Precision Medical Technologies, Inc. has received the results of its PEEK cell’s cleaning validation. All test method acceptance criteria was met. Premedtec earned an extraction efficiency percentage of 87% on the “Quantification of Extractable Residue by Gravimetric Analysis Final Report”. The standard used for this test method (ASTM F2459) requires the extraction efficiency to be greater than 75%. A bioburden test was completed and showed that bioburden is not of high concern on Premedtec’s devices. Going forward cytotoxicity will be tested on a quarterly basis.
Premedtec Establishes Second Rome City Facility
Precision Medical Technologies, Inc. of Warsaw, Indiana, has announced the establishment of a second facility in Rome City, Indiana. As a contract manufacturer of Orthopedic Implants and Instruments, serving OEM’s nationwide; the company specializes in Spine, Trauma, and Sport Medicine devices. There are two operating Divisions, Instrument Manufacturing and Implant Manufacturing; the expansion to Rome City will be part of the Instrument Manufacturing Division. The company will invest at least $1 million in new equipment and create a minimum of 10 new positions within the next two years. This new investment and additional employment are planned as business expansion not business transferred from the Warsaw facility.
Precision Medical Technologies, Inc. is currently ISO 13485:2003 certified, and is in the process of completing their Validation Master Plan for all machine centers and processes. The new facility in Rome City will be expected to become equally compliant.
Business owners Kurt Kamholz and Jeff Thornburgh view the Rome City area as a highly desirable location from which to attract skilled machinists and CNC programmers. Past experience has shown the north central region of Indiana to provide employees with strong, dependable work ethic on which manufacturers can depend. It is expected that equipment will be in place and operations will begin in the first quarter of 2012.
Premedtec will Exhibit at the North American Spine Society’s Meeting
Precision Medical Technologies, Inc. will be exhibiting at the North American Spine Society’s 26th Annual Meeting. NASS will be at the McCormick Place Lakeside Center in Chicago, Illinois, this year from November 2nd to the 5th.
Premedtec Installs New Image Dimension Measuring System
Precision Medical Technologies, Inc. has installed a Keyence IM-6000E image dimension measuring system. This high-precision measuring system uses a 6.6 mega pixel monochrome C-MOS camera with parallel light irradiated from the high-intensity LED. Once a pattern image is registered, the IM-6000E calculates the position and angle of the target by using pattern search processing. Operator error is all but eliminated with its +/-.00004 repeatability.
Premedtec to Exhibit at the 2011Orthopedic Design & Technology Show
Precision Medical Technologies, Inc. will be exhibiting at the Orthopedic Design & Technology show at the Grand Wayne Center in Fort Wayne, Indiana. The dates for this tradeshow are September 14th and 15th.