Protocol Studies for Medical Component Material

Our long-time customer asked us to evaluate an alternative material for one that was being discontinued. The discontinued material had been pre-blended and compounded by the manufacturer with a second material that is still available. As a cost savings, Klann suggested that it take over the blending of the two materials in-house, at the molding machines. The customer ordered a series of protocol studies to evaluate the new material as well as the in-house blending process.

The IQ, OQ, and PQ studies were conducted under strict time intervals and required that we chart and record all machine processes, mold temperatures, water temperatures, and pressures. Results were measured and recorded on an OGP Smart-Scope vision system.

Specifications