PHARMACEUTICAL PACKAGING INNOVATIONS
Co-located with PACK EXPO Las Vegas and drawing 250 exhibitors to its 100,000 net sq ft show floor, Healthcare Packaging EXPO 2019 was brimming with innovative packaging technologies.
A highlight at the Orics booth was news of a recently installed liquid unit-dose line (1) installed at a contract packager that supplies oxycodone to hospitals. According to Orics CEO Ori Cohen, this new approach brings much greater control over where the oxycodone goes and who consumes it.
The most conventional approach to packaging this dangerously addictive opioid analgesic is pills in a bottle. The downside to this format is that there’s really nothing to stop a hospital patient or employee from selling some of the pills in that bottle. And the street value of oxycodone makes such transactions just about irresistible.
In the new concept from Orics, the drug is in a liquid format. An Orics thermoforming system using vacuum and plug assist forms 10 cups, five across and two deep, with each cycle. The roll-fed material going into the thermoformer is high-density polyethylene, and the cup is 33 thousandths of an inch thick when formed. Then the freshly formed cups are indexed into a filling station where 10 dripless nozzles put 1.5 mL of liquid into each cup.
Filling accuracy, says Cohen, is ±0.1 mL. This high degree of accuracy is due in large part to the material used to make the pistons and cylinders. Typically such components are stainless steel, and as such they require gaskets and O-rings. In the Orics filler, stainless steel is replaced by ceramics, and no O-rings or gaskets are required, says Cohen. In addition to bringing greater accuracy, the use of ceramics practically eliminates maintenance issues, since there are no O-rings or gaskets to replace.
Next in the line is heat-sealing of the lidstock, a lamination of foil and paper. Preprinted information on this lidding material includes the name of the producer, the amount of liquid in each cup, and storage instructions. Perhaps most important is that it also includes a linear bar code. “When a patient in a hospital is given a dose, that bar code is scanned by a healthcare professional and so is the bar code ID on the patient’s wrist band,” explains Cohen. “This clearly associates one specific patient with one specific dose. If someone tries to divert doses for sale on the street, the hospital administration will see that no patient bar codes have been scanned in and associated with the bar codes on those doses.”
An ink-jet print head from Videojet traverses across the lidding material to print variable data on each cup. Right after sealing, matching male and female dies cut the individual cup from the continuous roll of lidding material. Due to the thickness of the material to be cut, hydraulic force is used to actuate the die-cutting tools. Also during cutting, each cup is held in place with a suction cup that comes down from above. After cutting is complete, the 10 indivdual cups are pushed down onto a conveyor taking them to a two-axis pick-and-place device that picks 10 at a time and places them into a clear plastic tray. These trays are also automatically picked from a magazine and placed where they need to be to receive the 10 cups.
Finally, the filled trays are conveyed to a clear film overwrapper a short distance downstream. The line comes to a close with a shrink tunnel that shrinks the film around the tray (2). As for throughput, Cohen says the line can run at speeds to 150 cups/min.
3D Printed Prototyping for Blister Cavities
Maruho Hatsuiyo Innovations unveiled a new service designed to reduce costs, producing usable blister cavity tooling from a 3D image in days rather than weeks. The 3D-printed ABS prototypes are ideal for test situations, with sample blister cavities nearly identical to final production tooling composed of metal. See the technology in a video at pwgo.to/5372.
On the flexibles side
The QuickPouch (3) Vertical ACS forms pouches from rollstock, monitoring for heat seal temperature, pouch length, and more. This new second generation of the machine, the ACS (“advanced control system”) was specifically designed for medical device, pharmaceutical, IVD, and healthcare companies requiring high integrity, high-quality packaging in a compact, validatable, automated machine. The system also packages cannabis products.
The cycle-on-demand form/fill/seal system, capable of speeds to 45 cycles/min, uses a pair of heated dies to form pouches from rollstock and utilizes integrated sensors, a Rockwell PLC, and a color touch screen HMI to monitor vital machine parameters such as heat seal temperature, pressure, and duration, as well as printer status, pouch length, and more.
The Vertical ACS can be integrated with UDI track and trace systems, as well as upstream and downstream automation, and forms pouches out of foil, clear laminations, or Tyvek.
