Based on the same components as the DMP 70, the DMP 35 produces complex workpieces from a wide range of materials and in the smallest possible space.
With traverse paths of 350mm x 420mm x 380mm on a width of 1,285mm, the DMP 35 is equipped with an inline spindle with 15,000rpm, direct absolute-path measuring systems in all axes, and the tool magazine has spots for 15 tools up to 150mm long. The modular system also includes a 24,000rpm spindle and an HSK-A40 or SK 30 interface. The DMP 35 is available with an integrated table for 5-axis simultaneous machining while the stable design ensures vibration-free, accurate milling with free chip fall. An internal coolant supply with 40 bar and a chip conveyor with up to 1,000cm³/min capacity is available.
Adding only 1.15m² of additional floor space, the compact WH 3 automation solution increases productivity. Featuring new input programming on the WH 3, the setup process is simplified and shortened so inexperienced programmers can set up components quickly and easily.
In the center of the uHTS machine: a Stäubli RX160.
PHOTO: STäUBL
The Genomics Research Center (GRC) in Taipei, Taiwan, a public research institute that’s part of Taiwan’s Academia Sinica, enhanced and accelerated its drug-screening capacity after the SARS epidemic in 2003. The Academy invested 300 million Taiwan dollars (US $10,716,060) and acquired a professional device for ultra-high-throughput screening (uHTS) of medical compounds.
Today, GRC uses its fully automated uHTS device to test 1,536 substances in one cycle. In the center of the machine, used 24/7 for developing COVID-19 medicines, is a Stäubli robot.
An automated device, the uHTS conducts tens of thousands of chemical, genetic, or pharmacological tests per day. This creates the pre-requisite for identifying bio-active substances which may be the starting point for designing new drugs and vaccines.
With uHTS on board, the GRC developed an effective anti-influenza drug in 2007 and currently is focused on fighting COVID-19.
Screening drugs by millions
The drug screening machine in Taipei was designed and manufactured by GNF, a subsidiary of Novartis. GRC’s uHTS system uses a microplate – no larger than the palm of a human hand – with 1,536 drugs (each with a volume of several µL) that can be screened in one cycle. It takes about 70 minutes to run but can overlap as the next cycle can start when another is already running. Collectively, more than 50 plates – 76,800 different substances – can be screened each day.
Why is such speed necessary?
“According to statistics, it’s necessary to search for more than one million compounds to have a chance to find a lead compound,” says GRC’s Dr. PoHsun Lin
.
These millions of compounds can be tested within 650 cycles (1,000,0000 compounds, divided by 1,536 drugs per microplate), and the machine works 24/7 with high speed and accuracy as the wells of the microtiter are extremely small.
The GRC stores up to 2 million compounds in its library, but not every project needs a complete screening.
“For the most common use, we keep around 100 microplates with 1,536 compounds each in our library, including FDA approved drugs, known drugs, bio- actives, small molecular, natural products, and representative compounds,” Lin says.
The plates with the substances and a special protein are conveyed to a reader station where the screening starts.
PHOTO: STäUBLI
One single robot
The uHTS machine features several stations for storing, commissioning, handling, and screening, and is built with a Stäubli RX160 robot in the center – which is fast, precise, but very versatile as it can fulfil different handling tasks.
In the screening process, the robot first takes a plate from the incubator and puts it on the dispenser station. Protein is then dispensed into the plate. Next the robot takes the plate of 1,536 drugs to a transfer station – an incubator and two dispensers – where further compounds and substances are added. Then the robot takes the ready-to-screen plate to a reader station for detection, followed by delivery to the station where the screening starts.
Selecting the right robot
When selecting the robot, engineers at GNF considered qualities such as speed, accuracy, availability, and longevity.
“Our uHTS system has been used successfully for many years; it simply doesn’t grow old. The Stäubli RX160 robot is still on the cutting edge in terms of precision and dynamics and impresses with remarkable reliability. The system delivers top performance, efficiency, and stability,” Lin says.
