An improved leak integrity testing rationale for pharmaceutical and pharmacy isolators

摘要

This technical review challenges the status quo for leak integrity testing of pharmaceutical (small scale) and pharmacy isolators, and proposes a new rationale. A single non-specific set of test values (from classification references like the ISO system) are insufficient; instead, both initial classification values and routine monitoring test values should be defined. On initial qualification, and at annual requalification, the more stringent classification criteria should be applied, but, during routine operation, a less demanding monitoring test level could be used to allow for inherent and, therefore, acceptable variability.