1.0 Objective: To describe the procedure for operation and cleaning of Alu-Alu packing machine.
2.0 Scope: This procedure is applicable to Alu-Alu 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 plate.
5.2.2 Change the guide track.
5.2.3 Change the channel, punching tool (cutter).
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 6-7 kg/cm2
5.3.4 Adjust press plate for forming cavity upon base foil or as per specified in the respective BMR.
5.3.5 First set the base foil and lidding 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 base and lidding 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.
5.4.9 Wash the hopper, bowl, feeding channel, guide track with tap water.
5.4.10 Finally rinse the hopper, bowl, feeding channel, guide track with purified water.
5.4.11 Mop & dry using lint free cloth.
5.4.12 Clean the machine, forming plate and counter sealing plate using clean dry lint free cloth, pointed spatula and compressed air.
5.4.13 Clean forming plate and counter sealing plate, keep in polybag label it for identification. Keep the punching tool in the other polybag & label it. After labeling, keep all change part in the change part cupboard.
5.4.14 Ensure the cleaning certification by QA.
5.4.15 Cover the machine with polyethylene roll and affix the ‘CLEANED’ status label.
5.4.16 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.
5.4.17 Affix ‘CLEANED’ status label.
5.4.18 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 |
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:
As per Manual, In – House
Annexure – 1
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 | |||