Packaging in space! Gallery

1971: Astronaut David Scott, commander, gives a military salute while standing beside the U.S. flag during the Apollo 15 lunar surface extravehicular activity (EVA).

More than five decades ago, it was quite a leap for packaging engineers to design and produce containers and materials that could function on a spacecraft. So during Space Week and on the cusp of the 50th anniversary of NASA’s historic moon landing (July 20), let’s celebrate the ingenuity of packages that have trekked into space.

Over the years, hundreds of books and shows have documented and analyzed our forays into outer space. But little has been shared about the product packages that helped keep all the astronauts alive during their voyages from the earth to the moon and back.

Whether you’re a space enthusiast (like me) or not, Packaging Digest has two out-of-this-world treats for packaging professionals:

1. A slideshow of packages designed for space travel, courtesy of NASA and the Air Zoo museum in Portage, MI (near Kalamazoo). Of the packages on display at the Air Zoo, exhibits and collections manager April Bryan says, “One thing we learned through the research process is that companies like Del Monte, Crest and Stouffers made products for the astronauts. Crest definitely went into space. For Apollo 11, Stouffers helped feed the astronauts during their post-moon landing quarantine.” Click to start the slideshow.

2. Stories about packaging in space from a famous astronaut who is still alive today (scroll down).

As a side note…If creating packaging for space sounds like a dream job for you, check out this open position for a packaging engineer at SpaceX, the company founded by Tesla CEO Elon Musk with the goal of lowering the cost of space travel so mankind can colonize other planets, such as Mars.

 

Lovell talks about packaging

Astronaut James (Jim) Lovell never landed on the moon, sadly. But he did travel there twice with the Apollo 8 and Apollo 13 missions, coming within about 60 nautical miles of earth’s lone satellite. During the 2014 Flexible Packaging Association fall meeting, Captain Lovell enthralled attendees (me included) with his stories of space, and the role packaging played in transporting and protecting products used on the spacecrafts.

In these select quotes from Lovell’s entertaining and inspiring luncheon speech, we learn that engineering packaging for waste management was one of the toughest challenges! Enjoy.

Innovation in packaging: “I did a little research on the flexible packaging industry and, I have to tell you, you’re a really exciting industry! When you think about it, everything comes in a package. From the stuff that’s in those large containers on a ship down to the aspirin that’s in a little bottle. The idea you have of innovation, of initiative, of imagination, is really prevalent in this particular industry.”

Vacuum packaging: “In NASA, we used a lot of packaging, of course. Everything was packaged at NASA, too. I’ll give you one example [from the early days of NASA, the Gemini and Apollo days]…we used a lot of freeze-dried food. Peas look like little flat things until you rehydrate them. We put them into a plastic package; one end of it had a little nozzle on it. But we vacuum packed these things so we could pack a lot in there [the spacecraft]. Then when you wanted to eat, you take the water gun and put it into the nozzle and it puts water back into the bag again. All the food would be rehydrated. And, for those days, it was pretty good. It kept us alive.”

Use a utensil or just squeeze: “If the food is thick enough, you can eat it with a spoon. Otherwise the water or anything has to be in a squeeze bag.”

 

NASA’s waste management challenge: “…One of the greatest challenges, the biggest problems NASA engineers had, in the early days of the space program was how to package a waste management system. You have to remember, the early days of Mercury…the early flights were very short. We didn’t think about that at all. As a matter of fact, we told the astronaut before he got in to be sure he went to the bathroom because there were no facilities on board.

“But then, when the days got longer—Gemini’s was five, eight and the last one was 14 days—it dawned on the engineers that, yes, we have to figure out some way of waste management.

“Like all good engineers, they went after it tooth and nail. They decided first of all that they’d build a round commode and put a hose in the bottom to make a pressure differential so it would be replacing gravity, which was zero gravity.

“The design engineer gave this device, after he had it all figured out, to the test engineer. We had a zero G airplane and it would do parabolas. At the top of a parabola, if the pilots were very careful, they could get zero G as it went over the top before it started to come down again and they had to pull out. That zero G would last about 20 seconds, 25 seconds. There were no windows on the plane and all of a sudden you’re floating.

“So this test engineer took it up. They warned him ahead of time because they were getting this thing ready, ‘Have a lot of food here in the next couple days. Be ready.’ So this test engineer went up. Later on in the day he came back and threw the thing up on the desk. He says, ‘Look. Twenty seconds isn’t enough time for anything.’ (audience laughter)

“So one thing these engineers finally had to come up with has to do with your business—packaging. What they finally came up with was a plastic bag, about this round, that came down about this long. Half way down the plastic, there was a little plastic insert just big enough for one finger to get inside. Because of zero gravity again, you need to get something in there. Then at the side of the pouch, you had a piece of toilet paper and then you had a little disinfectant bag. Because, on a two-week mission, we couldn’t throw anything over the side and you didn’t want them to blow up.

 

“Let me set the scene…

“This is my Gemini 7 flight with Frank Borman. Two weeks. Nine days have gone by and Frank says, ‘Jim, this is it.’ I said, ‘Frank, you only have five more days left to go.’

“I won’t tell you how you do all the stuff. I’ll just let you know that…position in life is everything.

“That was some of the hardest problems NASA engineers had to do.”

Business lesson learned from the aborted Apollo 13 mission: “Always, always expect the unexpected. When everything is going right, profits are up, product is selling, always look down the road there to see if there’s something coming in—an impending crisis.”

“Because when I started to maneuver—and remember that I had spent hundreds of hours learning how to maneuver a lunar module in simulators—but when I wanted to pitch down, it went into some wild gyration. I wanted to go left; it went right. I wanted to go up; it went down. What’s going on here? Why can’t I control the spacecraft?

“Then it dawned on me…that I had attached to the lunar module the command service module—a 60-thousand-pound dead mass. I needed the command module with the heat shield to get back through the atmosphere for a safe landing. The lunar module had never been designed to have the command service module attached to it and be maneuvered. I literally had to learn all over again. I had to know, when I put an input in, what the output was going to be to get to the proper attitude.

“But, I’ll tell you, when you are in deep trouble, you’d be surprised how quickly you learn.”

