Seal of approval31 October 2017
To help medical device companies change packaging materials quickly and easily, manufacturers are updating their sealing machines to prevent stops in workflow that more outdated models would have typically created. Sealing recipes can now be changed in a matter of minutes, but what are the pros and cons, and where is this technology heading?
There are all sorts of reasons why a pharmaceutical company might need to update a sealing recipe for a piece of packaging in a short space of time: an order may have changed, for example, or a last-minute update might mean that a product needs a new kind of container.
The older generation of sealing machines that were previously available on the market were not as equipped for up-to-minute changes, causing major disruptions to workflow and delays in getting a product to consumers.
The growth of online delivery also means that this part of the process is now more important. As a report on 2017 trends by the packaging technology company Viking Masek noted, “When products are shipped to consumers, it becomes even more important to have strong package seals, created with packaging machinery equipped with high-quality sealing jaws.”
But some companies are beginning to pick up on the change, and have introduced new lines capable of working faster and more accurately. One example is OK International’s Supersealer MBS, a rotary band sealer that can work with a wide range of materials and can hold up to 15 recipes at once.
Ring the changes
“At the push of a button, a user of the machine can change the recipe for a specific packaging material, such as heat, speed, air pressure and height, making it possible to run a pouch in a matter of minutes,” OK International product manager Ann Marie Kellett said in April 2017.
The medical device packaging industry is continuing a huge growth spurt, with over 6% increase in the past financial year, but this trend requires a new level of efficiency that is proving difficult for some manufacturers to deliver.
The industry now needs reliable packaging solutions with an emphasis on product protection, quality, tamper evidence, patient comfort and security, which some are convinced that a better sealing machine operation can help provide.
The Supersealer also features what OK International describes as an advanced monitoring system, to prevent mistakes and guarantee that workflow interruptions are kept to a minimum. These developments feed into the need for continuous improvement and innovation that is taking place in the wider medical manufacturing industry, such as anti-counterfeit measures, and are driving the growth of the market.
“The system monitors heaters and coolers using an electronic pressure regulator with analogue input,” Kellett says. “Sensors are available for detecting wrinkles and band breaks, and monitoring whether a bag is straight or crooked. A reject station at the end of the sealer can collect failed bags.”
Also equipped is a package that allows seamless communication between the coding that dictates the packaging recipe and the printing technology. “The system also uses an ethernet port to power the printer and the system’s vision system, allowing seamless data communication between the sealer, the vision system and the printer,” Kellet says. “This reduces the cost of integration, and allows the Supersealer user to control the printer and the camera from a single interface.”
And OK International isn’t the only company touting itself as an easy solution to the common problem of interruptions in workflow caused by last-minute configuration changes. The Eagle blister-packaging machine by Maruho Hatsujyo Innovations (MHI), which made its debut on the US market in 2017, has one up on the competition: it was specifically designed to suit the needs of the pharmaceutical industry because it is owned by medical manufacturer Maruho Co.
“The machine features fast, tool-free changeover in less than ten minutes, offers multizone preheating, recipe-driven format change, and is compatible with third-party feeders,” MHI said in a release ahead of the product’s launch. “The machine’s attractive attributes include ease of operation, user-friendly HMI, and easy expansion of feeder area when required.”
One new technology that has come to the forefront of industry discussions about recipe adaptability is an increased use of servo linear rotor motors, which can allow machines to complete increasingly complex motion tasks in a short space of time. These have been so effective that they were described as a ‘gamechanger’ at the PACKEXPO trade fair in 2016.
LinMot, a specialist in linear motor technology, is leading the development of this technology and its applications in packaging. The equipment’s adaptability means that changes can be reflected on a production line in a matter of minutes. “Adjustments that have been tested once can be saved and called up using recipes. This means that machine operators can change formats more quickly,” says Ernst Blumer, a sales director at LinMot. “Finally, the all-electric system requires no moving cables.”
At PACKEXPO, LinMot’s general manager Peter Zafiro was keen to tout its application for the pharmaceutical industry, the cosmetics business and the medical devices industry. “They need to worry about FDA validation, yet still have the ability to change over from one size of cap or bottle to another very quickly,” he said, showing how the machine can speed the process up. “It’s all about short runs, which in many ways is driving everything these days, not just in pharma.”
Other companies are breaking the technology down to its base components to maximise the ways in which packaging recipes can be changed quickly and accurately, thus helping the bottom-line while still providing effective packaging solutions. MGS Machine’s Collaborative Palletizer, for example, has been touted as an easy solution to these issues for pharmaceuticals and medical device manufacturers. Anchored in the CR-35iA robot, the Collaborative Palletizer can handle up to six cases a minute of packaging weighing up to 35kg. MGS has designed the technology so that a design can be changed in less than five minutes and recipes can be recalled in seconds.
A new generation of sealing machines is thus seeping through from other industries and could quickly help with one of most overlooked elements of the device industry – packaging that has become heavily regulated. With new technology, OEMs and contract manufacturers could be free from the costly hold-ups to which older machines were prone, and could be free to give more thought to the overall design and effectiveness of the packaging instead.
Signed, sealed and deliverable
With a new wave of improved machinery and future technology coming down the pipeline, it seems as if sealing machines will no longer be a reason for hold-ups in the production line for medical device manufacturers. The selling point of some machines, such as the models offered by MHI, is based on their small size, which can be less than 2.5m², making them easier to move and store. New systems can handle small batches and frequent changeovers that are tool-free and quick, with some models taking less than ten minutes. Sealing machines are becoming a boon to delivering quick, easy product in the world of medical devices.
What it doesn’t mean is that device manufacturers can rest on their laurels when it comes to packaging. The box a product comes in requires constant redesign to keep up with commercial changes, and anything that can reduce downtime should be given serious consideration.
Fixing the counterfeits
The anti-counterfeit packaging market in North America is expected to grow at a rate of more than 14%. Compared with pharma companies, the medical device industry has not had such a strong requirement to provide evidence to the regulatory bodies about their attempts to combat the rise of counterfeits. But new measures have improved patients’ access to safe medicines, the value of pharma brands has grown and the problem is becoming more widespread.
WHO estimates that “up to 8% of medical devices on the market are fakes, as are up to 30% of medicines”. As in the pharmaceutical industry, there are a greater number of challenges to fighting counterfeit medical products, such as the rise of new technologies, and increasingly complex value chains that mean more partners, more outsourcing and more devices being handled by third parties.
Yet it is a priority for patient safety and brand reputation. Global security consultants and manufacturers have joined forces for a series of industry-led measures to reverse the trend. But more must be done to help support these measures, and many agree that there should be further discussion on the sources of counterfeiting, as well as an exploration of the tools and technologies on the market.
One measure is a handheld detector developed by two Swiss companies, chemicals manufacturer Clariant and security solutions provider Sicpa. The device, known as Plastiward, integrates ‘proprietary security features into polymer compounds or concentrates’. According to the companies, data gathered from instant authentication using the detector can be uploaded and aggregated on a secure inspection platform that allows real-time monitoring across the world.
The companies say this device will enable pharmaceutical and medical-device companies to monitor their products from factory to distributor, identify emerging trends and improve response times if action is required. However, it’s impact on combatting counterfeit medical devices isn’t yet known. What is known, though, is that devicepackaging production must be smarter if the industry hopes to cope with the coming wave of counterfeits and security issues.