Analytical and microbiological test data are part of Quality Assurance of your production process, release of final products, process validation and stability studies. As part of Quality Assurance, analytical and microbiological test methods need to be qualified for its intended use, either by suitability testing or validation of the test method.
Sure Consultancy & Research is able to help and guide microbiological method validation for your Quality Control department, so they can focus on their core task.
Examples of such studies:
- Sterility testing (PhEur/USP)
- Microbiological xamination of non-sterile preparation (PhEur/USP)
- Endotoxin tests (PhEur/USP)
- Efficay of microbiological preservation (PhEur/USP)
- Stability studies as per ICH guidelines
- Accelerated aging testing for medical devices (ASTM F-1980)
- Bioburden testing of medical devices
- Sterility testing of medical devices
- LAL testing medical devices
- Package integrity testing
- Container closure testing (microbiological ingress testing)
- Gamma sterilisation validation as per ISO 11137
- Filter integrity testing
- Rapid Microbiological Methods