Moral of the story of Apollo 13: “What’s the moral of this story? I shouldn’t be here. No oxygen. No electrical power. No propulsion system. Two hundred thousand miles out. Attached to another spacecraft whose sole job was to land on the moon in order to get back again. I’m here because of the dedication to that crew back in mission control, back in April 1970 in Houston. Because they used good leadership, not just at the top of the organization like Gene [Krantz], but leadership throughout the group. And they used teamwork. Because teamwork is the glue that puts many organizations together. And then initiative, motivation. Because they figured out how to keep us from getting poisoned with CO2. And, finally, they had a lot of perseverance. Because some of the things they thought of weren’t going to work.

“I’ll leave you with a little saying that maybe a lot of you have heard. But I think it’s kind of apropos: There are three types of people in this world. People that make things happen. People that watch things happen. And people who wondered what happened.

“Back in 1970, there were people who made things happen.”

You, the global audience of Packaging Digest, make packaging things happen all the time on this good earth that benefit the world, too. Thank you!

 

On-pack QR code and NFC plug rum drinkers into Malibu brand

On-pack QR code and NFC plug rum drinkers into Malibu brand
Near-field communication (NFC) technology mates with QR code on Malibu rum to connect consumers to a special summer promotion and helpful recipes.

The Absolut Co., owner of the Malibu rum brand, is using smart packaging to create a closer connection with consumers. The company recently announced the launch of 300,000 “connected” Malibu bottles in the United States.

This limited-edition packaging design features dual smart-packaging technologies: a near-field communication (NFC) technologyin the closure as well as a quick response (QR) codeon the bottle’s front shoulder.

Consumers tap the closure with their phone or scan the QR code to participate in a summertime promotion called Malibu Gamesvia the Sunshine Slide mobile game, which offers prizes of Malibu merchandise.The NFC closure and QR code also provide access to drink recipes and sweepstakes competitions. The front of the bottle is printed with concise directions on how to use the smart features.

This year’s Malibu Games started in May and will conclude in early September. Malibu’s connected bottles will be distributed in Ohio and Texas, where they will be sold while supplies last.

Caitriona Murphy, Malibu global brand manager, answers Packaging Digest’s questions about the package and its smart features and benefits.

Why is the Malibu brand using both NFC and QR technologies on the same bottle?

Murphy: Our goal with connected-bottle experimentation is to find the right technology to ensure an added value and seamless consumer experience. NFC is gaining great momentum and becoming more prevalent as a technology. But in certain markets, QR is still much more familiar for our consumers to recognize and understand.

Simple label instructions explain how Malibu customers can access valuable extras by either tapping the closure or scanning the QR code.

Additionally, certain models of phone do not have a seamless interaction with NFC, and we want to avoid requiring consumers to download an app in order to interact.

For this year’s launch, we provided both technologies as access points, allowing us to test awareness and popularity of the two and to allow the maximum number of consumers to have a good connection experience.

Which technology do you see as ultimately coming out as the pervasive smart technology for packaging, either at Absolut or in the industry as a whole?

Murphy: We see a huge potential with NFC to provide both intuitive and personalized consumer experiences and the opportunity for brands to open up dialogue directly with those consumers, generating valuable insights into shopper behavior and recruiting to the brand.

If brands can successfully leverage the technology and educate consumers on the “tap” behavior, and the NFC industry can work to deliver cost-effective tags, there is certainly a huge potential for it to become the preferred method for creating smart-packaging experiences.

How do NFC and QR compare on cost, within the context of packaging applications?

Murphy: From a pure technology standpoint, NFC tags are currently more expensive to work with when compared with QR codes. However, it is important to consider not just the upfront costs but the value created by the campaign. If one technology gets a much higher engagement rate over the other or allows for a consumer experience that recruits more valuable consumer leads, then these are all extremely important considerations when weighing the costs and benefit.

 

What recommendations would you give other consumer-goods companies that are interested in “connecting” their package?

Murphy: To benefit and create value from the activation, there needs to be a clear consumer value exchange and reason for consumers to engage. The most successful connected packaging initiatives have been based on a clear creative idea that is immediately understood and appreciated by consumers—brands cannot repeat the mistakes of the past by linking to low-quality content that is not relevant and offers no added benefit.

What type of closure is used on Malibu’s smart bottle?

Murphy: The new Malibu connected bottles are equipped with a world-leading design that showcases an aluminum bottle cap integrating NFC technology.

 

Can you mention any of the packaging or technology suppliers you worked with in the development of this package?

Murphy: Malibu worked with Virtue (the creative agency by Vice Media) and Guala Closures Group, in association with Avery Dennison, during the development of its connected bottles.

Freaky Fridays: Nature’s artistic beer bottle

Freaky Fridays: Nature’s artistic beer bottle
Fate and nature turned an ordinary glass beer bottle into a work of art good enough for museum display.

Decades after being tossed into the Atlantic, a beer bottle transformed in a unique way ends up on display 1,500 miles away in a Wisconsin museum.

Packaging Digest debuts an informal series highlighting an assortment of unusual, even freaky things, from throughout the wide world of packaging.

Our first tale presents a unique kind of buried treasure that starts with a bottle from a now-shuttered New York brewery that ends up, decades later, in a Wisconsin brewery—after spending some time on the Atlantic seabed off the coast of Florida.

Originally it looked like any other glass beer bottle, but that was before fate and nature intervened and painstakingly turned it into something extraordinary and uniquely artistic.

I came across this one-of-a-kind coated glass bottle in a brewery display while on a daytrip getaway in early July to the quaint city of Monroe, WI. It was part of the classy exhibits in the impressive beer museum at the Minhas Craft Brewery, which stakes a claim as the Midwest’s oldest brewery and the second oldest in the nation. It was displayed alongside a standard glass bottle in case visitors needed a visual comparison.

A card seen in the accompanying photo informs inquisitive visitors like me that this bottle originally belonged to the Bartholomay Brewing Co., Rochester, NY, which operated from 1876 to 1933. It also states that the bottle was plucked from the Atlantic off the coast of Florida then ended up in a Hollywood, FL, antique store from which it was purchased by the brewery.

The coral had renovated the bottle between the drop into the drink and the pickup by a diver into the one-of-a-kind beauty you see—the nature-made artistry makes it a wonder to behold.

For those who appreciate the science behind the process, here’s a two-step edited summary of what happened according to the how coral reefs grow page of the Coral Reef Alliance (CRA):

  1. Free-swimming coral larvae attach themselves to the bottle to begin the process of forming coral reefs.
  2. The coral polyps then secrete skeletons made from calcium carbonate (aka, limestone) from the underside of their skin onto the bottle.

The site notes that different species of coral grow at different rates depending on water temperature, salinity, turbulence and the availability of food.

I left a question at the CRA website per instructions there and received a response within 24 hours: the spokesperson suggested the coral-making process “took several years if not longer,” but that’s all that could be deduced from the photo.

Coincidentally and on a personal note, my youngest brother who once lived in WI made his home in Hollywood for a number of years until relocating about a year ago a short distance away along the Florida coast.

Let us know if you’ve come across unusual packaging you’d like us to consider for a future Freaky Fridays column; my email is below.

SmartBottle safely dispenses and tracks opioids

SmartBottle safely dispenses and tracks opioids
The SmartBottle securely contains and dispenses liquid opioids, using biometrics to authorize proper usage.

Packaging is taking on a more prominent role in protecting opioids from abuse, misuse and theft, with innovative designs leading the way. One of these uses biometric (fingerprint) authorization to ensure that patients—and only patients—receive their prescribed doses of liquid opioid medications.

The tamperproof SmartBottle from Swiss-based Ethimedix, which holds up to one liter of medication in an internal cartridge, functions as a smart dispensing system. Prescriptions and the fingerprints of authorized users are programmed into the device’s chip to enable controlled access to the medication. If an unauthorized user tries to tamper with or force-dispense medication from the SmartBottle, the device immediately neutralizes the opioid.

Bicêtre Hospital in Paris has been testing the SmartBottle for more than 18 months. The device has not yet been approved for use in the United States.

Leila Smith, scientific and business consultant at Ethimedix, and Isabelle Nègre, M.D., anesthesiologist at Bicêtre Hospital and head of the Pain Relief Commission for Hôpitaux Universitaires Paris Sud, jointly answer Packaging Digest’s questions about the SmartBottle.

Is fingerprint authentication by both a recognized healthcare provider and a patient required to dispense a dose from the SmartBottle?

Smith: Yes and no. The patient’s fingerprints are absolutely and always required for dispensing each dose. In both situations—outpatient and hospital bedside—it is by swiping the patient’s finger over the detector that the patient receives his/her dose according to the prescription embedded on the device’s chip. For that, no healthcare provider or family member is required.

Additionally, if the patient is allowed an occasional “bolus” dose (that is, an extra pain-relief dose), it is with the extra swipe by either a healthcare provider or a family member, whose fingerprints are also captured on the device, that the patient can receive these additional doses, always according to the doctor’s prescription. This is a built-in way to ensure that the patient is able to receive this extra dose without risks, and that it doesn’t constitute an abuse or misuse, which can lead to addiction or additional health problems.

We also have a purely hospital (we call it Team) version. The healthcare providers within a ward who are authorized to give pain relief to their ward patients can safely leave their SmartBottle on the cart as they do their rounds, and swipe their own fingerprints to dispense a dose for their patients; they log the information, which allows for traceability and of course total safety, as the opioid cannot be stolen. The SmartBottle acts as a lockbox.

Having the pain medication at the healthcare providers’ fingertips allows them to provide relief to their patients in real time, without delay.

How is the SmartBottle used at Bicêtre Hospital?

Nègre: The pharmacy department of the hospital currently compounds the drug directly on-site by diluting an existing morphine solution, adding some preservative and dispensing it into the SmartBottle. The pharmacist locks the device, and it is then ready for use by any of our three wards: neurosurgery, orthopedic surgery and urology. Because we can have multiple fingerprints recorded onto one device, we can have multiple healthcare providers who can use it on a single ward. The device allows a decrease in pill/tablet inventory, which is safer and saves time.

Do healthcare providers and/or patients need much training or instruction to use the SmartBottle? Are there any instructions on the device?

Smith: The device itself is easy to use. Healthcare providers and patients need very little training, and we provide a manual that stays with the SmartBottle. Provided the users have detectable fingerprints, no reading or writing is required. The work of setting up the SmartBottle is in the hands of the pharmacist, who also enters the prescription in the SmartBottle’s processor—its brain—as well as the duration, possible bolus doses and fingerprints.

The pharmacy is responsible for tracking the use of liquid opioids and can download the usage log of the patient after the SmartBottle is returned. However, we have dedicated software and a user interface that simplify the pharmacist’s task of uploading all the information related to the opioid, including lot, shelf life, quantity, concentration, prescription, duration, patient—or healthcare provider—information and fingerprints.

How does the SmartBottle provide opioid traceability and trackability?

Smith: The pharmacy is responsible for entering and tracking the concentration, amount and lot number of the opioid used—just as it is for tracking dispensing of tablets and pills—before locking the device, and is also responsible for destroying the remaining solution upon return. The device keeps a log of all its uses, and users, which can be downloaded and exported, as needed. Both the software and the SmartBottle are password protected and have two levels of verification.

What is Bicêtre Hospital’s procedure for tracking opioids packaged in the SmartBottle? Is theft by staff members an issue?

Nègre: Unlike the United States, we do not currently have a crisis of similar proportions, and theft by healthcare providers is not considered to be a significant risk. However, the opioid is measured and tracked through a log book that indicates patient name, time and volume of delivery dose; it needs to match the SmartBottle’s own log and can be audited by the pharmacy before and after use.

Every morning, the healthcare-provider manager is asked to verify the concordance between administered doses to patients reported in the manual log book and the amount of delivered doses recorded by the SmartBottle.

Once tampered with, the SmartBottle no longer dispenses, and the ensuing neutralized solution cannot be used. It is discarded by the pharmacy—the only department that can open the SmartBottle and handle the opioid.

What are Ethimedix’s plans for bringing the SmartBottle to the United States?
Smith: It is a difficult question to answer precisely at this time, as we are proceeding step by step. We plan on working with the Food and Drug Administration (FDA) to find the fastest path for authorization to market in the USA.

Next steps include doing a real live test in the United States, and we have been approached by a few large medical centers that are interested in trying it with their outpatients who need pain relief and are currently managing it through pills/tablets—or for inpatients who are autonomous enough to manage their pain relief at their hospital bedside, and who do not need an IV.

Will Ethimedix be partnering with an approved prescription-drug manufacturer to run usability trials in the United States?

Smith: We are in discussions with potential vendors; trials could start before we have a final ready-made solution, provided that the hospital’s pharmacy has the ability to compound the opioid at the right concentration for our SmartBottle specifications.

Are liquid opioids commonly prescribed in the United States? If not, will this be a barrier to entry for the SmartBottle in this country?
Smith:
In some situations, in pain-management centers or addiction-treatment centers, doctors and healthcare providers already provide methadone in liquid form. Concentrated drops of morphine can also be prescribed (Tramadol). However, it does constitute a change in practice for many doctors and patients who have become accustomed to prescribing and taking pills and/or tablets.

The advantage offered by using this liquid form of opioid through our device is that you can neutralize it instantly (as the neutralizing agent is immediately discharged into the solution) if anyone tries to tamper with the SmartBottle—something that is not feasible with pills or tablets.

This is a huge benefit to the entire community surrounding a patient needing pain relief: Our SmartBottle provides a dose to the patient only at allowed time intervals, and only for the duration prescribed. The drug cannot be accessed otherwise, so it protects both the patient and family/friends from possible misuse, over-use, abuse and theft. When a patient goes home with his or her prescription of pills/tablets, these can easily be taken in excess (accidentally or not) or taken by the wrong person.

If we look at the FDA’s own estimate on the number of deaths by overdose, we could potentially save more than 17,000 lives per year with our abuse-deterrent device. This is why we feel it is important to accelerate our presence in North America and provide relief from the current crisis.

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In addition to leading suppliers showing the latest solutions in labeling, automation, food packaging, package design and more—WestPack 2019 (Feb. 5-7; Anaheim, CA) gives you access to the industry's leading educational offerings with the 3D Printing and Smart Manufacturing Innovations Summits, the MD&M Medtech Conference and free industry education at the Expo. Register to attend today!

3 packaging designs that tackle the opioid crisis

3 packaging designs that tackle the opioid crisis
Innovative packaging safeguards opioids from misuse, abuse and theft, and helps prevent people from getting hooked.

Pharmaceutical packaging, in the form of packs that control access to opioids, has been in the limelight recently, with recently enacted legislation driving regulatory changes in the United States.

With an eye on the new legislation and the U.S. opioid crisis more generally, packaging manufacturers and pharmaceutical companies have designed packages that limit opioid prescriptions to the amount medically indicated for the patient—and that also thwart theft.

With the ongoing opioid crisis continuing to destroy lives, these packaging efforts are timely. The Centers for Disease Control and Prevention report that 115 Americans, on average, die each day from an opioid overdose.

The passage into law of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, in October 2018, granted the Food and Drug Administration the authority to address the opioid crisis in several ways, including via packaging.

In a statement released soon after the bipartisan legislation was enacted, FDA Commissioner Scott Gottlieb, M.D., said the new law will allow “the FDA to require certain packaging, such as unit dose blister packs, for opioids and other drugs that pose a risk of abuse or overdose. The convenience of this kind of packaging could encourage prescribers to opt for shorter durations of use, thereby limiting the number of opioids dispensed to patients.”  

For example, a blister pack for opioids could be configured to hold seven days’ worth of medication rather than a month’s worth. The idea is to reduce the volume of opioids in circulation, thereby limiting new addictions and drug diversion.

As a related benefit, fewer leftover opioids would be stashed in bathroom cabinets and drawers, where children or others could find them. In another effort to reduce over-distribution, the new legislation allows the FDA to require that opioids be dispensed with a safe-disposal option, such as a mail-back pouch.

Drug manufacturers and packaging suppliers have gotten creative in designing packages that help prevent misusing or stealing the product. Here are three recent innovations:

1. Blister-pack solution

One package format that conforms with the new legislation isa limited-dose version of the Ecoslide-RX blister package from Keystone Folding Box Co. The package, which can be configured for one to 30 tablets, visually organizes medication in a daily-calendar format. The patient can see every dose, so if a dose were to be surreptitiously removed, it would be obvious to the patient. 

Significantly, the Ecoslide-RX pack is both child-resistant (CR) and senior-friendly. “Several iterations of the package were created and tested with both children and seniors until we struck the right balance—specifically, too difficult for children to open, but easy enough for seniors to unlock the locking feature,” says Ward Smith, director of marketing and business development at Keystone.

To work the reclosable locking feature on the blister pack, “the patient has to depress a button that allows the blister to slide forward, so doses can be accessed,” Smith says. “When the blister card is slid back inside the carton, it locks in place.” And “very little instruction is needed. What’s isn’t intuitive is plainly described in easy-to-follow directions” that are printed in three simple steps, as an illustration.

For patients with dexterity issues, Keystone has designed a small plastic clip that pharmacists can add to the pack to disable the CR function.

From an operations perspective, this package is “cost-effective for high-volume, high-speed automation,” says Brad Rayner, vp, sales and marketing, at contract packager Legacy Pharmaceutical Packaging.

Legacy has been filling the non-opioid Ecoslide-RX pack for more than seven years and is currently in discussions with pharmaceutical companies that “are looking at this as an option” for opioids, Rayner says. Legacy’s St. Louis plant runs five high-speed blister lines equipped with PharmaWorks blister machinery.

NEXT: Single-dose applicator

2. Single-dose applicator

For a high-strength opioid painkiller called Dsuvia, which the FDA recently approved, single-dose packaging was required. AcelRx Pharmaceuticals Inc. manufactures Dsuvia, which is a more potent version of fentanyl. The sublingual drug is not intended for home use, and patients are supposed to use it for 72 hours, maximum.

The FDA approved the drug for use in medically supervised healthcare settings like hospitals and emergency rooms and potentially for battlefield treatment of U.S. soldiers. Restricting where and how long Dsuvia is administered and the single-dose applicator are all geared to preventing improper use and diversion of the drug.

Each filled Dsuvia applicator contains only one tablet; healthcare providers use the applicator to deposit the tablet under the patient’s tongue. A plunger inside the disposable applicator pushes the tablet out. A removable lock on the applicator prevents unintended dispensing.

The body of the applicator is transparent, so a visual check shows when the tablet has been dispensed. The plunger is nonretractable, making it impossible to refill a used applicator with some other substance. Each filled applicator is packed in a sealed, tamper-evident pouch with fold-out directions for use.

