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Articles from 2016 In September


'Changing the game a little' in medical packaging

'Changing the game a little' in medical packaging
Image courtesy Eastman Chemical

Computer Designs Custom Thermoforming’s forte is designing packaging using almost any material, says Chuck Ortwein, account executive. The company started 20 years ago designing tooling for customers using CAD/CAM software, and “along the way people started asking whether we could make packaging for them,” he says. The company now makes tooling solely for its own thermoforming operations, of which about 70% is dedicated to medical applications.

So when Ortwein saw an article on Eastalite copolyester from Eastman Chemical, he was intrigued. “I thought, ‘Let’s do something different, innovative, that may change the game a little in the medical arena,’” he tells PMP News. “It has the creativity factor.”

Eastalite is a multilayer structure composed of a foamed copolyester core and Eastar copolyester 6763 (PETG) skins. Together, the multilayered sheet is called Eastalite. Eastman initially worked with film extruder Pacur and thermoformer Tek Pak Inc. to develop the new lightweight opaque material as an alternative to high-impact polystyrene (HIPS). Aneta Clark, market development manager for Eastman Chemical, told PMP News last year that the material can be thermoformed into almost any given shape. “Any applications that call for rigid, opaque packaging, including primary trays, can benefit from Eastman Eastalite and its attributes,” she says. “Thanks to its flexibility in design, it’s not only for sterile barrier, protection, and cushioning. The end application requirements, not the limiting factors of the material, dictate how it can be formed and used.”

After Ortwein learned about Eastalite, he thought of some of the challenges his customers are facing with HIPS. 

“Some customers have very large trays, with deep draws,” he explains. “HIPS can have impact issues, so maybe this little amount of foam could prevent a crack. Styrene is very crystalline and can also develop splinters for an angel-hair effect.”

"HIPS can be brittle after sterilization,” explains Clark of Eastman. “Breakage in the field is a window of opportunity to evaluate.”

Adds Glenn Petrie, sales development manager, specialty films, for Eastman: “We’ve seen people do all sorts of things with Eastalite, such as form inserts—it’s a great opportunity for change.”

Ortwein also believes “there may be some cost advantages, because we would most likely be able to eliminate any secondary operations and gain a little more overall economy of scale,” he adds.

The team at Computer Designs began experimenting with Eastalite by forming 5-in.-deep trays that weren’t too intricate. They ran the material “on existing tooling for a styrene part, and there wasn’t a lot difference in shrinkage,” reports Tom Tomasic, executive director. “It cuts very clean.”

With shrink characteristics identical to HIPS, “there would be no added expense of a new tool” should companies decide to switch, says Petrie. "CDI sees advantages and is evaluating Eastalite in sealed sterile barrier packaging as well."

Adds Ortwein: “It seems to run faster and easier [than HIPS], and there is good uniformity, because it processes similar to PETG. It’s form friendly and easy to manage through heat. We didn’t even change the profile settings [from that used for a HIPS thermoform]—we didn’t know where to start, so we just put the roll on.”

Eastalite can speed up cycle time. Petrie from Eastman explains that’s because Eastalite has a reduced density compared with HIPS.

Jim Banko, vice president of sales for Pacur, says that because Pacur PETG Foam made from Eastalite “seems to take heat fast, and it dissipates fast,” speeding up cycle time by as much as 50% is possible. In addition, thermoforming temperatures are lower than [those for] HIPS, creating energy savings as well, he says.

Computer Designs has been introducing the material to its medical device manufacturer customers and suggesting where to begin. For instance, “the safest place to make a change would be a work-in-progress handling tray,” says Tomasic.

With such WIP trays, Clark of Eastman says that the burden of proof would be lower, and the validations not as intense.

Ortwein says that he is currently working with a few customers, including one with a nonsterile application that would eliminate the need for CSR wrap.

Testing is also well underway. Petrie reports that Eastman has tested complete structures made from Eastalite both before and after sterilization and that it has completed biocompatibility testing. Click here for a video on impact testing. 

Speaking of the collaboration between Computer Designs, Pacur, and Eastman, “We’ve all been able to work together to help each other,” says Petrie.

“The support chain has been tremendous,” adds Tomasic.

Computer Designs Custom Thermoforming exhibited at MD&M Minneapolis in Booth #2644 and discussed its use of Eastalite as part of the Innovation Tour on Medical Packaging Technology on September 22 at 1 pm.

8 potential UDI code readability issues and the critical role of vision

8 potential UDI code readability issues and the critical role of vision
To overcome warped 2-D DataMatrix codes or codes with missing perimeter features, Cognex offers 2DMax with PowerGrid algorithm. PowerGrid can read codes that don't have quiet zones or clocking or finder patterns. Available on the X models of DataMan 300

September 2016 brings several key deadlines for Unique Device Identification (UDI), a system of medical device identification rules issued by FDA in 2013. UDI requirements state that the device labeler, in most cases the manufacturer, must include on medical devices a device identifier (DI) that identifies the labeler and the specific version or model of device and a production identifier (PI) that includes one or more of the following: lot or batch number, serial number of a specific device, expiration date of the device, and the date the device was manufactured.

As medical device manufacturers work toward compliance, they are encountering serious challenges, particularly in reading UDI codes. This article will identify 8 types of readability issues manufacturers may encounter and explain how sophisticated vision technology could help address them.

 

Above: The UDI consists of a device identifier and a production identifier.

 

THE RULES

While Class III medical devices have been required to carry UDI labeling since September 2014, by September 24, 2016, these Class III devices must carry UDI as a permanent mark on the device itself if that device is intended to be used more than once and is intended to be reprocessed before use. In addition, all Class II devices must now bear UDI on their labels and packages, and the dates on these labels must meet formatting rules (implantable, life-saving, and life-sustaining Class I and II devices have had to carry UDI labeling since September 2015).

By September 2018, all Class I devices must carry UDI labeling, and Class II devices that require DPM must carry the UDI on the device. Finally, Class I devices that require DPM must carry a permanent UDI on the device by September 2020. Click here for more details on the rules.

There have been some recent extensions for devices packaged together and for combination products, but significant numbers of medical devices must now comply with UDI requirements.

Click to the next page to learn about 8 Potential UDI code readability issues

8 Potential UDI code readability issues

UDIs are typically marked as a bar code, a QR code, or a DataMatrix code. Reading 1-D and 2-D UDI codes and text can be challenging in real-world applications because of the wide range of surfaces on which the codes may be marked, variations in the size, shape, position and orientation of the code, the potential for degradation in printing and marking of the codes, and variations in ambient lighting.

The task is even harder for medical devices that don’t have much room for a code, such as scalpels or syringes. Laser etching onto metals is the typical approach, but it’s not easy. The laser must be calibrated correctly, and the code must be marked clearly enough to be read.

Following are 8 potential UDI code readability issues:

1.       Low resolution. Many times parts or codes on one line can change in size, which means that a standard resolution bar code reader can read some codes, but not others. Look for readers that offer subpixel processing and reading capabilities.
2.       Missing perimeter features. Sometimes, codes are printed too close to an edge, causing the code to be missing key finder patterns. Look for readers that employ algorithms that can accommodate codes without a quiet zone or clocking or finder pattern.   
3.       Specularity. Specular reflection occurs often when codes are printed on glossy materials. These can be very hard for laser scanners because glare could occur through the laser line. Image-based readers just need a small sliver of the code in order to decode. 
4.       Warped. Warped codes can sometimes seem as though they are missing part of the code. Look for systems with algorithms that can read codes that do not have quiet zones or clocking or finder patterns. 
5.       Poorly marked. Poorly marked codes could be due to a printer being low on ink and having poor contrast for example. Powerful algorithms can read the most damaged codes.
6.       Small modules. For very small codes, a variety of lensing options can compensate and read the code.
7.       Scratched. Look for systems that only need a small portion of a 1-D code to read it, so if a code is marked with a marker or scratched it can still be read.
8.       Extreme perspective. Part or code placement can be difficult, and the code can sometimes be presented to the reader at an extreme angle. Look for systems that can accommodate such angles.   

Recent technology advancements are benefitting medical device manufacturers and other supply chain contributors rushing to comply with UDI regulations. For example, in the vision-based ID reader space, software algorithms have been developed that are able to find and decode even damaged and poorly marked 1-D or 2-D codes through a wide range of illumination, marking, and material variations. Another advancement involves application-specific solutions for vision systems that eliminate the need for programming and pre-built documentation that substantially reduces the time required for FDA validation.

TAKING ACTION

While UDI offers potential advantages in securing and improving the efficiency of the medical device supply chain, medical device manufacturers are encountering serious challenges to compliance.

FDA may fine-tune the regulations in the future. In the meantime, milestones are occurring on a regular basis. For instance, the number of products for which direct marking is required has increased. So it’s incumbent upon device manufacturers to make plans and take action to ensure compliance.

