SOP for Codification, Cleaning and Storage of Sampling Device

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Standard Operating Procedure for Codification, Cleaning and Storage of Sampling Device

Standard Operating Procedure for Codification, Cleaning and Storage of Sampling Device

1.0 Purpose:

To lay down a procedure for Codification, Cleaning and Storage of Sampling Device.

2.0 Scope:

The scope of this procedure is applicable for Codification, Cleaning and Storage of Sampling Device at [company name].

3.0 Responsibility:

QC Personnel:

  • To Store and Clean the Sampling Device.
  • To Code the Sampling Device.

Head QC/Designee: To monitor the activity

Head QA/Designee: To approve the list of Sampling Tools.

4.0  Definitions:

NA

5.0 Procedure:

5.1 Status label shall be available after each operation.

5.2 Separate Sampling Device shall be used for Sampling of Solid and Liquid Raw Material.

5.3 Finally, Sampling Device shall be dried with compressed air or in drying oven at 105°C temperature.

5.4 After proper cleaning Sampling Device shall be covered in cleaned polyethylene bag and labeled, which shall mention Cleaning Date, Validity of Cleaning, Cleaned By and Checked By and it shall be stored in designated place.

5.5 Sampling device shall be cleaned every time after usage and at the frequency of 4 days in case not in use.

5.6 Sampling Devices shall be handled carefully to avoid contamination.

5.7 Procedure for Codification:

  • Procedure shall be followed for Codification of Sampling Rod.

QCD/SARXX

Where,

QCD – Quality Control Department

SAR – Sampling Rod

XX – Serial Numbers like 01, 02, 03… etc.

  • Procedure shall be followed for Codification of Sampling Spatula.

QCD/SSXX

Where,

QCD – Quality Control Department

SS – Sampling Spatula

XX – Serial Numbers like 01, 02, 03… etc.

5.8 List of Sampling Tools shall be updated manually as per respective Format.

5.9 Based on QRM (Quality Risk Management), in case of API found with high-risk category sampling tools for that API shall be API dedicated.

5.10 Cleaning Procedure:

  • Flush the Sampling Device under running Purified Water.
  • Take Nylon Brush and Rub the inner surface as well as outer surface.
  • Remove the adhered material if any by scrubbing with nylon brush. Finally rinse the Sampling Device with Purified Water.
  • Finally, Sampling Device shall be dried with compressed air or in drying oven at 105 °C temperature.
  • Cool the sampling rod at room temperature and cover with cleaned polythene bag. Affix the Cleaned Label and place at designated place.
  • Similarly repeat the procedure for all the sampling devices.
  • Flush the brush with purified water and keep at its place.
  • All sampling device shall be maintained in a drawer as “Cleaned Sampling Device”.
  • Record the cleaning status in logbook.

5.11 Instructions post cleaning:

  • After tools cleaning, detach hose pipe immediately from their respective water point.
  • Deface the cleaned Label of Sampling device and discard the torn label in non- hazardous waste bin.
  • Hang the hose pipe in inverted position at their respective place, to drain out the remaining water from hose pipe completely. 

6.0 Acceptance Criteria:

6.1 Sampling device shall be visually clean.

6.2 No deposition shall be observed.

6.3 It shall be dry.

7.0 Frequency:

Cleaning: After every usage and in the frequency of 4 Days in case not in use.

8.0 Format for recording:

8.1 Cleaned Label

CLEANED LABEL

Cleaning Date              :______________________

Validity of Cleaning    :______________________

Cleaned By                  :______________________

Checked By                 :______________________

8.2 List of sampling Tools.

Sr. No.Sampling Tool NameSampling Tool No.Material NameShared/ DedicatedRemarksManually updated ByApproved By
        
        
        
        
        
        
        

Prepared By:                               Checked By:                                  Approved By:

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