NEXT: Opioids administered as liquids

3. Opioids administered as liquids

To provide better control over liquid opioids, Swiss-based Ethimedix has developed the SmartBottle. The device uses biometric technology—fingerprint recognition—to ensure that only qualified healthcare providers can dispense opioid medication from the SmartBottle in hospital mode. In a future outpatient mode, only the authorized patient can receive his or her medication dose within the constraints of the prescription embedded in the device’s chip.

The medication is contained in a tamper-proof cartridge that fits into the SmartBottle, and the patient’s prescriptions is programmed into the device. In addition, the fingerprints of one or multiple healthcare providers can be recorded in the device. If an individual with unrecognized fingerprints tries to dispense a programmed dose of the medication, the SmartBottle will not deliver any dose. If someone tries to tamper with the device, the SmartBottle neutralizes the opioid.

The SmartBottle may ultimately be available for home use, but for now Ethimedix is testing it at Bicêtre Hospital in Paris. “The ability to access pain relief when necessary, without delay and without the current risks of theft and abuse or misuse, clearly constitutes a benefit to the patient and caregiver communities,” says Isabelle Nègre, M.D., anesthesiologist at Bicêtre Hospital and head of the Pain Relief Commission for Hôpitaux Universitaires Paris Sud.

She adds, “In our hospital setting, it provides significant time savings to our healthcare providers, who can dispense the pain relief right when the patient needs it, as they do their rounds, without having to interrupt the rounds to get the restricted tablet of opioid from the locked cabinet. Additionally, the SmartBottle sits on their cart 24/7, without risk of illegal access or theft, since the neutralization function will be immediate in case of tampering.”

Also read “SmartBottle safely dispenses and tracks opioids” for exclusive details about the SmartBottle from Leila Smith, scientific and business consultant for Ethimedix, as well as further comments from Dr. Nègre.

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In addition to leading suppliers showing the latest solutions in labeling, automation, food packaging, package design and more—WestPack 2019 (Feb. 5-7; Anaheim, CA) gives you access to the industry's leading educational offerings with the 3D Printing and Smart Manufacturing Innovations Summits, the MD&M Medtech Conference and free industry education at the Expo. Register to attend today!

Medical packagers ready for Transition Tyvek

Medical packagers ready for Transition Tyvek
Most medical device manufacturers and their packaging material suppliers are well prepared for the switch from Legacy Tyvek to Transition Tyvek.

DuPont officially ceased production of Legacy Tyvek 1073B and Legacy Tyvek 1059B at the end of 2018, signaling the start of a new era for medical-device and pharmaceutical packagers. Replacing the materials are Transition Tyvek 1073B and 1059B.

Transition Tyvek is manufactured with a newer flash-spinning technology than the previous generation of materials. This approach has increased DuPont’s production capacity and, in turn, improved its ability to meet medical packagers’ demand for Tyvek.

Since 2011, DuPont has performed an exhaustive array of tests on Transition Tyvek, including tests that compared the material’s functional performance to that of Legacy Tyvek. The myriad tests examined, among other things, seal strength, microbial barrier, puncture strength, dimensional stability and printability. DuPont also evaluated the material’s performance during sterilization and the integrity, over time, of packages made from Transition Tyvek.

The company reportedly invested $30 million in the transition to the new material. It also worked closely with medical-device manufacturers and sterile-packaging manufacturers during the prolonged testing phase.

In 2015, the U.S. Food & Drug Administration (FDA) issued a letter confirming that “the performance of the new Tyvek material is functionally equivalent to the existing Tyvek material,” based on DuPont’s test results. Transition Tyvek began shipping in 2016.

The FDA further stated that medical-device manufacturers don’t need to notify the agency when changing from Legacy Tyvek to Transition Tyvek, unless they have received “a specific request or notice from FDA” or a risk analysis has raised questions about the new material’s functional equivalency to Legacy Tyvek.

Medical packaging experts Jenn Goff, product marketing director at Oliver Healthcare Packaging, and Karen Greene, Certified Packaging Professional (CPP) and president of Life Pack Labs, share their thoughts on the changeover from Legacy Tyvek to Transition Tyvek.

How ready is the sterile-packaging industry for the end of Legacy Tyvek?

Goff: From our perspective, most medical-device manufacturers are ready. There are, as expected, a few packaging applications that challenge performance limits and capabilities. But in general, the industry is ready and well equipped to make this transition.

Greene: The converters of sterile medical packaging, especially the authorized Tyvek converters, are well prepared and in an excellent position to manage the phase-out and implementation of Transition-protocol or “new” Tyvek.

Are most medical-device manufacturers (MDMs) prepared for this change, or will it come as a shock to some?

Goff: Most MDMs are ready for this change and have had ample time to prepare for this transition. As a part of the transition strategy, DuPont has spent several years communicating this change, making sure companies were prepared. Some smaller organizations, including start-ups, may be at risk if they are in the midst of a launch or were unable to perform the proper validations with the Transition materials. Converters like Oliver have been working with organizations like these—and all of our customers, really—to ensure they have what they need during this process. For some, this has meant last-time buys of Legacy Tyvek.

Greene: In my opinion, it would be a rare exception that a medical-device manufacturer is not prepared for the implementation of Transition-protocol Tyvek. Gap analyses and requisite qualification work may not be completed; however, the MDM will have a plan and will have begun executing its plan. DuPont has done an excellent job preparing the industry for this change.

Did sterile-packaging manufacturers stock up on Legacy Tyvek immediately prior to the cessation of production, either to meet the requirements of specific customer orders or simply to have it on hand if customers request it?

Goff: For us, almost all last-time-buy discussions have occurred, but they will continue based on customer need.

Greene: The time frame for “stocking up” on Legacy Tyvek has passed, and current inventories of Legacy Tyvek have been in place likely for more than 12 months.

What should MDMs do if they aren’t yet ready for a full switch to the Transition Tyvek material?

Goff: If they need support, customers should call their supplier immediately to discuss options. These may include how to manage the transition internally, last-time-buy discussions and more.

Greene: It is imperative that MDMs immediately implement a gap analysis of current validation activities versus their internal- and external-compliance requirements to implement Transition-protocol Tyvek. The gap-analysis assessment plan needs to be deployed ASAP, based on the MDM’s manufacturing needs.

