SOP For Cleaning of Blister Pack Machine

1. OBJECTIVE: 

The purpose of this SOP is to lay down the procedure for cleaning & effective removal of previous product / batch residue from blister pack machine Rotovac 210S.

2. SCOPE:

This SOP is applicable for cleaning & removal of previous product / batch residue from blister pack machine Rotovac 210S at manufacturing facility of xxx.    

3. RESPONSIBILITY:  

1. Officer/ Executive shall be responsible for the effective removal of previous product / batch residue from Blister packing machine. 
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.
   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. 

2. Remove dust from body with lint free dust/vacuum cleaner whichever is applicable.      

2. Destroy the rejected tablets / capsules by putting in water and record in BPR. 

2. Remove and destroy overprinting stereos and coding stereos of previous product          by cutting into pieces as per SOP. 
3. Remove all the foil pieces, empty blisters and tablets/capsules lying on the floor &           machine. Empty the collection box; clean the Blister Pack Machine outer body   and the change parts with clean lint free duster.
4. Dismantle different parts of the machine.
5. Take the dismantled parts to washing area :  collective parts- hopper,  hopper  lid,  bowl dish, feeding channel, tablet / capsule collection tray, sieve plate, chute and    feeder rubber roller, powder collection tray, guide brush, guide track in feed roller    box with feeding roller, pressure plate , and scrapper Plate , BFR , CSR , feeding                           roller  and  online de-foiling  system, ( Change parts  which are coming in Contact                            with Products) in poly bags to washing Area.

2. Cover the all parts with the polybag and take it to the washing area and wash of            Collective parts with 29 kg. Filtered potable water to remove the adhering material.

2. Clean the collective parts with water. 

2. Rinse above parts with 20 kg of filtered potable water to remove the traces of Detergent.

2. 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.

2. Check the surface of the clean part and ensure that they appear clean. If any part found unclean repeat the activity. 

2. Keep cleaned above parts in respective area at appropriate place.

2. Clean the PVC / PVDC cleaner assembly with the help of clean lint free duster.

2. Clean the PHR/ PSR with the help of clean soft brass wire brush.

2. Clean the reel holder of PVC and alu. foil assembly  with the help of  clean dry lint free duster.

2. Clean the punching tool assembly with the help of clean lint free duster.

2. Clean the Lifter & swiveller assembly with the help of clean lint free duster.

2. Clean the toolbox with help of clean lint free duster

2. Clean the primary cubicle belt with help of clean lint free duster.

2. Clean the vacuum cleaner with help of  clean lint free duster and  wash with purified water. 

2. Clean the bodies of machine, MMI, blister camera and camera PLC with help of clean dry lint free Duster.

2. Clean the area inside the machine guard with the help of clean dry lint free duster as shown in diagram.

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

1. Put OFF the main switch of blister pack machine.
2. Remove the ‘USE FOR’ label from the machine and affix ‘TO BE CLEANED’ label.   
3. Remove all the foil pieces, empty blisters and tablets/capsules lying on the floor & machine. Empty the collection box. Clean the body of the blister pack machine and the change parts With clean dry lint free duster.

3. Destroy the rejected tablets / capsules by putting in water, and record in BPR. 
4. Remove and destroy overprinting stereos and coding stereos of previous batch by cutting into pieces as per SOP. 
5. Remove  the  metal  stereo  from  the  metallic  plate  of  embossing unit of previous batch. (if applicable).
6. Remove ALu./ Glass and PVC  from their respective foil holders.
7. Remove main gears and printing gears.
8. Remove guide track, feeding channel, bowl dish and hopper.
9. Clean the PSR with soft brass wire brush.
10. Clean the PSR with soft brass wire brush.

3. Clean the body of machine and conveyor belt with clean dry lint free cloth.

13. Clean the scoring unit with the help of dry clean lint free duster ( if applicable.)  as shown in below diagram.

3. Clean the cubicle as per SOP NO.CQA-131.

3. Remove ‘TO BE CLEANED’ label and put ‘USE FOR’ label duly filled with product Name, date and signature of production officer. 

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.

5. TRAINING: 

Trainer : Head – Packaging / designee  

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: