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Easing Medical Device Validation with the SmartDispenser® The SmartDispenser® saves hours of medical device equipment validation time by stabilizing the dispense process with proper reporting. This reduces the equipment validation process cost. These steps reduce the cost of validating fluid dispensing equipment systems for the assembly of medical devices with the SmartDispenser®: Stabilize the drive system controlling the amount of fluid dispensed The linear drive system replaces erratic compressed air inside the syringe which guarantees that the forward and reverse motion of the dispense cycle will be exactly the same every cycle. Every linear drive system performs exactly the same since electricity replaces air. Replace the traditional air compressor and plumbing system with electricity The SmartDispenser® assures that the electrical current to every linear drive system is exactly the same by using a universal power supply and electronics. Every SmartDispenser® system dispenses fluid identical to the next due to the stable drive system and stable power. This design provides the foundation allowing medical device manufacturers to use one dispense program for a particular device on all SmartDispenser® systems worldwide regardless of location. Every workstation and every manufacturing facility performs exactly the same. The SmartDispenser® defines the production process. We control and can quantify electricity sent to each system’s motor. We can quantify forward movement of the piston. We can guarantee each system performs exactly as the next. The SmartDispenser® can document information such as; • The system operator •

Date of operation

Dispense program used.

Parts produced.

Syringe size

Dispense Tip

Weight of the fluid dispensed

How many dispenses were out of tolerance if any

ETC.

Stabilize the syringe filling process The SmartDispenser® syringe filling system is an automated air free filling system using an electronic actuator combined with the meter and cylinder. The SmartDispenser® communicates the fill volume via a USB electronic control tether allowing the syringe filler to automatically select the fill height. The


syringe fill volume is guaranteed to be the same on every syringe within a fraction of a cubic centimeter once human intervention is eliminated. An encoder confirms the proper volume was dispensed. Perform a capabilities study A capabilities study quantifies the impact of the fluid on the SmartDispenser®’s performance. Because the SmartDispenser® pushes on a column of fluid, different fluid dynamics have different impacts on the system performance. With the drive system, power, and syringe filling stabilized, the impact of the fluid is minimized and quantifiable. The capabilities study focuses on the target fluid deposit weight and the +/- tolerance. The SmartDispenser® is designed to communicate with an AND Analytical Weighing Sensor. Activate the weighing sensor option in the software, determine the dispense program, input the target weight, perform a weight study on a full syringe and the SmartDispenser® will automatically record the weight data in an Excel CSV file on the SmartDispenser® hard drive. Import into Excel for statistical analysis. Create a master capabilities report The master capabilities report is released to quality control, which will be the control document for future SmartDispenser® calibrations. Include the dispense program, testing criteria, and quantified study of the SmartDispenser®’s capabilities within the chosen assembly fluid. Create a program specification Outline the dispense program to be used for the particular medical device being assembled. The specification is released to production which instructs how to program each SmartDispenser®, ensuring all SmartDispenser®s for a specific product are programed exactly the same. By replacing air with the electrically controlled Linear Drive System, standardization is achieved. It assures that the results achieved by engineering in the product development phase are exactly duplicated when transferred to Quality for a capabilities study and creation of inspection criteria and exactly duplicated when transferred to production. The SmartDispenser® delivers to engineering, quality and production expectations all day, every day; station to station – facility to facility. The result is a solid cross-functional empowered work group delivering results that add to the bottom line. Monitor and verify documented traceability from the point of dispense The SmartDispenser® automatically records the dispense program used to assemble the medical device in an Excel CSV file saved on the hard drive. The production manager can verify post assembly process that the SmartDispenser® operator used the specified dispense program to assemble the medical device. About the Author: Fishman Corporation produces high quality, reliable fluid dispense systems for the application of assembly fluids. For more information please visit http://www.fishmancorp.com or call 877-493-0266.



Easing Medical Device Validation with the SmartDispenser®