Containment - Protection and Safety
The containment combined two aspects: Toxicologists are involved to protect human and environment at the production of high toxicological and high active substances, whereas quality departments are involved to produce the substances in a GxP environment. The common aim: Protection and Safety.
Both has their own claims. Firstly, the product has to be protect from the environment in order that there is no possibility of a cross-contamination or a contamination trough e.g. remain quantities of powder or the operator. On the other, personal protection at the workplace is important. Thereby limits for human and environment safety will be defined (OEL- Occupational Exposure Limit). Depending on the toxic or activeness of the products, the limits will be classified in bands (OEB - Occupational Exposure Band). At the moment, the OEB is classified in six bands.
Requirements on our Containment Plants
- The operator should be protected through appropriate containment solutions (closed systems) against the exposition of a substance (Creating of a containment concept)
- The plant should to be easily cleanable by WIP / CIP systems that no cross-contamination or no product residue exists
- The environment should be protected by appropriate filter and waste management systems against contaminated waste from production
- Results of customer risk analyses are strictly recognised (Quality and safety reasons e.g. ATEX areas)
- The documentation corresponds to the GxP directives (FS, HDS, VC, SDS, Cleaning Concept, Containment Concept, CE - Documentation)
Open Systems
Open systems with a venting system will be used for low toxic substances up to OEB 1-2.
Closed Systems
Closed systems (e.g. endless liner applications) are used for substances up to OEB 2-5.
Isolator Systems
Isolator systems are used to handle with high toxic and active substances up to OEB 5-6.