Home » Pharma SOPs » Production SOPs » SOP on Cleaning and Operation of Blister Pack Machine

SOP on Cleaning and Operation of Blister Pack Machine

1.0 Objective: To lay down a procedure for the operation of the Blister Pack Machine.
2.0 Scope: This procedure is applicable to the operation of the Blister Pack Machine in the production area.
3.0 Responsibility: Operator, Officer, Executive – Production Department
Manager – Production Department

SOP on Cleaning and Operation of Blister Pack Machine

4.0 Procedure for Blister Pack Machine:

4.1 Ensure the area and equipment are clean. Affix the ‘UNDER PROCESS’ label duly filled and signed on the machine and record all the observations in the equipment usage log sheet as per SOP “Making Entries in Equipment Usage Log Book

4.2 Equipment setting

4.2.1 It consists of two sets of reel support, reel fastening screw, reel adjusting screw, one PVC/PVDC foil sensor, and one aluminum foil sensor all activities controlled by PLC.

4.3 Loading of foil (PVC / PVDC and Aluminium foil)

4.3.1 Unscrew the reel fastening screws.
4.3.2 Adjust the back level control screw according to the width of forming foil.
4.3.3 Load forming material in such a manner that it should unwind in a clockwise direction.
4.3.4 Tighten reel-fastening screw

Read Also: SOP On Change of Aluminum Foil During Packing

4.4 Changing of PVC/PVDC foil

4.4.1 Unscrew the reel fastening screws
4.4.2 Mount the foil by the reel fastening screw and tighten it.
4.4.3 End edges of the wave are joints with the edge of the mounted roll and wrap them by cello tape.

4.5 Procedure for fixing forming die

4.5.1 Switch OFF the machine, PHR will lift upside.
4.5.2 Unscrew the centering bolt and fix the forming die on the shaft guiding.
4.5.3 Tighten the forming die with a screw in the star knob bolt till the almost reaches the face of the roller.

4.6 Procedure for fixing Counter sealing Die

4.6.1 Switch OFF the machine, PSR will lift up sides.
4.6.2 Counter sealing die is directly mounted on the sealing station shaft
4.6.3 Clamped / tight with a close tolerance hub.

4.7 Tablet feeding station

4.7.1 It consists of a hopper, vibrator, tablet level sensing proxy and sweeps brush, feeding channel, and universal feeder.
4.7.2 Speed of all vibrators is controlled independently by the potentiometer Provided in the operator panel.

4.8 Procedure for fixing PHR:

4.8.1 Isolate the supply to the machine.
4.8.2 Loosen the bracket-clamping screw.
4.8.3 Fix the PHR assembly through tightened bracket-clamping screw.
4.8.4 Tilt the heater towards BFR and maintain a gap of 2-4mm (approx).
4.8.5 Switch on the machine.

Read Also: SOP on Indent and Approval of Rubber Stereo for Overprinting

4.9 Procedure for fixing PSR

4.9.1 Isolate the supply to the machine.
4.9.2 Loosen the bolt of the mounting bracket.
4.9.3 Hold the pressure sealing roller assembly with the right hand under the alignment bracket.
4.9.4 Lift the assembly above the CSR and gently introduce the mounting bracket into the main shaft.
4.9.5 Fix the PSR assembly through tightened bracket-clamping screw.
4.9.6 Hold the PSR and gently allow lowering onto the CSR after the clamps maintain a gap of 5-7mm approx.

4.10 Embossing tool

4.10.1 It consists of the double electric crank, driven motor, servomotor, servomotor
Driven indexing roller, sucking arms and web guide register roller and punch
Safety sensor. It is situated below the perforation station and the process is done pneumatically controlled by PLC.

