SOP for Cleaning of Leaflet folding Machine

  1. OBJECTIVE: 

To provide procedure for cleaning & effective removal of previous product / batch residue from off – line leaflet folding machine.

  1. SCOPE:

This Standard Operation Procedure is applicable for cleaning of from off – line leaflet folding machine at manufacturing facility  of XXX.    

  1. RESPONSIBILITY:  
  1. Officer/ Executive shall be responsible for the effective removal of previous product / batch residue from off line leaflet folding machine as per procedure.
  2. Head of packing department shall be responsible for the effective implementation of the procedure.
  3. PROCEDURE:
  4. HEALTH, SAFETY AND ENVIRONMENT :
    1. Put ‘OFF ‘the electricity supply before starting the cleaning.
  5. PRODUCT TO PRODUCT AND BATCH TO BATCH CLEANING:
  1. Witch ‘OFF’ the mains of the main.
  2. Remove the ‘USE FOR’ label from the machine and affix ‘TO BE CLEANED’ label. 
  3. Remove all folding plate from leaflet folding machine and clean it with dry clean          lint free duster.
  1. Remove all deflection plate from leaflet folding machine and clean it with dry clean lint free duster.
  1. Clean feeder tray with dry clean lint free duster.
  1. Clean leaflet feeder gap setting roller with dry clean lint free duster.
  1. Clean the collection tray with dry clean lint free duster.
  1. Clean all rubber roller to remove paper dust deposition on the rubber roller with dry  clean lint free duster.
  1. Clean all stainless steel rollers of folding machine with dry clean lint free duster.
  2. Clean the wheel of the machine with dry clean lint free duster.
  1. Clean the platform of the machine with dry clean lint free duster.
  2. Clean the stacker with dry clean lint free duster as shown in below diagram.
  1. Clean the body of machine with dry clean lint free duster as shown in below diagram.
  1. Clean the PLC with dry clean lint free duster.
  2. Clean the Pharmacode reader unit & sensor with dry clean lint free duster.
  3. Clean the Control panel with dry clean lint free duster.
  4. Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ label duly filled with  equipment code number, previous product, SOP No., cleaned by, signature, date and the cleaning  due date on “ CLEANED VALID UP TO ” as per SOP. 
  5. Record the observation of the cleaning in area and equipment usage and cleaning log. 
  • TRAINING: 

Trainer : Head – Packaging Department 

Trainees :  Packaging Department 

  1. DISTRIBUTION: 

Controlled Copy No.1 :  Head of Department – Quality Assurance

Controlled Copy No.2 :  Head of Department – Packaging 

Original Copy :  Head – Quality Assurance 

  1. ANNEXURES  :

Nil

  1. REFERENCES:

Nil

  1. REVISION HISTORY: 

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