Insight into the New ISPE Guide: "Assessing the Particulate Containment Performance of Pharmaceutical Equipment"

 
Due to the growing number of highly-active products in the pharmaceutical industry, containment gains more and more in importance. The equipment suppliers have developed a great number of technologies for improving containment during the pharmaceutical production process. Since there are no standardised test criteria for assessing the performance of these technologies, they are often judged and chosen from a very subjective point of view.

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 provides a standardised method of measuring the performance of containment systems against a specific challenge. It is intended for the methodology to have global application.

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:

• Powders only (this may be extrapolated for larger elements such as tablets but is not appropriate for liquids or vapour containment).
• Airborne and Surface contamination
• Test conditions and test materials only.
  The test results provide information on performance, under simulated ‘typical’ operating conditions, and should not be considered as a guarantee of field performance. It is recommended that users evaluate the performance of equipment in their own installations, with their own materials and conditions, as this may differ significantly from results of the standardised test. … 

 
Furthermore, the Guide includes among others equipment-specific test protocols of the following systems:

Single-point transfer system (see illustration)

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: 
Harald Martin
CONCEPT HEIDELBERG