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Due to the growing number of toxic products in the pharmaceutical
industry, containment gains more and more in importance. Today, the
equipment suppliers offer a great number of technologies for improving
containment during the pharmaceutical manufacturing process. Since there
had not been standardised test criteria for assessing the performance of
these technologies, when searching for the suitable technology for a
specific use, the decision-makers often judged and chose it according to
highly subjective aspects.
For this reason, during the past two years a working group whose
participants came from different fields within the industry
(pharmaceutical manufacturers, equipment suppliers, engineers) developed a
guideline for an objective assessment of containment technologies.
About the Guide
The ISPE Good Practice Guide: Assessing the Particulate Containment
Performance of Pharmaceutical Equipment provides a standard
methodology for use in testing the containment efficiency of solids
handling systems used in the pharmaceutical industry under closely defined
conditions. It 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.
Environmental parameters are either set, or an allowable range of
operation specified, prior to testing. Test materials, details of
sampling, sampling equipment, and sampling location are all specified
based on best practice within the industry.
The Guide specifies the use of a surrogate test material and the
methodology described identifies the critical factors that need to be
controlled and monitored during the test. This includes guidance on the
essential features of the test room with recommendations for finishes, air
quality, and ventilation. It also addresses operator clothing and duties
during the test. The test material properties are specified, e.g.,
particle size distribution. Sampling requirements are defined including
positions of samplers and duration of monitoring, together with monitor
types. Also identified are the analysis details together with the
requirements of the final report.
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.
If you want to hear more about current GMP/FDA engineering aspects, we
recommend our 4-day intensive training
on pharmaceutical engineering in Barcelona from 31 May to 3 June 2005.
Contact:
Harald Martin
You can order the ISPE Guideline if you
click here.
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