Current containment technologies provide environmental control when completing different operations requiring product or compound protection. But the increasingly potent active ingredients and pharmaceutical compounds developed today require additional protection for the operators and environment. Occupational Exposure Levels (OELs) set by scientific committees and institutes are increasingly strenuous and containment performance can go as low as 10ng/m3, 8 hour Time Weighted Average (TWA).
Containment technologies such as isolator and glovebox fulfill the above requirement at any scale. ISPE defines containment technology as a ‘leak tight enclosure designed to protect operators from hazardous/potent processes or protect processes from people or detrimental external environments or both’ (see Figure 1).
The key priorities here are operator safety and drug quality. When developing new drugs, the risks at early stages are not always fully understood. An ultra-conservative philosophy has to be applied until there is sufficient established data for the product during the process development stage. A common method to establish containment performance is to use a placebo such as micronised lactose with a d50 at approximately 20µg, which accredited laboratories can detect at 2ng.
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