An alarm is triggered and displayed if any parameter falls out of pre-set ranges, preventing the machine from making pouches until settings have been restored and the alarm has been cleared. According to the company, “password protected recipes ensure that unauthorized personnel are unable to change any vital system parameters either intentionally or unintentionally.”
Additional standard features include separate pneumatic and electrical control panels, single exhaust output port, external validation ports, QuickChange hot swappable dies, leveling casters, PLC ethernet connectivity, integrated status light, low-maintenance sealed web brakes, and more.
See it in action at pwgo.to/5369.
Tablet rejects on the fly
Brand owners and contract service organizations continue to seek ways to minimize rejects in pharmaceutical packaging. When an individual pharmaceutical tablet is damaged, often the entire bottle is removed from the process.
At Healthcare Packaging EXPO, a number of machine suppliers offered an alternative to this wasteful concept: Instead of removing faulty bottles at the end of the process, a single tablet reject function eliminates damaged tablets from the filling process.
Uhlmann showcased its new system aimed at reducing waste by up to 99% when packaging solid dose products in bottles. The IBC 150 packaging line with its single tablet reject function is able to eliminate individual damaged tablets before they are filled into a bottle. As an example, this means only three faulty tablets–instead of potentially three bottles–are removed from the process when the tablets are damaged.
The basic version of the IBC 150 comprises a bottle infeed, servo-regulated bottle transport and tablet counter, capping unit, and bottle removal. The tablets or capsules already undergo inspection on the vibratory plate of the tablet counter. With the aforementioned single tablet reject function:
• If the system identifies a damaged product on the vibratory plate, e.g. with color chipping or fracturing, this is specifically and gently removed via one of the separately driven ejection channels.
• Production speed is not affected during this process.
• The single tablet reject function is fully integrated, both physically into the machine and electronically into the machine control system, enabling operation via a central display.
• Fitting and removal of the ejection channels requires no tools. The machine control system is used to set the parameters.
“Depending on the filling capacity, we are able to reduce the number of rejects by up to 99 percent using the single tablet reject function. That is of enormous benefit to all pharmaceutical companies that fill bottles with tablets. Single products are accurately eliminated from the process instead of having to remove filled bottles at the end,” explained Konstantin Gerbold, Product Manager Bottle Business at Uhlmann.
Another example at the show was the Aylward TCM. Aylward’s machine is a modular bottle filler that can reject single tablets without machine stoppage or slowing. Tablets adhere to a vacuum disc and are inspected with a color camera system. Non-conforming product is ejected, verified, and moved into a reject bin while the machine continues to fill conforming products. As Jonathan Fahey explained on the show floor, “This eliminates the need for costly reworked bottles.” For a video go to pwgo.to/5370.
Conforming tablets are dispensed into bottles one at a time, meaning that funnel clogging is not an issue and even small bottle openings can be accommodated. The TCM reached speeds up to 60 bottles/min at 100-ct, and more modules can be added for increased throughput.
For those packaging a variety of products, the vacuum disc is non-dedicated and changeover is speedy thanks to only four product contact parts. The machine features an open design—nowhere for tablets to hide. The unit was designed to be modular; it fits through a 36-in door and can move from packaging suite to packaging suite.
Switching gears from cosmetic defects, the HarleNIR chemical imaging system (see lead item) from SEA Vision, shown on a Marchesini Compact 12 monoblock unit at the show, can detect tablets with a different chemical composition.
In pharmaceutical processing, active ingredient uniformity tests—which must be passed in order for a batch to be released—are typically performed through off-line sampling via laboratory equipment. Offering an alternative to conventional methods, SEA Vision has developed a system that is installed directly on the production line.
HarleNIR offers qualitative analysis of solid products combined with real-time rejection of faulty products. The integrated vision system features a hyperspectral camera working in the near-infrared spectral band to perform quantity and quality analysis and offers non-destructive monitoring of 100% of the products as well as faster batch release times. It also cuts the risk of releasing out-of-spec product.
It was created to prevent commingling and to detect tablets with a different chemical composition or an incorrect concentration of the active ingredient, which would otherwise go unnoticed as they are the same shape and color as the others around them. The system can be used to analyze the chemical composition of oral solid dosage products such as capsules and tablets whether printed, molded, coated, flat, or embossed.