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In addition to leading suppliers showing the latest solutions in labeling, automation, food packaging, package design and more—WestPack 2019 (Feb. 5-7; Anaheim, CA) gives you access to the industry's leading educational offerings with the 3D Printing and Smart Manufacturing Innovations Summits, the MD&M Medtech Conference and free industry education at the Expo. Register to attend today!

Thermal technology produces color labels with no consumables

Thermal technology produces color labels with no consumables
The new Brother VC-500W printer, which is small enough to fit in the palm of a hand, uses heat to create full color labels using ZINK paper labels.

How can a printer produce color labels, or possibly even flexible packaging, without ink, toner or ribbons? It can be done—with high-quality results—using thermal-imaging technology like that incorporated in the ZINK Zero Ink printing system, which is now available for packaging applications.

The printing technology and substrate, which is a proprietary thermal paper, come from privately held ZINK Holdings LLC. The company’s foray into packaging follows its success in the consumer marketplace. For several years, brands like Canon, HP, Polaroid and LG have used ZINK’s technology in mobile photo printers designed for consumers.

Now ZINK has partnered with Brother International Corp., whose Brother VC-500W compact color printer was announced at the 2019 Consumer Electronics Show (CES) in Las Vegas. This printer, which uses ZINK’s inkless technology and paper, can print full-color digital graphics and text on labels with no drying time required. The Brother printer, which can also print photos, will launch in the United States in February 2019.

An integral part of ZINK’s technology is its thermal paper, which is waterproof and tear- and smudge-resistant. The paper contains seven layers, including internal layers of heat-sensitive colors, a protective overcoating and a pressure-sensitive adhesive backing. The colors in the paper are activated when the printer applies heat to the substrate.

ZINK-compatible printers print the paper in one pass. The paper is white when it goes into the printer, and it emerges with a full-color print. ZINK Holdings has about 80 issued patents in the United States and internationally to protect the various elements of its technology. These include U.S. Patent Nos. 8,009,184; 8,866,861; and 7,830,405.

Juan van Dijk, president of ZINK Holdings, answers Packaging Digest’s questions about the technology.

What is the technology behind ZINK’s “printing”?

van Dijk: All the colors required for high-quality, photographic printing are embedded in the ZINK paper. Each sheet of the ZINK paper contains dye crystals: some that can turn cyan, some that can turn magenta and some that can turn yellow. To activate this untapped, imperceptible “ink” in the crystals, add heat to the equation. Heat causes a chemical reaction in these specially designed crystals, turning them from colorless crystals to richly colored dye. Turning amorphochromic dyes from clear to color is achieved by application of heat pulses from a thermal printer. This video explains in full detail.

Because the equipment doesn’t need ink, toner or ribbon, it can be smaller than other printers. What are the exact dimensions of the Brother VC-500W printer?

van Dijk: 113x116x96 millimeters [4.4x4.5x3.7 inches].

Is ZINK licensing the technology to equipment companies, selling the paper or both?

van Dijk: Both. We sell the paper to our brand partners (not directly to consumers).

Is ZINK paper recyclable?

van Dijk: Yes. The base is a polypropylene material and can be recycled.

Many brands have a signature color. Can ZINK use PMS/matched colors?

van Dijk: We supply color maps to each customer based on its preference. However, we do not customarily use PMS/matched colors.

What is the maximum resolution of the images?

van Dijk: Resolution is limited only by printer type, and varies slightly from model to model. Typical resolution is 300 dots per inch (dpi) across web x 400dpi down web.

Could the ZINK paper be thermally printed and then formed into a pouch or bag?

van Dijk: In principle, yes. The paper can be coated on thinner polypropylene and could be formed. We have not tried this. Sealing equipment is likely to turn on the dyes (blue/black).

Rolls of ZINK labels, which are printed in full color, come in five widths.

What is the size range for ZINK prints?

van Dijk: ZINK offers a variety of paper sizes. For mobile printers: 2x3, 3x4 and 3.5x4.25 inches. For label printing: 3/8, 1/2, 3/8, 1 and 2 inch. The paper is made in 60-inch rolls and can be cut to any dimension up to that limit. Printing is limited by thermal-printer design.

Can you give us some examples of how businesses can use this technology to create packaging for their products?

van Dijk: To accommodate packaging scenarios, many businesses apply ZINK labels [printed with the brand’s existing label graphics] to products or packaging—incorporating hi-res images, branding, multicolor warnings, barcodes and more. Some design concepts (not yet in production) use non-contact printing technology to turn on the colors, which enables flexible and customizable packaging.

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In addition to leading suppliers showing the latest solutions in labeling, automation, food packaging, package design and more—WestPack 2019 (Feb. 5-7; Anaheim, CA) gives you access to the industry's leading educational offerings with the 3D Printing and Smart Manufacturing Innovations Summits, the MD&M Medtech Conference and free industry education at the Expo. Register to attend today!

Danone’s new yogurt jar conveys ‘natural’ and premium

Danone’s new yogurt jar conveys ‘natural’ and premium
Danone Argentina selected PET for its new yogurt jar because it is accepted widely for recycling in Argentina.

As the packaging professionals at Danone Argentina thought about how to package the company’s new, all-natural La Serenísima Original yogurt, they knew the packaging design had to communicate the product’s premium quality. But they also wanted a protective, durable single-serving package that would be easy to recycle.

The solution to their food packaging challenge is a polyethylene terephthalate (PET) jar topped with an aluminum-based seal and clear overcap. The jar is decorated with a shrink label, and the resin formulation includes an ultraviolet blocker. Danone developed the package in partnership with Amcor, which supplies the jars.

La Serenísima Original yogurt launched in Argentina late last year. It is available in six flavors: natural, natural sweetened, blackberry, lemon and ginger, strawberry and sweet squash. To fill the product, Danone has installed a Stork Food & Dairy Systems line with an annual production rate of 40 to 50 million units.

Maximiliano Sassone, research and innovation director at Danone Argentina, discusses the package and product.

What was the inspiration for this package design?

Sassone: For La Serenísima Original, the inspiring concept was the glass pot that was used for the original La Serenísima, the product that revolutionized the category in 1963. The new product’s appeal includes premium-looking packaging that is durable and increasingly sustainable. The new PET jar, designed by Amcor, supports the 100% natural positioning of Danone’s La Serenísima yogurt with featured engraving, a finely finished base and a body-wrap label.

