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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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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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