With single product rejection, the system can zero in and discard the individual faulty tablet, which prevents product waste and the need for re-processing a whole bottle for a single faulty tablet.
With the HarleNIR on the Compact 12 monoblock at the show, SEA Vision and Marchesini have incorporated counting and capping operations within a single unit. (For more, read about the two companies partnering for a blister packaging line go to pwgo.to/5371.)
The machine is set up to handle all the main types of capping systems (screw-on, press-on, crimped) and offers a wide array of applications to guarantee total product control. The tare weight and the gross weight of the bottle are checked to calculate the net weight of the product inside it.
The HarleNIR can be integrated through a series of proprietary algorithms that generate a data package for transmission to the machine on which the system is installed. To ensure ease of data transmission, the Ethernet D-Bus communication protocol is used, which allows ultrafast transmission (in under a millisecond).
For those who don’t need single tablet reject functions, Antares Vision debuted a 100% inspection unit for tablets and capsules bottled via slat filler (5).
AV Slat View can accommodate uncoated or coated tablets, and mono and bi-color capsules. Compatible with a range of OEM slat filler brands and equipped with an advanced color detection algorithm, the system is easy to set up while offering high accuracy, unlimited recipe storage, and low false reject rates. The system features a configurable alarm that flags and rejects bottles with potential objects, eliminating the need for line stoppage.
FDA-Compliant Labeling Unit in a Compact Footprint
On display at the HERMA booth (the subsidiary of HERMA GmbH) was the ultra-compact HERMA 211 HC Wrap-around Labeler, a semi-automatic unit designed to meet pharmaceutical manufacturers’ needs for an FDA-compliant labeler. Capable of applying approximately 30 labels/min, the machine benefits smaller batch manufacturers and companies transitioning from clinical trials to full production.
“The idea behind the new HERMA 211 HC is simple: compactness that doesn’t sacrifice accuracy or performance,” says Peter Goff, CEO of HERMA US. “And as specialty medicines and limited-run biopharmaceutical products become increasingly prominent, the unit also meets the growing need for modest yet robust machines for smaller, highly precise batch production.”
The HERMA 211 HC accommodates a wide range of cylindrical products including syringes, tubes, glass vials, and ampules. It handles webs as wide as 80 mm, and products ranging in diameter from 10-120 mm. After printing and inspecting variable information on labels, any defective labels are automatically rejected without being applied to the product. To prepare for labeling, product is placed into the rotating roller prism, then a pivot beak lowers and precisely applies the label, after which the product is removed manually.
Those who have printers compatible with the signature HERMA 400 Label Applicator take note: all printers compatible with the HERMA 400 range can be fitted on the HERMA 211 HC.
New at the show, New England Machinery’s (NEM) single-head servo capping machine was engineered to address the specific needs of pharmaceutical companies and “deliver specific results,” said the company The capper has four-axis servo control for both linear and rotating spindle motions and is capable of speeds to 50 bottles/min and applied torque of up to 30 in.-lb.
According to the company, it also offers data collection to customer specifications and closed-loop torque feedback. The CAM is programmable and recipe controlled through the Allen-Bradley level-1 password-protected HMI, offering real-time machine diagnostics and quick, repeatable changeovers. The capper is constructed of stainless steel and has a sloped-surface design with minimal cavity infiltration.
Medical device bagger
The Rollbag Magnum HS Med Automatic Bagger (6) that PAC Machinery demonstrated at the show is a medical pouch sealing system that’s capable of being independently validated, is designed for clean-room use, and can package products at speeds of up to 40 bags/min using Tyvek® Poly or medical-grade paper rollstock. Products packaged on the Rollbag Magnum HS Med Automatic Bagger are suitable for use with an autoclave or sterilizer.
The bagger features a control system that monitors all seal parameters, switching into alarm mode if any parameter goes out of range. External ports enable a user to reliably conduct the sealing parameter validation process. The Magnum HS Med can also communicate with a remote device for central monitoring.
Bag length changes are accomplished quickly using built-in job storage feature and a large, easy-to-use touchscreen display. Help and diagnostic screens are built into the operating system. The controller interface simplifies integration of counters, scales, robotics, and other feeding devices for improved automation and faster filling.
