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By Hoggar S.G.

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10-15 Pa) with doors closed. As with the ―bubble‖ there may be different pressure drops across each door. 03 in. g (58 Pa) below the lesser of the two room pressures. g. g. g. g. g. g. across GMP boundary 1321 1322 1323 1324 1325 1326 1327 "Sink" Pressure Relationships Figure 2-10 Pressure “sink” relationships It is often necessary to have pressure differentials at boundaries within the same air class area for operational reasons. g. 04‖ (10Pa) suggested. It is also sometimes necessary to have directional air flows for operational reasons without a measurable pressure differential, such as may be found in non-classified areas, such as oral dosage manufacture.

Other alarms often for the same variable at a worse condition may indicate that operating conditions have exceeded the specified states and production need to take action with the process to ensure product quality is not compromised. These alarms need to be relayed to the appropriate business unit. 49 ISPE GOOD PRACTICE GUIDE HVAC DRAFT FOR REVIEW 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034 2035 2036 2037 2038 2039 2040 2041 2042 2043 2044 2045 2046 2047 2048 2049 2050 2051 JULY 2008 The regulatory requirement is for a local alarm, notifying the operator when the conditions are outside the defined limits.

G. (15 Pa) with the doors closed. Pressure differential will drop momentarily while one door is opened, but will not drop to zero (as it would with no airlock or if all airlock doors were opened). In no case should pressure differential reverse. g. (5 Pa), being the minimum reliably detectable by current pressure sensor technologies. The pressure differential is measured across the airlock, not across each door. g. g. g. g. (15 Pa). There may be different pressure drops across each door due to building tolerances, or adjacent room conditions, this is not considered a problem.

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