Operation and Cleaning of Sampling Booth
- To lay down a procedure for the Operation and Cleaning of Sampling Booth.
- This SOP is applicable for Operation and Cleaning of Sampling Booth of warehouse
- Operator / Technician – For Operation and Cleaning of sampling Booth.
- Warehouse Officer / Executive – To maintain proper functioning of the equipment & procedure as per the SOP.
- 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
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 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
- Master copy – Quality Assurance
- Controlled copies – Quality Assurance, Raw Material Store.
Filter Cleaning Logbook
|Prepared by||Checked by||Approved by|
|Deptt. Head||Head QA|
|Sign & Date|
|Effective Date: Next Review Date:|
|Sr.No.||Date||Filter ID No.||Pressure Drop Before Cleaning||Cleaning Time||Pressure Drop After Cleaning||Cleaned By||Checked By||Remarks|
(Limit- 7.0 – 10.0 MMWC)