Why did Danone decide to use PET for this package?

Sassone: Aligned with our vision, last year Danone entered into an agreement with the Ellen MacArthur Foundation, which is dedicated to accelerating change towards the model of a circular economy. Following this, we have designed this packaging with the following criteria:

• Residual value: PET is a material that has value once discarded. By choosing PET, we are entering material into the recycling circuit, where there is demand for it.

• Maximum efficiency in distribution logistics: The choice of PET minimizes fuel consumption by maximizing the load.

• Social aspect: By choosing PET, we are capitalizing on Aguas Danone’s effort to articulate the actors in the recycling circuit. [Aguas Danone is Danone’s water division in Argentina.] This means making private-public alliances to empower waste pickers—improving working and living conditions and recognizing the role they play in waste management in the cities—and increase recycling rates in Argentina, with the support of the Danone Ecosystem Fund (a fund through which Danone invests in strengthening actors involved in the Danone ecosystem, like farmers, micro-distributors, urban recyclers and caregivers, among others). By choosing PET, we are choosing to join this movement, boosting the inclusive recycling chain with our packaging.

• Safety in production and consumption: PET is a safe material to work in production lines and to handle during consumption.

Is Danone’s PET jar a custom design?

Sassone: Yes. Danone developed this packaging in collaboration with the global packaging company Amcor. The jar is a transparent, 200-mL PET jar with a wide-mouth opening and an aluminum-PET-aluminum seal with a 65-mm overcap in clear polypropylene (PP).

Can you tell us about Danone’s new packaging/filling line for this product?

Sassone: Danone is filling this jar in Longchamps Plants, Buenos Aires, Argentina. For this project, we invested in a new line, adapted according to the requirements of food safety and the new-format PET jar.

For the filling process, we achieve the best food-safety standards. The line is composed of a disinfection station, filling-and-sealing machine, capping machine and secondary-packing machine (which packs corrugated crates).

Amcor invested in a new injection mold to produce the PET preform, as well as in a new packaging line to produce the PET jar at Amcor’s plant in Pilar, Buenos Aires, Argentina. This packaging line features a new blowing-and-wraparound machine and a shrink-pack machine to ship the cup in safe condition to Danone.

How does the production speed of Danone’s line compare with a typical yogurt-cup filling line?

Sassone: The capacity is similar to other preform yogurt-packaging lines.

Does the full-body shrink label come off easily so the containers can be recycled?

Sassone: Yes. When we designed the packaging, that was one of our priorities. We wanted a package developed under the concept of a circular economy. To have it come off easily, we are using a wraparound, biaxially oriented polypropylene (BOPP) label. We decided to choose PET because it already has a developed recycling market in Argentina. By doing this, we feed an inclusive recycling chain.

How important is recycling in Argentina?

Sassone: In our country, it is not very different from what’s happening in the rest of the world. At Danone, we will continue our portfolio transition to a circular economy because it is part of our vision and commitment towards the preservation of our planet. With La Serenísima Original, we have the opportunity to be the first yogurt brand in Argentina to speak about the circular economy and closed-loop recycling.

Why did you add an ultraviolet blocker to the PET resin?

Sassone: One of our top priorities was to guarantee the best quality of the product throughout the whole chain. To prevent oxidation of the product on the shelf, we added an ultraviolet blocker in the PET resin.

How difficult was it to maintain the PET’s clarity when adding the ultraviolet blocker?

Sassone: We don’t have any issues with maintaining the clarity, because the ultraviolet blocker is clear like the PET.

What is the product’s shelf life?

Sassone: The shelf life is similar to other refrigerated yogurts.

Are the PET jars sold as singles only or also in multipacks?

Sassone: La Serenísima Original is sold in single jars.

When did the product launch in Argentina? Where else will it be sold?

Sassone: We launched La Serenísima Original in December 2018. We are evaluating other markets in Latin America.

How have Argentinian consumers reacted to the PET package?

Sassone: So far, the reaction has been very positive, and we are taking the initiative to talk about the circular economy in the category.

What companies supply the foil seal and clear overcap for this package?

Sassone: Amcor is our third-party supplier [for both].

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You’ll find a generous amount of packaging options at PackEx Toronto 2019, June 4-6, from robotics to semi-automatic equipment and fresh ideas in containers and design. Plus join in free education at Centre Stage. For more information, visit PackEx Toronto.

Labeling/Claims

Regs addressing food-packaging claims will shape litigation risk in 2019

Regs addressing food-packaging claims will shape litigation risk in 2019
In 2019, the FDA is likely to move on regulations for "natural" labeling, among other issues. Photo credit: Designed by Freepik.

Label language will be in the crosshairs for food and beverage packagers in the new year, with new and updated regulations increasing litigation risk in some instances. On-pack claims like “healthy,” “natural” and “no genetically modified organisms (GMO)” are on the short list of labeling terms for packagers to monitor as the new regulations take shape.

Los Angeles-based attorneys Keri Borders and Dale Giali, who are both partners in the Litigation and Dispute Resolution practice of Mayer Brown, answer Packaging Digest’s questions about what to expect in food-labeling regulations and litigation in 2019.

Where will we see the most regulatory/litigation activity in 2019 vis-à-vis food and beverage labeling?

Giali and Borders: Though it is risky to handicap where the consumer class-action bar will be in the future (they are, after all, both relentless and adaptable), we expect to see significant developments in 2019 in the following categories of consumer class actions that were quite popular in 2018:

• Multifunction ingredients. Challenges to products labeled as not containing something (such as “no preservatives,” “no artificial flavors”) but having multifunction ingredients that could function as such things (that is, citric acid alleged to have preservative capabilities, malic acid alleged to a be an artificial flavor).

• The war on sugar. Challenges to products that are labeled/positioned as better-for-you, but that have what consumer lawyers claim is excessive amounts of sugar.

• GMO feed. Challenges to products labeled as made with natural ingredients or without GMO ingredients, but where there may be GMO feed in the supply chain of ingredients (such as cheese made from milk from a cow that ate feed that came from crops grown from GMO seed).

• Slack fill. Challenges to packaging that is too large for the amount of product inside.

What are the key regulatory changes to keep an eye on as we enter 2019? How can food/beverage companies prepare for these changes?

