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Operation of dispensing booth

 

  • 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
  • Forms and Records
    • Differential Pressure Record –  Annexure I
  • Distribution
    • Master copy – Quality Assurance
    • Controlled copies – Quality Assurance &  Production
  • History
Date Revision Number                   Reason for Revision
                      New SOP

                                                              Annexure I

Equipment Number: Area :

                                                                                                                   Magnehelic manometer calibration due on:

  Differential Pressure Done by Checked by
Date Pre-filter

(Limit: 1 – 5 mm)

Fine filter

(Limit: 5 – 10 mm)

HEPA Filters

(Limit: 10 – 20 mm)

Start Time

00:00 Hrs

mm of water Start Time

00:00 Hrs

mm of water Start Time

00:00 Hrs

mm of water
                 

 

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