Blister Validation Scheme

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. compliance. PROCEDURE:         

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INSTALLATION QUALIFICATION 1) 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 presence of Thermoforming Thermoforming foil and sticking blisters. blisters. Preheating device thermoforming foil. Thermoforming Thermoforming station (Pocket Depth , Pocket Rupture) Forming head pressure and pressure distribution Cooling water water supply for heated 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 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 •

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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: • •

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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