Kasey Tipping (above) serves as Technical Marketing Specialist - ID Products for Cognex Corp. (Natick, MA).

For more information, contact Cognex at One Vision Drive, Natick, MA 01760-2059 USA. Tel (Toll Free): 1-877-COGNEX1 (1-877-264-6391), Fax: +1 508 650-3344, Email: [email protected], Web: http://www.cognex.com/
 
 

Pam Test

This is my test article.

5 ways pressure-sensitive adhesives can help packaging engineers stay flexible

5 ways pressure-sensitive adhesives can help packaging engineers stay flexible
How can pressure-sensitive adhesives help optimize your packaging line operations?

The goal of every business is to grow. Developing new products and offering many variations of these products are two common ways for companies to increase their share in the market.

As the growth of new products and product proliferation increases, packaging operations need a reliable adhesive to help them meet the increasingly complex packaging demands they face. Although a small part of the process, adhesives play a huge role in making sure product packaging remains intact until it reaches the consumer.

Double-sided pressure-sensitive adhesives (PSAs), specifically, offer several advantages for the packaging industry:

1. Quick reworks: Reworking, or repackaging, can increase your costs and hurt your bottom line. PSAs offer a timely way to make products compliant and shelf-ready. Pressure-sensitive adhesives are safer than glue sticks and more discrete than traditional tape. Unlike glue sticks, pressure-sensitive adhesives do not require heat during application. The absence of heat eliminates burns and increases safety among plant workers. Additionally, PSAs are less intrusive on packaging graphics, providing the adhesion you need without sacrificing your brand image. Pressure-sensitive adhesives are a less visible packaging solution, preserving your brand and maximizing its impact.

2. Instant bond: When you apply a pressure-sensitive adhesive, you don’t need to wait for the adhesive to cure. The moment you apply it and compress your substrates is the moment adhesion takes place. Instant bonding increases your process speed, increasing your production.

3. Maintain brand image: Brand image relies heavily on the appearance of packaging. PSAs provide a bond that removes cleanly without damaging packaging or leaving behind residue. Preserving brand image adds to your consumer appeal.

4. User-friendly application: Easy-to-use adhesives ensure you spend less time figuring out how to apply them and more time fulfilling your packaging needs. Using pressure-sensitive adhesives requires no learning curve as they can be applied in three easy steps—place, press and peel.

5. Tackle variety of substrates and coatings: With product proliferation and packaging options expanding, manufacturers often have complex packaging needs. PSAs offer versatility to meet many requirements, whether it’s bonding metalized PET or being removable for consumers. Pressure-sensitive adhesives are available in a variety of sizes and tack levels to fit your exact packaging application.

From multipacks and gift baskets to point-of-purchase displays and sampling, double-sided PSAs provide a reliable bonding solution for many packaging applications.

Lauren Oliva is the marketing communications specialist for RS Industrial, an adhesive manufacturer and distributor that has been helping customers improve their adhesive processes for more than 22 years. RS Industrial manufactures a unique line of Adhesive Squares products for the packaging industry.

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See the latest developments in adhesives and other packaging materials and supplies at PackEx Montreal 2016 (Nov. 30-Dec. 1 in Montreal, Quebec, Canada).

What makes mass production so flexible that it can meet individual demands?

What makes mass production so flexible that it can meet individual demands?
Cosmetics maker Dr. Kurt Wolff GmbH & Co. KG uses an advanced solution from Siemens and OPTIMA to maximize filling and packaging production efficiency.

Cosmetics maker Dr. Kurt Wolff GmbH & Co. KG can manufacture different products on one single machine thanks to Siemens technology, enabling individual demands to be met…the future of manufacturing, here today. 

Small production volume – high flexibility

Fast and efficient – or customized and flexible. When it comes to consumer goods production, “either/or” was previously thought an unbreakable rule. Hard- and software from Siemens offers a new generation of machines no longer limited to strict either/or scenarios.

In the past 1 product = 1 machine was the rule for filling and related packaging lines. At best, a machine retool could be done to adapt new products, but this meant long, costly, and idle set-up times.

The machine builder Optima Consumer GmbH now uses advanced technology from Siemens offering a radically new approach to flexibility: one machine that can produce low volumes with increased productivity, and which is quickly and easily converted to accommodate the next product. Dr. Kurt Wolff GmbH & Co. KG, the first user, was able to dramatically reduce set-up times. The single machine currently manages five different products at one time and is continuously learning to accommodate more.

With the Multi-Carrier, custom versions of a product can be easily produced on the same line in a much shorter time.

This radical advance in mass production is made possible by two innovations:

1. The Multi-Carrier-System, which functions to more intelligently convey goods through the line compared to a classic production line. Where required, each single product may be modified individually.

2. A smart software concept from Siemens that provides the necessary intelligence for this type of dynamic control. Making it possible for the entire system to be highly automated, yet very flexibly.

Together, these innovations comprise a revolution in mechanical engineering.

Cosmetics maker Dr. Kurt Wolff GmbH & Co. KG uses an advanced solution from Siemens and OPTIMA to maximize filling and packaging production efficiency.

New standards were also set in the planning, development and commissioning of the machine by the Optima Consumer GmbH, Dr. Kurt Wolff GmbH & Co. KG and Siemens teams: The plant was largely developed and tested virtually. This way, the complex interplay of all the components is rehearsed and optimized on the digital twin long before the machine is actually built. The result: The time from concept to production-ready machine is considerably decreased.

“Everyone wants to have an individual solution,” Rainer Feuchter, ceo Optima Consumer GmbH. “It goes without saying that this requires us to think in a completely different way regarding machine building issues.”

Brief on the Multi-Carrier System

The transport solution ensures maximum flexibility within the machine. In this context, the dissolution of the rigid concatenation* of conventional transport paths creates new freedom and provides maximum dynamics.

In this configurable transport system, the transport carriages, which are driven by linear motors, are flexibly moved to the individual units, e.g. filling, closing or labeling unit. The system moves freely and exactly synchronously to the process and can be integrated in the existing intralogistics—including seamless loading and unloading of the carriages. The other transport paths remain unchanged.

The modular concept allows a quick conversion of the machine to different formats, other product types or seasonal requirements. The integrated concept allows the end user to control the transport movements and Motion Control functionality as well as the coordination of additional machine modules.

 

 Topology of the multi-carrier system

System configuration

•             Simple, modularly structured mechanical basic system;

•             Linear motor, basic profile and roller conveyor;

•             Passive carriage without motor and active electronics for low wear and low vibration transport movement;

•             Powerful controller:  full integration of control and Motion Control tasks for the complete system.

Technology in detail

The control and drive package ideally supports the flexibility of the mechatronic system:

Flexible system integration: Mechanical and electric

•             Operation of the multi-carrier system and further electric axes in a SINAMICS S120 axis group

•             Use of all technological degrees of freedom of a SIMOTION (e.g., upwards and downwards synchronization on cam disks).

Multi-dimensional software architecture for efficient commissioning

•             Free programming option based on the SIMOTION SCOUT engineering system (user-specific program section, simplification through standard application for Multi-Carrier-System with “zone concept“, mapping of a carrier on a virtual axis);

•             Convenient integration of the basic system functionalities via an Open Architecture library (implementation of all segment transitions, switchover of the control modes closed loop - open loop, minimum collision detection);

•             Efficient implementation of the machine application using the project generator easyProject.

Standard hardware

•             The use of proven hardware ensures the wordwide availability of components and service.

Benefits

Cost Effective:

•             Precise dynamics where the process requires it;

•             Combination of linear track + intralogistics system;

•             Reduced maintenance costs due to low wear.

Industry suited

•             Robust and simple mechanics;

•             Corrosion protected and easily cleanable surface;

•             Protection degree IP65 (higher degrees of protection on request).

Easy to maintain

•             Exchange of motors without disassembly of the track;

•             Free access to motor cables;

•             High availability due to standard components.

Siemens has posted a short video of the revolutionary Multi-Carrier-System in action.

See it at Pack Expo booth # N4941

 For more information contact:

Binu Thomas
Business Development- Packaging Industry

Siemens Industry, Inc.

Digital Factory

Factory Automation- Production Machines

5300 Triangle Parkway, Norcross, GA30092

Phone: 770-871-5654

Fax: 770-625-5662

Mobile : 678-427-9330

mail to: [email protected]

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Explore cutting-edge packaging, manufacturing and automation solutions at PackEx Montréal, November 30, 2016 to December 1, 2016. 

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Want ecommerce success with consumers? Think premium packaging

Want ecommerce success with consumers? Think premium packaging
The effect of packaging on consumer perception for online purchases. Source: Dotcom Distribution study

An exclusive interview about a new ecommerce survey for online shoppers reveals much about what consumers want in packaging, from sustainable packaging and personalized notes to unboxing pleasure.

The continuing need for speed has pushed ecommerce markets into ever more rapid deliveries. But it's not only speedy delivery that drives consumer satisfaction, a new study also underscores the co-starring role package aesthetics play in the customer experience.

