SMEPAC Test

The objective of the SMEPAC test is to evaluate particulate emissions of the containment systems

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.

The compliance with the prescribed limited values is checked by our SMEPAC experts

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.

Safety check by simulated operation

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.
 

Our service includes:

• Preparation of testing plans in accordance with ISPE methodology
• Provision of measuring devices for the SMEPAC test
• SMEPAC test measurements (static, on persons and surfaces) with a surrogate at the customer site by trained personnel and GMP-compliant test protocol
• Evaluation of samples in the analytical laboratory with validated high performance liquid chromatography (HPLC)
• Final containment report with statistical results according to EN 689:2018 – “Work place exposure. Measurement of exposure by inhalation to chemical agents. Strategy for testing compliance with occupational exposure limit values.”

Your advantages:

• Cooperation with a competent GMP service provider.
• Standardized and reproducible measurement method for determining the prevention efficiency of particle emissions of pharmaceutical production/containment systems.
• Containment report