In this section of GMP-inspection.com, our translators provide definitions and explanations of various specialized terms from the pharmaceutical industry and GMP (Good Manufacturing Practice).
The term containment refers to systems and processes that are used to prevent contamination in the manufacture of drugs. By using containment systems, human intervention in the production areas is reduced to a minimum, which means that the risk of products manufactured under aseptic conditions being microbially contaminated as a result of the production environment is significantly reduced. However, containment systems also serve to protect operators and the environment by preventing the release of toxic substances.
The main aspects of containment systems are:
Containment systems are used in various areas of pharmaceutical production, particularly in the manufacture of injectable and ophthalmic preparations, the manufacture of immunobiological preparations and in the handling of highly active and toxic substances.
The use of containment systems is a crucial aspect in ensuring the quality and safety of pharmaceutical products, meeting legal requirements and protecting both the product and operator from contact with potentially hazardous substances. They are a key element of the risk management strategy for the manufacture of drugs.
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