Video metrology speeds medical quality control
A
Nikon UK product story
Edited by the Engineeringtalk editorial team
Feb 13, 2002
A new video metrology system has fully automated the task of taking complex three-axis measurements on samples created from new tools for nmedical device manufacturer Owen Mumford.
Owen Mumford is recognised throughout the world as an innovative manufacturer of small medical devices for capillary blood sampling, drug delivery and sexual medicine.
Its patented autopen is well known by diabetics as a convenient and highly accurate insulin delivery device.
The company specialises in injection moulding of plastic components, insert moulding of blood lancets and manual and automated high volume device assembly.
Much of this patented technology, in-house design development and manufacturing expertise is offered to major pharmaceutical and diagnostic companies for which they develop devices to meet their specific drug package and diagnostic tests.
The company is totally committed to quality and has adopted a philosophy of excellence in all areas (including approvals to ISO9001 and EN46001).
As part of this philosophy, a quality assurance group has been established as an independent body, servicing the quality engineering and regulatory needs of the company.
Among its many processes the company specialises in injection moulding, using multicavity tools, for the manufacture of small but complex plastic mouldings.
Such tools require an ISIR (initial sample inspection report) prior to any volume manufacturing taking place.
These tools can last for years and will easily produce millions of components, many of which are associated with the administration of life giving medication.
Errors at the tooling stage could be very costly indeed for the manufacturer and potentially problematical for the end user, but a validation report on a multi-cavity tool could take weeks if handled manually, which is why the company invested in a video metrology system from Nikon - the NEXIV.
The NEXIV unit was installed in August 2001 and has fully automated the task of taking complex three-axis measurements on samples created from new tools, employing the highly accurate TTL laser technology built in to the system.
Many variables have to be taken into account when taking these measurements, including heat, pressure, cycling speed and the material used in the injection moulding process.
Bernard Sedwards, Quality Engineering Manager explained, "The key factor for such volume manufacturing is repeatability and NEXIV provides the constant from which all standards of manufacturing can be set and establishes the basis for future repeatability".
Steve Miles, Corporate Quality and Regulatory Manager for Owen Mumford, takes up the story.
"We looked for solutions at the last INSPEX show and considered many options before finally deciding on Nikon's NEXIV.
I had been tasked with providing rapid reports to our toolmakers on the performance and suitability of multi-cavity moulds in a variety of situations.
After testing and evaluating a number of systems we chose the NEXIV for its accuracy, speed, repeatability and value for money.
Once the decision was made the unit was installed in our quality centre in August 2001 and, after initial training, was soon earning its keep".
Miles added, "Payback time for our investment in NEXIV has been less than a year and we are still only scratching the surface of its capabilities.
With the help of Nikon's excellent technical support team we intend to extend and develop applications in the future and will be using the unit for reverse engineering as well as more complex metrology tasks".
Miles went on to say, "The support and advice we have received from Nikon has been invaluable.
Our system was installed on time and the initial training completed when promised".
Miles revealed that the tasks currently being performed by NEXIV would not have been practical using traditional, manual metrology methods.
He also confirmed that significant commercial advantages had been gained from using the system.
"NEXIV enables us to provide a full process validation report to a toolmaker in just 48 hours.
Such a report would have taken weeks and many more employees, particularly if you consider all the variables that need to be taken into account.
Needless to say we are delighted with our investment and look forward to increasing the number of applications in the future".
Owen Mumford has provided solutions for many of the world leading pharmaceutical and diagnostic companies and its client list includes Bayer, Glaxo Wellcome, Serono, Rhone-Poulenc Rorer, Sanofi, Lifescan, Lilly, B Braun, Janssen-Cilag, Berlin-Chemie, Medisense and Knoll among others.
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