sop on operation & cleaning of blister packing machine

1.0 Objective: To describe the procedure for operation and cleaning of blister packing machine.
2.0 Scope: This procedure is applicable to blister packing machine

3.0 Responsibility: Operator / Production Officer / Executive
4.0 Accountability: Department Head shall be accountable for the compliance of the system.
5.0 Procedure:

5.1 Operation:
5.1.1 Check the cleanliness of the machine as well as the area. There should not be any remainants of the previous product.
5.1.2 Affix “Cleaned” label on the machine.
5.1.3 During operation affix “Under Process” Label.
5.2 Changing the Part:
5.2.1 Change the forming and sealing roller.
5.2.2 Change the punch gear and stereo –gears.
5.2.3 Change the channel.
5.3 Procedure:
5.3.1 Switch on the machine.
5.3.2 Switch on water cooler, water pump, sealing heater and forming heater.
5.3.3 Start the air-compressor keeping the air-pressure between 3-4 kg/cm2
5.3.4 Adjust heating as per PVC roll or as per specified in the respective BMR.
5.3.5 First set the PVC and aluminum foil followed by setting for cutting operation.
5.3.6 Use only number stereo of particular batch.
5.3.7 Check the ink-pot for ink and ink-aid.
5.3.8 Before starting production check the Batch No., Manufacturing Date, Expiry Date, MRP, Leak Test and inform QA Department.

5.4 Cleaning: [For Product Change Over]
5.4.1 Remove ‘TO BE CLEANED’ status label.
5.4.2 Ensure removal of previous product material from the machine.
5.4.3 Remove the scrap of previous product packing material and previous product tablets from the machine cubicle.
5.4.4 Remove PVC and printed foil roll from the machine.
5.4.5 Remove rubber stereos from machine & destroy immediately after completion of the batch record it in stereo record.
5.4.6 Dismantle hopper, bowl, feeding channel & guide track. Shift to the wash area.
5.4.7 Wash the hopper, bowl, feeding channel, guide track with tap water followed by steam.
5.4.8 Scrub the hopper, bowl, feeding channel, guide track using nylon scrubber with Hot Water Wash the hopper, bowl, feeding channel, guide track with tap water.
5.4.9 Finally rinse the hopper, bowl, feeding channel, guide track with purified water.
5.4.10 Mop & dry using lint free cloth.
5.4.11 Clean the machine, forming roller and counter sealing roller using clean dry lint free cloth, pointed spatula and compressed air.
5.4.12 Clean forming roller and counter sealing roller, keep in polybag label it for identification. Keep the cutting gear in the other polybag & label it. After labeling, keep all change part in the change part cupboard.
5.4.13 Ensure the cleaning certification by QA.
5.4.14 Cover the machine with polyethylene roll and affix the ‘CLEANED’ status label.
5.4.15 Use the cleaned machine within 72 hours after cleaning. If not used within 72 hours, Mop dry with lint free cloth & ensure the re-certification by QA.
5.4.16 Affix ‘CLEANED’ status label.
5.4.17 Log the cleaning/ re-cleaning entries in the equipment usage log.
5.5 [For Batch Change Over]
5.5.1 Ensure removal of bulk of the previous batch.
5.5.2 Ensure that the environmental conditions are maintained.
5.5.3 Use the machine within 8 hours after completion of previous batch.
5.5.4 If the batch is not started within 8 hours, re-clean the machine.
5.5.5 At the end of closing hours, remove the bulk, dismantle the machine. Rinse with purified water & mop dry.
5.5.6 Log the cleaning / re-cleaning entries in the equipment usage log.
5.6 Maintenance / Repairs:
5.6.1 If the equipment/machine do not work properly them it should be labeled as “under maintenance” and inform to engineering department.

 

6.0 Abbreviations:

Abbreviation	Expanded Form
SOP	Standard Operating Procedure
PR	Production
QA	Quality Assurance
BMR	Batch Manufacturing Record
PVC	Poly Vinyl Chloride

7.0 Forms and Attachments:
Annexure – 1: Equipment Log Book

8.0 Distribution List:

S. No.	Department Name	No. of Copy
1.	Quality Assurance	01
2.	Production	01

 

9.0 References:
In – House

 

Annexure – 1

Department:	Page No.:
Name of Equipment	Equipment ID No.:

Equipment Usage Log Book

S. No.

Date

Product Name

B. No.

B. Size

Operation Time

Cleaning Time

Done By

Ckd. By

Brk. Down Time

Done By

Remarks