Clean Room Manufacturing,
Assembly and Packaging
As cleanroom manufacturers, BMP Medical conducts all manufacturing in a certified Class 8 cleanroom with 16 injection molding and 4 injection blow molding machines. This area is for our customers that demand a high level of material handling and packaging to maintain product integrity. All products are treated as if they are sterile products. This means strict gowning and gloving procedures to minimize any possible contamination. Several products are certified RNase/DNase free for a particular customer that manufactures a PCR test kits. The cleanroom is audited on a regular basis for compliance.
BMP Medical is proud to offer RNase/DNase free production of custom medical devices and OEM parts. There are occasions when customers require that parts be free of RNase/or DNase. These two enzymes break down DNA and RNA respectively, which can cause problems when performing PCR (Polymerase Chain Reaction) testing. By utilizing clean room manufacturing and cGMP’s for gowning, gloving, and masking, BMP Medical is able to produce high-quality parts that are consistently free of RNase or DNase. These parts are tested by a third party with a standard sampling technique for our customer. Certification documents follow this product.
- Class 7 assembly
- Modular cleanrooms
- ISO Class 8 cleanroom
- RNase/DNase free manufacturing
- 21 CFR 820 Quality System Regulation FDA
- Certified by MedAccred
- ISO 13485:2016