Borders: We are looking for the Food and Drug Administration (FDA) to issue new regulations governing healthy labeling and to issue definitive statements about its direction on regulating natural labeling. (See more here.)

Giali: Natural labeling is perhaps the most litigated label term out there.

Borders: We are looking for U.S. Department of Agriculture to issue regulations on mandatory labeling of the presence of GMO in food products. USDA has issued draft regulations, but the final regs have not yet been published. You can find the proposed regs at this link. We are pretty confident there have been modifications to these proposed regs, though exactly what has been modified has not yet been disclosed.

Giali: Companies have plenty of guidance on how to avoid the attention of consumer class-action lawyers by understanding what has gotten companies in trouble in lawsuits over the last eight years.

Will we see a loosening of the federal preemption of state-level consumer-deception claims against USDA-approved labels?

Giali: Products with meat and poultry are regulated by USDA (not FDA) under two federal laws—the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA). Significantly, under those acts, USDA conducts a pre-market inspection of the product labels. FDA, which regulates food products without meat or poultry, does not conduct a pre-market inspection of labels.

As part of its inspection, USDA determines whether the labels are false or misleading. If the labels are compliant with the FMIA/PPIA (that is, they are not false or misleading), USDA approves the labels, and the products are released for sale.

For many years, courts have ruled that this USDA pre-market inspection and approval preempts challenges under state consumer-protection laws that the labels are false or misleading. Consumer lawyers, however, continue to challenge that principle, including primarily in state court. Recently, a minority of courts have not seen the preemption issue in the same way. We expect clarity on the issue in the upcoming year from the appellate courts, with the preemption principle fully restored.

Will allergen-labeling regulations be changing?

Giali: We are not monitoring any particular changes to allergen labeling that we believe will result in litigation risk.

Can we expect any activity around non-GMO labeling and/or place-of-origin labeling?

Giali: We expect plenty of litigation on both of these topics, consistent with prior activities. Regarding lawsuits challenging non-GMO claims, we expect the new USDA regulations to have an impact.

What about possible changes in gluten-free labeling regulations?

Borders: We are not monitoring any particular changes to gluten-free labeling that we believe will result in litigation risk.

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In addition to leading suppliers showing the latest solutions in labeling, automation, food packaging, package design and more—WestPack 2019 (Feb. 5-7; Anaheim, CA) gives you access to the industry's leading educational offerings with the 3D Printing and Smart Manufacturing Innovations Summits, the MD&M Medtech Conference and free industry education at the Expo. Register to attend today!

FDA looks to pilot projects to enhance pharma track-and-trace

FDA looks to pilot projects to enhance pharma track-and-trace
To improve the safety and security of drugs through the supply chain, the FDA is looking at various new track-and-trace technologies and processes.

The U.S. Food and Drug Administration (FDA) is asking pharmaceutical packaging companies, brand owners and entities engaged at various levels of pharmaceutical distribution to make the prescription-drug supply chain more secure. The mechanism for the work will be a group of pilot projects focusing on drug traceability and verification.

The FDA initiative, which is part of the Drug Supply Chain Security Act (DSCSA), supports development of an improved electronic track-and-trace system for prescription drugs. Scheduled to go live in 2023, the system will reduce drug diversion and introduction of counterfeit products into the U.S drug supply chain, with system users sharing information electronically.

Until March 11, 2019, FDA will be accepting requests from entities within the pharma distribution supply chain to participate in the DSCSA pilot-project program. Participants’ pilot projects will use new and emerging technologies to identify the best processes and attributes for the nascent DSCSA drug-tracing and -verification system.

Answering Packaging Digest’s questions about the pilot-project program is Ilisa Bernstein, deputy director of the Office of Compliance, Center for Drug Evaluation and Research, FDA. For more information about participating in the program, click here.

What does FDA hope to achieve with the DSCSA pilot-project program?

Bernstein: The DSCSA pilot-project program is intended to assist FDA and members of the pharmaceutical distribution supply chain in the development of the interoperable, electronic track-and-trace system to be established by 2023.

How will the pilot-project program improve pharmaceutical track-and-trace?

Bernstein: FDA expects that the pilot projects will:

• aid in identifying the system attributes needed for enhanced package-level product tracing and verification;

• assess approaches to identify, manage and prevent the distribution of suspect and illegitimate product; and

• identify and evaluate efficient ways to electronically exchange product-tracing information across the supply chain in an interoperable manner.

What types of entities are expected to participate in the program?

Bernstein: FDA wants participants from across the pharmaceutical distribution supply chain, including manufacturers, re-packagers, wholesale distributors and dispensers and other stakeholders. FDA would like the pilot projects to reflect the diversity of the supply chain, including large and small entities from all industry sectors.

Is there a maximum number of entities that can participate in the program?

Bernstein: FDA is open to accepting multiple pilot projects that meet the established criteria. FDA will accept as many pilot-project proposals as it can manage.

What types of technology might participants use as the basis for their projects?

Bernstein: FDA is aware that blockchain is one of many technologies that is being researched for product tracing and verification. FDA is open to considering all viable technologies and methods to be included in pilot projects.

What are some examples of practices, processes and systems that ideally will be piloted?

Bernstein: FDA previously held a public meeting in April 2016 to discuss proposed design objectives of pilot projects that will explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain.

Participants will test new technologies that can help spur greater accountability and improve FDA’s ability to trace prescription drugs at every point in the supply chain. There are some ideas in Table 1 of the Federal Register notice [with project topics such as product identifiers, bar codes and interoperability], but the program will consider other proposals, as well.

When will the pilot-project program conclude, and when will FDA release a public report summarizing the results of the pilot projects?

Bernstein: The duration of the DSCSA pilot-project program will depend on the pilot project(s) accepted into the program, and when the projects are completed. When the program concludes, FDA intends to issue a final report and post it on our website. That report will include:

• the names and industry sector(s) of the pilot-project participant(s);

• the pilot project’s objectives and evaluation methods;

• the duration of the pilot project; and

• the key findings and lessons learned from the pilot project.

Participants in the DSCSA pilot-project program must start their pilot projects within four months of receiving a letter of acceptance from FDA. How long after they ask to become a participant will they receive an acceptance letter?

Bernstein: FDA is excited about this program and is committed to reviewing the applications in a timely manner. While FDA hopes to contact program participants by early April, the response time will depend on how many requests FDA receives.