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Cleanrooms

Medical Device Cleanrooms

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We are recognised manufacturer, supplier and exporter since past several years in Clean room business. We understand client's requirement and application as per that give solutions so his need can be fulfilled. While designing and manufacturing of Medical Device Clean room, our Experienced and professional employees knowledge comes into play to make sure to serve client with best solution...

ACME CLEANROOM TECHNOLOGIES is having expertise on medical device, pharmaceutical, nutritionary and medical provider cleanrooms. Contact us we'll discuss and understand your need and submit a project quote inside stipulated time, cost...

Common Cleanroom Class Option:

Type of Process Cleanroom Class
Aseptic manufacturing and filling Class 100/ISO5
Assembly and packaging of devices that will be terminally sterilized where low particle count on devices is desired Class 10,000/ISO7
Convenience kits and assembly of medical  devices that need to be free of visible particles Class 100,000/ISO8/controlled environment
Manufacturers that repackage and/or re-label unpackaged bulk devices contract sterilizers, and re-manufacturers that change the original condition of devices, Subject to QS (Quality Systems)/GMP (Good Manufacturing Practices)
Pharmacy Drug compounding (per USP website) Class 100 hood in class 10k room
Monitoring Method
Air – Particle count Air sampler (particle counter)
Work surfaces – microbes Surface contact plates or settling plates
Regulations
Airborne particulate cleanliness FED-STD-209E
Personnel training  820.25 ( QS)
Buildings 21 CFR 820.70 (QS)
Cleaning Procedures CFR 820.70 (QS)
Pharmacy Drug compounding USP797


Per FDA factors to consider when planning and using a controlled environment:
  • proper attire and dressing anteroom;
  • controlled use of, and entry into, controlled areas;
  • prohibiting eating, drinking, smoking, or gum chewing;
  • preventing use of lead pencils;
  • regulating the storage of glassware and containers;
  • preventing or controlling the cutting, tearing or storage of cardboard, debris, etc.;
  • cleaning the room and production equipment per written procedure;
  • the original design and cleaning of work surfaces and chairs;
  • selecting correct furniture and eliminating all nonessential equipment;
  • controlling room air quality (amount of particulates, pressure, velocity, and exchange rate);
  • eliminating electrostatic charges by controlling work surface composition or grounding;
  • ensuring cleanliness of raw materials, components and tools;
  • controlling the purity, sterility, and non¬pyrogenicity of process water; and
  • Maintainingprefilters, HEPA filters, and electrostatic precipitators.


Clean Room Specification: