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Test Area Validation And Flexible Containment System Performance: Testing To The SMEPAC 2005 Guidelines

Source: ILC Dover

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Article: Test Area Validation And Flexible Containment System Performance: Testing To The SMEPAC 2005 Guidelines

By Alan E. George
Pharmaceutical Product Line Manager, Containment Products
ILC Dover

The pharmaceutical industry is insisting that manufacturers provide test data on containment systems they are considering for installation and use. Testing must be performed by a reputable third-party test company with industrial hygiene (IH) experience, and must be conducted in a consistent and defendable manner using standard methodology.

To establish a standardized methodology for measuring the performance of containment systems, the International Society for Pharmaceutical Engineering (ISPE’s) Standardized Measurement of Equipment Particulate Airborne Concentration (SMEPAC) Committee created a good practice guide titled "Assessing the Particulate Containment Performance of Pharmaceutical Equipment." This document provides invaluable insight into the main factors affecting test results for specific contained solids handling systems, including material handling, room environment, air quality, ventilation, and operator technique.

This article describes the design and production of a test facility, along with the third-party validation and testing of that facility using the SMEPAC guidelines. The basic scope of the project was as follows:

  • Clean room design and installation
  • Clean room validation and certification
  • Standard operating procedures for the test facility
  • Development of industrial hygiene sampling protocols
  • Industrial hygiene sampling to demonstrate the efficacy of the containment systems

Click Here To Download:
Article: Test Area Validation And Flexible Containment System Performance: Testing To The SMEPAC 2005 Guidelines