Operation and Cleaning of  Sampling Booth

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

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   

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