SOP for Pressure Control Test in the Pharmaceutical Industry

OBJECTIVE

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

SCOPE

The procedure applies to the Air Handling Unit located in the 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 Airflow workstations should be in Operation while conducting this test.
• All doors should be closed in the connected or interconnected areas where the test is performed.

• No Traffic is permitted during the test, so that the performance base line can be arrived.
• Locate low-pressure sensitive areas for test probing to achieve the optimum results.
• Open and close the doors to check the pressure reaches the baseline within 30 seconds. Repeat the test for the reliability of the system.
• The aggregate differential pressure concerning the atmosphere or to the location of the Magnehelic gauge shall be established.

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ACCEPTANCE CRITERIA

• The pressure differential between adjacent areas should match with design parameters under static conditions.
• The variation permitted during operating conditions 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 conditions 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 positive pressure is maintained under normal conditions and all doors are closed.

ABBREVIATIONS

SOP: 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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