Specifications of the controlled zone

Specifications for structure and infrastructure

The demand on infrastructure, equipment, work process and personnel is 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.

The controlled zone has to be separated from the office and warehouse area by a sluice area. This spatial separation minimises the risk of contamination through germs.

It is also indispensable that all surfaces, including walls, ceiling, equipment and so forth, in the controlled zone as well as the sluice area can be completely disinfected. In addition, the air in the controlled zone is cleaned by HEPA filters and the ambient air is controlled by an air conditioner.

Monitoring of material / flowing of goods / storing of finished products

Storing material in an aseptic environment is essential for achieving the required quality of a controlled zone product. infochroma stores all required material exclusively in the sluice area.

Alongside, we introduced a strictly separated goods flow system which allows us to visually and accurately identify the current status of a controlled zone product. The finished product is stored protected from light, in ambient temperature and a particle free area until delivery to the customer.

As of summer 2016, the finished products will be stored at a controlled and stable temperature in the controlled zone. The shelf life of a controlled zone product is two years from date of production.

Controlled zone staff

The controlled zone production at infochroma is exclusively operated by trained personnel.

Trained personnel only is allowed to enter the controlled zone.

Access to the controlled zone is only allowed to personnel wearing protective clothing.

Catalogue 2017
pdf 17.3 MB
infoNews 2017
pdf 4.4 MB
infochroma Controlled Zone
Controlled Zone Specifications
Work process, equipment, quality control and lot specific certificate
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