Raw
Material
The finest quality stainless steel AISI 420S3 is
imported from Sandvik (grade 13C26), Sweden and carbon steel (125 CRI) from
Switzerland.
Packaging
Both Stainless Steel and Carbon Steel Blades 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.
Benchmarking
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.
Consistency
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.
GMP
Compliance
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.
