ROUTINE MICROBIAL ANALYSIS
Sure Laboratories performs routine microbiological tests on a large scale base in compliance with international guidance for medical devices, personal care products and utility testing. We are keen to provide you reliable results with fast turn-around-times, as Sure Laboratories recognizes the importance of time management within your Quality Control department.
Pharmaceuticals and personal care products
- Total Aerobic Microbial Count according to European Pharmacopoeia 2.6.12
- Total Yeasts and Moulds Count according to European Pharmacopoeia 2.6.12
- Test for specified organisms according to European Pharmcopoeia 2.6.13
- Bacterial endotoxin testing according to European Pharmacopoeia 2.6.14 (chromogenic kinetic)
- Incubation, interpretation and reporting of clean room agar imprints
- Incubation, interpretation and reporting of biological indicators
Biological indicators – spore count
Medical Devices
- Bioburden testing according to ISO 11737-1
- Sterility testing according to ISO 11737-2
- Bacterial Endotoxin Testing according United States Pharmacopoeia <161>
Water and utilities
- Microbiological quality of water according to PhEur 01/2009:0008 bioburden and endotoxin testing
- Microbiological quality of water according to ISO 6222 36 ± 2 ˚C
- Microbiological quality of water according to ISO 6222 22 ± 2 ˚C
