ISPE releases new good practice guide on particulate containment

ISPE, the International Society for Pharmaceutical Engineering, has released its newest technical publication, the ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment.

This guide 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. The guide further specifies the use of surrogate test material, and the methodology describes and identifies the critical factors that need to be controlled and monitored during the test. It includes guidance on the essential features of the test room, with recommendations for finishes, air quality, ventilation, operator clothing, and duties during the test. It provides information specific to various types of equipment 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.