According to a newly-released study by Dotcom Distribution, How Fast Delivery and Quality Packaging Drives Customer Loyalty, 87% of online shoppers identified shipping speed as a key factor in the decision to shop with an e-commerce brand again. The study found that 67% of online shoppers would pay more money to get same-day delivery if they needed the package by a deadline, such as an anniversary.

Also, 47% would pay more for same-day delivery simply because they wanted their package more quickly.

Consumers also care about aesthetics, too. In fact, 40% of online shoppers said they would be somewhat more likely or much more likely to purchase from a retailer that offers premium packaging. The same percent of shoppers stated that branded or gift-like packaging affects their perception of the online retailer that shipped the item.

Maria Haggerty, Dotcom ceo, responds to Packaging Digest’s questions about the study and ecommerce packaging.

What was the biggest surprise in the packaging portion?

Haggerty: The biggest surprise was seeing the large year-over-year increase in the number of online shoppers who value upscale packaging.In 2015, 29% of online shoppers said they’d be more likely to engage in repeat purchases if an order came in upscale packaging, but this year, that number was 40%. That 11% increase year over year proves that shoppers seek out, if not expect, a positive and luxurious packaging experience with their order.

That’s a sharp increase—what more can you say about that?

Haggerty: As more brands are embracing upscale packaging, shoppers are latching on and are increasingly making packaging a priority in their experience with the product and the brand. Shoppers want to be convinced that they made the right choice in ordering and that what they chose is upscale and worth the price. Packaging appears to have a very convincing role in that process.

Details like eco-friendly packaging, free extras and personalized notes further elevate the unboxing experience and confirm for the shopper that they have invested in a luxury product, even to the point that they want to share the purchase, its packaging included, on social media. Our 2015 study found that shoppers are 1.5 times more likely to share pictures of branded or gift-like packaging on social than traditional brown boxes.

 

Specifically, what does "gift-like or premium" packaging look like?

Haggerty: Obviously the specific look and feel varies by brand, but I’d encourage retailers to think outside the plain brown box. Put simply, retailers should give the same consideration to their packaging that they do to their in store experience, brand advertising or website look and feel. Packaging is another opportunity to tell shoppers who you are, what you offer and why you’re unique. Why would you not take advantage of that?

Another aspect to consider is the process of unboxing.

Extending the experience of unwrapping an order, as long as it isn’t inconvenient, makes receiving a package more fun and enjoyable for the shopper. Including special tissue paper, ribbons and free extras ups the anticipation and heightens the experience.

We already know that shoppers want their order as fast as possible and are willing to pay extra to get that.

However, making them slow down and enjoy the experience of unwrapping the box is something that sticks with them and something they’ll seek out again next time.

We’re seeing the trend of shoppers enjoying this so much that they wind up sharing photos or video of the unboxing on social media channels.

In another Dotcom report, Fulfillment & Unboxing Excitement, we find that when consumers have pleasurable experiences, the brain releases dopamine, serotonin, and oxytocin causing a boost in mood. Oxytocin is responsible for the increased desire to form bonds, to reduce social fears and to enhance trust and empathy. This leads to less inhibition in online shoppers and the desire to share a personal experience with strangers. A positive unboxing experience makes people want to share it with others, often leading to a social media post. For the brand, this means exposure to potentially thousands of consumers, and therefore an increased brand awareness.

 

Does this mean that pricier packaging yields better value?

Haggerty: The packaging doesn’t necessarily have to be more expensive to have a bigger impact. What matters is the experience that packaging creates and how it relays your brand promise. We can see from the study that a premium packaging experience is drawing the shopper in and maintaining their loyalty, as 40% said they would be more likely to purchase from a retailer again if their order came in a gift-like or premium package. While some extra touches may cost more than a simple brown box, an investment in the packaging experience pays off in terms of customer loyalty.

Additionally, 44% to shoppers agreed that if upon purchase they were not sure they would keep their purchase, upscale packaging could push them over the edge and confirm that is was in fact worth the price.

Any other advice to share with our audience of packaging professionals?

Haggerty: The online shopping experience needs to stand out because the internet offers so many options all without a physical storefront that used to define a retailer's brand. Now that feeling, experience and brand needs to be communicated to an online audience in other ways. Packaging is proving to be a great avenue to include in that.

Additionally, the findings of this study should help shift brands away from thinking that their responsibilities with customer experience ends once the order is shipped. Shoppers want to be impressed by as many of their touchpoints with a brand as possible, and packaging is shaping up to be one of those touchpoints that should be taken very seriously.

