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).
- 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.
- 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
- 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|
- Forms and Records
- Differential Pressure Record – Annexure I
- Master copy – Quality Assurance
- Controlled copies – Quality Assurance & Production
|Date||Revision Number||Reason for Revision|
|Equipment Number:||Area :|
Magnehelic manometer calibration due on:
|Differential Pressure||Done by||Checked by|
(Limit: 1 – 5 mm)
(Limit: 5 – 10 mm)
(Limit: 10 – 20 mm)
|mm of water||Start Time
|mm of water||Start Time
|mm of water|