The model on the floor at PACK EXPO featured an integrated thermal transfer printer, allowing the operator to print graphics, UDI bar codes, and text right on the bag, simplifying the labeling process.
According to Greg Berguig, VP Sales and Marketing at PAC Machinery, this versatile departure from conventional medical pouch sealers features an easy-to-operate, automatic pouch-making system. This bagging solution provides the benefits of faster fill speeds, even up to 70 bags/min with polyethylene tubing. The system creates a chevron seal for peelable pouches and may be configured to create a straight seal on poly tubing and a variety of other materials.
The medical pouch sealer is a good fit for a dynamic, fast-moving production environment. The bagger is easy to use, accommodates a variety of packaging materials and sizes, adapts quickly to changing production demands, and requires very little maintenance. When all the benefits are combined, the result will lead to a significantly lowered total cost of ownership.
Developments in packaging materials
On the packaging materials side of things at Healthcare Packaging EXPO, Paxxus introduced an expanded range of its Stream™ brand of flexible mono-material packaging solutions (7) that are compatible with recycle streams #1, #2, and #5 to support sustainability initiatives for life science and medical device manufacturers.
Materials in the Stream family can be tailored to precise package requirements without sacrificing performance, and many of the Stream recycle-ready materials allow for down-gauging of up to 50% compared to traditional lidding and pouch materials, providing additional reductions in waste and energy.
The wide sealing window of each Stream material offers versatility and ease of use. These flexible materials can be printed and are suited to lidding, pre-made pouches, 2D form/fill/seal, and flow wrap applications.
StreamOne® is a lamination consisting of ClearFoil® M2 high-barrier polyester and biaxially oriented polyester extrusion coated with Paxxus’ Exponent™ 2 polyester sealant. Designed for the #1 PETE recycle stream, StreamOne provides the same benefits as its parent StreamOne®, including high barrier properties and smooth seal and peel from APET, CPET, and PETG trays, with the additional features of being suitable for retort or autoclave sterilization. Opaque and clear options are available to suit product visibility requirements.
The material offers consistency—seal and barrier integrity are maintained even after the sterilization process—with reliable hermetic pouch seals that protect the product throughout the supply chain.
Also new is StreamTwo® Recycle-Ready HDPE. Compatible with applications requiring radiation sterilization, these materials were engineered for the #2 High Density Polyethylene recycle stream and designed to provide an ultra-smooth peel from HDPE trays. Opaque and transparent options allow this material to be tailored to a variety of product visibility requirements.
Finally there’s StreamFive™. As the name implies, it was designed for the #5 Polypropylene recycle stream. This material seals to and peels smoothly from PP trays or itself in pouch form creating an entirely polypropylene packaging system designed for performance in patient-care environments. High-barrier options ensure that both product protection and shelf-life are extended. StreamFive is suitable for retort or autoclave sterilization.
“The Stream product family now makes it easier than ever for medical device and life sciences companies to access the right recycle-ready packaging for their applications,” says Dwane Hahn, Chief Strategy Officer at PAXXUS. “These visionary companies can distribute with the utmost confidence that their products are saving lives today with packaging that protects tomorrow for future generations.”
Another important aspect of packaging materials in the healthcare packaging space is the whole issue of child resistance. At Healthcare Packaging EXPO, Colbert Packaging Corp. displayed its new Locker 420 (8), a senior-friendly paperboard packaging system for an array of cannabis products including flower, capsules, and edibles.
The system, currently undergoing child-resistance testing, protects products with a two-step locking mechanism that includes an area for pressing down and a tab for easy pulling. The design is production-friendly for ease of implementation and customizable for a variety of carton sizes. Cold foil graphics are also available to add metallic decoration for shelf appeal.
The carton is available in Colbert’s “Clean Carton” formula, featuring water-based inks, coatings. and adhesives that meet environmental and safety standards safe for indirect contact with products. Constructed from Solid Bleached Sulfate (SBS) paper, there are no heavy metals or volatile compounds, and Clean Carton provides for performance on the press, resulting in less waste and lower consumption of raw materials and ink.
