SOP for Cleaning of De-blistering Machine

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  1. OBJECTIVE: 

The purpose of this SOP is to provide procedure for cleaning & effective removal of previous product / batch residue from de-blistering machine Make- Elmach. 

  1. SCOPE:

This SOP is applicable for cleaning of de-blistering machine at manufacturing facility of XXX.     

  1. RESPONSIBILITY:  
  1. Officer/ Executive shall be responsible for the effective removal of previous product / batch residue from De-blistering 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. Wear snood, hand gloves and nose mask at the time of cleaning.
    2. After cleaning all guards are fixed in its original position.
    3. Put ‘off ‘the electricity supply before starting the machine cleaning.
  5. PRODUCT TO PRODUCT CLEANING:
  1. Put ‘OFF’ the mains of de-blistering machine.
  2. Remove the ‘USE FOR’ label and affix ‘TO BE CLEANED’ label to the machine as Per SOP. 
  3. Clean the machine body with wet clean lint free duster.
  4. Remove all the foil pieces, empty blister and tablets stuck to the Blister guide, tablet collection bin, De-blistered blister collection bin, Rubber roller, De-foiler roller and other machine parts. Destroy the rejected tablets/ Capsules by putting in water, and record into BPR. 
  1. Rinse the collective parts rubber roller, S.S. Rotary shaft, collection box, SS   guard, acrylic guard with XX kg potable water and machine body with clean wet   lint free duster.
  2. Clean the collective parts with water. 
  3. Rinse above parts with XX kg of filtered potable water to remove the traces of           detergent.
  4. Finally, rinse it with XX kg purified water and wipe it with clean lint free duster.       Ensure that the parts are dry and there are no traces of previous product.
  5. Clean machine body with clean wet lint free duster and wipe with dry clean lint free duster.
  6. Clean the cubicle as per SOP.
  7. 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.
  8. Record  the  observation  of   the  cleaning  in  area  and  equipment  usage  and  cleaning log.

               NOTE:-

  1. If the cleaned equipment is not used within 48 hour after cleaning or if there are any traces of dust or powder settled on the outsides surface, then it should be wiped with wet lint free duster followed by clean dry lint free duster.
  2. If the cleaned equipment is not used after cleaning within 72 hours then Re clean the equipment before use.
  1. BATCH TO BATCH CLEANING
  1. Put ‘OFF’ the mains of de-blistering machine.
  2. Remove the ‘USE FOR’ label and affix ‘TO BE CLEANED’ label to the machine. 
  3. Clean the machine body with dry clean lint free duster.
  4. Remove all the foil pieces, empty strips and tablets stuck to the rubber roller, S.S. roller, collection box and other machine parts. Destroy the rejected tablets / capsules by putting in water, and record into BPR. 
  1. Clean  the  acrylic  guard , SS guard , collection  box  and  machine body with dry clean lint free duster as shown in below diagram.
  1. Clean the cubicle as per SOP. 
  2. 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. 
  3. Record  the  observation  of  the  cleaning  in  area  and  equipment  usage  and  cleaning log.

               NOTE:-

  1. If the cleaned equipment is not used within 48 hour after cleaning or if there are any traces of dust or powder settled on the outsides surface, then it should be wiped with wet lint free duster followed by clean dry lint free duster.
  2. If the cleaned equipment is not used after cleaning within 72 hours then Re clean the equipment before use. 
  3. If the equipment is used on campaign basis remove and clean the contact parts like hopper, bowl disc, channel / chute, flooding box completely at the last working day of the week or after 5 batches, whichever is earlier.
  4. TRAINING: 

Trainer :  Head – Packaging Department 

Trainees :  Packaging / QA Staff  

  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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