ISPE SMEPAC Guidelines… let’s get clear!


The increase in drug manufacturing using HPAPIs means that pharmaceutical manufacturers are having to invest in high potency facilities and equipment to deal with the associated risks, and these have to be implemented and validated.

In the late 1990s, occupational health professionals focused on worker exposure measurement as the primary target to qualify containment equipment through workflow outcomes, regardless of the source. The method was formalised as SMEPAC, later adopted and revised by the ISPE.

Growing demand for high potency active pharmaceutical ingredients (HPAPI) and the rising prevalence of specific therapy areas, such as oncology, immune-suppressants and hormone, are fuelling the need for high potency handling capabilities. As the use of high potency containment systems is rising, manufacturers are looking at more innovative containment strategies and containment verification has never been so important. However, it’s critical to understand the variations in testing and the challenges posed by potential differences in the interpretation of results.

Ensuring operator safety and reducing levels of contamination is essential during high potency manufacturing. As human intervention is present at almost every stage of pharmaceutical manufacturing processes, solutions to counter the potential risks are vital.

The containment should also be validated at each step where potential exposure is present in its normal environment, including full risk assessment for the whole process.

CSV Containment is present in the pharmaceutical market and is focused on providing engineering, construction and validation solutions for the LifeScience world. For more information:


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