Eindhoven, North Brabant, Netherlands
Sure Laboratories is an independent, young and well experienced microbiological laboratory based in the Brainport Region Eindhoven, close to Pivot Park, Brightlands campuses, the Antwerp region and Germany. We are dedicated to pharmaceutical and medical device microbiological analysis asa well as disinfectant testing to support our customers in the Life Science Industry and High-Tech Food/Agro Industry. It is our mission to accelerate your R&D and QC processes, using short communication lines with a high level of microbiological knowledge. All work is executed according to an ISO 13485:2016 quality system and an approved EU-GMP quality system. What we do: - Validation of disinfectants and disinfection procedures in production environments - Qualification of chemical disinfectants according to EU guidelines (surface and hand hygiene) - Method validations of microbiological tests/analyses - Microbiology for Cannabis and cannabis related products - Clean room design (microbiological), validation and IOPQ thereof - Validation of irradation processes based on ISO 11137 (and related guidance) - Quality systems (ISO 13485, ISO 9001) - Pharmaceutical microbiology - Rapid Microbiological Methods (sterility testing; bioburden) - Design of microbiological laboratories - Development, validation of and microbial analysis of pharmaceuticals and medical devices. - Microbial capability screening of production processes 2WaveDiagnostics enables new platforms and laboratory testing for diagnostic purposes.
EU-GMP license for microbiological testing ISO 13485:2016 certified microbiological research & testing services Opium Acts Exemption Experts in Cannabis microbiological testing Disinfection Efficacy Studies Antimicrobial effectiveness studies Innovative sterilization and preservation processes Pharmaceutical and medical device microbiology Hygiene and disinfection of production areas Clean rooms cleaning, disinfection and performance monitoring Microbiological validation and qualification Sterilisation validation (gamma)
Enabling new platforms and laboratory technology for diagnostic purposes.
- As a member of the TC 216 NEN mirror group reviewing TC 216 documents. - Representing the Netherlands (NEN) in: CEN/TC 216 WG 01 "Human Medicin" CEN/TC 216 WG 03 "Food, Hygienic and Domestic and Institutional use"
Support and consultancy for QC laboratory.