sop of Operation of dispensing booth

March 29, 2016September 9, 2024 Pharmaceutical Guidanace

sop of Operation of dispensing booth

Objective:To lay down a procedure for operation of dispensing booth.

Scope:This procedure is applicable to the Raw material Store at (Pharmaceutical Company Name).

Responsibility:

Raw material Store personnel shall be responsible to follow the procedure mentioned in this SOP.

Raw material Store in-charge shall be responsible for implementation of the procedure mentioned in this SOP.

Accountability:

Concerned Department Head and QA Head shall be accountable for implementation of this SOP.

Abbreviations and Definitions

QA :Quality Assurance

WH : Warehouse

RM : Raw Material

SOP: Standard Operating Procedure

RLAF:Reverse Laminar Air Flow

HEPA :High efficiency particulate air

SS : Stainless Steel

Procedure

Before the operation of dispensing booth, warehouse and QA personnel or their trained personnel must ensure the following:

Dispensing Area and equipments are cleaned.

The waste bin must be clean & closed properly.

Temperature and Relative Humidity of dispensing area are within the specified limit.

All the log books of the respective areas are updated.

The RLAF i.e. “Reverse Laminar Air Flow” is switched “ON” by pressing button on the panel 15-20 minutes before the dispensing activity starts.

Wait until the pressure differential across the HEPA filter comes within the limit.

If any abnormal noise or problem in instrument is observed then inform the engineering department for its repairing.

After achieving required differential pressure of gauge then allow for further dispensing activity.

Fill the differential pressure at start of shift as per Annexure – I.

After completion of activity switch off the RLAF and mains electric supply.

Remove the powder present. Affix the “TO BE CLEANED” label duly filled and signed.

Fill the dispensing operation details in Sequential Equipment logbook.

Ensure that the differential pressure gauges show the following pressure drop as below:

Type of filters	Filters	Pressure Differential (mm of water)
Pre- filter	10 µ Pre-filter	1 – 5 mm
Fine-filter	5 µ Fine- filter	5 – 10 mm
HEPA-filter	0.3 µ (HEPA)	10 – 20 mm

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