What is the minimum and maximum pressure required in pharmaceutical working rooms as per guidelines??
Differential Air pressure between areas of different environmental standards shall be at
least 15 Pascal (0.06 inches or 1.5 mm water gauge). Suitable manometers or gauges shall be
installed to measure and verify pressure differential.
Reference: Schedule M- THE DRUGS AND COSMETICS ACT, 1940 and
THE DRUGS AND COSMETICS RULES, 1945
CGMPAND REQUIREMENTS OF PREMISES, PLANT, AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS,
Part-1A, SPECIFIC REQUIREMENTS FOR MANUFACTURE OF STERILE PRODUCTS,
PARENTERAL PREPARATIONS (SMALL VOLUME INJECTABLES AND LARGE
VOLUME PARENTERALS) AND STERILE OPHTHALMIC PREPARATIONS.
Regarding minimum DP Limit between different grades it is 10 Pascal as per WHO and FDA