CSP Technologies Inc., a supplier of packaging products for healthcare, food and nutrition and industrial applications, has completed a 100,000-square-foot expansion at its Auburn, AL, headquarters.

The new Material Science Lab houses R&D equipment and provides a venue  for streamlined collaboration between engineers, R&D and production personnel.

The expansion includes a Material Science Lab, which, in addition to housing integrated R&D equipment, now hosts a venue for streamlined collaboration between engineers, R&D and production personnel, said the company in a press release. Other areas in the facility will be used for labeling and other secondary packaging processes.

The expansion is in response to recent growth in several sectors of CSP Technologies’ business, particularly pharmaceutical packaging and medical devices. The additional space comes on the heels of the addition of a thermoforming line dedicated to the production of pharmaceutical packaging as well as an upcoming portfolio of antimicrobial products for food safety.

Over the last three years, CSP Technologies has greatly increased its global in-house design, engineering, material science and project management capabilities, providing a “one stop shop” from concept to commercialization, said the company.

Currently, most of the new space is used for warehousing. As CSP’s primary manufacturing needs continue to expand, an increasing portion of the additional room will be converted to manufacturing space and dedicated to producing packaging solutions for medical devices and sensitive pharmaceutical products.

Producing a successful part requires a process that transforms raw materials into a final product that satisfies design requirements while taking into account both technological and geometric constraints. But, more than that, a truly successful process will also be cost effective for the business.

Striking a balance between meeting requirements and reducing production costs requires a multi-perspective view. There isn’t a better way to design a beautiful part that misuses resources than by ignoring the viewpoint of a machinist.

Engineers and machinists tend to have different backgrounds, interests, and perspectives on the manufacturing process. These differences can lead to misunderstandings and miscommunication. I have been fortunate enough to work in both engineering and machining roles and understand the frustrations on both sides.

As engineers, we’re responsible for translating the customer’s prints and specs into a method, programs, and an inspection plan that work flawlessly. It requires a lot of time as well as tremendous attention to detail, creativity, and problem solving to design a process for manufacturing a complex part. Opening up that work to feedback and possible criticism is tough. But to get the best results, we must balance confidence with curiosity and remember that no one person holds all of the answers.

We all have blind spots, and the beauty of a cohesive team is that different perspectives come together to create a complete picture, a more accurate plan, and a better product. Here are just a few reasons why you should consider—and seek—the perspective of a machinist.

Efficiency and Simplicity

When machinists get a sketch, they immediately look for ways to avoid unnecessary steps and will often challenge features, specs, and tolerances that seem extreme or out of the norm. They know that if they can simplify, they can save time and money while reducing the chance for error. Taking the process onto the floor, the machinist knows that an adjustment that spares a mere second or two can add up to significant savings over the life of the project. The machinist is looking for opportunities to ensure that the product can be efficiently, and cost effectively, manufactured.

Maximized Machines

While the engineer is examining the geometry of the part and statistics of the process, the machinist focuses on what’s happening inside the machine. It’s the intimate understanding of each machine’s capabilities and limitations that allows the machinist to know how to make the setup and production run as successful as possible and how a part should be held to ensure access and clearance at every orientation. Consulting with a machinist helps you choose the best tools for each specific area of the part so they can be easily adjusted to blend. The machinist might also suggest a different way to introduce the tool to the part or suggest coming in from a different angle to achieve better results with less part movement.

Options and Ideas

Collaborating with machinists opens your eyes to new design challenges and more creative ways to address them. A machinist can help you think about availability of tooling and about the possible wear and tear on that tooling over time. By thinking from a machinist’s perspective, you can anticipate design elements that might cause spindle crashes or that might prevent a process from being able to be run unattended.

A great way to open up communication between machining and engineering is to ask for feedback on an operation sketch that clearly outlines what you’re thinking. Machinists appreciate being able to see how you anticipate the process coming together. Although this extra step may seem like a hassle, the more clarity you can create before the part is in the machine, the less machine time you’ll burn during setup.

In addition to a sketch, it’s helpful to empower machinists with simulation software, like Vericut, so that they can prove out processes and ideas before going through a complete machine setup and first-time run.

Superior Sequencing

A machinist might see that an alternate order of operations makes more sense, or suggest that specific features be machined together. For example, maybe after cutting a pocket, you could reach through to machine the other side without flipping the part.

The machinist knows how parts move through the machine and throughout the floor and can help identify opportunities to save valuable time and optimize resources. They can also suggest changes that might allow for things like easier inspection or in machine deburring and finishing.

The Future is Collaborative

Working in manufacturing requires an ever-growing library of skills and knowledge. From new programs and methods to tools and measuring and inspection strategies, it is impossible for even the most experienced engineer to have all of the information needed to develop the most innovative solution possible. And that’s not where we should put our energy.

The most successful engineers of the future won’t be the ones eager to prove their designs are the best, but the ones who are most willing to rely on the experience and expertise of a team to make their work even better.

