Service
- ICH Stability Testing Services
- Batch Release Services
- Raw Material Testing Service
- Method Development and Validation
All Raw Material Testing Service
- Pharmacopeial Monographs
- Excipients, Ingredients, API and Finished Products
- Pharmaceutical Microbiology Services