MicroPulse uses both quality labs as well as shop-floor installed CMMs, accessed by both quality technicians and machinists in their medical device manufacturing facility.
OGP offers more than equipment to help their medical
device manufacturing customers, especially smaller operators for whom medical manufacturing is relatively new. For ex- ample, OGP offers tools and services to help companies meet regulatory requirements for installation qualification (IQ) and operational qualification (OQ), two of three phases required to make measurement systems compliant with FDA regula- tion. “We also offer workbooks to assist companies in prepar- ing for the process qualification [PQ] phase, although they must do the actual qualification on their own,” explains Rose. “We are seeing an increase in the services that we do. I think that is because there are more manufacturers getting involved in the medical device supply chain. A number of aerospace component manufacturers have added medical because, really, there is much similarity between the two.” Establishing a foundation of accuracy is as important as in-
process control. “Te most challenging areas within the medical market are makers of implants, such as hip and knee replace- ments,” agrees Clive Warren of Renishaw (Hoffman Estates, IL). “Tese require complex machining processes to exacting stan- dards.” Complying with medical manufacturing quality standards means proving CNC machines are capable of cutting to stated
tolerances. “Ballbar analysis is a proven method for determining machine tool capability, and is the most practical, convenient and comprehensive tool for assessing the performance and accuracy of CNC machines,” according to Warren. Te QC-20W measures to ±0.1 µm. “Te new QC-20 wireless ballbar means testing is much faster and safer, since you do not have to route the wire out of the machine or override the door interlock,” he says. Currently, ballbar tests defined in ASME and ISO stan-
dards are limited to the three primary working planes and do not address the challenges presented by four and five-axis machines. However, new test routines have been proposed that include a machine’s rotary axes and are currently being considered for inclusion in a new ISO 10971-6 standard, and there are also references to four and five-axis tests in Appendix J of ASME B5.54 2005, according to Warren. To determine the angular accuracy and repeatability of rotary axes, Ren- ishaw recently launched the XR20-W, a wireless rotary-axis calibrator. “It uses an ultra-high accuracy encoder, originally designed for the new generation of active probe heads such as the new Renishaw PH20,” said Warren. Designed to work with their XL-80 or ML-10 laser interferometer systems, the XR20- W measures to better than ±1 arc-second.