1. Standard Parameter Settings
-
For high‑grade aseptic pharmaceutical scenarios: Air‑shower duration 15‑20 s, spray disinfection duration 15 s, stable air velocity 25‑30 m/s, medium‑high atomization concentration, to guarantee thorough dust removal and sterilization.
-
For general‑grade aseptic scenarios in food and cosmetics industries: Air‑shower duration 10‑15 s, spray disinfection duration 10 s, moderate atomization concentration, balancing cleanliness and operational efficiency.
-
For scenarios with frequent personnel access: Intermittent disinfection mode can be enabled to prevent excessive mist accumulation caused by over‑disinfection. All configured parameters shall be archived. Frequent arbitrary modification is prohibited.
2. Standard Operating Procedures
Before entering the clean area, personnel shall wear complete cleanroom suits, face masks and gloves. After entering the air‑shower chamber, close both inner and outer doors. The unit starts automatically via sensor to perform air‑blow dust removal together with atomization disinfection. Personnel are allowed to enter the clean workshop only after disinfection finishes and mist is fully exhausted. Overcrowding inside the chamber, door‑open blowing operation and skipping disinfection procedure are strictly forbidden to eliminate compliance loopholes.
3. Key Points for GMP On‑Site Inspection
Regulatory inspectors focus on the following items: normal function of interlocked double doors, qualified air‑shower velocity, valid spray disinfection performance, compliant disinfectant selection, complete equipment operation logs, clean chamber interior free of dust and water accumulation, and unclogged nozzles. Enterprises shall maintain intact equipment functions, compliant parameters and full records without non‑compliant operations.
4. Compliant Ledger & Documentation Management
The following records shall be established: equipment operation log, disinfectant replacement log, filter‑element replacement log, equipment maintenance & calibration log. All usage, maintenance and replacement activities shall be traceable to meet requirements for routine GMP inspections.