The Locker 420 joins Cobert’s MedLock EZ™, a child-resistant, senior-friendly, and sustainable unit-dose alternative to amber prescription vials. The system has tested to F=1 for child-resistant and senior-friendly effectiveness and consists of an outer paperboard shell that houses a pill blister card locked into place with an integrated, patent-pending locking mechanism. The user disengages the lock by squeezing and holding touch points at one end of the paperboard shell while sliding the blister card out through the other end. Once the blister card is exposed, medication can be pressed through one of the individual blisters. Sliding the blister card back into the outer shell reengages the lock.
On-demand label printing
Healthcare labels benefit from color printing for a multitude of reasons, including efforts to:
• Color code for different strengths of an injectable drug
• Improve user reading comprehension with images, symbols, or copy
• Employ hospital ID bracelets with patient photos or allergy indications
• Add anti-counterfeiting features
Though color printing is often desired for reducing errors and improving patient safety, it can be cost-prohibitive for certain facilities and manufacturers.
At PACK EXPO, Epson America launched the first digital printers specifically designed as a color upgrade to black-only thermal transfer printers for industrial applications. The lineup includes four new ColorWorks On-Demand Color Label Printers: ColorWorks C6000A, C6000P, C6500A, and C6500P. The new models deliver on-demand labels at a reportedly comparable price to thermal transfer.
The printers enable industrial and commercial organizations to produce high-volume color labels for production use, printing labels at speeds up to 5-in/sec. Featuring up to 1200 dpi resolution, the models print crisp images comparable to pre-printed labels. 4- and 8-in. models cover a spectrum of label sizes to meet the varying needs of healthcare label printing.
As employees may be wearing gloves in the healthcare or production setting, two of the models are the first ever color inkjet printers to support peel-and-present capabilities for fast hand or automated label application (C6000P and C6500P). The C6000A and C6500A include an auto-cutter to create variable length labels and enable easy job separation.
The time it takes to peel labels is eliminated with this option, representing labor savings. For those employing robotic systems for label application, it’s often hard for the robot to peel the label. By offering a peel-and-present option, efficiency is increased with the robotic arm being able to quickly grab and apply.
When hospitals use UV light to sterilize clinical rooms, an adverse effect can occur where colors on medical device labels fade. As Andy Scherz, Senior Product Manager, Commercial Label Printers, Epson America, Inc. notes, “You can enter the patient room or the OR, with all the medical devices waiting to be used in a procedure, and it looks like a used bookstore,” though the products are not old at all. Durable color inks in the ColorWorks line withstand UV lights, preserving the label readability on medical device packaging.
Scherz highlights that on-demand printing is an important part of many food and cannabis operations, where label content may need to change rapidly for regulatory or ingredient updates. A company may need to add copy or warnings for GMOs, allergies, and more. “The amount of critical information on every label is growing and changing frequently,” he says.
The printers are compatible with ZPL II, SAP®, major middleware and more, and built to accommodate remote printer management to offer easy integration with existing workflows. As medical device manufacturers and other life science companies are often global enterprises, remote management tools mean IT personnel can perform firmware updates no matter where the printer is located.
“The industry recognizes the benefits of on-demand color label printing, but we also know it can be difficult to make the transition from a black-only thermal transfer printing process that is already set up in the current workflow,” says Scherz. “This new family of ColorWorks on-demand label printers provides an easy transition for customers looking to make that vital switch, with similar media handling capabilities, speed, features, and connectivity options that deliver seamless integration with existing workflows, so customers can get up and running with a new, more colorful system, fast.”
Scherz explains that the media loading process is versatile, with printer doors opening multiple ways. Also, there’s easy access to all parts of the machine for quick resolution of jams. The models feature permanent printheads, meaning users avoid the costs and hassle of replacement printheads.
Overcoming the challenges of printing with white ink, LimitronicUSA, a division of Graphic Solid Inks, introduced its V7 White printer for high resolution 2 in. tall printing (9) as well as the V6 CMYK full-color single-pass inline printer.
The V7 White printer is suitable for a variety of dark substrates including black. It can print real-time data, including traceability data, offering flexibility for short runs and promotions. Optional features include barcode verification after printing, alarm beacon lights, and barcode scanning for product identification.
