New Product Transfer Automatic Assembly Machine Validation/Qualification

Achievements and Results

• Complicated automated machine comprehensively tested and validated
• Project completed on time, in three months

The Problem

A manufacturer with a complicated automatic assembly machine wished for the entire process to be validated and tested for qualification. The assembly had numerous interlocking processes and parts, including: vibrating feeder bowls with vision sensors for orientation, accumulating conveyors, pad printing station (Tampo Print) with a vision system to detect bad or incomplete prints, unwinding media rolls to feed media, a cutting system with a servo motor, a spin cutting and cleaning station, pick and place for media and filter housings, ultrasonic welding for plastic housing of housing seals, a leak test on Uson leak testers, a Mitsubishi robot for placing on leak testing nests, and a Sator laser printer.

The Solution

All main machine systems were validated. An engineering study was performed in order to determine the leak test parameters for fill time, span time, leak test time and exhaust time. Another engineering study was performed in order to determine optimum welding parameters on the Herrman ultrasonic welder.

A full software validation installation and operational qualification was executed, and all inputs and outputs were verified, in addition to verification of control systems, alarms and event conditions.

A full installation qualification was performed, including: preventative maintenance instructions; a spare part list; an Environmental, Health and Safety Assessment; utilities verification and calibration verifications.

A full operational qualification was performed, including standard operating procedures (SOP) for machine use. Testing parameters were obtained during engineering studies, and using these parameters, product tests were performed during which product was tested until failure.

A full process and product qualification was performed, during which 3 lots of 4,000 products were manufactured. All products passed all tests, including field trials.

Benefits Realized

The expert was able to provide the client with a comprehensive study of their manufacturing progress. Numerous automatic machine assembly processes were studied, tested and validated, and all was performed in less than 3 months, per the client’s specifications.

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