Evaluating particulate emissions of containment systems

The objective of the SMEPAC (Standardized Measurement of Equipment Particulate Airborne Concentration) test is to evaluate particulate emissions of containment systems.

These are used in the manufacturing of pharmaceutical drugs and active ingredients, biotechnological and chemical substances, as well as in the area of high-quality food. They 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.

smepac-test-syntegon — Syntegon Containment-System

Our SMEPAC experts check the compliance with the prescribed limited values

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 as to which extent the installed equipment prevents the emission of airborne particles during manufacturing processes.

Safety check through simulated operation

A surrogate with similar material properties is used to check the safety of the containment system regarding process-critical material for simulated operations on site. It also considers possible risks of the release of particles through manual interventions, which are often part of the filling, weighing, or production process.

The sampling positions are defined in advance and in accordance with the recommendations of the ISPE directive following 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 the 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, performed by trained personnel and with 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 – “Workplace exposure. Measurement of exposure by inhalation to chemical agents. Strategy for testing compliance with occupational exposure limit values.”

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Dr. Ellen Sons-Brinkmann
Phone: +49 69 153 293 709

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