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SOP on Procedure for the Blister Pack Machine

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1.0 Objective: This document aims to establish the operational procedure for the Blister Pack Machine.

2.0 Scope: The procedure outlined here applies specifically to the operation of the Blister Pack Machine in the production area.

3.0 Responsibility
The following personnel from the Production Department are responsible for the implementation of this procedure:
Operator
Officer
Executive
Manager

SOP on Procedure for the Blister Pack Machine
Blister Pack Machine

4.0 Definitions
N/A

5.0 Procedure
5.1 Preparation and Equipment Check
5.1.1 Ensure that the area and equipment are clean.
5.1.2 Attach the ‘UNDER PROCESS’ label, duly filled and signed, on the machine.
5.1.3 Record all observations in the equipment usage log sheet, following SOP on Making entries in equipment usage and cleaning log sheet.

5.2 Equipment Setup
5.2.1 The equipment setup consists of two sets of reel support, a reel fastening screw, a reel adjusting screw, one PVC/PVDC foil sensor, and one aluminum foil sensor. All activities are controlled by the PLC.

5.3 Loading of Foil (PVC / PVDC and Aluminum Foil)
5.3.1 Unscrew the reel fastening screws.
5.3.2 Adjust the back level control screw according to the width of the forming foil.
5.3.3 Load the forming material in a clockwise direction.
5.3.4 Tighten the reel-fastening screw.

5.4 Changing the PVC/PVDC Foil
5.4.1 Unscrew the reel fastening screws.
5.4.2 Mount the foil using the reel fastening screw and tighten it.
5.4.3 Join the end edges of the wave with the edge of the mounted roll and wrap them with cello tape.

5.5 Fixing the Forming Die
5.5.1 Switch OFF the machine; lift the PHR up.
5.5.2 Unscrew the centering bolt and fix the forming die on the shaft guiding.
5.5.3 Tighten the forming die with a screw in the star knob bolt until it almost reaches the face of the roller.

5.6 Fixing the Counter Sealing Die
5.6.1 Switch OFF the machine; lift the PSR up.
5.6.2 Mount the counter sealing die directly on the sealing station shaft.
5.6.3 Clamp and tighten it with a close tolerance hub.

5.7 Tablet Feeding Station
5.7.1 The tablet feeding station includes a hopper, vibrator, tablet level sensing proxy, sweep brush, feeding channel, and universal feeder.
5.7.2 The speed of all vibrators is independently controlled by the potentiometer provided in the operator panel.

5.8 Fixing the PHR (Product Heat Roller)
5.8.1 Isolate the supply to the machine.
5.8.2 Loosen the bracket-clamping screw.
5.8.3 Fix the PHR assembly by tightening the bracket-clamping screw.
5.8.4 Tilt the heater towards BFR and maintain a gap of approximately 2-4mm.
5.8.5 Switch on the machine.

5.9 Fixing the PSR (Pressure Sealing Roller)
5.9.1 Isolate the supply to the machine.
5.9.2 Loosen the bolt of the mounting bracket.
5.9.3 Hold the pressure sealing roller assembly with the right hand under the alignment bracket.
5.9.4 Lift the assembly above the CSR and gently introduce the mounting bracket into the main shaft.
5.9.5 Fix the PSR assembly by tightening the bracket-clamping screw.
5.9.6 Gently lower the PSR onto the CSR, maintaining a gap of approximately 5-7mm.

5.10 Embossing Tool
5.10.1 The embossing tool includes a double electric crank, driven motor, servomotor, servomotor-driven indexing roller, sucking arms, web guide register roller, and punch safety sensor. It is situated below the perforation station and is pneumatically controlled by the PLC.

5.11 Operation
5.11.1 After receiving line clearance from Q.A., affix the “UNDER PROCESS” label on the machine.
5.11.2 Enter the start time of the machine in the equipment usage log sheet as per given SOP.
5.11.3 Switch ON the mains from the electrical panel.
5.11.4 The blister packing of tablets should be carried out in a controlled area with a temperature of 23°C ± 2°C and relative humidity of 50% ± 5%.
5.11.5 Switch on the heater and adjust the thermostat to provide the predetermined heating conditions for the particular product, as mentioned in the BPR.
5.11.6 Fix the printed aluminum foil and PVC/PVDC foil rolls on the machine, as per the BPR.
5.11.7 Record the temperature of the forming and sealing units in the BPR.
5.11.8 Fill the inkpot at the overprinting kit of the machine to the requisite height.
5.11.9 Affix the approved stereos/metal letters to the stereo drum of the BCP Unit/Embossing unit, following the instructions given in the BPR.
5.11.10 Check the sealing performance, overprinting/embossing, and cutting of strips. Make adjustments if required.
5.11.11 Affix the specimen of overprinted/embossed matter, approved by the production officer and Q.A. officer, to the BPR.
5.11.12 Cross-check that the containers of the product to be blistered have an ‘APPROVED’ status label.
5.11.13 Cross-check the weight of the product and record the total weight on the packing BPR.
5.11.14 Load the product to be blistered in the hopper, cover it with a lid, and start the machine.
5.11.15 Run the machine through the PLC, following the instructions for operation.

5.12 Operation of PLC
5.12.1 Switch ON the main switch.
5.12.2 MMI shows…
5.12.3 Press “login” and enter the password.
5.12.4 Then press the switch; the MMI shows…

Run mode/JOG Mode – Guard (Active/ Bypass)
Vib. (Auto/Manu) – PHR (ON/OFF)
PSR (ON/OFF) -Heater Bypass
Embossing (on/off) – PRC-PRO
PRC (ON/OFF) – NFDS head
NFD (Active/ Bypass) – CE (Active/ Bypass)

5.12.5 Press the “production data” switch for editing product details such as name, batch number, manufacturing date, and expiration date. The screen will display…

Good blister – Rejected blister
Machine run time – Machine stop time
Machine alarm stop – Operator name
B. No. – Mfd. date
Exp. date – Reset production data

5.12.6 Press “Recipe” for editing, saving, and loading. The screen shows…

  • Current Recipe
  • Load Recipe
  • Edit and save the Recipe
  • Delete Recipe
  • Display Recipe

5.12.7 Press “display” for setting parameters like NFD count, number of tracks, pack release delay, dry ink pack rejection, sealing reject count, PRC count, etc.
5.12.8 Affix the ‘TO BE CLEANED’ label on the machine and record all observations in the equipment usage log sheet.

5.13 Precautions
5.13.1 Any tablet or blister that comes into contact with the sealing roller should be removed and discarded.
5.13.2 The roller should be stopped by switching it off. During tea and lunch breaks, ensure that no tablets are retained in the feed chute.
5.13.3 After restarting the machine, run a few empty blisters initially to ensure the overprinting details are clear. Remove the empty blisters from the line before starting the packing.
5.13.4 At the end of the working shift, remove any remaining product in the hopper or vibratory bowl and channel. Also, remove any blister lying on the packing line.

6.0 Abbreviations:
BPR: Batch Packing Record
CSR: Counter Sealing Roller
MMI: Main Machine Interference
PLC: Programmable Logic Control
PSR: Pressure Sealing Roller
RH: Relative Humidity
DIP: Dry Ink Pack
NFD: Non-fill Detector
PRC: Printing Registration Control
SOP: Standard Operating Procedure

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