SUBJECT:

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

• Verify Alarm Control

• Perform Calibration Requirements identified in the manual or established by the validation team
• Operate the equipment at Low, Medium and High speed as per operational manual to verify the
operating control
• Verify that all the switches and pushbuttons are functioning properly
• Establish procedures for operation , maintenance and calibration.
• Establish training program for the relevant staff
For a blistering process following critical points can generally be identified:

• 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

Identify check of used materials

Visual Inspection of the blister appearance
Correct function of fills control system
Correct blister code embossed or printed
Correct function of perforating station
Blister seal quality (leak testing)
Time interval: prior to daily production start; every hour during production