Our all products are individually foil packed with strip of VCI (Volatile Protector Inhibitor) paper. This packaging inhibits rusting, and greatly enhances packaging strength. Samples are continuously drawn from each lot during production and tested under vacuum to test seal integrity and insure that all products are shipped sterile.
We use the BS2982 and Bard Parker FDA interim standard to benchmark our products. You will find our blades more sharpened and our hardening process gives our blades the extra strength.
Each Automatic Grinding Machine is PLC controlled and optimized for a particular blade configuration to prevent lot to lot variation. Our proprietary polishing and de burring process insures superior surface finish and a clean cutting edge.
Our manufacturing facilities are periodically audited by DNV for GMP compliance. We are an ISO 9001 certified manufacturer and our products carry the accreditation of CE 0434 mark. The product inspection & packing is done is class 100,000 certified clean rooms. Bio-burden and sterility testing is done on each production lot by a fully equipped independent Quality Assurance facility.
TRACEABILITY & ACCESSIBILITIES OF RECORDS
Lot numbers are clearly identified on both unit packs and the individual foil pack. Bath records are maintained to insure that products can be traced through out the distribution chain. Should a product record be discovered, recalls are easily accomplished.