Glaukos has received FDA approval to market the iStent inject Trabecular Micro-Bypass System. The nod gives the San Clemente, CA-based company an opportunity to pull ahead of competition in the minimally invasive glaucoma surgery (MIGS) market. Glaukos said the iStent inject is designed to optimize the natural physiological outflow of aqueous humor by creating two patent bypasses through the trabecular meshwork, the main source of resistance in glaucomatous eyes, resulting in multi-directional flow through Schlemm’s canal.

It includes two heparin-coated titanium stents preloaded into an auto-injection system that allows the surgeon to precisely implant stents into two trabecular meshwork locations through a single corneal entry point in a straightforward click-and-release motion. Each iStent inject stent is about 0.23 mm x 0.36 mm, or about one-third the size of the first-generation iStent.

The iStent inject is the company’s next-generation trabecular micro-bypass technology and is based on the same fluidic method of action as the company’s first-generation pioneering iStent. The company received FDA approval for the first generation of the device back in 2012.

“The approval of iStent inject represents another major Glaukos milestone in the pursuit of our mission to transform glaucoma therapy and further strengthens our position at the forefront of micro-scale innovation,” said Thomas Burns, Glaukos President and CEO.

Glaukos’ approval puts the company even further ahead of other MIGS firms.

Most of the smaller MIGS companies have been acquired. Allergan kicked off consolidation in the MIGS space when it picked up Aquesys and the Xen stent for about $300 million in cash. In 2016, Novartis acquired Transcend Medical – developer of the CyPass stent. Santen Pharmaceutical doled out about $225 million for Miami-based Innfocus.

What happens when a leading medical cannabis company hooks up with a respiratory device company? 

Dose-metered, nasally-delivered cannabis-based medicines, according to Columbia Care and Rhinomed. The two companies have inked a licensing agreement for the collaborative development of just such a product.

New York-based Columbia Care and Richmond, Australia-based Rhinomed plan to develop one or more new versions of Rhinomed's existing device. The program, which will be developed in Columbia Care's research and manufacturing facilities, will aim to optimize delivery of consistent doses of Columbia Care's pharmaceutical-quality cannabis-based medicines via nasal administration.

The companies said nasally-delivered, dose-controlled, targeted medical cannabis formulations open up a new pathway and opportunity across a range of indications for this class of medication within the clinical and over-the-counter consumer health settings. 

Rhinomed’s nasal technology platform has broad application across a range of markets. The company has commercialized two variants in sport and exercise (Turbine) and primary snoring and nasal obstruction (Mute). Columbia Care is the largest U.S.-based medical marijuana operator. 

"By offering consumers and clinicians access to a range of products that solve specific unmet clinical needs, we firmly believe that we can modernise, and indeed, medicalise this market in a new and radical way," said Rhinomed CEO Michael Johnson. 

As MD+DI previously explored in this slideshow, there are a number of device-based technologies that already target the medical cannabis market.

Draeger Medical Systems is recalling its Jaundice Meter JM-103 and JM-105 models after some users have misinterpreted display messages that have resulted in serious injuries, according to an FDA notice.

The Jaundice Meters are used to measure bilirubin in newborns. Specifically, the JM-103 model displays three blinking dashes (---) and the JM-105 meter displays dash-zero-dash (-0-) when the bilirubin level in the patient is higher than the maximum level of detection. Measurement of high bilirubin indicates a need for immediate medical evaluation. Some users have interpreted the two display messages as indicating a low or zero value instead of high bilirubin levels. When this happens, FDA said, treatment may be delayed or not offered, which could lead to brain damage and possibly death in some babies.

The out of range display is visible; however, the interpretation of the reading is not intuitive or clear, FDA said.

The recall includes 2,449 JM-103 models manufactured between June 2008 and August 2017 and distributed between July 2008 and September 2017; and 2,063 JM-105 models manufactured between September 2013 and April 2018 and distributed between October 2013 and April 2018.

FDA noted that the Jaundice Meters are intended for use in hospitals or doctors' offices under a physician's supervision or at their direction to assist clinicians in monitoring newborn infants. The device is not intended as a standalone screening device for diagnosis of hyperbilirubinemia, the agency said. It is used as a screening device along with other clinical assessments and laboratory measurements.

The JM-105 meter is a modification of the JM-103 meter. The basic functionality, including the measuring probe, hardware, and software used to process the measurements are identical to the earlier model. The display of the later model includes a larger screen and touchscreen, and data storage and transmission functionality. 

The Bag-in-Box (BIB) packaging solutions specialists at Smurfit Kappa (Cedex, France) have expanded the range of packaging solutions for hot-fill apple juice market with the custom-engineered Thermo Bag.

