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
Date | Revision Number | Reason of Revision |
00 | New SOP |