Pharmaceutical Machinery

Pharmaceutical machining is judged at the product-contact surface. Anything the drug touches has to be crevice-free and cleanable in place, which in practice means Ra 0.8 µm as a floor and Ra 0.4 µm or better where ASME BPE is cited — achieved by electropolishing, not by a finer end mill. Material provenance is not negotiable: 316L needs an EN 10204 3.1 certificate tying the part back to certified stock, and polymer parts have to be grades with USP Class VI or FDA 21 CFR 177 support, so the substitutions other industries accept are off the table. The second pressure is time: format and change parts are what a validated packaging line waits on, and a line that is down costs more per day than the parts do — which is why single-piece orders and 3-day turnarounds matter more here than unit price.

ASME BPE

We machine and finish to the product-contact surface grades ASME BPE cites, and report the achieved Ra per lot rather than asserting it generically.

cGMP (21 CFR 210/211)

We understand what cGMP purchasing controls expect from a parts supplier: controlled processes, lot-level traceability and a certificate of conformance with every shipment.

EN 10204 3.1

Stainless product-contact parts ship with 3.1 mill certificates tying the finished part back to the certified heat.

USP Class VI / FDA 21 CFR 177

We source PEEK, PTFE and acetal in grades with USP Class VI or FDA 21 CFR 177 support, and never substitute a polymer grade without written approval.

We understand and support these requirements; certification and documentation scope is confirmed per order.