Protocol Studies for Medical Component Material

Case Study – 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

• Component Name – Medical Component

• Capabilities Applied/Processes – Injection Molding, Custom Blend up to four materials, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)

• Equipment Used – Manufacturing: In House Injection Molding Machine, Testing: Measured on OGP Smart-Scope Vision System

• Material Blended – Blended Material, Blowing Agent and Colorant Added at Machine

• Typical Protocol Operations – Installation Qualification (IQ) – Followed customer specified documentation, Operational Qualification (OQ) – Followed customer specified documentation to review standard operating procedure for start up, maintenance and safety, Performance Qualification (PQ) – Inside and Outside Diameter Testing performed

• Typical Molding Operations – Injection Mold the Knob, Apply Printing to the Knob label insert using a Pad Printing Process, Assembled the Product and delivered a ready-to-use part

• Delivery Time & Location – 3 Months for 23 Parts, Virginia, USA

• Industry for Use – Medical