Blister Pack - Updated

Blister Packing system:
Scope:
Blister packing system complying with requirements of current regulatory trends is capable
of producing normal blisters(PVC/PVdC) and Alu/Alu blister in a single machine.
It provides hermetic sealing of Oral solid Dosage forms thus keeping the drug products safe
and efficient during its shelf life.
PVC/PVdC Blister protects drug product from Environmental contamination.
The system has inspection system capable of detecting empty blisters, empty
products,different products,broken/chipped products and rejecting the defects thus doing
away with manual inspection that is dependent on Visual acuity of Visual inspectors.
It is also capable of producing Alu/Alu blisters that is required for packing of moisture /heat
sensitive products.
The system is capable of hot/cold thermoforming ability thus making packing of thermolabile
product in a single machine.
The “I”mark sensor helps in reducing the consumption of packing material thereby reducing
the packing material cost.
The machine is run by servo motor that bring back the setting to zero/home position during
power interruption thus making the operation less time consuming.
Its plug and play type of change parts makes assembling and disassembling in shorter period
thereby reducing the non value added time.
Only minimum parts comes in direct contact with product thus greatly reducing the clean
time.
The complete system shall be designed as per current relevant standards,agreed technical
specification and User requirement specifications to comply with the clients requirement.
Technical specifications of all the equipment, instruments, valves etc. are as per the offer, the
Purchase Order, and the client’s Requirements.
Training on the system to be provided to operation staffs those are involved in Blister
packing system
Operation and Maintenance:
1. The installation of the machine takes less time as the machine is of plug and play type.
2. The Machine to be installed in controlled environmental conditions with sufficient space
around the machine for engineers to work on the lubrication of moving parts.
3. Switch Off the main and unplug the electrical cable.
4. Install Forming plate, sealing plate ,feed track, chute on the machine as per change parts .
5. Load the PVC foil on the forming side and ensure proper formation of Blister.
6. If any forming is not proper, Check the plug and air hole for any obstruction.
7. Install guide plate and align with Forming and sealing plate.
8. Switch On the water cooler and ensure proper temperature (8-12℃) and circulation of
feed water.
9. Load the lidding foil on the sealing side and switch On the heater to attain temperature of
160℃.
10.Load the PVC and lidding foil and check for proper formation of empty blister
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11.Conduct leak test and ensure it passes.
12.Switch on the inspection system and challenge the system for proper rejection empty
blister,empty pockets, different product.
13.Bring the machine to “Home” position ans start the operation of the machine.
14.The Monthly,trimonthly,Half yearly and annual preventive maintenance program is
prepared and shall be performed for proper functioning of the machine.
15.After completion of the batch/end of the day cat the forming plate with liquid paraffin to
prevent damages to knurling portion.
Preventive maintenance:
1. Disconnect the power supply and affix under maintenance label.
2. Clean inside surface of the machine, motor body with dry clean cloth and hand blower.
Lubricate the motor and ensure the belt is in proper condition.
3. Clean external body of machine with dry clean cloth. Use 70% Isopropyl alcohol
solution to remove stains if found.
4. Check the condition of Embossing Plate.
5. Check the vacuum(air), temperature for sealing and forming which meet the requirement.
Ensure the gap between two forming plates, and check the sensor.
6. Check the main tension spring, sealing pressure, cooling air, guide track , chain
connection and adjustment for Forming plate and sealing plate.
7. Check the condition of vibrator.
8. Check the conveyor, speed, rotation, electrical line, and apply lubrication oil if
necessary.
9. Check the cutter assembly, gear box and oil level of gear box.
10. Check for any abnormal sound / vibration, if required rectify / replace.
11. All the preventive maintenance activity shall be recorded and maintained by Head
maintenance
12. Affix the label, “Ready for use”.
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