The objective of the SMEPAC (Standardized Measurement of Equipment Particulate Airborne Concentration) test is to evaluate particulate emissions of the containment systems.
In the manufacturing of pharmaceutical drugs and active ingredients, biotechnological and chemical substances and also in the area of high-quality food, containment systems are used. These are intended to avoid the contamination of the product but also to prevent the emission of particles during operation with dust-forming substances or highly effective biological agents.
Syntegon Containment System
The efficiency of the containment systems is described by limit values (Acceptable Daily Exposure (ADE) and Occupational Exposure Limit (OEL)) and classification (Occupational Exposure Band (OEB)). The SMEPAC test is carried out in accordance with the "ISPE Good Practice Guide 2012", “Assessing the Particulate Containment Performance of Pharmaceutical Equipment (APCPPE)”. It is used as evidence to which extend the installed equipment prevents the emission of airborne particles during manufacturing processes.
To check the safety of the containment system with regard to process critical material in the future, a surrogate with similar material properties is used for simulated operations on site. Possible risks of the release of particles through manual interventions, which are often part of the filling, weighing or production processes, are also considered.
In advance, the sampling positions are defined in accordance with the recommendations of the ISPE directive and after a risk-based evaluation of the manufacturing process. The sampling is then carried out with suitable calibrated pumps.