Hot filling is widely used in the production of fresh, not-from-concentrate apple juice, a method that has grown increasingly popular due to the beverage's freshness and health benefits. During hot filling, the product is pressed, filtered, pasteurized, heated and filled at a high temperature to facilitate sterilization and then immediately cooled for preservation and taste. This method has the advantage of extending shelf life, removing any harmful microorganisms, reducing costs and simplifying the process.

When paired with Bag-in-Box packaging, it becomes an attractive eco-friendly and cost-efficient option for both consumers and producers that maintains product quality.

The innovative Thermo Bag is a barrier bag made from special coextruded polyethylene, medium-density PE (MDPE) for thermo-resistance, linear-low density PE (LDPE) for flexibility and an ethylene vinyl alcohol (EVOH) oxygen barrier.

“Usually apple juice makers heat the juice at 80 to 85 deg C (176 to 185 deg F) for pasteurization,” Smurfit Kappa spokesperson Veronika Necasova tells PlasticsToday. “This Thermo Bag is perfectly adapted to these high temperatures because it’s more heat-resistant, doesn’t change visually even after heating that could occur with other bags and has less risk of stress-cracking.”

This enhancement doesn’t represent a shelf extension because that mainly depends on the juice itself, she adds.

The use of MDPE in the coextruded structure is unusual in this market.

“It is rarely used in bag-in-box packaging, which is typically made using LDPE,” Necasova explains. “Use of a new film is always a challenge and requires many tests in lab, but also on filling machines. For example, the film has to be slippery enough to be pulled properly through the forming funnel of a bag-forming filling machine.”

The new structure is FDA-compliant for applications in the United States and throughout North America.

“We are not aware of any special approval for apple juice hot filling in North America, although there is one for dairy products,” Necasova points out. “In any case, testing methods are the same; the requirements even lower than in Europe.”

In development for about a year, PlasticsToday learned that the new packaging carries about a two percent premium versus standard BIB films.

Most of the interest in the new BIB option is expected to come from large companies. “This bag is particularly suitable for bigger companies using high temperatures to fill their apple juice and who require higher quality for their packaging because their juice goes to retail,” Necasova says. “For example, it is being sold in Switzerland, Poland and Sweden.”

A low-cost sensor made from semiconducting plastic can be used to diagnose or monitor a wide range of health conditions, including surgical complications or neurodegenerative diseases. The sensor was developed by a research team led by the University of Cambridge in the United Kingdom and King Abdullah University of Science and Technology in Saudi Arabia (KAUST).

Image courtesy King Abdullah University of Science and Technology/University of Cambridge.

The sensor can measure the amount of critical metabolites, such as lactate or glucose, that are present in sweat, tears, saliva or blood, reports the University of Cambridge in a press release. When incorporated into a diagnostic device, the sensor could allow health conditions to be monitored quickly, cheaply and accurately. 

The researchers used semiconducting plastics that are being developed for use in solar cells and flexible electronics, but have not yet seen widespread use in biological applications. Since the sensor does not contain metals such as gold or platinum, it can be manufactured at a low cost and can be easily incorporated in flexible and stretchable substrates, enabling implementation in wearable or implantable sensing applications. The research is published in the journal Science Advances.

“In our work, we’ve overcome many of the limitations of conventional electrochemical biosensors that incorporate enzymes as the sensing material,” said lead author Dr Anna-Maria Pappa, a postdoctoral researcher in Cambridge’s Department of Chemical Engineering and Biotechnology. “In conventional biosensors, the communication between the sensor’s electrode and the sensing material is not very efficient, so it’s been necessary to add molecular wires to facilitate and ‘boost’ the signal.”

To build their sensor, Pappa and her colleagues used a synthesized polymer developed at Imperial College in London that acts as a molecular wire, directly accepting the electrons produced during electrochemical reactions. When the material comes into contact with a liquid such as sweat, tears or blood, it absorbs ions and swells, becoming merged with the liquid. This leads to significantly higher sensitivity compared with traditional sensors made of metal electrodes.

Initial tests of the sensor were used to measure levels of lactate, which is useful in fitness applications or to monitor patients following surgery. However, according to the researchers, the sensor can be easily modified to detect other metabolites, such as glucose or cholesterol, by incorporating the appropriate enzyme. The sensor’s detectable concentration range can be adjusted by changing the device’s geometry.

“This is the first time that it’s been possible to use an electron-accepting polymer that can be tailored to improve communication with the enzymes, which allows for the direct detection of a metabolite,” said Pappa. “It opens up new directions in biosensing, where materials can be designed to interact with a specific metabolite, resulting in far more sensitive and selective sensors.

“An implantable device could allow us to monitor the metabolic activity of the brain in real time under stress conditions, such as during or immediately before a seizure and could be used to predict seizures or to assess treatment,” said Pappa.

The researchers now plan to develop the sensor to monitor metabolic activity of human cells in real time outside the body. 

The research was funded by the Marie Curie Foundation, the KAUST Office of Sponsored Research, and the Engineering and Physical Sciences Research Council.