As clean room manufacturers, BMP Medical currently has an ISO Class 8 cleanroom with 5 injection molding machines. This area is for our customers that demand a high level of material handling and packaging to maintain product integrity. All product is treated as if were a sterile product. This means strict gowning and gloving procedures to minimize any possible contamination. The product produced in the cleanroom is routinely tested and certified RNase/DNase free for a particular customer that manufactures PCR test kits. The cleanroom is monitored on a regular basis for positive pressure and particle count.
Capabilities within ISO Class 8 Cleanroom include DNase-RNase free manufacturing, packaging, sterilization, and assembly:
- 21 CFR 820 Quality System Regulation FDA
- Certified MedAccred