CERTIFAB

A helping hand to a turn-key plan, whatever your needs demand

banniere

Projects we realized

(partial list):

ISO 13485 Support for Cleanroom Manufacturing of Medical Device, ABK, Halifax, NS.
Design, Build, and Certification ISO 7 Medical Device Showcase Cleanroom, Agile MV, Montreal, QC.
Certification, Monitoring, and Cleaning of Aerospace Laboratories, Canadian Space Agency, St-Hubert, QC.
Certification of Hygiene and Hospital properties of Furniture and Seating Systems, ADI, St-Hubert, QC.
Certification of Electrostatic ESD properties of Furniture and Seating Systems, ADI, St-Hubert, QC.
Manufacturing Process Validation, Master Plan, Interim Plans, IQ/OQ/PQ, for medical devices, Plastiques Moore, St-Damien, QC.
Cleanroom (USP797) Performance testing and Certification Sterile Pharmacy, Hôpital Haut-Richelieu, St-Jean-sur-Richelieu, QC.
Cleanroom Re-Furbishing, Start-up, and Certification, McGill University Eath Sciences, Montreal, QC.
Design, Specifications, construction and certification FDA, SOPs and IQ/OQ/PQ Cleanroom (ISO7) for medical devices, Plastiques Moore, St-Damien, QC.
Construction protocol, site supervision, testing and certification ISO NEBB Cleanrooms ISO 4 to 8, Research Facility C2MI for ebc Construction, Bromont, QC
Cleanroom (USP797) Performance testing and Certification Sterile Pharmacy, Hôpital du Surôit, Valleyfield, QC.
Design, Specifications, construction and certification FDA, SOPs and IQ/OQ/PQ Cleanroom (ISO7) for medical devices, Kamek, Baie d’Urfé, QC.
Design, Specifications, construction and certification sterile BCL3 Cleanroom, Warnex, Laval, QC.
Construction protocol, site supervision, testing and certification ISO Cleanrooms, Canadian Space Agency, St-Hubert, QC
Cleanroom performance testing and Certification Sterile production, TYCO Healthcare Group, Pointe-Claire, QC.
Analysis and certification of high purity gases for sterile manufacturing, Sanofi Aventis, Laval, QC
Analysis and certification of high purity gases, IBM Canada, Bromont, QC
Design, Specifications, construction and certification FDA, SOPs and IQ/OQ/PQ Cleanroom (ISO7) for Pharmaceutical Active Ingredient, Synthetica, Vaudreuil-Dorion, QC.
510K filing, ISO9000 Quality system implementation, Class 2 injection device, Duoject Medical, Bromont, QC.
Construction protocol, site supervision, testing and certification ISO Cleanrooms ISO 5, Nanotechnology micro-electronics, McGill University, Montréal, QC.
Construction protocol, site supervision, testing and certification ISO Cleanrooms ISO 5 for medical devices, ANRAD Canada, St-Laurent, QC.
Turn-Key, design, construction, testing and Certification and Start-Up ISO 5, Class 100 Cleanroom, Stocker Yale Canada, Dollard-des-Ormeaux, QC.
Turn-Key, design, construction, testing and Certification US FDA ISO 7 Grade C Biological Cleanroom for Medical Devices, CryoCath Technologies, Kirkland, QC.
Design and Consulting for HVAC sterilization, Isolation rooms and ISO 7 cleanrooms, Hôpital Ste-Justine, Montréal, QC.
Turn-Key, design, construction, testing and Certification and Start-Up Class 10 000, AlfaLight Canada, Vaudreuil-Dorion, QC.
Design and Engineering for Reliability Testing Burn-in ovens, AlfaLight Canada, Vaudreuil-Dorion, QC.
Design and testing ISO4 Class 10, Cleanroom and Ultra-Pure Water for Garment laundering and sterilization, SIC Inc., Bromont, QC.
Construction protocol, site supervision, testing and certification, and Start-up of Cleanrooms Class10/ISO4, 100/ISO5, 1000/ISO6), l’Institut National de Recherche Scientifique, Ste-Julie, QC.
Consulting for design, construction, start-up and operation of cleanroom laboratories (Classes 10000 et 1000) and high purity services, Earth Sciences. President Kennedy Pavilion, Université du Québec à Montréal, Montréal, QC.
Personnel Training for Cleanroom Procedures and GMPs, all the above projects.

nettoyage desinfection

aspiration dépoussiérage

lavage des murs