For further information, read the study:How Fast Delivery and Quality Packaging Drives Customer Loyalty.

About Dotcom Distribution                                                               

Dotcom Distribution provides a variety of services to growing brands. The company offers multichannel fulfillment, e-commerce fulfillment, membership and subscription, drop shipments, kitting and assembly, freight management and global logistics. It also houses a full-service e-commerce photography studio that provides clients with high-quality images, allowing brands to better drive conversation rates and enhance the normal customer experience. For more information on Dotcom, its services and its clients, visit www.dotcomdist.com.

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Want to deliver packaging with impact? Consider attending PACKEX Montréal 2016 November 30, 2016 to December 1, 2016

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How thermoforming could bring diagnosis to the point of care

Lab-on-a-chip technology promises to speed up disease diagnosis and bring it to the point of patient care. These “labs” are actually disks designed with microsized channels and chambers that are prefilled with small amounts of diagnostic reagents. The consumable disks are placed into tabletop centrifuge systems where they are filled with patient fluid samples or swab samples; as the fluids pass through the channels and into chambers, the system optically detects positive or negative test results.

Hahn-Schickard has been manufacturing lab-on-a-chip systems since 2007, calling the technology a "pocket lab."  

Some of the company’s projects are funded by either the European Union, the German government (BMBF), or the state of Baden-Wuerttemberg, reports Dr. Daniel Mark, Associate Director of Hahn-Schickard, to PMP News. “Additionally, we perform development for and funded by industry,” he says.

While the company has been using injection-molded microfluidic disks, it decided to investigate an alternative: inexpensive plastic test elements produced by thermoforming polymer films with chambers and channels. 

“There is a clear benefit [to] thin-walled disks for fast PCR applications, due to the better heat transfer through the thinner polymer walls compared to injection molded disks,” says Mark. “Additionally, we see the potential for inexpensive mass-manufacturing in the future based on a fast roll-to-roll process.” 

For these thin-walled polymer disks, Hahn-Schickard is employing thermoforming technology from Rohrer AG. “Rohrer has been an excellent partner in the last years in the process of upscaling our prototyping-level thermoforming process to an industrial, automated process,” says Mark.

Albert Birkicht, General Manager, Rohrer Processing & Packaging Technology, tells PMP News that “Hahn-Schickard wanted to bring diagnostics to markets that had not had them before and to look into alternatives for a low-cost approach.” The use of point-of-care diagnostics is especially appealing for markets that lack “personnel and a dedicated infrastructure for handling and transporting blood,” he adds.  

In addition, “the company didn’t want to use the traditional injection-molded approach because it is extremely expensive,” he continues. “Each tooling run and modification can be about $50,000, so it’s prohibitive to do a few iterations on a design.” 

The project was perfect for Rohrer. Birkicht says that his company is known for innovation and taking on small, very specialized projects. “We concentrate on specialty projects that generally require modifications to a proven standardized blister machine. We have a modular approach to building machinery, and we rarely build finalized machines the same way.”

Hahn-Schickard and Rohrer began working together to develop the project using a specific machine, Rohrer’s R760, and Rohrer handled tooling design and engineering. 

Rohrer modified its R760 blister-forming machine to thermoform disks with channels down to 50 microns deep. “The system has to apply the right amount of pressure and precision in heating during the forming process,” Birkicht says. “We also had to design the system so that there would be absolutely no air bubbles under the film or foil when forming. And the cooling system had to extract heat at the right point during the cooling process so we wouldn’t destroy the formed disk.” Critical geometry parameters of the thermoformed disk are optically verified using sophisticated measurement equipment. 

Typical blister thermoforming lines produce between 20 and 100 cycles per minute, but because of the manufacturing precision needed for the disks, this modified machine is capable of producing one cycle per minute. The cycle time, however, is competitive with that of injection molding, Birkicht says. With an in-house, dedicated R760 machine, the team is working to get the cycle time even lower.

Above: The R760S from Rohrer

Birkicht says that the project needed a material that turns “almost liquid” during thermoforming “without getting destroyed.” The material needed to be durable enough to withstand exposure to high pressure during the forming and vacuum process.

The team identified a 10-mil-thick cyclic olefin polymer (COP) as the ideal material. In addition to being suitable for the high-temperature, high-pressure thermoforming process, Mark from Hahn-Schickard says that “for us, COP (and COC) proved compatible to the optical and biochemical requirements for most of our applications.” 

