According to GMP guidance, disinfection procedures shall be validated. Sure laboratories assists its clients with the performance of disinfection studies according to current (European) Guidelines. Sure Laboratories takes pride in its flexibility and fast turn-around times, being aware of the importance of time management within your Quality Control department.
Disinfectants and antiseptics (according to European Guidelines)
- Phase 1 testing: Basic bactericidal activity tests according to EN 1040
- Phase 1 testing: Basic fungicidal activity tests according to EN 1275
- Phase 2 / Step 1 testing: Suspension tests with or without organic soil
- Phase 2 / Step 2 testing: Surface tests without mechanical action (EN 13795)
- Phase 2 / Step 2 testing: Surface tests without mechanical action (EN 16615)
- Customized disinfection testing for proving disinfection efficiency of medical devices for e.g. UV-C disinfection
Sure Laboratories is a member of Technical Committee 216 Disinfectants and antiseptics. TC 216 represents the Netherlands at the CEN commission and advises CEN on European Standards related to microbiological tests.
Challenge tests and Antimicrobial Efficacy Testing
- Antimicrobial Efficacy Testing according to European Pharmacopoeia 5.1.3
- Antimicrobial Effectiveness Testing according to United States Pharmacopoeia <51>
- Antimicrobial preservative testing for assessing discard date contact lens care products according to ISO 14730
- Antimicrobial effectiveness testing of lens care product regiment tests accrediting to ISO 14729 Evaluation of the antimicrobial protection of a cosmetic product according to ISO 11930.
“Sure Consultancy & Research has been of great help during our research project by offering microbial analysis, sharing knowledge, actively participated in the research project and added value to discussions” .