Certifications and standards
All our equipment is designed, manufactured, and validated under the most demanding international standards. We provide qualification documentation and full traceability for each project.
International standards we comply with
Our commitment to quality is reflected in strict compliance with globally recognized standards for contamination control equipment.
NSF/ANSI 49
North American standard for the design, construction, performance, and field certification of Class II biosafety cabinets. Defines containment tests, airflow velocity, and leak tightness.
EN 12469
European standard specifying performance requirements for microbiological safety cabinets, including operator protection, product protection, and cross-contamination control.
ASHRAE 110
Standard method to evaluate the containment performance of laboratory fume hoods using face velocity testing, smoke visualization, and SF₆ tracer gas testing.
EN 14175
European standard for laboratory fume hoods. Establishes requirements for design, safety, containment test methods, and aerodynamic performance.
ISO 14644
International standard defining air cleanliness classification in cleanrooms and controlled environments (ISO Class 1 to 9). Basis for pharmaceutical and industrial cleanroom design.
ISO 16890
Classification system for air filters in general ventilation. Rates filters based on efficiency for PM₁, PM₂.₅, and PM₁₀ particles.
FDA 21 CFR / EMA GMP Annex 1
Good Manufacturing Practice regulations for the pharmaceutical industry. Define air requirements, pressure differentials, and area classifications for drug production.
ISPE HVAC
Guideline from the International Society for Pharmaceutical Engineering for HVAC system design in pharmaceutical facilities. Reference for AHU sizing and pressure cascades.
OSHA / ACGIH
Occupational safety regulations and industrial hygiene guidelines for exposure limits to chemicals, particles, and biological agents in the workplace.
NFPA 30 / 45
Standards from the National Fire Protection Association for storage of flammable liquids (NFPA 30) and use of chemicals in laboratories (NFPA 45).
Validation and documentation
We provide complete qualification documentation for each piece of equipment, ensuring traceability and regulatory compliance from the factory to installation.
Design Qualification
Verification that the equipment design meets user requirements (URS) and applicable standards.
Installation Qualification
Documented verification that the equipment is installed according to specifications and in compliance with the approved design.
Operational Qualification
Performance testing: airflow velocity, particle counting, filter integrity, differential pressure, and leak tightness.
Performance Qualification
Verification that the equipment consistently operates within parameters under real operating conditions.
Do you need validation documentation?
All our equipment can include DQ/IQ/OQ/PQ protocols tailored to your specific regulatory requirements. Contact our team.
Request information →Do you need technical advice for your project?
Our team of engineers is ready to help you find the ideal solution.
Talk to an engineer →
