Spotlight – Another test
Chris Berry, Manager of Medical Device Physical Testing at Smithers Pira, UK, talks to Ellis Davies about the company’s new medical device testing facility.
Tell me about your role at Smithers Pira.
I’m the manager for the new medical device testing lab that has opened in Shawbury, on the site of Smithers’ rubber and plastics facility. Within this new facility we will be specifically dealing with physical test requirements for medical devices.
What prompted the opening of a dedicated facility?
It gives us the opportunity to develop and expand our existing offerings and the ability to support clients with a new Current Good Manufacturing Practice (CGMP) compliant laboratory. The idea is that by offering this service within a dedicated facility we can have tighter control of quality requirements, traceability and calibration – all the things we know from our current client base to be important.
We set the facility up in our Shawbury location because we have the room to grow the business in line with our client needs. The operation we have at the moment is housed in a renovated building with four laboratories, but we have space on site to expand the offering when the need arises.
What does the facility do?
This facility will expand on the services offered previously at the company by focusing on routine testing. By medical devices we’re including device components, assemblies, packaging and accessories – anything associated with medical equipment. The packaging is considered part of the device, and we will be looking to test any
and everything we can with the facilities we have. We are going to be looking into what other testing we can do with our equipment, and where feasible develop new testing capabilities in response to client requirements, which is historically what we have been doing in this sector.
What testing methods do you use?
A broad range of standard tests, with an option to develop new methods or transfer client tests. Clients often have their own in-house bespoke testing methods, and if they wanted us to perform these tests we would do so and validate our methods against theirs. We typically perform functional tests and measurements designed to verify the design requirements for the components of assembly. These tests include assembly, disassembly and separation and actuation forces, as well as, for dose delivery, making sure that the accuracy of dosing is correct and testing connection forces. We conduct physical testing as opposed to analytical or chemical.
In this laboratory we’re principally concerned with device functionality. We will look at integrity, leak testing and ease of use. With packaging, the important tests are seal integrity and strength, durability, and looking at overall sealant conditions and leakage.
We mostly use machinery for tensile and compression testing, torque testing, optical and contact measurement, spectral transmission and weight gain or loss.
Do you have any plans for expansion?
This operation has effectively expanded our service offering. This kind of testing would usually be done at our Leatherhead site, but because of spatial restraints and limitations on the quality offered, the establishment of this dedicated laboratory means that the service is improved, and it is easier for us to achieve CGMP compliance.
What we’re looking to do is grow in response to client inquiries, and we will move wherever the market is going. Much of this form of testing uses universal equipment, allowing us to use these physical testing apparatus to expand as required.
Where is the market going?
There seems to be a greater focus on regulatory testing, submission testing and post-market surveillance – monitoring products that are available on the marketplace to ensure that they perform as required. This is in response to European and American regulatory requirements.
Augmented reality for non-destructive testing
The Fraunhofer Institute for Non-destructive Testing (IZFP), Germany, has developed the 3D SmartInspect, a testing solution that is able to automatically generate a digital protocol, and display the results via augmented reality (AR) glasses, tablet, PC and smartphone.
The initial prototype has been completed but does not feature AR compatibility yet. IZFP says that in day-to-day work an inspector would wear the AR glasses while viewing the object to be tested, run the sensor over the object, and the corresponding area on the glasses’ display will change colour to indicate that 100% of the object has been tested.
Once the data is collected, it is displayed immediately on either the glasses or a screen. Areas with defects appear red, and the inspector can act swiftly to repair the flaw. IZFP says that this kind of digital approach to testing offers economic advantages because of a reduction in downtime.
Rugged and ready
Created to cope with tough environments, the XL Go+ VideoProbe by Nexxis, USA, has been specified by the US Navy for use on its fleet of aircraft because of its portability, at just 1.73kg, and durability.
The XL is manufactured to resist an array of challenging industrial workplaces and is able to withstand a range of environmental conditions. The device features high-output LEDs to allow sharp and detailed inspection levels, an integrated warning system to protect the device from extreme temperatures and guided inspection software that can auto-generate reports to decrease reporting time by up to 70%.
Linde plugs the leak
Linde LLC, USA, has launched the MAPAX LD leak-detection system, which can quickly find leaks in modified atmosphere packaging (MAP). The company says the system is ideal for packaged meat, poultry, seafood and prepared foods packaged with tray sealers or thermoforming machines.
The system works by adding a small amount of hydrogen, to be used as an indicator, to the gasses during the package sealing stage of production. The system’s sensor then identifies the hydrogen when the packages reach the leak-detection stage.
If a leak exists due to a pinhole, tear or defective seal, an alarm goes off so that the issue can be resolved or investigated. This item can then be removed from the production line.
New NDT platform from DolphiTech
Norwegian company DolphiTech has launched a new non-destructive testing solution, DolphiCam 2, with interchangeable transducers over a wide frequency for a range of materials and applications. The product also includes features for robotics integration, general network connectivity and remote expert inspections.
DolphiTech says that its current range of NDT systems are optimised for carbon fibre reinforced polymers, but is looking to offer a complete solution for multi-material structures. The DolphiCam 2 is the beginning of this R&D venture for the company.
Sierra-Olympic launch new thermal camera
Thermal imaging technology company Sierra-Olympic (SO), USA, has introduced an affordable, easy-to-use, thermographically calibrated thermal camera to its range. The Viento-GT is billed as a highly reliable, high-resolution thermal imager capable of delivering thermographically calibrated digital data for every pixel.
The camera can be used to measure temperature, conduct non-destructive testing, hot-spot detection, bio and medical imaging, industrial inspection, quality control and assurance. Available with either 320 x 240 or 640 x 480 pixel resolution, the Viento-GT also comes in two form factors – enclosed or split board.
Boeing opens new non-destructive evaluation lab
The Boeing Company, USA, recently worked with researchers at Missouri University of Science and Technology, USA, to establish a new non-destructive evaluation laboratory at the Boeing Research and Technology Centre in Charleston. The new lab is focused on R&D efforts in advanced manufacturing, including composite fuselage and propulsion systems production.
The lab uses millimetre wave technology to detect flaws in coatings, surfaces and materials. The technology can detect flaws under attenuative materials and make thickness measurements of dielectric coatings. Boeing is also working with Missouri University to investigate a millimetre wave crack detection method, looking to improve ultrasonic and eddy-current approaches to small-crack detection.
Element Houston awarded Nadcap accreditation
Global materials and product qualification testing company Element Materials Technology has gained Nadcap accreditation at its Houston lab for radiography, ultrasonic inspection, liquid penetration and magnetic particle inspection.
The accreditation is the second achieved by the site for materials testing, and is accredited under audit criteria AC7101, spanning hydrogen analysis, micro- and near-surface examinations, impact and temperature tensile testing and standard specimen machining.
The company says that the achievement will allow them to further serve aerospace clients by offering a complete range of testing and inspection services approved at the highest level.