The technical publication, called the ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment, provides standard methodology for use in testing the containment efficiency of solids handling systems used in the pharmaceutical industry under closely defined conditions.
Containment performance is an important factor in the evaluation of the risks of operator exposure and process cross contamination in pharmaceutical manufacture. The guide covers the main factors that affect the test results for specific contained solids handling systems, including material handled, room environment, air quality, ventilation, and operator technique.
It also specifies the use of surrogate test material and the methodology described and identifies the critical factors that need to be controlled and monitored during the test. The document details the essential features of the test room with recommendations for finishes, air quality, ventilation, operator clothing, and duties during the test.
Information specific to various types of equipment is provided and includes descriptions of each system, together with air sample and swab positions, and describes how data should be recorded, to allow interpretation by suitably qualified persons.
At the moment the guide is available in soft cover only, although ISPE said an electronic version will be available at the end of this month.
More information on the guide is available here.