95 Standardised Measurement of Equipment Particulate Airborne Concentration (SMEPAC) monitoring

What is Standardised Measurement of Equipment Particulate Airborne Concentration (SMEPAC) monitoring? Who does SMEPAC monitoring? How is it done and what do I need to know about SMEPAC monitoring? The fundamental principles you need to be aware of when dealing with SMEPAC monitoring. When new equipment is installed in pharmaceutical industries an APCPPE-test (Assessing the Particulate Containment Performance of Pharmaceutical Equipment) should be performed to collect knowledge about the exposure profile of the equipment. This was formerly known as SMEPAC-test and the name is still commonly known and used, although the ISPE guideline (International Society for Pharmaceutical Engineering) was edited to APCPPE long ago. The above raised questions will be discussed in the presentation. Strategy and method for exposure monitoring will be laid out at an example for pharmaceutical equipment. The theoretical approach of APCPPE-testing will be complemented with experiences from practice as “lessons learned” and conclude with the assessment of the results and the pass/fail decision making.