GMP News No. 341
GMP News
26 August 2003 |
Insight into the New ISPE Guide: "Assessing the Particulate Containment Performance of Pharmaceutical Equipment" |
Therefore, over the past two years, a working group with members from all areas of the industry (pharmaceutical manufacturers, equipment suppliers, engineer's offices) has developed a guideline for the objective assessment of containment technologies. This new ISPE Guide will shortly be published. The following excerpt is
meant to give you a first insight: |
The guide has been developed to establish an agreed and valid method that can be used to meet the requirements of practitioners and supplier organisations. The current test method applies to:
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![]() The content of these test protocols consists of the description of the equipment and of the test to be carried out together with the procedures and the materials to be used as well as information on the measuring methods and sampling points, which are additionally shown in an illustration. The results can then be summarised in a report, for which you will find a template in Appendix C. Source: Draft ISPE Guide "Assessing the Particulate Containment Performance of Pharmaceutical Equipment" Author: |