Evaluating emissions around containment systems

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 chemical substances 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 conducted 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 analysis methods like high-performance liquid chromatography (HPLC)
• Final containment report with statistical results according to EN 689:2018+AC:2019 / – “Workplace 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 to determine the prevention efficiency of your containment systems
• Reliable containment report