EN
Good Manufacturing Practice (GMP) — the global regulatory framework governing pharmaceutical production — imposes rigorous requirements on the design, selection, installation, and maintenance of process equipment. Within GMP-regulated facilities, valves represent critical fluid-control points whose compliance status directly impacts drug-product quality, patient safety, and manufacturing authorization.
GMP requirements for pharmaceutical-service valves can be distilled to four core principles: material safety (all product-contact materials must be pharmacopoeial-grade and non-reactive); cleanability (design must be free of dead legs, fully drainable, and accessible for CIP/SIP); sealing integrity (preventing cross-contamination between product streams, utilities, and environment); and traceability (complete material certification and batch-level documentation throughout the equipment lifecycle).
Regarding materials, GMP mandates that all metallic wetted surfaces employ corrosion-resistant stainless steel (typically 316L per EN 10088 or ASTM A240), while elastomeric seals must comply with FDA 21 CFR Part 177 or European Pharmacopoeia standards for extractables and leachables. AVM supplies full material-certification packages (EN 10204 Type 3.1 inspection certificates) with every valve delivered.
Cleanability-by-design is the second critical compliance dimension. Internal flow passages must be smooth and free of sudden geometry changes; dead legs should not exceed 1.5–3 times pipe diameter (per ISPE Baseline Guide, Volume 4); and the valve must be self-draining when installed at the prescribed minimum slope. Diaphragm valves and butterfly valves — with their simple, crevice-free flow paths — are the predominant choices in pharmaceutical piping systems.
From a validation perspective, GMP requires all critical equipment to undergo Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Valve manufacturers must provide supporting documentation including: material certificates; dimensional inspection reports; surface-roughness test records; hydrostatic test certificates; and weld documentation (where applicable).
AVM holds both ISO 9001 international quality-system certification and 3-A Sanitary authorization. All products are manufactured per DIN, SMS, 3-A, IDF, ISO, and BS standards. The company provides complete qualification-support documentation packages for every product, meeting the rigorous GMP validation requirements of pharmaceutical engineering projects worldwide.