Adds Birkicht: “Because the specimen extractions are read optically, the disk has to be transparent. The very thin, transparent material offered a huge advantage.”

When asked how Rohrer’s thermoforming technology played a role in enabling Hahn-Schickard’s innovations, Mark says that “as [we are an] R&D service provider ‘from visions to products,’ it is very important for us to supply our customers with a perspective beyond the prototype.”

“With the new, industrial fabrication process for thermoformed disks, our customers can perform trials [and] clinical studies and are also ready for market entry with the prototypes we develop together with our partners,” he says. 

Hahn-Schickard is “currently entering discussions with our customers to bring first products to market in the near future,” concludes Mark. “As a creative R&D service provider, we still have many ideas for improvements to make the products of our customers more powerful and even easier to manufacture. Rohrer has an excellent technology background to support these ideas and bring them to industrial fabrication levels.”

Inaugural Sustainability Conference: Sustainability in packaging takes top billing

“Natural is not necessarily environmentally friendly,” and “Fact: Packaging protects far more resources than it uses.” These provocative statements—and many more—characterized last week’s gathering on sustainability in Orlando.
More than 150 packaging professionals spent two days listening intently to 26 speakers outline various aspects of packaging sustainability at the inaugural Sustainability in Packaging conference. The conference was organized by Intertech-Pira and sponsored by Packaging Digest and Converting magazines.
A fairly evenly mixed audience of brand owners and packaging suppliers came to learn about the year’s hottest topic in packaging. During two jam-packed days, the attendees heard several themes emerge.
Sustainability must become a part of every corporation’s culture, from top management down. It must dominate all corporate decisions, from what kind of copier paper is purchased (recycled, of course) to how products are designed and made, and then to how they are transported to the customer.
Life-cycle analysis is critical to measuring the sustainability success of any packaging. However, there are not yet any common metrics by which to make this assessment. Wal-Mart, of course, has offered its scorecard as a guideline. The speakers at the conference spent much time explaining their directives, but each had slightly differing emphases.
Sustainability will never succeed without consumer education. How this information will be disseminated—and by whom—remained undetermined, other than the education process will probably have to be shared by packaging machinery manufacturers, packaging materials suppliers and the consumer goods brand owners, not necessarily in that order of priority. Associations will also play a pivotal role, as well as the media. Sustainability is, for now, an evolutionary journey that requires much more research. A trial-and-error period is only now beginning for most corporations. While many of the larger materials companies have had sustainability directives for as long as a decade, most consumer goods manufacturers are only now embarking on this journey.

Soft-touch robot picks variable, soft products

Soft-touch robot picks variable, soft products
A new kind of single end-of-arm tool (EOAT) that can handle a range of objects without the need for tool changes or software modifications between cycles.

A new kind of single end-of-arm tool (EOAT) allows robots to handle a range of products and packaging without the need for tool changes or software modifications between cycles.

We live on a planet that has a world of variability, which makes it both exciting and problematic when it comes to robotic pick-and-place operations.

For example, with fresh produce like apples or peaches, there is variability in the size and shape of each piece.

Similarly, delicate applications can range from fresh baked items, enrobed chocolate or other topping, to fresh hamburger patties.

That’s where a partnership between JLS Automation and Soft Robotics offers a solution using a new kind of single end-of-arm tool (EOAT) that can handle a range of objects without the need for tool changes or software modifications between cycles.

The Soft Robotics’ EOAT has been proven to grasp difficult-to-handle products with variable characteristics such as fresh produce, raw dough or filled bags using a single device.

At Pack Expo 2016, the Soft Robotics grippers will be integrated with an Osprey robotic case packer in the JLS booth where daily demonstrations of a “kitting” application will be performed. The particular application displayed will be a salad kit where several items—such as a bag of lettuce, a package of croutons, a pouch of dressing and various fresh produce products—will all be placed into a case using a single EOAT.

Pack Expo Booth N-5427

Contract manufacturing and packaging help bring orphan drug to market

Contract manufacturing and packaging help bring orphan drug to market
Almac packages Galafold in a Dosepak format

Galafold was recently approved in Europe as a first-line, long-term monotherapy for Fabry disease in patients with amenable mutations. The Almac Group has helped Amicus Therapeutics Inc. with Galafold’s packaging along the way, first working with the drug company in 2009 when it needed an outsourcing partner for Phase III clinical manufacturing and packaging of its solid oral AT1001 compound. Almac’s Pharmaceutical Development and Clinical teams have continued to work with Amicus to advance the drug product through scale up, registration, and now into commercial supply.

