SOP For Cleaning of De-foiling Machine

1. OBJECTIVE: 

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

2. SCOPE:

This SOP is applicable for cleaning of strip de-foiling machineat manufacturing facility of XXX.    

3. RESPONSIBILITY:  

1. Officer/ Executive shall be responsible for the cleaning & effective removal of previous product / batch residue from De-foiling machine as per procedure.
2. Head of packing department shall be responsible for the effective implementation of the procedure.
3. PROCEDURE:

1. HEALTH, SAFETY AND ENVIRONMENT :
2. Wear snood, hand gloves and nose mask at the time of cleaning.
3. After cleaning all guards are fixed in its original position.
4. Put ‘off ‘the electricity supply before starting the machine cleaning
5. PRODUCT TO PRODUCT CLEANING:

1. Put ‘OFF’ the mains of de-foiling 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 strip and tablets stuck to the Strip guide plate, slitter blade assembly, SS Guard and other machine parts. Destroy the rejected tablets/ Capsules by putting in water, and record into BPR.

5. Remove all the foil pieces, empty strip and tablets stuck to the inside area of de-foiling machine.

               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 seven days then Re clean the equipment before use. 
3. BATCH TO BATCH CLEANING: 

1. Put ‘OFF’ the mains of de-foiling 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 machine body, S.S.    Guard, slitter blade assembly, slitter guide plate and other machine parts. Destroy the    rejected Tablets / capsules by Putting in water, and record into BPR. 
5. Clean the Machine body, Slitter blade, SS guard, other machine part with lint free duster as shown in below Diagram.

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.
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  

6. DISTRIBUTION: 

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

Controlled Copy No.2 :  Head of Department – Packaging 

Original Copy :  Head – Quality Assurance 

7. ANNEXURES :

 Nil

8. REFERENCES :

  Nil

9. REVISION HISTORY: