CERTIFAB

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

banniere

Services and Standards

QUALIFICATIONS

For more than 25 years ensuring consulting, coordination and management of all aspects of laboratory, cleanroom, and contamination controlled processes. Expertise in architecture, interior systems, mechanical, ventilation, plumbing, decontamination, and testing : as such offering complete services, such as:

Standards and Quality

ISO 9000, ISO13485, ISO14644

US FDA 510k

Standards and Good Manufacturing Practices US FDA, CE, ISO, WHO

Aseptic Pharmacies, USP797, USP800, OPQ, NAPRA.

Standards ASTM, CSA, UL, ASME, BS, AFNOR, JSA, ASHRAE

Validation, Certification and Testing

Cleanrooms (ISO14644, US-Fed-209, CEN, FDA)

Laboratory and Hoods NSF ASHRAE

High purity gases

Biocontamination CETA

Environment

Balancing NEBB

Temperature

Humidity

Vibration

Noise

Electrostatic

Decontamination and Start-Up

Janitorial

Parts and Equipment Cleaning MIL Standards

Development of cleaning procedures

Systems Design Engineering

High Purity (water, air, gases)

Workstations and supplies (clean benches and hoods)

Aseptic Systems FDA/ CGMP (laboratories and services)

Concept and Specifications, Turn-Key Projects, such as:

Cleanrooms ISO 14644

Laboratories

Anhydrous rooms

Part Cleanliness Testing

Automotive ISO 16232, VDI



Providing all the required services to support your activities.

nettoyage desinfection

aspiration dépoussiérage

lavage des murs