Industry

Pharmaceutical

Hygienic valve systems meeting cGMP and FDA standards

Pharmaceutical

Industry Overview

Pharmaceutical manufacturing requires valves that maintain product purity, are easy to clean and fully traceable. AIRA's hygienic valve range is manufactured to 3-A Sanitary Standards and FDA CFR 21 requirements.

Key Challenges

Zero-contamination and crevice-free design
CIP (Clean in Place) and SIP (Sterilise in Place) compatibility
Validation documentation and material traceability
USP Class VI elastomers and polished Ra < 0.8 µm surfaces
Compliance with FDA 21 CFR and EHEDG guidelines

Recommended Products

Case Study

Hygienic Valve Package for Sterile API Manufacturing Facility

FDA-compliant, full validation documentation, Ra 0.4µm surface finish
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