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Procedure for Operation & Cleaning of Mass Mixer.

1.0       OBJECTIVE:

            To Lay Down the Procedure for Operation & Cleaning of Mass Mixer.

2.0       SCOPE:

            This SOP is applicable for production Department for Operation & Cleaning of Mass Mixer 

          3.0       RESPONSIBILITY:

3.1       Officer production & QA personnel shall be responsible for this SOP.

4.0       ACCOUNTABILITY:

4.1       Manager Production & QA Head Shall be accountable for this SOP.

5.0       ATTACHMENTS:

            Not applicable

PROCEDURE:

    • Operation Procedure:
      • Ensure that the Equipment and Area are cleaned and released by the QA Department for Production.
      • Connect power supply.
      • Charge the sifted raw materials in the mass mixer.
      • Close the lid of mass mixer. Dry mixing operation is to be done as defined in product BMR.
      • During mixing add the binder (through inspection window) as defined in product BMR.
      • Operate the mass mixer for the mentioned time in product BMR.
      • Tilt the mass mixer by turning the wheel provided and transfer the granules in FBD bowls
      • Remove all sticky material by scrubber and nylon brush.
      • Affix “To Be Cleaned” status label on the Mass Mixer.
      • Record the operating data of the Mass Mixer in Machine Equipment Sequential Log.
    • Cleaning Procedure:
      • Type ‘ A ’ Cleaning (Product to product change over)
        • Switch ‘OFF’ the main Power supply.
        • Clean the Outer & Inner surface contact parts (lid, shaft, blade, and wall) with dry Lint Free cloth &

           remove the rejected powder for waste disposal.

  • Put sufficient quantity of Potable Water in the Mass Mixer close the lid of mixer and run the mixer

           for 05-10 min.

  • Drain out wash water through the movable hand wheel.
  • Drain out wash water through the movable hand wheel.
  • Use nylon brush for scrubbing of sticky material to inner wall, shaft, shaft corners and edges.
  • Clean the Mass Mixer again with Potable Water.
  • Dismantle the change parts ie, filter cloth and brushes  of capsule polishing machine for cleaning and  Clean the Capsule polishing machine assembly, by using clean cloth.
  • Repeat the step till the traces of cleaning agent is not completely removed.
  • Finally rinse the mass mixture with Purified water & Dry the Inner & Outer surface with Lint Free

           cloth and mop the inner surface with the 70% IPA.

  • A wash/Rinse water sample can be collected after visually verification by QA if specified in the respective SOP and sent to Quality Control along with sample request for determination of residual drug and cleansing agent.
  • Affix a `CLEANED’ label on the machine with the details of the previous product used.
  • Record the activity in “Equipment Sequential Log Book” and remove “To Be Cleaned” label from the machine.
  • If cleaned equipment is remained idle for more than 72hrs , then again Type ‘A’ cleaning shall be done before going to start next batch.
  • Type ‘ B ’ Cleaning ( In case of batch to batch change over )
    • Switch ‘OFF’ the main Power supply.
    • Remove “To Be Cleaned” label from the machine
    • Clean the Outer & Inner surface contact parts (lid, shaft, blade, and wall) With dry Lint Free cloth &

           remove the rejected powder for waste disposal.

  • Affix a ‘CLEANED’ label on the machine with the details of the previous product used.
  • Record the cleaning details in Equipment Sequential Log Book & Sign by production supervisor and QA officer.
  • Record the activity in “Equipment Sequential Log Book” .
  • If equipment is idle for 72 Hrs. after Type ‘B’ cleaning then again Type ‘A’ cleaning shall be done.

  Note: The personnel working on the Granulation area shall wear protective aids i.e., Mask with air filters, and surgical hand gloves in addition to the normal gowning of secondary area.

     REFERENCES:

       In-house

8.0        ABBREVIATIONS

             SOP         –    Standard Operating Procedure

             IPA          –     Iso Propyl Alcohol

9.0        DISTRIBUTION LIST:

             Quality Assurance

             Production

10.0      HISTORY OF REVISION:

Version No. Effective Date Reason for Revision
00 12/09/13 New SOP
01 12/09/15 Periodic revision
02 09/10/17 Periodic revision

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