Operation and Cleaning of  Sampling Booth

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Operation and Cleaning of  Sampling Booth

Objective

  • To lay down a procedure for the Operation and Cleaning of Sampling Booth.

Scope

  • This SOP is applicable for Operation and Cleaning of Sampling Booth of warehouse

Responsibility

  • Operator / Technician – For Operation and Cleaning of sampling Booth.
  • Warehouse Officer / Executive – To maintain proper functioning of the equipment & procedure as per the SOP.

Accountability

  • Warehouse Department In charge & 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
  • API                             :            Active Pharmaceutical Ingredients
  • IPA                             :            Iso Propyl Alcohol

Procedure

sampling booth

Operation of Sampling Booth

  • Before starting the sampling activity, warehouse and QC personnel or their trained personnel must ensure the following:
  • Area and equipments are cleaned.
  • Temperature and Relative Humidity of sampling 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” 15-20 minutes before the sampling activity starts.
  • Verify the pressure differential across the HEPA filter.
  • After achieving required differential pressure of gauge then allow to further activity.
  • After completion of activity switch off the RLAF.

Procedure for cleaning of Sampling Booth:

  • Check the electric supply of RLAF is switched-off.
  • The Pre Filter, HEPA Filter grills, SS table and floor of sampling area shall be cleaned.
  • Wipe from top to bottom S.S. grills or metal surfaces, balances etc. with a cleaned wet lint free cloth wet with 70% v/v IPA.
  • Mop the entire floor with lint free cloth wetted with disinfectant solution rotated weekly. Finally wipe entire floor with dry lint free mop.
  • For cleaning of supply Filter & Riser Filter, first dismantle the filter, cover it in polybag and transfer to washing area and then clean with water and dry with compressed air.
  • Record the details of operation and cleaning activities.

Cleaning Frequency:

  • Cleaning activity shall be done after completion of the sampling activity.
  • Pre-Filter of RLAF (Sampling booths) shall be cleaned on after every sampling.
  • If the Differential pressure across the limit inform to engineering department.
  • The Riser /Supply Filters shall be cleaned fortnightly by store department.
  • If any maintenance activity is performed in sampling area then clean the sampling area as per the cleaning procedure.

Forms and Records (Annexures)

  • Filter Cleaning Logbook –           Annexure-I

Distribution

  • Master copy –          Quality Assurance
  • Controlled copies – Quality Assurance, Raw Material Store.

History

Annexure-I

Filter Cleaning Logbook   

Prepared byChecked byApproved by
Deptt. HeadHead QA
Sign & Date
Name
Designation
Effective Date:                                                                                Next Review Date:
Location:
Sr.No.DateFilter ID No.Pressure Drop Before   CleaningCleaning TimePressure Drop After CleaningCleaned ByChecked ByRemarks
HEPA Filter

(Limit-7.0-10.0 MMWC)

FromToHEPA Filter

(Limit- 7.0 – 10.0 MMWC)

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