GMP workshop visual management and control project in a biopharmaceutical factory
Under the premise of complying with clean area specifications, stainless steel closed cameras are installed to monitor the operational compliance of key processes and maintain operational traceability records required for regulatory inspections.
Project Overview
Project basic information
project site
Real scene of project site
Project background
The client's main business is biological products, and the production process must meet GMP specifications and pass regulatory inspections. The original monitoring facilities cannot meet the requirements "Key processes must be traceable" requirements, this transformation will be launched in October 2021.
Special requirements for clean areas
| Restraints | Countermeasures |
|---|---|
| No new openings can be added | All existing inspection openings and reserved casings will be used |
| Equipment must be sterilizable | 304/316L stainless steel guard, IP69K |
| No dust accumulation | Arc design of the shield, no exposed screws |
| No contamination during construction | Operators wear clean clothes, and tools are ultrasonically cleaned before entry |
Compliance value
After the system goes online, all key processes can be located according to the batch number and the corresponding operation video within 3 minutes. In the two subsequent regulatory unannounced inspections, it was evaluated as "complete traces and convenient retrieval".
Project difficulties
Issues that need to be addressed during project advancement
Clean areas have extremely high dust and hygiene requirements
Conventional camera housings cannot meet cleaning and disinfection requirements
Drilling holes through the wall may cause cleaning failure
Construction must not produce any pollution in the clean area
Supervisory unannounced inspections need to provide complete operational traces
Videos of key processes need to be stored for a long time and can be quickly retrieved
There is a risk of solvent evaporation in some areas
Equipment must have corresponding protection levels
solution
Technical and construction measures taken to address the above difficulties
All clean areas use stainless steel closed shields
can withstand daily disinfection and scrubbing, and there are no dead corners for dust accumulation
Use the existing wiring holes and inspection openings for laying
No new openings in the clean area are required
180-day double backup of key process videos
Supports quick location of operation videos by batch number
The solvent area adopts equipment with corresponding protection levels
the shield has corresponding anti-corrosion capabilities
Project results
Actual operating data after the system goes online
Main equipment list
This project mainly uses equipment (XLD is mainly self-developed)
- Stainless steel sealed cameras — 168 units, dedicated to clean areas
- Bolts with improved protection level — 36 units, solvent area
- Clean grade cable tray — 580 meters, 316L stainless steel
- 64-channel NVR — 6 units, dual-disk hot backup
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