Built and Documented for Regulated Manufacturing

Our equipment is designed, manufactured and validated to the standards that pharmaceutical and life-science manufacturers are inspected against — so it integrates into your quality system, not around it.

Standards & Regulatory Alignment

Designed to the Frameworks Your Auditors Expect

cGMPCurrent Good Manufacturing Practice — the baseline for every design and build decision.

FDA 21 CFR Part 11Electronic records and signatures — audit trails, access control and data integrity in our control systems.

EU GMP Annex 1Manufacture of sterile medicinal products — barrier, airflow and contamination-control design.

ISO 14644Cleanroom air-cleanliness classification and testing (ISO 5 / Grade A capability).

ISO 10648-2Containment enclosure leak-tightness classification for isolators and airtight equipment.

USP 1208Sterility testing in isolator systems — validated VHP decontamination efficacy.

Our Quality Approach

Quality Verified at Every Stage, Not Just at the End

Design qualification against user requirements and cGMP criteria before fabrication begins
Material traceability for SUS304 / SUS316L product-contact surfaces
Factory acceptance testing — leak-tightness, airflow, filter integrity and VHP efficacy — before shipment
Installation and operational qualification on site, connected to real utilities
Performance qualification confirming reproducible results under process conditions
Complete documentation package: protocols, test reports, material certificates and operation manuals

Company Credentials

Registered Enterprise Credentials

Shanghai Fenggu Medical Equipment Co., Ltd. holds the following enterprise credentials. Product-level certifications (such as ISO 9001, CE) are issued per configuration and available on request for specific projects.