Laminar Air Flow Machine, Purpose :
Laminar Air Flow Machine, The purpose of this SOP is to describe the operation, calibration and cleaning of Laminar Air Flow used for the Filling Area in the Dialysis Fluid unit (DFU) at XX Pharmaceuticals Ltd.
Laminar Air Flow Machine, Scope :
This procedure describes the application of Laminar Air Flow, for the Filling Area of formulated drug product at the XX Pharmaceuticals Limited.
Definitions / Abbreviation:
[][]SOP: Standard Operating Procedure.
[][]LAF: Laminar Air Flow
Responsibilities:
[][]The roles and responsibility is as follows:
Executive, Production
[][]To ensure that this procedure is followed.
[][]To maintain the records properly as per SOP.
Manager, Production
[][]To ensure that this procedure is kept up to date.
[][]To confirm that the SOP is technically sound and reflects the required working practices.
[][]To arrange training on the SOP to all concerned personnel and to ensure implementation of the SOP after training.
[][]Schedule calibration of the instrument at the defined intervals.
Head of Quality Assurance
[][]Approval of the SOP.
Procedure:
Precaution(s):
[][]Ensure the Safety Precaution.
[][]No Water Contact on the switch Board.
Operation
[][]Ensure that all surface area is clean with PVC curtain.
[][]Check the Electric line ON
[][]Ensure that the Laminar Air Flow is cleaned on the day use.
[][]Plug on the electric line. .
[][]Switch on the power its main.
[][]Power on the Laminar Air Flow Light
[][]Switch ON the LAF operation.
[][]Check Pressure Gauge Meter.
[][]Ensure the Reading of air Differential Pressure 150pa-200pa.
[][]Record the Operational data in the Operation Logbook of Laminar Air Flow as per Annexure – II.
[][]Power off the Laminar Air Flow.
[][]Switch off the power from its main.
Cleaning and maintenance:
[][]Clean the outside case of the Laminar Air Flow using a mild detergent or disinfectant (e.g.75% IPA) if required.
[][]Clean the area around the Laminar Air Flow and wipe immediately. Special care should be exercised when cleaning up IPA 75% (usually).
[][]When required, clean all wires and contacts to avoid corrosion.
[][]Inspect the cables of the LAF for any signs of broken insulation.
[][]Inspect the Light Shade Dry Cleaned Cloth.
[][]Rinse through with Purified Water of PVC Curtain.
[][]Make sure that no water Flow to the HEPA Filter, Light Shade.
Annexure:
Annexure I Equipment Use Log Book
Annexure-II: Logbook for daily Operation of Laminar Air Flow.