ISPE Releases New Good Practice Guide on Particulate Containment
(TAMPA, FL, March 11, 2005) – ISPE announces the availability of 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 described 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.
This Guide 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.
Available currently in soft cover only, the electronic version will be available at the end of this month.
Guide on Particulate Containment
ISPE Releases New Good Practice Guide on Particulate Containment
(TAMPA, FL, March 11, 2005) – ISPE announces the availability of 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 described 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.
This Guide 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.
Available currently in soft cover only, the electronic version will be available at the end of this month.
For more information about the ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment, visit http://www.ispe.org/Template.cfm?Sec...actice/APC.cfm ■