Qualification forms part of the overarching validation masterplan (VMP). However, it’s just one of the verticals that feeds into the wider Validation process. There are no Qualification or Validation shortcuts. And with no standardised GMP documentation formats to follow, there are always subtle style differences. Yet, it’s good practice to keep this documentation as tight as possible, ensuring the content is unambiguous. Detailed but of a manageable size, without deviating from the original design qualification.

Medical/Life Science micro-moulding is another key sector. Often using a smaller tonnage machine, the limit of what can be moulded can be as light as 0.0003g, with walls as thin as 0.01mm and dimensional tolerances to ±0.005mm

The medical market, particularly diagnostics, was strongly influenced by the Coronavirus pandemic. As expected, there has been a natural slow down in the consumable business related to the pandemic. Currently, there is a stronger leaning towards larger strategic and more complex projects, such as drug delivery devices and pen style injectors. This is due to the global growth in diabetes care.

One of the main advantages of this process is material availability as virtually any material can be CNC machined. For this reason, and its use in industry since the 1940s, CNC machining remains the most common means of prototyping to date

Approximations of the general parameters of each process are detailed on WayKen.com in the company’s Technology Selection Guide, and a supporting Materials Selection Guide.

WayKen specializes in an ability to machine a range of plastics (opaque and optically clear) and aluminum. In the CNC process, a toolhead gradually subtracts material from a solid block. As such, molecular stability of the base material remains constant producing a part with unparalleled tensile strength.

Home diagnostic and wellbeing solutions driven by the aging population and telehealth and outpatient care will inevitably direct future treatment pathways.

3D printing services at WayKen are primarily laser-powered, offering a high level of speed and accuracy. WayKen stereolithography (SLA) is a UV based curing process, and selective laser sintering (SLS) uses a carbon dioxide laser.

Luckily, the company’s quoting system quickly responds to enquiries within 24 hours by our allowing “On-time delivery — every time, no exceptions.” Request a quote from WayKen Rapid online now at WayKen.com.

The tolerance requirements for the medical sector over the last decade has got increasingly stricter. Processing stability, dimensional accuracy and repeatability are critical. Medical devices often comprise multiple components. If just one element is out of tolerance, the device might not meet the performance expectations. Comprehensive quality control and traceability of parts production are essential for minimising risks.

The development of process optimisation systems, integrating material and knowledge with simulation tools is probably the most exciting development on the horizon. This will enable processors to observe advanced settings and capture deeper processing insights. Our ultimate vision is an intelligent machine that can independently make predictions about part quality, machine wear and failures and deliver optimisations online. Enabling greater process consistency, enhanced product quality and for real-time machine maintenance to be adjusted accordingly.

Customers that cannot determine their needs can always draw upon our pool of medical experts to populate a document with the design detail. This consultancy support gives a level of transparency to all parties, helping to circumvent renegotiations later down the project line. Having a defined structure also enhances the overall production quality.

High profile acquisitions of diagnostics companies, IPO listings, advances in liquid blood testing technology provide further assurance that the diagnostics market is on the cusp of another huge growth curve. This all indicates that there are clearly exciting opportunities ahead for moulders operating in the high tech medical device and diagnostics product development and production space.

It depends on the application. Typically they will be medical grade plastics, which are biocompatible and suitable for products such as MRI casings, prosthetics etc. Some applications will need a higher melting point, others sterility, tensile strength or anti-corrosive properties.

“Traditional” processes at WayKen cover CNC plastic/metal parts machining, vacuum injection molding and rapid injection molding. In the case of CNC machining, a solid block of raw material can be used.

The competitive price point for all services, according to the company’s website, is “normally 30%-50% less than the US/European prices, due to lower labor costs. Moreover allowing a quick project start compares to other rapid prototype companies.”

Our medical team can provide support and guidance right up until the Site Acceptance Test (SAT). Once configured with the mould tooling, automation and other periphery equipment, the customer assumes overall responsibility for the production cell. At that point really everything should have been checked with regard to the material influences and how the moulding machine performs.

Additionally, the accompanying documentation can get really complex. Predominantly due to liability risks. With all medical packages, Sumitomo (SHI) Demag issues the Qualification documentation on installation. These files are signed and sent from the location where the machine order was fulfilled.

