Test & measurement M
edical device manufacturers understand the importance of a reliable manufacturing process, which
is fully compliant with industry regulations, such as the biocompatibility regulation ISO 10993. Naturally, this compliance must include the fixtures that secure the components during quality testing to ensure ISO/IEC 17025, which requires competent testing and calibration, throughout the whole manufacturing process. When measuring small, intricate
components, Original Equipment Manufacturers (OEMs) get the most accurate results quickly when the part under inspection is secured. Fixtures, for example, are key when inspecting medical components, such as syringes, because they provide 360-degree access and keep them in place without exerting too much pressure and damaging the part. This is particularly important when using a touch probe, like the Micro-Vu with touch probe accessory, as it requires access to all areas of the component for visual inspection and internal tactile probing. These techniques can guarantee the measurements of components conform to the same standard as when it was qualified.
CHooSInG A fIxTuRE OEMs have two choices of fixture, static or automated. Manual fixtures require operators to physically turn the fixture between each measurement, which can be a very time- intensive process. Both techniques have their place, but automated fixturing can deliver considerable benefits where it is suitable. Automated fixtures take out the time-
consuming process of manually turning the spar between measurements. The automated fixture integrates a high precision rotary indexer that automatically turns the parts. The operator does not have
Automating the fixturing process
According to the McKinsey Center for Government, a medical device manufacturer experiences an average ten per cent drop in share price after a single, major product recall event. Remaining compliant is key to avoiding recalls, so providing ridged support during medical device quality testing stops unwanted movement and ensures testing is compliant. Here Mike G John CEng IMechE, head of engineering at industrial metrology supplier The Sempre Group explains the importance of fixtures in the medical device industry.
to wait for the measurements to take place, so can carry out jobs that require human intervention, such as data analysis.
BESpoKE fIxTuRInG SoluTIonS Manufacturers will not always be able to find an off-the-shelf solution that suits their application. If the part has a complex geometry, like a hip joint, it can become unstable in a standard modular fixturing system, which will alter the accuracy of the measurement. In these
circumstances OEMs can work
with a fixturing provider to create a bespoke solution that securely holds the part and is compliant with medical regulations, reducing the risk of human error and improving accuracy. Sourcing external expertise provides manufacturers with the R&D, testing and production skills that avoid the risk and time-consuming process of designing the fixtures in-house. Metrology providers can also integrate
automated SPC software, such Prolink, with the fixturing process to automatically measure the part and store the data in a single, centralised data collection point. Engineers can review real-time data at any point in the production process and analyse it to prove compliance and accuracy. The software also automatically produces first article inspection (FAI) reports at the click of a button that manufacturers can share with stakeholders. Contacting a metrology one stop shop, such as The Sempre Group, allows OEMs to have an end-to-end turnkey solution to their metrology process. Metrology providers can assess quality testing needs and make recommendations, create the required fixtures, validate the parts based off industry regulations and deliver, calibrate and install the
technology and software. The Sempre Group
www.thesempregroup.com 60 February 2022 Instrumentation Monthly
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74
