Surrogates such as naproxen sodium, lactose and mannitol are used in place of an API to determine particulate containment provided by a containment equipment such as an isolator. Selection of a surrogate, surrogate properties (moisture content, particle size distribution), methods for surrogate monitoring, locations of area positional samples, and Containment Performance Target (CPT) concentrations, are critical in the decision making, among other factors. The speakers will share surrogate monitoring methods utilizing ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment.
The webinar was created by:
• Maharshi Mehta, CIH, CSP, FAIHA, President
• Ankit Sharma, CIH, LFOH, Associate Director, International Safety Systems, Inc (ISS)
- Identification Of Concerns
- Process Safety
- Hazard Information
- Waste Management