Procedure for the Cleaning of Comminuting Mill

• Objective

To lay down the procedure for the Cleaning of Comminuting Mill.

• Scope

This Standard Operating Procedure is applicable for formulation plant Make: Clit,

• Responsibility
  • Trained worker / Operator shall be responsible for cleaning the machine as per this SOP.
  • Production Supervisor / Officer shall be responsible for implementation of the cleaning procedure as per this SOP.
  • Head-production / designee shall be responsible for compliance of this SOP.
• Abbreviations and Definitions

S.S.    –           Stainless Steel

IPQA –           In-process Quality Assurance

SOP   –           Standard Operating Procedure

QA     –           Quality Assurance

• Procedure

Refer SOP f Cleaning policy for Type ‘A’ and Type ‘B’ Cleaning criteria.

• Procedure type ‘A’ cleaning :
  • Affix ‘Under cleaning’ status label duly filled and signed.
  • Switch ‘off’ the main power supply of the machine from service floor.
  • Lift the feed hopper pan to the back.
  • Unscrew four wing nuts to detach the feed hopper from Comminuting Chamber.
  • Open the motor pulley guard. Rotate manually the motor pulley in anticlockwise direction to remove the belt.
  • Remove the sieve fitted to Comminuting Chamber.
  • Remove the blade assembly by unscrewing the Lend screw provided on the comminuting chamber.
  • Dedust the machine and remove any powder adhered to the machine with vacuum cleaner.
  • Clean all the S. S. parts with sufficient quantity of potable water and nylon scrubber for 8 minute. Wash with sufficient quantity of potable water for 3 minute and finally rinse with Purified Water 3 minute.
  • Wash all the detached S. S. parts and body of comminuting mill with sufficient quantity of potable water for 5 minute. Rinse thoroughly with purified water for 3 minute.
  • Use 0.5% w/w solution of Sodium Lauryl Sulphate as cleansing agent in case of previous product containing Nimesulide and repeat the above step.
  • Cleaning of screen:
    • After removal of screen, soak in potable water for 15 minutes.
    • Take out the screen and scrub with nylon brush on both sides of the screen till all the material is removed.
    • Then wash with potable water for 5 minute and finally rinse with purified water for 2 minute and check the sieves visually for its cleanliness.
    • Use 0.5% w/w solution of Sodium Lauryl Sulphate as cleansing agent in case of previous product containing Nimesulide.
    • If still the material is adhering to the screen then boil 15 L potable water and soak the screen for 15 minutes in boiled water and after cooling to normal temperature around 40⁰C scrub again with nylon brush and repeat the above step.
    • Check the screen visually for cleanliness and wipe with clean dry cloth and wrap with the stretch wrap.
  • Reassemble it in reverse order by placing the blade assembly as per the required operating position (Knives forward or Hammer forward).
  • Affix ‘Cleaned’ status label duly filled and signed.
  • Record all observations in Machine Log Sheet.
  • Frequency: During the product to product change over or after completion of five consecutive batches of same product which ever is early.
  • If cleaned equipment is remained idle for more than 14 days, then again Type ‘A’ cleaning shall be done before going to start next batch.
• Procedure type ‘B’ cleaning :
  • Switch ‘off’ the main power supply of the machine from service floor.
  • Lift the feed hopper pan to the back.
  • Unscrew four wing nuts to detach the feed hopper from Comminuting Chamber.
  • Remove the sieve fitted to Comminuting Chamber and clean with dry cloth.
  • Dedust the machine, the sieve blades and all S. S. parts with vacuum cleaner and clean with clean dry cloth.
  • Reset it in the reverse order.
  • Affix ‘Cleaned’ status label duly filled and signed
  • Record the cleaning operation in Machine Log Sheet.
  • Frequency: After end of every batch.

            Note: The personnel working on the Comminuting Mill  shall wear protective aids i.e. Mask with and hand gloves in addition to the normal gowning of secondary area.

• Forms and Records
  • Cleaning Check List –          Annexure-1
• Distribution
  • Master Copy –          Documentation Cell (QA)
  • Controlled Copies –          Production, Quality Assurance  and Quality Control
• History

MFR OF MULTIVITAMIN SYRUP