Webcast to share new data for packaging validations, regulatory submissions

Europe’s Medical Device Regulations are ushering in some new considerations for medical device packaging. For instance, does your packaging take into account the generally acknowledged state of the art? Transportation and storage risks? Final end-user needs at the point use? 

Are your validations complete? Does your labeling include all expected symbols and Unique Device Identification? Have you addressed the possibilities for device reuse?

The impact of the EU MDR will be addressed in an upcoming Webcast, “Speed Up Your Compliance Process—With Help from DuPont Tyvek.” On October 5, Thierry Wagner, Regulatory Affairs Director—Europe, Middle East & Africa; and Nicole Kaller, Application & Package Engineering Specialist—Europe, Middle East & Africa, members of the DuPont Tyvek Medical and Pharmaceutical Protection Team, will review the new EU MDR/IVDR (Device Regulations and In Vitro Diagnostics Regulations) and explain the impact on sterile packaging.

Wagner recently contributed to the white paper, “Europe’s Emerging Medical Device Regulations and Their Impact on Packaging Decisions.” Says Wagner: “The new MDR introduces a few specific changes to the general safety and performance requirements that have to be met by packaging. There will be new labelling and documentation requirements and more scrutiny by notified bodies. The transition time is short; it is important to start as early as possible.”

Wagner and Kaller will also discuss the full suite of tools available from DuPont to help MDMs accelerate their product regulatory submissions and certifications.

“DuPont’s tools are based on in-depth analysis of industry regulations and MDM requirements,” says Kaller. “They help you to find the data and information you need for the validation of sterile barrier systems made with Tyvek and provide valuable design and application guidance.” 

Wagner and Kaller will also discuss the new Tyvek Technical Reference Guide, which is designed to support MDMs with the regulatory information required for technical documentation. It includes the latest data and information for Transition Tyvek 1073B, Transition Tyvek 1059B, and Tyvek 2FS. 

If you are planning to work on a gap analysis for your packaging applications versus the new MDR or you are interested in new Tyvek data, listen in and use the opportunity to participate in the Webcast question-and-answer session on October 5.


Source Article from http://www.packagingdigest.com/medical-packaging/pmp-webcast-to-share-new-data-packaging-validations-regulatory-submissions-170925

What does a packaging engineer do?

A packaging engineer identifies the three common industry activities that characterize the regular duties of a packaging engineer in any supply chain in today’s fast-paced market.


When I first transferred into the packaging program at UW-Stout, I’m pretty sure my friends thought I would be packing boxes for a career. Little did they know that packaging engineers have existed for quite some time, and their roles and responsibilities are often multi-faceted as packaging intersects with so many crucial aspects of an organization.

Whether you’re working with consumer packaged goods companies, food or durable consumer goods, the core principles and activities of a packaging engineer are very similar across the board.

To shed a little light on the subject, here’s a look at the three common activities a packaging engineer actually does:

1)     New Product Development (aka, new product introductions)

Let’s face it, those new products that marketing wants to launch aren’t going to pack themselves. Packaging teams often collaborate with various stakeholders from cross-functional teams to ensure all key criteria is achieved in the design and performance of the package.

Common activities within this category include:

▪   Project management and communication with packaging materials vendors;

▪   Packaging design and development;

▪   Collaborative reviews with key stakeholders and executive sponsors;

▪   Sustainability metric evaluation;

▪   Distribution testing;

▪   Specification development; and

▪   Product lifecycle management (PLM).



2)     Cost Savings Initiatives (aka, value engineering or continuous improvement)

Second to new product launches are the cost take-out initiatives. Some products are rushed into the market before thoroughly evaluating their packaging and supply chain effectiveness, sometimes with excessive packaging to ensure of a successful launch. Once—products have been in the market, opportunity often exists to re-evaluate and value engineer costs out of the package and supply chain system. This can range anywhere from a redesign project to harmonizing common packaging components across multiple SKUs to the creation of compliance standards to integrate at a partnership comprised of multiple organizations.


3)     Firefighting and Damage Control

Every job has some level of firefighting. Same goes for packaging engineers.  Often these “fires” can be attributed to addressing equipment downtime, jammed packing/ filling/ assembly lines, or last minute communications with vendors or internal stakeholders.

A bigger bucket concerning firefighting often relates to damage reduction. Some of these challenges are driven by executive directives, while others are along the lines of continuous improvement.

Wrapping it all up

Whether you’re in bricks-and-mortar retail, e-commerce or the medical device packaging industry, a packaging engineer plays a major role in your operations. Packaging engineers address a wide variety of issues and opportunities that have a direct impact upon a business’s bottom line. We aren’t simply seeking a better design (although we absolutely love doing that), we’re searching for cost-saving opportunities and sustainability improvements across the entire supply chain.

I know it was easy for my friends to assume my career would be limited to boxes and tape, but each time they rely on the supply chain to deliver a product, I’ve proven just how valuable a packaging engineer can be.

