Phone Number
+91 9665893777
Welcome to Leader in Industrial Solution since 2005
Phone Number
+91 9665893777
Email Address
[email protected]
Contact with us through our representative or submit a business inquiry online.
CONTACT USWe 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 |