Therefore, it can contribute to COVID-19 remedy research in 24/7 mode, and is why GNF still uses Stäubli robots for their current HTS and uHTS screening machines.
Labeling in a distribution center is a key step in medical device supply chains. Modern factory production lines benefit from efficient labeling while maintaining compliance. Cloud-based solutions can streamline label printing and enable modern workflows.
PHOTOS: NICE LABEL
Medical device approval processes can be time-consuming, regulations can change across borders, non-compliance could mean costly delays, and competition demands shorter times to market. These challenges require efficiency, and though labels may be physically small, their overall impact on supply chains will play a large role in the medical device industry for years to come.
Dated labeling procedures, such as manually hard coding label templates, verifying items by eyesight, or locally managing disparate printers and label data sources across facilities, won’t provide the agility needed to succeed. Adopting a modernized digital labeling strategy will be key for medical device manufacturers seeking to gain a competitive edge, maintain compliance, and improve supply chain processes.
Globally meeting compliance
Medical device manufacturers that operate internationally must align labeling with different standards, such as the EU Medical Device Regulation (EU MDR) as well as the U.S. Food and Drug Administration’s (FDA) guidelines.
Seemingly minute variations among regulations can be important. A manufacturer shipping in the U.S. that complies with FDA Unique Device Identification (UDI) guidelines, may be nine-tenths of the way to also meeting EU MDR standards. However, nuanced variations with differing label requirements can halt supply chains if an organization is not prepared to address them.
The MDR requirement to include an MD symbol inside a box, for instance, can present a major roadblock when altering labels manually. This often results in errors causing noncompliance or having to use information technology (IT) resources to code label changes in programs such as SAP, requiring more labor and slowing operations.
Modernizing, increasing efficiency
For organizations shipping overseas or domestically, improving label management brings many benefits. Migrating from hard-coding label templates to dynamic ones reduces IT workloads. Digitizing the entire quality control and assurance procedures improves manufacturing workflows for label approvals and changes, without needing manual operations such as printed proofs. Operations can be streamlined further by automating label approval and change procedures on a mass scale across many facilities, removing the need to individually design and approve hundreds or thousands of different labels for every stock keeping unit (SKU).
To incorporate automation, a label management system can create approved label templates for every SKU and then those templates can be locked down with the device identifier (DI) data needed for UDI sections of U.S. and EU requirements. Labels can then be prepared for production, where production identifier (PI) data – retrieved from enterprise resource planning (ERP), product lifecycle management (PLM), and manufacturing execution (MES) systems – can be added and merged.
Using a label management system that seamlessly integrates with ERP, PLM, and MES systems is key to efficiency because these systems provide highly accurate information, such as the DI and PI data used to satisfy regulations. Adding to efficiency is the rising adoption of validation-ready cloud labeling solutions.
Cloud migration
When implementing a label management system, carefully examine hidden costs that can be eliminated. Determine the role IT will play when quality and regulatory teams get involved. Juggling these concerns can be simplified by using a cloud-based system.
Moving to a cloud-based medical device labeling solution allows organizations to swiftly integrate labeling with their other systems to ensure regularly updated and readily compliant label templates.
Many cloud solutions guarantee that up-to-date documentation is readily available for the installation qualification (IQ) portion of validation, easing the validation burden and allowing teams to focus on operational qualification (OQ) and performance qualification (PQ). This allows manufacturers to efficiently respond to fast-changing regulations, even if teams are operating in separate locations.
Workflows and managing compliance can be further simplified with a cloud-based solution that has an extended print history, role-based access to the system and label templates, configurable approval processes, and better version control.
Labeling: now to the future
A 2020 study from Loftware revealed 91% of professionals across industries believe that maintaining one standardized labeling solution across their enterprise provides time and cost benefits, while more than 50% reported that the pandemic increased their company’s likelihood to adopt cloud-based solutions.