“Providing quality drug product and sufficient drug supply is critical to ensuring a successful launch of Galafold for Fabry patients who have an amenable mutation,” said Enrique Dilone, Ph.D., RAC, Senior Vice President, Technical Operations at Amicus Therapeutics Inc., in a statement. “Almac has been an outstanding outsourcing partner for Amicus, and we look forward to continuing the relationship as Galafold becomes available across the EU.”

To support Galafold’s launch across Europe, Almac manufactures and packs Galafold at its United Kingdom commercial facility in Craigavon, Northern Ireland. 

Considered an orphan drug, Galafold is supplied as an immediate-release hard capsule in PVC-PCTFE-PVC/Al blisters contained in a wallet/Dosepak presentation, explains Stuart Hunter, Packaging Design Manager, Almac Group. “With a dosing regimen of one capsule every other day, patient compliance was a key requirement when the final pack format was being designed. Child resistance and senior friendly packaging was also required.”

Hunter tells PMP News that the blister/wallet design used throughout the clinical studies evolved from the simple blister/wallet pack to what now is the approved commercial package, a child-resistant, senior-friendly format that aids patient compliance. 

“Throughout the clinical trial process, Amicus engaged with patient focus groups to gather their valuable feedback on the packaging format,” says Hunter. “This, together with input from the Almac multi-disciplinary project team (including Packaging design, production, and engineering) and the specialist packaging personnel at the [Dosepak] component supplier Westrock, the final pack format was agreed.”

The team’s challenge: design the package in a way that would encourage patient compliance with an “every other day” dosing regimen. Amicus together with Almac’s in-house packaging team designed a compact monthly wallet pack. The design “guides the patient through the dosing regimen with innovative design aspects such as an area to note start date, a clear day 1 to 28 schedule and ‘non dosing days’ being identified with perforated circles that would then be punched out,” says Hunter.

Currently only one SKU for Galafold is marketed, with plans for further country launches. “One pack presentation will service all European markets, but with each European market having its native language and associated printed artwork,” says Hunter. “Minimizing stock holding for smaller markets, Amicus has launched a Nordic pack--this is its first multi-country / multi-language pack. Implementation of further regionalised packs may prove useful to Amicus as the launch of Galafold is rolled out to more EU countries.” Amicus is currently submitting regulatory applications in other markets, and it is envisioned that Almac will service those markets from its Craigavon facilities, he adds.

The wallet features built-in tamper-evident solutions as well as the capacity for serialized data to be applied as required.

“It’s great to see the launch of this precision medicine addressing a debilitating unmet medical need, and it is gratifying to have played our part in its development and commercialization,” states David Downey, Vice President, Commercial Operations at Almac. “Amicus drew upon many of the services Almac has to offer, from development, through clinic, and into commercialisation. We look forward to a growing partnership as Amicus services the needs of the Fabry patient population who have an amenable mutation.”

Almac expanding in the United States

The Almac Group has just announced a $5.2 million investment and the creation of almost 80 new jobs across its Durham, NC, facilities. The company is currently celebrating 20 years in North America: In 1996, Almac opened its clinical trial operations in Audubon, PA; by 2000, it had expanded its North American presence into North Carolina through the acquisition of Applied Clinical Concepts Inc (ACCI) and Duke Clinical Research Institute Pharmacy (DCRIP), which merged to form Clinical Trial Services based in the Research Triangle Park, Durham. 

“This latest investment and increase in capacity at our Durham facility is a sign of our continuing commitment to offer market driven solutions to our client base,” said Donna Christopher, Global VP Operations, Almac Clinical Services, in a statement. “We are delighted to mark our 20th year in the US with such a significant announcement – once again reinforcing our dedication to global expansion.”

The $5.2 million investment will support the expansion of its Clinical Services facility along with the development of its Diagnostics and Clinical Technologies operations based in the same area. Almac currently employs more than 1600 individuals across 6 facilities in the United States and almost 3000 people based in Europe and Asia.

Commenting on Almac’s 20-year milestone in the United States, Robert Dunlop, President & Managing Director, Almac Clinical Services said: “Almac’s commitment to our customers remains as strong as it was when we first opened in the U.S. twenty years ago.  Our ongoing success would be impossible without the support and loyalty of our dedicated employees who remain committed to Almac’s vision. We are delighted to announce further investment in our Durham facilities enabling us to continue to support our clients’ needs and meet the increased demands for our integrated services and I look forward to our continuing success over the next twenty years and beyond.”