Quality and controls
Each cleanroom door, airlock, ventilated passbox and control cabinet is designed to meet the most stringent requirements. The materials we use guarantee that all our hermetically sealing doors, pass-throughs and passboxes/hatches boast exceptional mechanical strength. Our quality department verifies the tightness of each door and airlock over time, even under particularly harsh operating conditions.
At the end of this long manufacturing process in our workshops, we test 100% of our production. Our unwavering dedication to a systematic disciplined approach guarantees that our equipment offers unrivalled tightness specifications.
Our quality control department has demanding criteria that go well beyond all current standards. Precision, tightness, robustness, craftsmanship and ease of use are features that provide compelling evidence of Bio-dis’ outstanding expertise. Not forgetting, of course, the durability of our cleanroom passboxes, doors and pass-throughs.
Our products have been extensively tested at an independent laboratory, which has validated the products’ overall sealing and mechanical performance. One test simulates the pressure resistance of the inflatable seal door over 24 hours, maintaining an operating pressure of 2.5 bars. The stainless steel door hinges, with anti-friction bearings, were tested to 200,000 cycles.
Bio-dis is famous for its cleanroom, grayroom, clean zone, and lab equipment installations. To ensure the tightness of these models at a specific positive and negative pressure, the equipment is placed in a test cell (white zone). This zone is then pressurised to a defined level to ensure that each tested model is fully compliant with current quality standards.
CE marking
All our products are CE marked, ensuring their compliance with the requirements defined in European regulations.
National and international benchmarks and standards
The equipment installed by Bio-dis is fully compliant with national and international benchmarks and standards:
ISO 14644-1, ISO 14644-3, ISO 14644-7
Bonnes Pratiques de Fabrication (BPF)
Bonnes Pratiques Pharmaceutiques Hospitalières (GHPP)
NF T 72-281 (decontamination and biocides standard)
Agence Régionale de Santé
Good manufacturing practice (GMP)
Food and Drug Administration (FDA)


