SOP for Handling and Cleaning of Dispensing Tools

Standard Operating Procedure for Handling and Cleaning of Dispensing Tools
Standard Operating Procedure for Handling and Cleaning of Dispensing Tools

Standard Operating Procedure for Handling and Cleaning of Dispensing Tools

1. Purpose:

To lay down a procedure for handling and cleaning of dispensing tools in the pharmaceutical warehouse.

2. Scope

The scope of this is applicable for handling and cleaning of tools used for dispensing activity in the pharmaceutical warehouse at [company name].

3. Responsibility

Warehouse Person: Cleaning operation

Warehouse supervisor: To monitor material cleaning operation.

Head Warehouse: Effective implementation of SOP

4. Definitions

Not Applicable

5. Procedure

• Stainless Steel (SS) Scoops, SS Spatula, SS Spoon, SS Container, Glass boats, or Glass pipettes, are used for dispensing of material depending on nature of material, quantity of material and material handling criticality.

• To dispense the Active Pharmaceutical Ingredients (APIs), API dedicated dispensing tools to be used. This will eliminate the risk of cross contamination. Similarly, any material that has Permitted Daily Exposure (PDE) value < 10 µg also should be considered to use material dedicated dispensing tools.

• In case any material that is difficult to clean, disposable dispensing device can be used. Disposable tools issuance and disposal record to be maintained.

• Each deepening tool shall have unique identification number

• Material of construction for of dispensing tools should be chose in such a way that material should not be reactive, additive, or absorptive so as to alter the identity, safety, strength, purity, and quality of the material and product.

• Nomenclature of utensil shall be done in such a way that the engraved/ marked area should be visible and should not come in contact with material.

• For the API or material dedicated tools, write name of API/ material on the tool for ready reference and to prevent accidental use of tool for other API or material.

• List of dispensing utensil shall be maintained and regularly updated as and when new utensil is procured or old one is removed (except disposable dispensing tool). Any update in the list shall be duly signed by one person and verified by second person.

Dispensing of raw material shall be done using respective SOP. At the time of use of dispensing tool, ensure that the status label on the tool is “Cleaned” and clean equipment hold time is within the validity.

• Record the details of dispensing tools in the dispensing tool usage logbook.

• After use of dispensing tool, affix the “To Be Cleaned” status label and on it shall be stored at their respective places.

• Use hand gloves during cleaning activity of utensils.

• Whenever new API or potent molecule is introduced, dedicated sampling tool shall be procured for same.

• API name/ material name and unique numbering shall be assigned to new sampling tool.

• New tool for dedicated material shall be numbered as following:

  Tool/Material Name-AAA

  AAA-Serial number, start from 001

• Tool used for dispensing of excipient shall be numbered as following:

• Tool/EXP-XX

   BBB-Serial Number, start from 001

• When new tool is procured, cleaning shall be done as per procedure for cleaning of sampling tool.

• After cleaning, tool, label shall be affixed with cleaning date, cleaned by, hold time validity of clean tool shall be covered in poly bag and stored in dedicated place.

• List of dedicated tools shall be prepared as per respective format.

• Procedure for cleaning of utensils:

• The used utensils shall be labeled as “To Be Cleaned” and transferred to cleaning area.

• Clean all dispensing tools in the cleaning are using potable quality water.

• Remove adhered material using scrubber (preferable one time use nylon scrubber).

• Wash the dispensing tool with hot water and finally rinse the dispensing tool using purified water.

• The dispensing tools shall be dried using fresh lint free duster and using compressed air.

• Clean dispensing tool shall be kept on dispensing tool storage area.

• Individual dispensing tools shall be cover with double poly bag with ‘Cleaned’ label. The label shall be fixed between both the polybags.

• Record the details in dispensing tools cleaning record.

• If cleaned utensils are not used within [specify cleaned equipment hold time validity], clean the dispensing tool using purified water and dry using dry lint free duster and compressed air before use.

6. Frequency

• List of dispensing tools shall be updated as and when new tool is introduced or old tool is removed.

• Cleaning of tool after every use and after crossing the clean equipment hold time validity.

7. Formats

7.1 Format for dispensing tool cleaning record

7.2 Format for list of dispensing tool

7.1 Format for dispensing tool cleaning record

Date     

Previous Product

Product Name  

Batch No.

Material Name

Dispensing tool Id. No. 

Cleaned by        

Checked by       

Remark

7.2 Format for list of dispensing tool

Sr. No. 

Dispensing tool Id. Number

Name of material

Tool type (Material dedicated/ Non dedicated)

Updated By

Checked By       

Remark

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