SOP for Cleaning and Usage Procedure of Sampler and Dies

1.0 OBJECTIVE:

To lay down the cleaning and usage procedure of sampler and dies.

2.0 SCOPE:

This Standard Operating Procedure (SOP) covers the detailed cleaning and usage procedure of sampler and dies in In-process Quality Assurance (IPQA) at [company name].

3.0 RESPONSIBILITY:

IPQA Personnel

Production Personnel: For cleaning of sampling rod and dies

Head – QA for compliance

4.0 Procedure:

4.1 Cleaning of newly received sampler and dies:

4.1.1 Transfer the sampler and dies in poly bag to the wash area with Label defining “ TO BE CLEANED ” status.

4.1.2 Record the details in the current version format “ Accessories/ Utensils/ Intermediate Product containers Washing and Drying Record”.

4.1.3 Remove the label defining “ TO BE CLEANED ” status from the sampler and tear it then put it in waste bin.

4.1.4 Flush the hot purified water before use for 30 second.

4.1.5 Clean the inner and outer surface of the sampler and dies with hot purified water jet with nozzle mixing battery as per the sop “Operating and Cleaning Procedure for Mixing Battery” for not less than 2 min.

4.1.6 Finally clean the sampler and dies thoroughly with the nylon brush and hot purified water.

4.1.7 Remove the excess water by compressed air and with lint free cloth.

4.1.8 Dry the sampler and dies using Infra Red Dryer as per SOP “Operating and cleaning procedure for IR DRYER (UMBRELLA TYPE)” for not less than 10 min. or with lint free cloth and then wrap the sampler with shrink film and keep dies in poly bag and keep them in common clean container room.

4.1.9 Put the “CLEANED” label on the sampler and dies duly checked and

Signed by QA personnel.

4.2 Cleaning of Sampler and Dies:

4.2.1 Transfer the sampler and dies in poly bag to the wash area with product specific Label defining “ TO BE CLEANED ” status.

4.2.2 Record the details in the current version format “ Accessories/ Utensils/ Intermediate Product containers Washing and Drying Record”.

4.2.3 Remove the product specific label defining “ TO BE CLEANED ” status from the sampler and tear it then put it in waste bin.

4.2.4 Remove the loosely stuck powder from the sampler and dies with the help of nylon brush.

4.2.5 Flush the hot purified water before use for 30 second.

4.2.6 Clean the inner and outer surface of the sampler and dies with hot purified water jet with nozzle mixing battery as per the sop “Operating and Cleaning Procedure for Mixing Battery” for not less than 2 min.

4.2.7 Finally clean the sampler and dies thoroughly with the nylon brush and hot purified water.

4.2.8 Remove the excess water by compressed air and with lint free cloth.

4.2.9 Dry the sampler and dies using Infra Red Dryer as per SOP “Operating and cleaning procedure for IR DRYER (UMBRELLA TYPE)” for not less than 10 min. or with lint free cloth and then wrap the sampler with shrink film and keep dies in poly bag and keep them in common clean container room.

4.2.10 Put the “CLEANED” label on the sampler and dies duly checked and Signed by QA personnel.

4.2.11 Clean the sampler and dies after every use.

4.2.12 If sampler and dies not used within 15 days from the date of cleaning then re-cleaning should be done before using with 70% IPA.

4.3 Usage of Sampler and Dies:

4.3.1 Perform the entries as per Annexure I.

4.3.2 Check the cleaned status of Sampler and Dies before use.

4.3.3 Remove the “CLEANED” label and shrink film from the sampler and tear it.

4.3.4 Open the Sampler and take the product specific dies.

4.3.5 Fit the Dies in the space provided in sampler and close the sampler.

4.3.6 Perform the sampling as per the protocol from different locations.

5.0 ANNEXURE(S) :

Annexure – I Sampler and Dies Usage Record