Medical Device Cleanrooms

Medical Device Cleanrooms

Medical Device Cleanrooms Manufacturer, Supplier & Exporter

Manufacturing high integrity Medical Device Cleanrooms in Mumbai-India

Purchase Medical Device Cleanrooms at Best Cost

Medical Device Cleanrooms


Axenic system is based in Mumbai-India; we are established manufacturer, supplier and exporter in this clean room business .Experienced : professional Turnkey Complete Cleanrooms, Modular Cleanrooms, Modular Hard wall clean Rooms, Modular Softwall Clean Rooms, Modular Dry Clean room or Dry Cleanroom, LEED Cleanroom, Medical Device Cleanrooms, Cleanroom Ceilings design, manufacturing, installation and certification since 2000. We had built more than 100 cleanrooms. Axenic System Quality construction: We manufacture all our components in house. Installation is done by our factory team. We will design, manufacture and install a custom cleanroom based on your application.

Axenic System is an expert on medical device, pharmaceutical, nutritional and medical supplier cleanrooms.

Axenic System has a track record of delivering clean room solutions for a large number of companies. We deliver on time and on budget at very competitive prices. Contact us today and we'll discuss and understand your requirements and submit a project quote within stipulated time...

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.