1.0 Objective: To describe the procedure for operation and cleaning of strip packing machine.
2.0 Scope: This procedure is applicable to strip 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 Set the require set of change part on machine by putting sealing roller in shaft provided on front side of the machine, back gear on shaft provided on back side of the machine and cutting gear shaft provided on right side of machine.
5.1.2 Ensure the line clearance and record in BPR.
5.1.3 Adjust the cutting with the help of cutting gear, dropping with the help of pin gear.
5.1.4 Connect the electric supply and start heaters and adjust the temperature of sealing roller at 140C+ 10 C.
5.1.5 Ensure that environmental conditions are with in limits & record in BPR.
5.1.6 Bring the released tablets of required product. Record the weights of tablets received for packing.
5.1.7 Set printed and plain aluminum foil rolls on machine.
5.1.8 Affix checked stereo’s to batch printing unit and spread the ink on felt roller.
5.1.9 Check the temperature of sealing roller on display and record in BPR.
5.1.10 Check the sealing, pocket cut, cavity and tablet dropping / fall performance of the machine.
5.1.11 Check the printing and overprinting on foil, get it approved from QA.
5.1.12 Affix the approved specimen of foil to the batch record.
5.1.13 Start machine and take out 10-15 strips. Ensure the strips for overprinting, printed matter, sealing performance, cutting length of strips, and proper fall of tablets in pocket.
5.1.14 Load the tablets in hopper and start machine, take out initial strips for leak test.
5.1.15 Perform the leak test as per respective SOP.
5.1.16 Continue strip sealing and check the quality parameters during strip sealing operations.
5.1.17 Adjust the speed of vibrator with the help of control knob provided on the panel.
5.1.18 Adjust the speed of the machine with the help of screw provided on the machine.
5.1.19 Remove the rejected strips and label it. Defoil the tablets from rejected strips.
5.1.20 Pass the good strips for inspection on line.
5.1.21 Whenever machine is stopped do not keep product in contact with sealing rollers.
5.1.22 At the end of working hours, do not keep tablets lying in hopper of machine.
5.1.23 At the end of batch, check rejected foil for presence of product if any, remove it. Record the foil reconciliation in BPR.
5.1.24 At the end of batch, return balance foils to stores on material return note.
5.1.25 Log the operation entry in the equipment usage log.
5.1.26 Affix “TO BE CLEAN” status label in case of product change over.
5.1.27 Ensure that the environmental conditions are maintained use the Strip Packing Machine within 8 hours after completion of previous batch.
5.2 Cleaning: [For Product Change Over]
5.2.1 Remove ‘TO BE CLEANED’ status label.
5.2.2 Ensure removal of previous product material from the machine.
5.2.3 Remove the scrap of previous product packing material and previous product tablets from the machine cubicle.
5.2.4 Remove foil rolls from the machine.
5.2.5 Remove rubber stereos from machine & destroy immediately after completion of the batch record it in stereo record.
5.2.6 Dismantle the hopper, bowl and chute from the machine.
5.2.7 Wash the hopper, bowl and chute with tap water followed by steam in the washing area.
5.2.8 Scrub the hopper, bowl and chute using nylon scrubber with Hot water.
5.2.9 Wash the hopper, bowl and chute with tap water.
5.2.10 Finally rinse the hopper, bowl and chute with purified water.
5.2.11 Mop & dry using lint free cloth.
5.2.12 Clean the machine and sealing roller with clean dry duster, pointed spatula and by using compressed air.
5.2.13 Keep cleaned hopper, bowl, chute, sealing roller and gear in the labeled polybag. Then keep in the change part cupboard.
5.2.14 Ensure the cleaning certification by QA.
5.2.15 Cover the machine with polyethylene roll and affix the ‘CLEANED’ status label.
5.2.16 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.
5.2.17 Affix ‘CLEANED’ status label.
5.2.18 Log the cleaning/ re-cleaning entries in the equipment usage log.
5.3 [For Batch Change Over]
5.3.1 Ensure removal of bulk of the previous batch.
5.3.2 Ensure that the environmental conditions are maintained.
5.3.3 Use the machine within 8 hours after completion of previous batch.
5.3.4 If the batch is not started within 8 hours, re-clean the machine.
5.3.5 At the end of closing hours, remove the bulk, dismantle the machine. Rinse with purified water & mop dry.
5.3.6 Log the cleaning / re-cleaning entries in the equipment usage log.
5.4 Maintenance / Repairs:
5.4.1 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:
In-House