Rob Kaszubowski is Sr. Packaging Consultant at Chainalytics’ Packaging Optimization where he is focused on reducing product damage and implementing packaging cost reduction initiatives. Rob also contributes to the Packaging Matters blog. Connect with Rob on LinkedIn and on Twitter @KazPack1


Constrained by your current production and supply chain options? Assess new connections in packaging and more during MinnPack in Minneapolis November 8-9. It’s part of a comprehensive all-in-one 6-event plastics and advanced manufacturing exhibition. For more information, visit MinnPack.



Source Article from http://www.packagingdigest.com/supply-chain/what-does-pkg-engineer-do1709

Compostable ‘crafted’ cartons perform for artisan food brand

New packaging for No Evil Foods entire line of plant-based meat alternatives is more durable and eye-catching than before—and 100% compostable now to better fit with the company’s environmental vision and make it easy for consumers to dispose of the packaging, even in a home compost.

Previously, the company wrapped its products with butcher paper, which were sealed with pressure-sensitive labels. Jamie Cook, public relations specialist for No Evil Foods, explains, “Our previous package was butcher paper wrapped around the product with a sticker on the front and back, the stickers were not biodegradable and made it difficult to compost the rest of the package.”

Now, there are no stickers or labels on the package that would prevent it from being composted.

The new biodegradable Kraftpak carton board, supplied by KapStone Corp., is unbleached kraft, printed with plant-based ink and sealed with water-soluble adhesives.

The carton’s unique fold-out design re-creates the feeling of unwrapping from the original butcher-paper wrapper. Cook says, “Each of the boxes opens in an origami style to simulate the same unwrapping that took place with our previous packaging.”

The Product Regulatory Compliance Information about this particular cartonboard goes on for six pages. The cartonboard meets the requirements of the European Standard for Packaging EN13432 for biodegradability, recyclability and compostability—giving consumers easy options for environmentally friendly disposal options.

“We are making sure to inform our consumers that the packaging is compostable,” Cook says. “One of the inside flaps carries the 100% Compostable distinction.”

The new packaging is just out in stores now, but it’s already getting recognition. The Comrade Cluck “No-Chicken” design won the NEXTY Award for Best New Packaging Innovation. This awards program for Natural Products Expo East recognizes innovative leaders in the natural products industry.

“Our new design illustrates our commitment to environmental responsibility in a really fun way. [The graphics are] bold and edgy and unlike anything we’ve seen in the alternative-meat space before, all while showing off our personality as a brand,” says No Evil Foods co-founder Sadrah Schadel.



Learn what it takes to innovate in the packaging space at MinnPack 2017 (Nov. 8-9; Minneapolis). Register today!

Source Article from http://www.packagingdigest.com/packaging-design/compostable-crafted-cartons-perform-for-artisan-food-brand-2017-09-25

Can adaptive machinery help deliver per-patient packages to order?

Mass customization has been in demand for consumer goods for a few years, and now thanks to personalized medicine as well as serialization, healthcare products, too, are being ‘customized.’ The new category of machinery, the adaptive machine, is emerging to meet such needs, according to a new white paper from B&R Industrial Automation North America.

The adaptive machine is a “game changer,” says John Kowal, director, business development for B&R Industrial Automation Corp. “Consumer demand and especially e-commerce are driving mass customization. Instead of producing to stock, building huge distribution centers, and carrying huge inventory costs, it makes sense to find an economical way to build the elusive batch size one. Build to order, let the customer have exactly what they want, and ship direct from the factory to the consumer.”

Specific trends in pharma and medical packaging are driving this need. “In pharma, the automated hospital and mail-order pharmacies can kit the medications for an individual patient, with less opportunity for human error, in a sterile environment, and with built-in QA and serialization,” says Kowal. And in “medical devices, from surgical kits to catheters and ostomies, to orthotics, to dental implants, to parenterals, the adaptive machine again produces, assembles, doses, and packages to order, per patient, per instance.”

It has been a somewhat slow progression. “In packaging, we talk about Gen3, which started with SIG’s announcement for the 1999 interpack show that it was introducing ‘third generation packaging machinery’ designed from the ground up for servo motion control (aka, mechatronics),” he says. “But batch size one and mass customization have eluded the packaging industry. Rainbow packs, for example, are typically repacked manually at distribution centers.”  

But now, thanks to adaptive machinery, “they can be produced inline with the primary packaging process, and combinations selected by the customer,” says Kowal, offering the following examples in food packaging. “Instead of two each chocolate, vanilla, and strawberry, you can select one chocolate, four vanilla, and one strawberry. You can select different portion sizes in the same order. You can order a birthday cake with a customized message in automatically applied icing, then packed in the appropriate sized cake box and shipper, all inline.”
Several advances are making such customization possible, and these are available to pharmaceutical and medical device companies. “Adaptive machine technology, with track technology at its core and enabled by multiple technologies—synchronized robotics, advanced software algorithms, high-speed I/O, predictive maintenance monitoring, networked safety and more—is ideally suited to pharma and medical processing, assembly, testing, and packaging,” Kowal says.