The system is capable of printing UV LED inks onto curved surfaces—it was exhibited at the show using an integrated Fanuc robotic arm—or flat surfaces with a conveyor. Designed for ease of use, the system features an intuitive user interface and on-screen layout preview (WYSIWYG).
To see it in action, go to pwgo.to/5373.
2D Microcodes for small spaces
2D codes are prominent in anti-counterfeiting strategies, but limited real estate on packaging poses a challenge for many small products including pharmaceuticals, med devices, cannabis, and consumer goods. Complete Inspection Systems showcased its HD MicroCode, capable of printing at 600 dpi in a tiny 4.5 mm square with up to 45 characters embedded. When printing at 3200 dpi, the code can be as small as 1 mm square. Companies receive a “code generator” to embed security features, and encryption and security capabilities are maintained by the user. Codes can only be read by authorized smartphones.
Systech’s next-generation platform is a brand protection suite that integrates fool-proof product authentication with serialization, traceability, and insight.
Systech, a global technology provider of digital brand protection and authentication, launched its Systech Brand Protection Suite™ at PACK EXPO Las Vegas. The platform delivers a fully integrated system to combat counterfeiters, solve product diversion and meet regulatory compliance.
The Suite is designed to seamlessly integrate the key pillars of brand protection—serialization, traceability, authentication, and insight—and transform a simple package barcode to give brand owners end-to-end visibility and actionable, data-driven insight about a specific product as it moves across the supply chain.
“As counterfeiters and gray market criminals become more and more sophisticated, traditional measures like holograms and special inks alone are not enough to combat supply chain threats while other technologies like RFID are too expensive for most products,” says Ara Ohanian, CEO of Systech.
Different parts of the suite can be used individually and can integrate with others’ technology, says Systech Director of Enterprise Serialization Stephen Lisa. “But one of the benefits of a single-stack solution is that we handle all the integration and we don’t have the issues with compatibility. If we upgrade one solution, we know it’s compatible with all of our solutions.”
While the highly regulated pharmaceutical market is an obvious choice for the technology, brand owners outside of the pharmaceutical space who aren’t serializing their products can still benefit from Systech’s new platform because such CPG companies frequently have to address issues with counterfeiting.
For a company running 100 million bottles of high-end shampoo, each one will have the same UPC code on it. As good as the print looks on the UPC codes, looking more deeply beyond what the eye can see, there are variations in ink color. “To the eye it looks like a black bar, but there are different layers of black—it’s more of a grayscale from the camera perspective. That’s what makes it a unique print,” says Lisa. Temperature, vibration, humidity, and even the stock it’s printed on all contribute to the uniqueness of each UPC print.
“You’ll never have two variations that are completely identical. By using fingerprinting technology, the brand owner is actually able to identify each and every bottle as unique. So in a sense, you don’t have to serialize every item to take advantage of the technology, making it feasible in other markets,” including cosmetics, personal care, and wine, for example.
If a bad actor were to take a used product’s packaging, refill it, and apply a new tamper-evident label with an identical code, Lisa notes, “with Systech technology, the system could tell it’s not the original print.”
Customer engagement is made possible by the Suite’s offerings, allowing manufacturers to reach their customers when they scan codes through apps. What information is shared with the consumer is up to the brand owner, from authentication information to product instructions to incentives and more.
Since its soft launch earlier this year, the Systech Brand Protection Suite has been adopted by major brands across multiple industries including pharmaceuticals, e-cigarettes, cosmetics, and spirits.
The MG America booth (the U.S. subsidiary of Italy-based MG2) featured its brand new patented EXTRUDOR™ dosing unit, which allows users to modify the dosed powder quantity through simple and rapid adjustments without changing the dosing disc.
The system is designed to offer flexibility, accuracy, and uniformity, increasing the dosing precision and reducing powder dispersion, resulting in shorter cleaning times and lower maintenance costs. At the show, the unit was installed on MG2’s intermittent-motion capsule filler model AlternA70N, which can reach speeds to 70,000 capsules/hr. The AlternA70N can be equipped with a powder or pellet dosing unit, or a combination and handles capsule sizes from 00 to 5, including elongated and tamper-proof capsules.