Professional Documents
Culture Documents
To describe the procedure for the validation of the blistering machine to ensure that it meets
installation, operational and performance qualification requirements.
RESPONSIBILITY:
It is the responsibility of the production manager and technical services manager to follow the
procedure. The Quality Assurance manger is responsible for SOP compliance.
PROCEDURE:
1) INSTALLATION QUALIFICATION
Verify approved purchase order
Verify Invoice
Check Manufacturer and Supplier
Verify Model Number and Serial Number
Check for any physical Damage
Confirm location and Installation and requirements as per recommendation of manufacturer
Verify that the required utilities are available
Installation shall be conducted as per instruction provided in the manual.
Ensure that all relevant documentation is received.
User Manual
Maintenance Manual
List of change parts
Electrical Drawings
Mechanical Drawings
Control Panel
Central EDP Control Unit
Detector for presence of Thermoforming foil and sticking blisters.
Preheating device thermoforming foil.
Thermoforming station (Pocket Depth , Pocket Rupture)
Forming head pressure and pressure distribution
Cooling water supply for heated and cooled tools
Vacuum Exhaust system
Empty Hopper detector
Fill Control System
Detector for the presence of lidding foil and sticking blisters
Light beam for steering of pulling off preprinted lidding fol.
Printer for printing of blank lidding foil
Sealing Station (foil strain shift)
Sealing Station overload protection
Cooling station
Code embossing and printing station
Perforating station
Compensation loop before punching station
Punching Station (foil strain shift)
Machine Safety Guards
Blister ejector
2) OPERATIONAL QUALIFICATION
• Forming of a Blister
• Feeding of the product into the blisters pocket
• Fill Control System
• Sealing of the Blister Pack
• Application of the Blister code.
3) PERFORMANCE CONTROL
Select and run available products and confirm the following attributes