SOP For Cleaning of Strip Pack Machine

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  1. OBJECTIVE: 

The Purpose of this SOP is to provide the procedure for cleaning & effective removal of previous product / batch residue from strip pack machine Make – satellite.

  1. SCOPE:

This SOP is applicable for cleaning of strip pack machine at manufacturing facility of XXX.   

  1. RESPONSIBILITY:  
  1. Officer/ Executive packaging shall be responsible for the effective removal of previous product / batch residue from Strip pack machine as per procedure.
  2. Head of packaging 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.
    4. Wear heat resistant hand gloves for handling heated parts.
  5. PRODUCT TO PRODUCT CLEANING:
  1. Switch OFF the mains of blister pack machine.
  2. Remove the ‘USE FOR’ label from the machine and affix ‘TO BE CLEANED’ label. 
  1. Destroy the rejected tablets / capsules by putting in water, and record in BPR. 
  1. Remove and destroy overprinting stereos and coding stereos of previous product          by cutting into pieces as per SOP. 
  2. Remove FSR and BSR foil from foil holding assembly.
  3. Dismantle different parts of the machine.
  4. Take the dismantled parts collective parts–Hopper, hopper lid, bowl dish and feeding channel, powder collection tray in poly bags to washing Area.
  1. Wash of Collective parts with 25 kg. Filtered potable water to remove the adhering material.
  2. Clean the collective parts with water. 
  3. Rinse it with 20 kg filtered purified water and to remove the traces of Detergent.
  4. Finally rinse the collective parts with 20 kg. of purified  water and  clean  it  with clean lint free duster, use compressed air to dry if required to ensure that the part are dry and there are no traces of Previous product.
  5. Clean the sealing roller with soft brass wire brush.                                                                                                
  1. Remove the remaining change parts of previous product from machine. Clean them with lint free cloth and keep them in its place in the storage racks.
  2. Clean the body of machine with clean lint free duster as shown in below diagram
  1. Clean the pneumatic rejection flap system with the help of clean dry lint free              duster as shown in below diagra
  1. Clean the cam toe of the machine with the clean dry lint free duster as shown in    below diagram.
  1. Clean  the  body  and area  inside  the control  panel  with  the clean dry  lint free  duster as shown in below diagram.  
  1. Clean the tool box and ink/thinner box with the clean dry lint free duster as shown in below diagram. 
  1. Clean the NFD system, cutting assembly and rejection assembly with the clean dry lint free duster as shown diagram below.
  1. Cleans the FSR holder, BSR holder, foil guide roller and foil sensor with the                clean dry lint free duster.
  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. BATCH TO BATCH CLEANING: 
  1. Put OFF the power switch of strip pack machine.
  2. Remove the ‘USE FOR’ label from the machine and affix ‘TO BE CLEANED’ label.
  3. Remove dust from body with dry lint free duster / vacuum cleaner whichever is applicable.  
  4. Destroy the rejected tablets / capsules by putting in water, and record in BPR.             
  5. Remove and destroy overprinting stereos and coding stereos of previous batch by cutting into pieces as per SOP.
  6. Remove FSR and BSR foil from foil holding assembly .Remove all the foil pieces, empty blisters and tablets / capsules lying on the floor & machine. Empty the collection box.
  7. Clean the sealing roller with soft brass wire brush.                                                                                                      
  1. Clean the bowl, hopper Lid, feeding channel, powder collection tray, with clean lint free duster at place.
  2. Clean the body of machine with clean dry lint free duster as shown in below diagram.
  1. Clean the cubicle as per SOP. 
  2. Remove ‘TOBE CLEANED’ label and put ‘USE FOR’ label duly filled with product Name, date and signature of production officer. 

Record the observation of the cleaning in area and equipment usage and cleaning log.        

  1. NOTE: 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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