Richard Denk

5 min. reading time | by Richard Denk

When designing facilities there are numerous aspects to consider. These include not only the regulatory and normative requirements but also the functionality and cost effectiveness as well as the principles of hygienic design.

The literal meaning of containment is “holding together” or in its common sense “limiting expansion”. In the active ingredient, pharmaceutical and biopharmaceutical industries it is understood to mean the enclosure of a production process or a dangerous location.

The first draft of version 9 of Annex 1 of the EU GMP Guide on 20 December 2017 attracted a lot of interest globally – firstly because it was the first publication on the topic in almost a decade, and secondly because PIC/S and WHO co-authored the document.

Looking at Annex 1, the use of barrier systems such as RABS or isolators is very common. Since Contamination Control Strategy (CCS) requirements are an important part of selecting the appropriate barrier technology, closed RABS or isolators should be preferred. As isolators have the additional feature of automatic surface decontamination with vaporized or finely nebulized H2O2 compared to a closed RABS and can be installed in a grade C/D cleanroom area, isolator technology is more commonly used. It also offers the highest level of safety and is more sustainable, as it requires fewer cleanroom zones and associated airlocks with the energy-intensive room air technology they require.