On Monday, 30 October, Dave DiProspero, Director of Pharmaceutical Process Technology, CRB, and ISPE OSD Baseline® Guide Steering Committee Manager, led “Understanding the Architectural, HVAC, and Risk Management Considerations for OSD Facilities,” an OSD Baseline Guide program and education session at the 2017 ISPE Annual Meeting & Expo in San Diego, California.
Session content was based on architectural and HVAC considerations in OSD facility design as presented in the newly revised ISPE Baseline Guide Volume 2: Oral Solid Dosage (OSD) Forms (3rd edition), released in November of 2016. The session was drafted and prepared in association with OSD Community of Practice.
DiProspero was joined by two primary speakers—Terry Jacobs, Partner, JacobsWyper Architects; and Norman Goldschmidt, President, Genesis Engineers Inc. Terry Jacobs spoke first, discussing architectural considerations in OSD manufacturing facilities.
Jacobs noted that architecture and design can minimize risk by providing appropriate space, designing for logical material and personnel flows, designing for appropriate segregation within the building layout, and providing appropriate construction materials and finishes. Risk mitigations may include process closure and enclosure, environmental room controls, adequate space and separation, as well as personnel and administrative controls.
Jacobs also compared differences in protection levels between the second and third editions of the Guide, and concluded by explaining the changes created by continuous processing, which he called “a game changer in terms of traditional layouts” that “changes how we look at facilities. Norm Goldschmidt spoke next, discussing risk-based HVAC and considerations in oral solid dosage.
“How do we mitigate cGMP with environmental controls?” he began. First, protect the product from ambient particulate contaminants. Assure product stability by protecting it from excess temperature and humidity, which can also create problems in machinability, flowability, and potency. “Controlling the environment means all of these,” he said. “Most important is to protect the product from cross-contamination with other products.
“Risk management is a multistep process,” he said. “Start by asking ‘What rooms do I have and what unit operations are in those rooms?’ Look at every step and every substep, then use the fixed taxonomy guidewords to conduct a risk assessment. Some people say, ‘Why don’t you just tell me what I should do?’” he continued. “But that’s not practical. I can’t write a document that will be suitable for every situation.
“This is an accelerating process,” he continued. “As you do this—and think about what happens in the case of human failures, leaks, etc.—once you do this a few times, it becomes easier. You begin to think about what you can do to mitigate.”
One HVAC risk mitigation is space classification. “Some regulatory bodies now insist on this for OSD products,” said Goldschmidt, “even when the regulations don’t require it.” Additional air filtration, improved room air distribution, and additional dilution airflow are other mitigations to prevent cross-contamination. “We’re getting to empirical and quantitative evaluations, rather than qualitative,” he explained. Another is a 100%-exhaust system configuration. “Don’t recirculate anything,” Goldschmidt cautioned.
“And remember: cross-contamination controls must be tested and monitored regularly. You have to know you can achieve these reductions.
“The new guide has a lot in it,” he concluded, calling it a tool to evaluate risk. “But it’s not a cookbook. It’s meant to inform and provoke discussion.”
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