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SOP for Pressure Control Test in Pharmaceutical Industry

OBJECTIVE
To demonstrate the capacity of the air handling and circulation system to control pressure levels within the specified limits.

SCOPE
Procedure applies to the Air Handling Unit located in plant facility.

RESPONSIBILITY
Officer/Executive Engineering: Shall be responsible for the measurement of pressure levels in beta facility.
Manager-Engineering: To ensure that the procedure is properly followed.

EQUIPMENT USED FOR TESTING
Magnehelic gauges with a resolution of 0.2 mm of W C.

PROCEDURE:
  • All HVAC and Laminar Air flow workstations should be in Operation while conducting this test.
  • All doors should be closed in the connected or interconnected areas where test is performed.
  • No Traffic is permitted during the test, so that performance base line can be arrived.
  • Locate low pressure sensitive areas for test probing so as to achieve the optimum results.
  • Open and close the doors to check the pressure reaches the base line within 30 seconds. Repeat the test for reliability of the system.
  • The aggregate differential pressure with respect to atmosphere or to the location of the Magnehelic gauge shall be established.

ACCEPTANCE CRITERIA
  • The pressure differential between adjacent areas should match with design parameters under static conditions.
  • The variation permitted during operating condition shall be documented in the design level.
  • It is suggested that a minimum of 0.5 mm of differential pressure should be maintained between rooms of the same cleanliness class with air cascading towards the least critical area and 1.5 mm between areas of different cleanliness class levels.
  • The system will not be acceptable if, at any time during normal dynamic or static or stress condition the pressure in the primary environment becomes less than zero.
  • Supply air, Return air & Fresh air CFM should be as per design CFM. If you want more pressure then slowly close the Riser damper.
  • The system should not at any cost equalize or show reduction between 2 adjacent areas where a positive pressure is maintained under normal conditions and all doors are closed.

ABBREVIATIONS
SOPs : Standard operating procedures
No. : Number.
MMWC: Millimetre Water Colum
CFM : Cubic Feet per Minute

ATTACHMENTS
Attachment 1: Differential Pressure Test

 
REVISION HISTORY
Nil

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