Blister Defects and Remedies in Pharmaceutical

Blister Film is a plastic processing technique that involves heating a flat plastic sheet, applying a vacuum to mold a surface, and then cooling the mold before filling it. This technique is widely used in plastic packaging, lighting, advertising, and decoration. However, issues related to the quality of blisters and defects in Pharmaceuticals may arise during the Blister formation process. These types of problems related to blister defects and remedies are explained below.

Blister Defects and Remedies:

Following are the issues that are encountered during the blister packing process:

  1. Leak test failure
  2. Wrinkle on Blister
  3. Cavities Defects
  4. Blister Cavity stuck in forming Plate
  5. Forming station does not open fully
  6. The camera system not working
  7. PRC out of the bend
  8. Pinhole detector not working Probable causes:
  9. Homing not done
  10. Blister Damage in sealing station
  11. Motor overload
  12. Emergency machine stop
  13. Blister-dropping problem, machine not stared after pressing green button
  14. Bend Blister or Twisted blister
  15. Web direction uneven
  16. Dott Impression on PVC/PVDC foil after pocket formation
  17. Web slipping at the punching station
  18. Low air Pressure
  19. High-temperature cooling water
  20. Thermocouple check/ perforation blade

1. Leak test Failure:

Probable causes Suggested Action
Improper sealing due to less pressureMaintain sealing pressure up to 5 bar
Sealing temperature less than requiredMaintain sealing temperature as per BPR
Ink or extra material deposition on sealing rollerClean the sealing roller with a brash brush

2. Wrinkle on Blister

Probable causes Suggested Action
Guide plate alignment with a counter-sealing roller is not properAlign the guide plate properly with the counter-sealing roller
Aluminum foil unwinding pressure lowIncrease the unwinding pressure to the required level
Guide roller is not perpendicular to the Front PlateCheck if the guide roller is not perpendicular and correct it.

3. Cavities Defects

Probable causes Suggested Action
Air went partially closed in some areaCheck vent, do clean it if required
Failure of heaterCheck heater properly
Height differences between heating and forming stationSet heating and forming station height and level.

4. Blister Cavity is stuck in Developing Plate.

Probable causes Suggested Action
Forming plate not sufficiently cleanedCheck the cooling system, and reduce the temperature if required
Ejection pins are stucksCheck ejection pin

5. Forming station does not open fully

Probable causes Suggested Action
Maybe due to jamming in moving Platelubricate piller bearing
Servo motor coupling is loose, or rubber is worn outclean if foreign particles are deposited in the sliding part, replace the rubber

6. The camera system not working

Probable causes Suggested Action
Signal or disconnection camera systemCheck the signal coming from a camera
Camera key in special function is not activatedActivate camera key in a special function

7. PRC out of the bend

Probable causes Suggested Action
Eye mark shifted while the machine runningTeach the PRC scanner
Distance between two eye marks on foil is not as per drawing.check the distance between two eye mark.

8. Pinhole detector not working Probable causes:

Probable causes Suggested Action
Input in PLC is not connectedConnect pinhole detector
Distance between pinhole and rejection system is not properInput right distance between pinhole and rejection system

9. Homing not done

Probable causes Suggested Action
Homing is not performedPerform homing of all axis

10. Blister Damage in a Sealing station

Probable causes Suggested Action
PRC setting is not properSet the PRC
Improper sealing station knob tightnessFixed the sealing station

11. Motor overload

Probable causes Suggested Action
Motor is overheated-Eliminate the error, wait until the motor has cooled down
-Check the mechanical parts for roughness and blockage
-Clean the drive unit
-Lubricate the moving part

12. Emergency machine stop

Probable causes Suggested Action
An emergency push-button activatedUnlock the emergency knob by turning it.

13. Blister dropping problem, machine not started after pressing Green button.

Probable causes Suggested Action
Splice sensor-Change the number of tracks selected in the PLC after the changeover.
-Check the splice sensor, whether it is loose or not
-Do the challenge test for PVC sensor and Alu splice

14. Bend Blister or Twisted blister

Probable causes Suggested Action
Guiding roller before the indexing rollerUse the guiding roller having a diameter of 5mm less than blister width, for example, blister having 110x45mm which is 110mm in length and 45mm in width then, use the guiding roller having a diameter of 40mm. (45mm width-5mm=40mm) to prevent bend blisters.

15. Web direction uneven

Probable causes Suggested Action
Forming plateCheck the lower forming plate position, tight the lower screw

16. Dott Impression on PVC/PVDC foil after pocket formation

Probable causes Suggested Action
Heating plate surfaceUse the heating tap on the identified surface from which impression generated

17. Web slipping at punching station

Probable causes Suggested Action
Incomplete forming cavities, wrong blister setting in indexing rollerRemove the web from punching and check causes
Improper pickupCheck pickup assembly for any damaged vacuum pipe, tight their nuts, Check Vaccum.
Misalignment of support plate in punching plateAlign The plate as per blister size

18. Low Air Pressure

Probable causes Suggested Action
-No compressed air, leakage in the air pressure line
-pressure seal defective or set incorrectly
-Faulty setting pressure regulator
-Wire break in cabling in air pressure controller
Activate the compressed air supply, check the pressure gauge or maintenance unit

19. High-temperature of cooling water

Probable causes Suggested Action
Thermocouple for cooling water is not connectedConnect the thermocouple, replace the defective one

20. Thermocouple check/ perforation blade

Probable causes Suggested Action
Actual pressure of thermocouple blade is below 50°C-Check thermocouple connection
-Replace the defective thermocouple
-Set the perforation blade temperature above 50°C

Conclusion:

The quality of the blister depends on the material and machine setting as per the given parameters. But sometimes, small problems can lead to harm to the quality of products. So, hope topics related to blister defects and remedies are covered all these problems.

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