Inspection, Testing & Commissioning
Documented confirmation that every system we deliver performs to its intended design criteria — from design review through installation, operational qualification and the first year of operation. Validation is built into the equipment, not bolted on afterwards.
A systematic path from design intent to verified performance
Commissioning is the systematic process that provides documented confirmation that a system functions according to its intended design criteria. Fenggu follows a structured DQ / IQ / OQ / PQ lifecycle so that containment, sterilization and cleanroom equipment reach the site ready to validate and pass inspection.
Testing and validation across every critical parameter
Quality Assurance
Rigorous inspection protocols aligned to ISO and cGMP standards, applied at every stage rather than as a final gate — so equipment meets, and exceeds, compliance requirements.
Safety & Risk Assessment
Early hazard identification and robust mitigation across containment, pressure and electrical systems, ensuring a safe working environment for operators and maintenance staff.
Performance Testing
Functional testing and benchmarking against industry standards — airflow, filtration integrity, leak-tightness, VHP distribution and cycle reproducibility — to guarantee reliability.
System Validation
Design verification and operational qualification confirming that each unit operates within established tolerances and holds its qualified state over time.
Documentation & Certification
Detailed, auditable record-keeping and issuance of qualification and compliance documents — protocols, test reports and certificates — ready for regulatory inspection.
Training & Handover
Comprehensive operator and maintenance training with full documentation delivery, ensuring a smooth transition to routine operation and long-term compliance.
Measured, recorded and reported against acceptance criteria
- HEPA / ULPA filter integrity (PAO / DOP scan)
- Airflow velocity & uniformity mapping
- Chamber pressure-decay & leak-tightness
- Recovery & cleanliness class (ISO 14644)
- VHP concentration, distribution & 6-log efficacy
- Residual peroxide aeration to ≤ 1 ppm
- Interlock, alarm & safety-function testing
- Temperature / humidity mapping
- Containment performance (SMEPAC, OEB)
- Data-integrity & audit trail (21 CFR Part 11)
Need equipment that arrives ready to validate?
Share your qualification requirements and site conditions. We will align our commissioning and documentation package to your validation master plan.
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