For the medical device industry, centralized and cloud-based solutions are proving useful. And for those faced with adapting labeling to changing regulations or new normal working conditions, it’s an opportunity to go digital and to the cloud.
No matter an organization’s location, efficiently meeting compliance in medical device labeling technologies is a necessity, which is why cloud-based or digital label management technologies that centralize and streamline operations are becoming more valuable to medical device manufacturers. For those still feeling beset by the challenges of maintaining labeling compliance, upgrading labeling will allow them to ease current operations, and then be equipped to compete in years to come.
About the author: Susan Gosnell is a product marketing manager at Loftware, which recently combined with NiceLabel, and can be reached at labelingsolutions@loftware.com or 603.766.3630.
Reliably cleaning X-ray tube parts
Features - Cover Story
Philips Medical Systems turned again to Ecoclean when a plant that cleans spiral groove bearing components needed to be replaced.
The components of spiral groove bearings are cleaned in a standard machine.
PHOTO: PHILIPS MEDICAL SYSTEMS DMC GMBH
Shortly after Wilhelm Conrad Röntgen discovered X-rays in 1895, Philips Medical Systems DMC GmbH began developing and manufacturing X-ray tubes with Carl Heinrich Florenz Müller, a glassblower born in Thuringia, Germany. By March 1896, he made the first X-ray tube in his workshop and three years later was granted the first patent for a model with water-cooled anti-cathode. The speed of tube development and X-ray technology success spurred worldwide demand, turning the craftsman’s workshop into an X-ray tubes specialty factory. In 1927, Philips, the only shareholder at the time, took over the factory and has been shaping X-ray technology with innovative solutions and continuous improvements ever since.
Clean, precise manufacturing
Products used in Philips Healthcare systems, and those sold under the Dunlee brand, contribute significantly to advances in diagnostic imaging, computer tomography (CT), and interventional radiology.
“Besides modern manufacturing technologies, high precision, and ongoing process optimization, component cleanliness plays an important role in ensuring the functional reliability and longevity of our products,” says André Hatje, senior engineer for process development in the X-ray Tubes division. Residual particle contamination specifications must be met when cleaning the various X-ray tube parts – two or fewer 5µm particles and one or fewer 10µm size – underlining the cleanliness required in the process.
Removing molybdenum grinding dust
When a Philips spiral groove bearing components cleaning plant needed to be replaced, the company set meeting high cleanliness requirements as a main criterion. Molybdenum bearings form the heart of high-tech X-ray tubes, and after the groove structure has been applied by laser, a dry grinding step is performed. This is followed by cleaning, during which the grinding dust and traces of smoke left in the grooves from the laser process must be removed. To simplify process validation, a compact standard machine was needed for cleaning. Against this backdrop, a process developer approached several cleaning equipment manufacturers, including Ecoclean GmbH in Filderstadt.
After conducting cleaning tests with various manufacturers, researchers determined that required cleanliness for the spiral groove bearing parts was only possible with the EcoCwave from Ecoclean.
Equipped for fine cleaning
The machine for immersion and spraying processes operates with the same acidic cleaning medium previously used at Philips and has a 6.9m2 footprint. Fitted with three flood tanks, one for washing and two for rinsing, the flow-optimized, cylindrical design, and upright position of the tanks prevent dirt accumulation. Each tank has a separate media circuit with full-flow filtration, so cleaning and rinsing fluids are filtered during filling and emptying and in the bypass. Deionized water used for final rinsing is treated in the integrated Aquaclean system.
Frequency-controlled pumps allow flow volume to be adapted to parts during flooding and emptying. This allows the working chamber to be filled to different levels for more intensive media exchange in critical areas of components. Parts are then dried by hot air and vacuum.
