Gurney-Read Consulting ¦ Containment System Design and Project Management

Gurney-Read Consulting, in association with selected Occupational hygiene companies and accredited laboratories, is able to offer containment testing consultancy, sampling, analysis and reporting in accordance with the new ISPE good practice guide 'Assessing the Particulate Containment Performance of Pharmaceutical Equipment’ produced by the SMEPAC committee.

Background to the development of the SMEPAC guide

With many new and existing engineering control systems available to provide containment it has been difficult for prospective purchasers to match their requirement to the actual performance of the equipment available. This has been difficult because of the lack of good plant based performance data and the fast pace of equipment developments, meaning that few relevant installations exist. Also the attempts by the equipment manufacturers to test their equipment, either in-house or by a third party, has produced results which are not comparable due to the variation in equipment test methods and test facility design.

It was vital therefore to create a guideline for a standardised method of testing the containment efficiency of solids handling equipment that would allow direct comparison of test results both for similar and different equipment types.

The challenge to produce such a guideline has been met by ISPE following the work of a group from representatives of the end users, contractors, consultants, suppliers and test laboratories (SMEPAC Committee). The group contains occupational hygienists and engineers and is represented by people resident in Europe, USA and Japan.

In order to ensure the group was steered by an independent viewpoint, Paul Gurney-Read was appointed Chairman in 2001.

The good practice guide, ‘Assessing the Particulate Containment Performance of Pharmaceutical Equipment’, has now been published and is available for purchase from ISPE.

ISPE’s Web Site can be viewed at http://www.ispe.org/