B&R will be showcasing such adaptive technology at Pack Expo Las Vegas. “We have one major pharma manufacturer that has asked us to hold an executive roundtable and invite all its major OEMs to attend during Pack Expo Las Vegas, where we are also demonstrating the technology,” he says.

For more details and to obtain a copy of the white paper, visit B&R at Booth #S-6163.


Source Article from http://www.packagingdigest.com/automation/pmp-can-adaptive-machinery-help-you-deliver-per-patient-packages-order-170924

How to tackle challenges with patient adherence

Package designs that offer more-thorough self-administration instructions could help pharmaceutical companies address patient adherence issues. In a presentation at Healthcare Packaging EXPO (Sept. 25-27; Las Vegas Convention Center), Alan Davies, global design manager, Essentra (Booth #N-540), will discuss how engaging, clever packaging can allow for more effective communication to patients who are controlling their own dosages at home. The session, titled “Why Patient Adherence is the Next Big Challenge for Pharmaceutical Packaging Providers and How They Should Tackle It,” will take place on the Innovation Stage Tuesday, Sept. 26 at noon.

Davies answers a few questions below on better understanding the scope of the challenge and the ways that drug companies can tackle it.

Q: What are some of the most significant challenges to patient adherence beyond the simple mistakes that can happen during self-administration?

Davies: Beyond the mistakes that can occur during self-administration, another factor affecting patient adherence is the sheer number of patients a doctor has to debrief on a daily basis. Misunderstandings can occur at the point of consultation, when doctors advise patients on new medications and proper protocol to follow. Doctors have to keep in mind that patients are often concerned about their health situations in these settings and may not fully absorb instructions. The introduction of patient-centric teams that are dedicated to helping patients and communicating prescription information is helping to address this issue. However, the advent of biosimilars brings additional complications to the drug regimen itself—particularly in clinical trials.     

Q: Which types of drugs have the lowest levels of patient adherence? 

Davies: Drugs using new biologics can pose significant challenges to patient adherence because they require different treatment patterns. Patients injecting themselves with these types of drugs may need to hold them in for a couple of seconds longer than they expect in order to administer the correct dosage. Additionally, drugs that rely on the cold chain can pose additional complexity. For these drugs, exposure beyond their optimum temperature corridors can affect their validity. Inhaler medications can be complicated to administer and require clear instructions. Regardless of how patient adherence issues happen, they can become very expensive in the context of clinical trials or at-home treatments. When a patient in a clinical trial setting does not follow instructions correctly, an entire trial can encounter complications.

Q: What are some important considerations pharmaceutical manufacturers must make when designing a package with this in mind? 

Davies: Both branded Rx companies and generics manufacturers alike should involve package designers as well as packaging and labeling suppliers early on in the production process to develop solutions that encourage patient adherence. User-friendly design, temperature-abuse flags, tamper-evident features, and greater product protection during shipment are essential early considerations. This is especially important for medical device manufacturers, over the counter (OTC) drug manufacturers, and clinical trial markets as these sectors seek differentiation from competition. Particularly for these companies, standardizing packaging and labeling would impede efforts to meet the specific application needs required by certain products.

Q. Can you discuss some important packaging innovations that have already improved the situation?

Davies: Actively engaging the consumer with the package can help improve patient compliance. Patients are able to study and learn about a prescription in different ways, including auditory and visual methods that transfer information from the caregiver to the patient. We see some momentum behind package designs that incorporate these features, whether through digital components or thorough illustrations.

Q: What are your predictions for the evolution of packaging (and the customer/supplier dynamic) as more drug companies take aim at overcoming this challenge?

Davies: We are likely to see more drug manufacturers consider the benefits added by features that foster greater patient adherence in their packaging—especially for applications in the medical device and biologics sectors. These companies generate most of their revenue in the first few months after their products are launched, so initial impressions and differentiation matter. Developing smarter packaging to ensure accurate dosing is a crucial part of the patient experience. The companies that master the art of instruction will empower both patients and doctors as they look to treat often life-altering conditions with the utmost confidence.

To learn more about Essentra’s Innovation Stage presentation, view the full schedule of sessions and register for Healthcare Packaging Expo at www.hcpelasvegas.com. The show is produced by PMMI (PMMI.org), The Association for Packaging and Processing Technologies, and co-located with Pack Expo Las Vegas.

Essentra plc is a leading global provider of essential components and solutions. For further information, please visit www.essentraplc.com.

Source Article from http://www.packagingdigest.com/adherence/pmp-how-to-tackle-challenges-with-patient-adherence-1709