“We are very satisfied with the cleaning result. All parts come out of the plant so clean that we can transfer them directly into a cleanroom for further processing,” Hatje says, noting the next steps include annealing and coating the components with liquid metal.
The ultrasonic fine cleaning system, equipped with 12 treatment stations, ensures cleanliness specifications of two or fewer particles of 5µm or one or fewer particles of 10µm are reliably met when X-ray tube parts undergo final cleaning.
PHOTO: PHILIPS MEDICAL SYSTEMS DMC GMBH
Ultrasonic system
The spectrum of parts cleaned at Philips in an 18-year-old, multi-stage ultrasonic machine from UCM AG range from small screws and anode plates to cathode sleeves and housing pots with a 225mm diameter. The metals from which the parts are made are equally diverse – nickel-iron materials, stainless steel, molybdenum, copper, tungsten, and titanium.
“The parts are cleaned after different processing steps, such as grinding and electroplating, and before annealing or brazing. Therefore, this is the most frequently used machine in our material supply system, and it continues to deliver satisfactory cleaning results,” Hatje says.
However, the company reached its capacity limits and decided to invest in a second machine from UCM, a division of the SBS Ecoclean Group specializing in precision and ultra-fine cleaning. Even though the existing machine could handle the process, the number of cleaning and rinsing steps, and the drying process, Philips wanted a new cleaning system that would be faster, more versatile, and deliver better results.
Some components were not optimally cleaned in the intermediate cleaning stage with their current system, which doesn’t impair the subsequent processes.
Fast, flexible processes
Including loading and unloading, the fully enclosed ultrasonic cleaning system features 12 stations and two transfer units. They are freely programmable, as are the process parameters in the various tanks.
“To meet the different cleanliness requirements for the various parts and downstream processes, with this system we use around 30 different cleaning programs, which are automatically selected via an integrated barcode system,” Hatje explains.
The system’s transport racks are equipped with varying grippers, which can pick up cleaning containers and perform functions such as lifting, lowering, and rotating at the treatment stations. Depending on the program, the feasible throughput is 12-to-15 baskets per hour in three-shift operation six days a week.
The integrated spray rinse with deionized water removes very fine dust particles still sticking to the surface after cleaning and the first immersion rinse.
PHOTO: PHILIPS MEDICAL SYSTEMS DMC GMBH
Optimal cleaning results
After loading, the first four tanks are designed for cleaning processes with intermediate rinsing steps. For better, faster results, the cleaning tanks are fitted with multi-frequency ultrasound (25kHz and 75kHz) at the bottom and on two sides. With plate transducers flange-mounted in the tank, there are no components in the tanks for dirt to collect. Additionally, the cleaning tanks feature a bottom filtration system and a two-sided overflow for discharging suspended and floating particles. This ensures that any removed impurities accumulating on the bottom are detached by a flushing nozzle and sucked off at the lowest point of the tank. Fluid from the surface and bottom filtration systems is treated via separate filter circuits. The cleaning tanks are also equipped with devices for electrolytic degreasing.
“We already developed this function together with UCM for the old machine because it also enables us to get parts clean that have dried polishing paste on them,” Hatje says.
A new addition, however, delivers significantly better cleaning results. A spray rinsing device with deionized water is integrated into the fifth treatment station to remove very fine dust still sticking to the surface after cleaning and the first immersion rinse.
Spray rinsing is followed by three immersion rinsing stations. For components made of ferrous materials, a corrosion inhibitor is added to the deionized water used in the last rinse cycle. All four rinse stations have separate lift-out equipment for removing baskets after the defined dwell time and and agitating the parts while rinsing. The next two part-drying stations are fitted with combined infrared vacuum dryers. In the unloading station, an enclosure with integrated laminar flow box prevents component recontamination.
“The new cleaning system gives us a lot more cleaning options, enabling us to achieve better cleaning results with shorter cycle times. That’s why we are planning to have our old machine appropriately modernized by UCM,” Hatje concludes.