We can help customers by qualifying the equipment sold against the defined parameters specified. To make the entire Validation process easier for customers we can provide high quality consultancy at the outset of any project, drawing in all stakeholders when scoping out the machine design and user requirements specifications (URS). This helps to avoid over-specifying equipment or providing machinery that will never meet the processing tolerance requirements.

To comply with the FDA, GMP Annex 1 and CFR Part 211 requirements, the equipment used in the manufacture, processing, packing or holding of a drug product needs to be of an appropriate design, adequate size and suitably located.

The rapid production time of 3D printing means it is finding increased uses throughout the medical industry. WayKen SLA & SLS 3D printing for medicine can be used to make hand held appliances, concept models, and new devices in low volume, e.g. diagnostic equipment, surgical instruments, electronic apparatus and ultrasonic systems. These devices are valuable for surgical planning, simulation and also to map dental correction procedures.

There is a strong move towards “copy & paste” systems and processes in both Europe and North America. We are also seeing requests for remote system access to historical machine data for troubleshooting and monitoring validated process settings.

As a true global medical team, it’s essential that we continue to foster greater collaboration. This sharing of project successes leads to global partnerships that are so pivotal to a responsive market aligned to future medical needs. Being support by trusted partners is proven to yield the strongest and fastest results.

Process optimisation, enhanced productivity and TCO can have the biggest impact on profitability. Again, these are greatly enhanced by the high-performance drives. Confirmed by comprehensive lifetime tests performed on both the machines and components. Spindles tested under the toughest production conditions showed no signs of visible wear, even after millions of cycles.

Typical items being micro moulded using this technique can comprise a wide range of surgical, endoscopic, point of care testing, diabetes management, drug delivery and DNA research and sequencing devices. Additionally, the expanding market includes catheter components, hearing aids, dental prosthetics, microfluidics, vials, caps, specimen cups, vacuum blood and serum collection tubes, syringes, and IV parts.

SLS and SLA 3D printing are useful for fast response solutions. With digital operational tools like slicer software, the process does not require as much specialized training as CNC machining. With little labour involved, the manufacturing cost of 3D printing is priced based on the amount of materials. As larger parts cost more 3D printing is advantageous for small volumes and lightweight parts. Realtively simple structures, wth less demand for surface quality and precision parts, also benefit the most from WayKen’s 3D printing services. The technology is ideal for protoyping small medical devices, industrial tooling, and outer covering of electrical tools.

CNC machined parts at WayKen on the other hand can be used to make functional prototypes which are suitable for engineering evaluation and testing. In contrast to the SLA and SLS services offered, CNC machining requires specially trained engineers to pre-program the processing parameters and toolpaths, then machine according to the programs. Manufacturing costs are therefore quoted taking the extra labor into account. CNC’s advantage is for machining parts with special requirements such as dimensional tolerances and surface qualities.

The question is – which technology should you choose? As a WayKen spokesperson states, “it is very difficult to get a standard answer to the cost comparison between 3D printing and CNC machining.” Instead, technology should be selected based on application.

As far as resolution is concerned, the accuracy of CNC machining at WayKen is typically higher than 3D printing, between 0.02mm and 0.05mm – 0.10mm depending on geometry. Turnaround time for 3D printing is typically faster at just 2-5 days versus 3 – 8 days for CNC. This does however come at a tradeoff with the volume of products than can be produced. A typical SLA/SLS run can create 1 – 10 parts, whereas CNC has a range of 1 – 50.

In some cases, it may even be beneficial to combine both additive and subtractive manufacturing process to complete an end goal. As an example, SLA and SLS could be used as a preliminary stage before moving the CNC machining.

There are also a number of velocity and injection power features that can be overlooked. However, when used correctly and repeatably by moulding operatives, it results in faster cycle times and more stable start-ups. Training and field site support can be really valuable to moulders seeking higher productivity.

Medical manufacturers that create their own GMP documentations benefit from having a consistent tool to track the qualification of all associated equipment, including mould tools and automation solutions.  This makes it much easier to manage defined steps for design, installation, operational and production Qualifications and Validations.

The choice of moulding machinery selected for cleanrooms is generally customer-specific. Where medical components need to be manufactured and packed in a self-contained cleanroom environment to meet ISO Class 7 or 8 standards and comply with any GMP Annex 1 and FDA regulations, a fully configured all-electric injection moulding machine is typically the best option.

