The requirements on infrastructure, equipment, work process and personnel are high in a controlled zone. The specifications for structure and infrastructure have to be strictly observed in order to achieve the quality required of a controlled zone product.

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.