Precision Medical Devices: Resolving Leakage Issues

A certain medical device company produces a testing product, a disposable pipette with a 2.381 glass ball at the bottom serving as a switch. This device demands excellent roundness of the glass ball; any deviation can lead to leakage, affecting the testing efficiency. The customer specifies a roundness requirement of 1 micron for individual balls, with a batch tolerance of ±2 microns. Previous suppliers consistently failed to meet these requirements during bulk production, resulting in complaints about excessive deviations in roundness (up to 5 microns in maximum ellipticity) and batch tolerance falling below 8 microns.

Upon contacting GELINDE, we conducted extensive technical discussions and proposed a solution to the customer. Our plan included achieving a roundness of 0.5 microns for individual balls, a batch tolerance of ±1 microns, and controlling the roundness variation across the entire batch to be within 0.3 to 0.5 microns. After implementation, the customer experienced no complaints regarding leakage, and our solution earned recognition from their clients. We are currently in close collaboration with the customer, ensuring continued success in our partnership.