Containment Flexible Containment Is Useful — but Not for Every Application, Argues One Expert
Without doubt, flexible containment systems — single-use or multi-use, with disposable elements covering either individual components or entire systems — have many benefits. But there are inevitably problems too — problems which often seem to be being overlooked. So, is flexible containment really a panacea, as some people are trying to persuade us? Are its short-term benefits outweighed by less apparent drawbacks?
There is a conflict over containment in the pharmaceutical industry. On one hand there is a growing requirement for higher levels of containment to match the increasing potency of pharmaceutical ingredients. Occupational exposure limits (OELs) for some active ingredients are now down to 5–10 ng/m3, equivalent to a grain of pollen in an average-sized living room. On the other hand is the rising demand for the benefits of flexible containment, which can be cost-effective, space-saving and easy to clean. Factor in the tendency for some compounds to be manufactured in very small quantities — down to less than 1 kg a year — and you have a difficult clash of priorities.
Engineers developing a pharmaceutical process should select the right equipment through quantitative risk assessments backed up by a sound knowledge of industry custom and practice. That means weighing established technologies, such as solid glove box isolators with rapid transfer ports, and glove box isolators designed for nanogram-scale operations, against flexible solutions. Outside the pharmaceutical industry the latter are also not new, having been used for many years in semiconductor manufacture, in space technology and for the removal of hazardous contaminants.
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