knowledge
centre

Small and Medium Enterprise Pharmaceutical Analytical Control (SMEPAC) testing, established by the International Society of Pharmaceutical Engineers (ISPE), stands as a meticulous standard for evaluating and ensuring the particle containment capabilities of various pharmaceutical manufacturing equipment. This article touches on SMEPAC testing, shedding light on its evolution, necessity, intricate methodology, notable limitations, and the pivotal role it plays in upholding the integrity of pharmaceutical processes.

Evolution of SMEPAC Testing:

Initially introduced in 2005, the SMEPAC testing methodology underwent a transformative revision in 2012, leading to the current edition titled "Assessing the Particulate Containment Performance of Pharmaceutical Equipment." Anticipated for release in 2023-24, the revised guideline signifies the industry's commitment to adapting and refining testing methodologies in line with technological advancements and emerging challenges.

The Necessity of SMEPAC Testing:

As pharmaceutical ingredients continue to evolve, becoming more potent and with occupational exposure limits (OELs) dropping below 10 µg/m3, the imperative for greater containment intensifies. SMEPAC testing emerges as a crucial step in this trajectory, designed to verify the actual performance of containment equipment and devices. Its role extends beyond mere compliance with regulatory mandates, ensuring the prevention of occupational exposure and cross-contamination.

Methodological Precision of SMEPAC Testing:

SMEPAC testing is a multifaceted process, involving the strategic placement of industrial hygiene air sampling pumps to collect airborne particulate matter of a surrogate compound (e.g., lactose, naproxen sodium, mannitol) on specific filter media. The methodology also includes the collection of surface swipe samples to assess the potential for surface contamination. Notably, the execution of SMEPAC testing demands the expertise of Certified Industrial Hygienists, Occupational Hygienists, or similarly qualified professionals. Furthermore, the analysis of collected samples requires the services of accredited industrial hygiene laboratories specializing in the pharmaceutical industry.

Navigating Limitations in SMEPAC Testing:

While SMEPAC testing stands as a gold standard, it does have limitations that necessitate careful consideration. The establishment of a containment performance target (CPT) is pivotal, requiring a comprehensive understanding of the compounds processed and future plans. SMEPAC testing is tailored for powders, rendering it unsuitable for liquids, vapors, or gases. Variations in processing conditions, equipment specifications, and activity duration can impact the reliability and applicability of SMEPAC testing results.

Conclusion:

As the pharmaceutical industry navigates the evolving landscape of potent ingredients, the demand for greater containment becomes non-negotiable. SMEPAC testing, with its intricate methodology and evolving standards, serves as a linchpin in validating the efficacy of containment devices. While acknowledging its limitations, the industry's commitment to SMEPAC testing as a periodic and iterative process ensures that containment devices not only meet but exceed the desired performance targets. In doing so, the pharmaceutical sector upholds its commitment to the safety of workers and the unwavering quality of pharmaceutical products.

For further advice call us on 0870 701970 or email: sales@euroenvironmental.co.uk