Performance qualification in high containment isolators and systems (SMEPAC)
The containment capacity of equipment is an extremely important factor in assessing the risks associated with handling pharmaceutical materials.
Performance qualification through the SMEPAC (Standardized Measurement of Equipment Particulate Airborne Concentration) test consists of verifying the actual performance of isolation cabinets in relation to particle containment. Through this test it is possible to verify:
- The potential for particle release within the installation;
- The potential for operator exposure;
- The potential for external environment exposure;
- The efficiency of the cabinet cleaning process.
All work is carried out in accordance with current regulations:
- ISPE Guideline: “Assessing the Particle Containment Performance of Pharmaceutical Equipment”, second edition, 2012;
- UNI ISO 7708 Quality: Size fractions definitions for sampling related to health effects;
- UNI EN 481: 1994 Workplace atmospheres. Size fractions definitions for measurement of airborne particles.
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