Configuration of the in-house clean room
Requirements on structure and infrastructure
- An airlock separates the clean room from the office and warehouse area.
- All surfaces of the clean room and the airlock such as walls, ceilings, instruments and so forth can be sanitised.
- HEPA filters clean the air in the clean room, an air conditioner supplies ambient air.
Monitoring of material / flow of goods / stocking of finished products
The aseptic dealing with material is an essential prerequisite to achieve the high quality required of a clean room product.
- All work equipment is exclusively stored in the clean room area.
- A strictly separated flow of goods guarantees that the actual condition of a product can be clearly identified without fault at any moment.
- Finished products are stocked in the clean room area under controlled and stable ambient air until being dispatched to the customer.
- The shelf life of a clean room product is two years from date of production.
Clean room personnel
- Trained personnel exclusively works in the clean room.
- Only personnel working in the clean room have access.
- The clean room may only be entered in adequate protective clothing.