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Cleaning of Rapid Mixer Granulator with Cone Mill

Cleaning of Rapid Mixer Granulator with Cone Mill

Standard Operating Procedure (SOP)

Objective:

  • To lay down a procedure for cleaning of Rapid Mixer Granulator with cone mill.

Scope:

  • This SOP is applicable for the cleaning of Rapid Mixer Granulator with cone mill located in oral section at formulation plant.

Responsibility:

    • Operator / Technician is responsible for cleaning of the equipment as per this SOP.
    • Production Officer / Executive is responsible to implement this SOP.
    • IPQA Personnel – To verify the cleanliness of the equipment.

Accountability:

    • Production Head shall be accountable for the compliance of the SOP.

Cleaning Procedure:

  • Following three types of cleaning process are recommended for cleaning the equipment.
    • Type ‘A’
    • Type ‘B’
    • Type ‘C’
  • Type ‘A’ cleaning:
  • Pre cleaning activity:
  • Check and ensure the completion of the processing activity.
  • Ensure the product and respective documents from previous batch are removed from the area.
  • Check and ensure that all the electronic and electrical devices shall be in “Switch OFF” mode and covered with polybag to avoid the penetration of water.
  • Check and ensure the AHU supply has been stopped.
  • Ensure that all the material is completely discharged from mixer bowl.
  • Remove the Status label and affix ‘TO BE CLEANED’ status label on the equipment.
  • Check and ensure the availability of accessories used for cleaning.
    • Nylon brush.
  • Nylon Scrubber.
  • Clean lint free cloth/duster.
  • Clean LDPE bags.
  • Teflon spatula.

Cleaning:

    • Remove the powder adhered to the impeller blade, chopper blade, and inner surface of the bowl using Teflon spatula followed by lint-free cloth.
    • Check and ensure the discharge valve is closed and Compressed air supply is on.
    • Fill the mixer bowl with purified water up to impeller with conical cap is immersed completely.
    • Close the lid and run the impeller and chopper at slow speed for 5 minutes.
    •  Open the discharge valve and collect all washing in the IPC.
    • Transfer the washed water to drain point.

 Procedure for dismantle of RMG parts:

  • Dismantle the following parts one by one and keep them on SS pallet.
    • Impeller blade.
    • Chopper blade.
    • SS Vent cover.
    • SS cover for Co-mill.
    • Anchor blade of Co-mill.
  • Cleaning procedure for dismantle parts:
  • Before start the cleaning, ensure the cleaning of ceiling and wall of the respective area has been completed.
  • Clean all the dismantled parts one by one using wet lint-free cloth followed by sufficient quantity of purified water.
  • Remove the wet mass adhered to the dismantled parts using nylon brush / nylon scrubber followed by purified water.
  • Clean the each gasket using lint-free cloth followed by sufficient quantity of purified water.
  • Clean all the dismantled parts until it must be visibly clean.
  • Check and ensure the cleanliness of all the dismantled parts.
  • Clean the SS pallet using wet lint-free cloth followed by sufficient quantity of purified water.
  • Ensure the area has been cleaned before start the final rinsing of the dismantled parts.
  • Rinse all the dismantled parts using sufficient quantity of purified water.
  • Wipe all the cleaned dismantled parts using cleaned and dry lint-free cloth.
  • Ensure the dryness of all the dismantled parts before re-assembled.

Cleaning procedure for equipment:

  • Remove the any traces of powder adhered to the inner surface and outer surface of mixer bowl using nylon scrubber/brush followed by wet lint-free cloth dipped in purified water.
  • Clean the inner surface, outer surface of the lid using wet lint-free cloth dipped in purified water.
  • Clean all the other parts of the machine using wet lint-free cloth dipped in purified water.
  • Open the discharge valve and clean inside and outside using wet lint-free cloth dipped in purified water.
  • Rinse the outer surface, inner surface, discharge valve, inner surface and outer surface of the lid and other parts using sufficient quantity purified water.
  • Wipe the outer surface, inner surface, discharge valve, inner surface and outer surface of the lid and other parts using cleaned and dry lint-free cloth.
  • Open the discharge valve and clean outer surface and inner surface using clean lint-free cloth.
  • Check and ensure the complete cleanliness of the equipment.

Swab / Rinse sample collection:

    • Inform IPQA to collect the Rinse / Swab sample as per specification if the equipment is required to be used for the next product.

Note: The Rinse/ swab sample shall be sent after cleaning of Product to product changeover and Batch to batch change over of same product but from higher strength to lower strength. The result of previous batch shall be considered for next product/ batch.

  • Reassembling of dismantled parts:
    • Reassemble the dismantled parts using proper tooling.
    • Fix the impeller blades to the shaft and lock with hexagonal nuts.
    • Fix the conical cap to the impeller blades.
    • Fix the chopper to the chopper shaft and lock with hexagonal nuts.
    • Fix the cleaned and dried vent cover and tight with clamps.
    • Fix all the gaskets to their respective places.
    • Fix the anchor blade and SS cover of Cone mill.
    • Check and ensure that all the parts are assembled and tightened properly.
    • Connect the electrical supply and release air valve.
    • Switch on the equipment and take a blank trial for one minute.
    • After the verification of cleanliness by the production personnel, affix dully filled ‘CLEANED’ status label on the equipment.
    • Record the cleaning activity in the Equipment usage and cleaning log book. 

Type ‘B’ Cleaning:

Pre cleaning activity:

  • Check and ensure the completion of the processing activity.
  • Ensure the product and respective documents from previous batch are removed from the area.
  • Ensure that all the granulated loose material is completely discharged from mixer bowl.
  • Check and ensure that all the electronic and electrical devices shall be in “Switch OFF”      mode.

Cleaning procedure:

Remove the powder adhered to the inner surface, impeller blade, chopper blade, and discharge valve using Teflon spatula followed by cleaned and dry lint-free cloth.

Clean the outer surface and lid of the mixer bowl using clean and dry lint-free cloth.

Remove the powder if any from the surrounding area of the RMG using cleaned and dry lint free cloth.

Ensure the cleanliness of the equipment.

After the verification of cleanliness by the production personnel, affix ‘CLEANED’ status label on the equipment and write cleaned as per Type ‘B’ cleaning.

Record the cleaning activity in the Equipment usage and cleaning log book.

Type C Cleaning :

  • Check and ensure that the maintenance activity is completed.
  • Remove the “UNDER MAINTENANCE” label from equipment affix the “TO BE CLEANED” label on equipment.
  • Perform the cleaning activity as per SOP.

List of Annexure / Format:

Not Applicable.

References (if any):

  • Instruction Manual.

Reason for revision:

  • New SOP

Abbreviations:

  • RMG:      Rapid Mixer Granulator
  • IPQA:     In-Process Quality Assurance
  • SS:          Stainless steel
  • QC:         Quality Control.

END OF SOP

 

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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