SOP for Co-mill : Pharmaguideline

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SOP for Co-mill

Standard operating procedure of colloid mill used for wet milling of granulated material from Saizoner mixer granulator.

1.0 Purpose:

To lay down the cleaning and operation procedure for Co-mill.

2.0 Scope:

This procedure is applicable to Co-mill, Make: Tapasya Engineers Pvt. Ltd. used for wet milling of granulated material from Saizoner mixer granulator.

3.0 Reference & Attachment:

3.1. References:

3.1.1. Instruction manual.

3.2. Attachments:

3.2.1. Attachment- 1. Sequential Logsheet

4.0 Responsibility:

4.1. Operator:

4.1.1. To clean the Co-mill as per defined procedure.
4.1.2. To operate the Co-mill as per defined procedure.

4.2. Production:

4.2.1. To check cleaning and operation of the Co-mill as per defined procedure.
4.2.2. To maintain equipment sequential log.

4.3. Quality Assurance:

4.3.1. To ensure the proper cleaning and operation of the Co-mill.
4.3.2. To ensure the maintenance of records.

5.0 Distribution:

5.1. Manager Quality (Master Copy)
5.2. Manager Production
5.3. Production Shop Floor (Display Copy)
6.0 Definitions of terms:
6.1. BMR: Batch Manufacturing Record

7.0 Procedure:

7.1. Cleaning procedure for product changeover
7.1.1. Ensure that ‘To be Cleaned’ label is put on the equipment
7.1.2. Ensure that the mains are switched ‘OFF ’.
7.1.3. Cover the motor cover with poly bag.
7.1.4. Loosen the clamp and remove milling chamber and screen aside.
7.1.5. Remove all adhered material from the chamber and material charging port.
7.1.6. Wash all above parts inside, outside and screen with 20 liters of running tap water followed by 1 liter of 2% non ionic detergent solution using nylon scrubber.
7.1.7. Wash all above parts with 30 liters of potable water to remove detergent.
7.1.8. Finally, rinse all above parts with 50 liters of running purified water.
7.1.9. Wipe all external parts using clean dry duster.
7.1.10. Visually ensure the cleanliness of the machine.
7.1.11. Intimate QA dept. to collect wash water sample and wait for approval.
7.1.12. On receipt of QA approval, dry all the parts using filtered compressed air.
7.1.13. Remove ‘To be Cleaned’ label and affix duly signed ‘Cleaned’ label on the equipment.
7.1.14. Assemble the Co-mill.
Note: The cleaning of the equipment remains valid for 48 hours. If the equipment is not used within 48 hours then it should be recleaned as per above procedure starting from step 7.1.8.

Related: SOP for Product Changeover in Manufacturing

7.2. Cleaning procedure for batch to batch changeover:

7.2.1. Ensure that the mains are switched `OFF’.
7.2.2. Remove all adhered material from the milling chamber and material charging port.
7.2.3. Wipe all external parts using dry duster.
7.2.4. Ensure the cleanliness of the Co-mill.
7.2.5. Affix ‘ Cleaned’ label on the equipment.

7.3. Operating procedure:

7.3.1. Checks and precautions: Wear hand gloves, over coat and nose mask during the sifting operation. Check the integrity of the sieve before and after operation. Ensure that edges of the blade are not touching to the screen. Ensure that FBD/FBP product container is placed under the Co-mill.

7.3.2. Procedure: Remove ‘Clean card ’ label and affix it in the BMR Affix ‘Area/equipment’ label on the equipment. Fix the unit to the bottom end of the discharge port using tri clover fitting. Switch ON the mains. Start SMG and open the discharge port. Allow the wet mass to pass to the Co-mill. Control the wet mass feed rate by adjusting the speed of the SMG. Collect the milled wet material in FBD/FBP product container. At the end of the operation, switch OFF the mains, loosen all holding clamps and remove aside the complete unit. Remove ‘Under Process’ label. Affix ‘To be cleaned’ label on the equipment after completion of the operation.

8.0 Abbreviations:

8.1 SOP - Standard Opreating Procedure
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