The primary SLA material used by WayKen is an ABS-like photopolymer, suitable for use in the lost-wax method of casting favoured in jewelry making and dental industries. SLS uses powdered Nylon feedstock, which acts like a support material throughout 3D printing, cutting down post-processing times. Parts made using SLS also benefit from the potential of nesting meaning that more designs can be 3D printed within the same build.

In automotive, WayKen applies a plethora of CNC prototyping and rapid tooling methods to the production of spare parts. The services are useful to car manufacturers running limited trials of a car/motorcycle, and allow volume customization. WayKen automotive rapid prototyping is delivered as a complete service, guiding customers through proof of concept design reviews and mechanical component engineering tests, to show car projects and exterior/interior prototypes.

Established in Hong Kong and located in Shenzhen, WayKen is a contender for China’s most experienced prototype manufacturer. The WayKen Prototype shop operates across two sites, one for plastic and one for metal. In total, the facilities span 20,000 square feet, employing over 60 dedicated personnel. WayKen’s specialist prototyping services include 3D printing (particularly SLA and SLS), CNC milling and rapid tooling technology.As a service bureau operating within high value automotive, medical, and aerospace industries, WayKen Rapid’s expertise is in selecting the right technology for the specific application, and delivering results at a cost competitive with the west.

LSR is increasingly used due to its safety, durability, temperature and chemical resistance and biocompatibility. The material is often used in baby-care products, as well as the medical industry for syringes, catheters and hearing aids. It is even feasible to combine LSR and thermoplastic moulding in one cleanroom moulding cell, allowing medical moulders to switch between the two.

It should be noted that over committing to a cleanroom classification could leave medical manufacturers exposed to unwarranted compliance requirements that, once approved, they must continue to adhere to. Sometimes effective ventilation is all that’s required. Yet, for sterile medicinal products, the requirements - defined by Annex 1 of the EU and PIC/S GMPs – are now even more stringent.

As observed during the pandemic, the shift towards virtual appointments, larger scale adoption of home healthcare programmes and smart diagnostic devices is no longer seen as being untenable. For medical moulders already producing vital monitoring devices, e.g. oxygen, weight, glucose and ECG devices, as well as infusion pumps and cannulas etc. and already meeting the exacting healthcare standards, the transition to homecare device production should be relatively seamless.

That said, laboratory equipment and diagnostics equipment remains clearly important. For these types of applications, manufacturers generally utilise larger machines within the IntElect series. The company is also closely monitoring the corona preventative agent market, including oral tablets and nasal administration pumping sprays.

Additionally, our company’s energy recovery system offers increased capacity. This not only improves efficiency, but also increases the longevity of the electrical components. Improving the temperature control of the spindles, motors and inverters all contribute to the safe machine operation, even in the most demanding applications.

Strict user parameters ensures that explicit ISO 13485 medical component quality assurance and validation standards are consistently adhered to. The key areas that might impact a stable process include changes in pressure, temperature, flow rate and cooling rates. If these are altered in any way without approval it can trigger a costly re-validation exercise.

High-precision direct drive technology ensures more precision and repeatability. The result -  higher quality medical components. Our Medical Package direct drives are known for being clean, cool, fast and quiet. These drive systems are tailored to the applications, which lowers energy consumption and also results in less heat having to be dissipated from air-conditioned environments. All of these features help to reduce operating costs.

One thing all of these applications have in common is their need for total accuracy and zero defects during the moulding process.

CNC operation is determined by computer aided design (CAD) or computer aided manufacturing (CAM) data translated into Gcode – as used by 3D printers. The precision tool path in a CNC system creates an excellent surface finish, and parts can be sanded and finished on the same machine.

We are extremely excited to share with visitors all of the latest company developments and our application-specific medical expertise, including our in-house automation offerings, our expansion in Ireland and how this supports the medical/life sciences community, plus how processors can increase productivity and machine availability.

To support these efforts, Sumitomo (SHI) Demag is continuing to develop an IoT dashboard to facilitate this data analysis and visualisation, transfer and storage of know-how, as well as maintenance planning and prediction. Within this assistance system, additional autonomous and interconnected functions are being conceived to provide valuable insight into the machine performance and different production variables.