SOP for Cleaning Procedure of Communiting Mill

OBJECTIVE

To lay down a procedure for cleaning of Communiting mill.

SCOPE

This procedure applies for the production department in the Pharmaceutical Manufacturing Facilities of XYZ Limited. 

RESPONSIBILITY

The concerned operator is responsible for the implementation of the process.

The Production In-Charge is responsible for the execution and compliance of the procedure.

PROCEDURE

Type “A” Cleaning Procedure

• This procedure has to be followed at the time of:

1. Batch-to-batch changeover
2. From lower to higher strength
3. At the end of the day

• Ensure that the status label is updated as “TO BE CLEANED”.
• Ensure that the Communiting mill main is switched off before cleaning.
• Remove labels, materials and containers of the previous batch from the milling area.
• Remove any adhering material from the outer surface of the Communiting mill.
• Dry clean the parts like body surface, clamps, lid, feeding and discharge hoppers, stainless steel plate, gaskets, and screen by using dry lint-free cloth.
• Ensure complete cleanliness visually.
• Update the status label as “Cleaned”.

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Type “B” cleaning

This procedure has to be followed at the time of:

• Product-to-product changeover
• From higher to lower strength
• Change in color
• After any major breakdown or preventive maintenance
• After continuous production of 6 days (of the same product)
• If equipment is idle for 7 days from the date of cleaning or before the use.

1. Affix the status label “TO BE CLEANED” on the equipment.
2. Ensure that Communiting mill mains are switched off before cleaning.
3. Update the status as “Under Cleaning” on the display board.
4. Remove labels, materials and containers of previous products from the granulation area.

Dismantling of the Communicating Mill Parts

• Remove the feeding hopper with a sliding lid and gasket by rotating the wing nuts in an anticlockwise direction.
• Remove the Communiting mill chamber by unlocking the ring nuts and gasket.
• Remove the perforated screen and screen holding plate by rotating the ring nuts of the studs in an anticlockwise direction.
• Transfer all the dismantled parts duly covered with polybag in SS trolley to the washing area after affixing the “TO BE CLEANED” label.

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Cleaning of Main Body

• Remove any adhering material to the Communicating mill body.
• Wipe the body with a lint-free cloth dipped in potable water until no adherent material is seen followed by wiping the Communiting mill body with a lint-free cloth dipped in purified water.

Cleaning of Communiting mill parts

• Give an initial rinse to parts using approximately 35 liters of potable water.
• Apply approximately 50 ml of liquid detergent to all parts and scrub with the help of a nylon scrubber over a period of 3-5 minutes until no powder residues are seen.
• Wash the parts using approximately 50 liters of potable water till the equipment part is visibly free from powder and detergent residues.
• If any visible residue or adherent material is found repeat the above steps.
• Ensure thorough and complete rinse of the total surface of each equipment part by suitably keeping it on both sides and tilting sideways as appropriate using approximately 30 liters of potable water.
• Give the final rinse with approximately 40 liters of purified water to all parts.
• Wipe the parts using a dry lint-free cloth.
• Transfer the cleaned parts to the cleaned equipment area duly covered with a polythene bag using an SS trolley after fixing the “CLEANED” label.
• Fix back the dismantled parts in the reverse order of dismantling.
• Finally, wipe the outer surface of the Communiting mill and all the parts with a lint-free cloth. Ensure complete cleanliness visually.
• Update the status label as “CLEANED”.

Note:

1. Store the cleaned screen in clean polythene cover and label it as “CLEANED”. Mentioning all the details given in the cleaned label.
2. Check the integrity of the screen before and after cleaning. In case of any damage to the screen, the screen to be destroyed

• Record the entry in the equipment cleaning log.

REFERENCE

SOP: Preparation, Approval and Control of Standard Cleaning Procedures for equipment.

ABBREVIATION

Q.A: Quality Assurance

SOP: Standard Operating Procedure

No.: Number

P.D: Production

ANNEXURE

Nil.

REVISION HISTORY

Nil

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