Read Also: SOP on Destruction of Rubber Stereos

4.11 Operation of Blister Pack Machine

4.11.1 After line clearance from Q.A., put the ‘’ UNDER PROCESS’’ label on the machine.
4.11.2 Enter the start time of the machine in the equipment usage log sheet as per SOP No.: PRD/006-00.
4.11.3 Switch “ON “the mains from the electrical panel.
4.11.4 Blister packing of tablet shall be carried out in a controlled area Temp =23°C ± 2°C and RH 50 ± 5 % Note: It may differ from product to Product).
4.11.5 Switch on the heater and adjust the thermostat to provide the heating condition predetermined for the particular product as per mention in BPR.
4.11.6 Fix printed aluminum foil and PVC/PVDC foil rolls on the machine as per BPR.
4.11.7 Record the temperature of forming and sealing units in BPR.
4.11.8 Fill the inkpot at the overprinting kit of the machine with the requisite height.
4.11.9 Affix the approved stereos/metal letters to the stereo drum of the BCP
4.11.10 Unit/Embossing unit as per the instructions given in the BPR.
4.11.11 Check the sealing performance, overprinting/embossing, and cutting of strips and adjust if required.
4.11.12 Affix the specimen of overprinted/embossed matter approved by the production Officer and Q.A. officer to BPR.
4.11.13 Cross check the containers of the product to be blistered are having ‘APPROVED’ status label.
4.11.14 Cross-check the weight of the product and record the total weight of the product on packing BPR.
4.11.15 Load the product to be blistered in the hopper, cover it with a lid and start the Machine to run the machine through PLC as follows.

Read Also: SOP on Handling Products During a Power Failure

4.12 Operation of PLC as per the following instructions

4.12.1 Switch “ON” the main switch.
4.12.2 Press login and enter the password.
4.12.3 Press the production data to switch for editing product detail like name /B.No. Mfd and Exp. then the screen display. 4.12.4 Press Recipe for Edit, Save, and Load, screen shows.

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

4.12.5 Press display for the setting parameters like NFD count, No. of track.
4.12.6 Pack release delay, Dry ink pack rejection, Sealing reject count, PRC count, etc.
4.12.7 Affix the ‘TO BE CLEANED’ label on the machine and record all the observations in the equipment usage log. sheet as per SOP “Procedure for Making Entries in Equipment Usage Log Book”.

4.13 Precaution

4.13.1 Any tablet or blister that would have come in contact with the sealing roller should be removed and discarded.
4.13.2 The roller should be stopped by means of a switch-off. When the machine is stopped during tea and lunch breaks, it must be ensured that no tablet is retained in the feed chute.
4.13.3 After the machine is restarted, a few empty blisters should run initially to ensure the overprinting details are clear. An empty blister should be removed for the line then packing started.
4.13.4 At the end of the working shift the product left in the hopper or vibratory bowl and channel should be removed, and any blister lying on the packing line should also be removed.

Read Also: SOP on Reconciliation & Destruction of Packing materials.

5.0 Cleaning Procedure for Blister Pack Machine:

5.1 TYPE A:

5.1.1 Change over from one batch to the next batch of the same product and same potency and of a similar product with ascending potency.
5.1.2 Replace the ‘TO BE CLEANED’ status label with the dully filled and signed ‘UNDER CLEANING’ status label.
Ensure that the main power supply is turned ‘OFF’.
51..3 Vacuum clean and/or Dry wipe the equipment with a dry lint-free cloth as per the respective equipment cleaning SOP.
5.1.4 Replace the ‘UNDER CLEANING’ status label with the dully filled and signed ‘CLEANED’ status label.
5.1.5 If the same product is processed for more than 7 days, then follow the procedure of type –B cleaning.

5.2 TYPE B:

5.2.1 This is a cleaning procedure for Change over of product with different actives/color / descending potency or after the maintenance of contact parts.
5.2.2 Follow the procedure from step no. 5.1.1 to 5.1.3.
5.2.3 Dismantle and clean the equipment with purified water and a nylon scrubber. Finally, wipe with 70 v/v % IPA as per respective equipment cleaning SOP.
5.2.4 If the equipment is idle for 72 hours or more after cleaning, then replace the ‘CLEANED’ status label with the ‘TO BE CLEANED’ status label.
5.2.5 Re-clean by wiping with 70 % v/v IPA solution before use. Wipe with a dry lint-free cloth.
5.2.6 Replace the ‘TO BE CLEANED’ status label with the ‘CLEANED’ status label.
5.2.7 Swab samples shall be taken after each type –B cleaning.

Read Also: Isopropyl alcohol 70 % Preparation SOP

6.0 Frequency

6.1 Type ‘A’ cleaning is applicable after the completion of every batch of the same product.
6.2 Type ‘B’ cleaning is applicable in case of product changeover, the same product is processed for more than 7 days, change in product potency, and strength.

7.0 ABBREVIATION(S):

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

Sharing Is Caring:

Leave a Comment

error: Warning!! Content is protected !!