From Design to Validated Delivery
Full-process engineering for pharmaceutical containment and sterilization equipment — design, manufacturing, factory acceptance testing, installation and validation, under one accountable partner.
One Partner, From Requirements to a Qualified System
Fenggu takes responsibility for the whole equipment lifecycle, so what arrives on site is ready to install, ready to validate and ready to pass inspection.
User-requirement review, engineering design and design qualification to cGMP criteria
In-house fabrication of SUS304/316L bodies, controls integration and assembly
Factory acceptance testing — leak, airflow, VHP and functional verification before shipment
On-site installation, connection to utilities and installation qualification
OQ/PQ validation, documentation package and operator training
The Engineering Behind Validatable Performance
Stainless Fabrication
SUS304 and SUS316L bodies with radiused corners, continuous welds and CIP-ready surfaces for cleanability and corrosion resistance.
VHP Bio-Decontamination
Flash-vaporization VHP systems engineered for even, condensation-free distribution and a validated 6-log sporicidal reduction, aerated to ≤ 1 ppm.
Controls & Data Integrity
Siemens PLC and HMI control with recipe management, alarms and audit-trail data logging compliant with FDA 21 CFR Part 11.
Containment Engineering
Negative-pressure barriers, airtight seals and OEB5-capable designs, verified by pressure-decay and SMEPAC-style testing.
HEPA Air Handling
H14 HEPA supply and exhaust, unidirectional laminar flow and BIBO safe-change filtration for high-containment air management.
Validation Support
DQ/IQ/OQ/PQ protocols, factory and site acceptance testing, and complete qualification documentation packages.
Designed & Documented for International Compliance
- cGMP (current Good Manufacturing Practice)
- FDA 21 CFR Part 11 (electronic records & data integrity)
- EU GMP Annex 1 (sterile product manufacturing)
- ISO 14644 (cleanroom classification)
- ISO 10648-2 (containment enclosure leak-tightness)
- USP 1208 (sterility test isolator validation)
- ISO 14644-7 (separative devices / isolators)
- H14 HEPA filtration (EN 1822)
Have a Containment or Sterilization Project?
From a single isolator to a complete turnkey sterilization suite, we engineer, build and validate to your requirements.
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