Glossary of pharmaceutical and GMP terms with explanations

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).

Containment

However, containment systems also serve to protect operators and the environment by preventing the release of toxic substances.

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:

  • Physical isolation: Containment systems are designed to physically separate the manufacturing process from the external environment, including equipment and staff. This can be achieved through the use of isolation chambers, controlled pressure cabinets and other isolation equipment.
  • Contamination control: The main aim of containment technology is to prevent contamination (German translation: Kontamination) of the product, materials and equipment by external particles, microorganisms or chemicals.
  • Sterility standards: These technologies are particularly important in the manufacture of sterile products, where the requirements for sterility and freedom from pyrogens are especially strict.
  • Process integration: Containment systems can be integrated into various production processes such as filling, freeze-drying (translation into German: Gefriertrocknung), weighing and mixing.
  • Automation: Containment technologies often incorporate elements of automation in order to minimize the efforts of human error and therefore improve the accuracy and safety of manufacturing processes.
  • Operator and environmental protection: Exposing employees and the environment to toxic dusts, vapors or gases can be reduced to a minimum.

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.

Our GMP translators will prepare pharmaceutical translations for your company (SOPs, inspection reports, SMFs, etc.). Contact our pharmaceutical interpreters if you would like language support during a GMP inspection.

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