Containment-Verification Testing For Pharmaceutical Equipment Performance - Pharmaceutical Technology

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Containment-Verification Testing For Pharmaceutical Equipment Performance
A Good Practice Guide from the International Society of Pharmaceutical Engineering provides a framework to assess how well pharmaceutical equipment contains hazardous APIs.


Pharmaceutical Technology
Volume 37, Issue 5, pp. s24-s27

Conclusion

Containment-verification testing of equipment and containment systems is an accepted means for evaluating the containment capability of containment systems and processing equipment in the pharmaceutical and biotechnology industries under defined conditions. ISPE’s Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment describes the methodologies for performing containment verification testing for both FAT and SAT scenarios. The guide specifies a methodology using a surrogate material to verify containment performance by setting a CPT and then performing air and surface sampling as outlined in standard protocols for containment systems. By following the guidelines, users can generate accurate and repeatable data to perform statistical analysis and confirm that airborne-release concentrations will not normally exceed the CPT. >

References>

1. B.D. Naumann and E.V. Sargent, “Setting Occupational Exposure Limits for Pharmaceuticals,” Occup. Med. , 12(1): 67-79 (1997). >

2. OSHA, Sec. II: Ch. 1, “Personal Sampling for Air Contaminants,” in OSHA Technical Manual (OTM) (Washington, DC, June 24, 2008). >

3. OSHA, Sec. II: Ch. 2, “Occupational Skin Exposure V. Wipe Sampling Methodology,” OSHA Technical Manual (OTM) , (Washington, DC, June 24, 2008). >

4. ISPE, Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment (Second Edition, Tampa, FL, 2012) >

All figures and tables courtesy of the International Society of Pharmaceutical Engineering.


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