Report: Innovative New Pharma & Medical Devices at PACK EXPO Connects
PMMI Media Group editors—covering a virtual event instead of an in-person exposition—divided and conquered to collectively take in as much of PACK EXPO Connects as possible. Here’s what they saw in the pharma category.
BellatRx’s Constellation Monobloc is a new servo-driven fill-weigh-cap system for unstable pharmaceutical microtubes, vials, and cartridges.
The size and shape of certain vials and microtubes can make them difficult to stand on their own, adding difficulty in automated filling because they cannot be placed on a standard conveyor and moved from one machine to another. Life sciences manufacturers producing high-value liquid drugs may also be challenged by inaccurate fill volume or weight control, or product loss at the end of a batch.
To combat these issues, BellatRx Inc. has launched its Constellation Monobloc (1) to pre-weigh, fill, post-weigh, cap, torque, and inspect vials to ensure adherence to specifications. The system is suited to small or large batches of high-value liquid products where accuracy is key for pharma, biotech, diagnostic, and healthcare customers. Constellation is able to index unstable vials in a safe way that prevents tilting or leaking. It features a standard speed of 60 vials/min, with higher speeds available with dual-robotic stations.Image #1 in the article text.
What really sets the system apart is its dual-weight control of vials and microtubes before filling and after filling. “The system measures a tare weight and gross weight, subtracting the tare to obtain an accurate net weight as a verification of the fill volume,” said Alan Shuhaibar, president at BellatRx. This eliminates the risk of underfilled vials.
Robotic pick and place stations unload vials from trays into pucks that index the tubes gently throughout the process of filling, capping, and inspection. Grippers match the diameter of the vials for delicate handling. At the filling station, servo-controlled pumps deliver precise volumes into vials, and nozzles are lifted to reduce contact and reduce aeration.
“The robotic modules that we’ve added to the system allow us to handle product that usually is very difficult to handle in an automatic format,” explained Shuhaibar. “The controls are Allen-Bradley (Rockwell Automation), with a large 10-in touchscreen. The robot itself is a Fanuc robot, while the software and the robotic stations are developed in-house.”
Capping stations are also servo-controlled—rotation and downspeed are synchronized to match the pitch of the threads. The capping system is equipped with torque feedback sensors.
A vision inspection system verifies the presence and placement of caps on vials. If a fill weight or cap issue is detected, rejected vials are tracked to a reject lane without disrupting the system’s operation (tagged in the HMI with the appropriate reason).
Finished product is then robotically loaded back into trays at the end of the line. Subsequent labeling and laser etching of vials or cartoning can be incorporated with the modular design of the Constellation system. If there is an interim operation, vials can also remain in trays to be stored in refrigeration.
The system shown at PACK EXPO Connects fills less than 1 mL, but Constellation can accommodate larger fill volumes. In its smallest configuration, the monobloc is 48 in. x 53 in., however when fully configured with three robotic stations it is approximately 156 in. x 53 in.
Modules feature surround status lighting that changes color depending on machine status. When operator intervention is necessary, Constellation illuminates the work area in white lighting for enhanced visibility.
Image #2 in the article text.Constellation can be changed over with minimal product loss. The filling trolley can be unlocked from the system and pulled away for further dismantling without tools. A CIP cycle can be activated to flush wetted surfaces without dismantling.
The system is already at work at multiple facilities filling vials for COVID-19 test kits with swabs and rapid (oral) tests. “The trend we’re seeing across the board is a drive towards automation. This includes tasks that were performed manually in the past—because operators could handle the unstable vials,” said Shuhaibar. The shift to automate and increase uptime is driven both by the skilled worker shortage, as well as the desire to reduce contamination (and exposure) from operators breathing near or coming in close contact with the product. “This way they are able to load a tray and step away from the area, versus having to place one microtube at a time,” said Shuhaibar.
Check out the many packaging solutions featured by BellatRx at their PACK EXPO Connects Virtual Showroom, found at PE.show/225.
Roll-fed sealing system for med devices Many medical device packages are sealed individually in pre-formed thermoformed trays and pre-cut Tyvek lidding that requires manual lid placement by operators. A tray is loaded into the machine, product is placed in the tray, pre-cut lidding is placed on the tray, and the heat platen is activated to seal the lidding to the tray for a predetermined time, pressure, and temperature.
Sonoco Alloyd’s new patent-pending medical sealing system (2) was demonstrated on the Aergo 2 machine at PACK EXPO Connects, where the need for placing pre-cut Tyvek lidding is eliminated by integrating a roll-feeding system into the sealing machine. The roll-feed technology is also offered on the Aergo 2 Plus heat sealing machine.
Two heavily guarded side panels contain the roll and rewind rolls necessary for the automatic placement of the Tyvek lidding (unguarded nip rollers can be hazardous for operator safety). The system accommodates 1073B printed Tyvek, 1059B, and super lightweight 2FS, sterilizable by ethylene oxide (ETO), gamma or E-Beam. Available starting in January 2021, the system is designed to increase speed, seal quality, and seal accuracy, which are all critical for medical devices to arrive safely to the healthcare setting.
In some applications, the new roll-fed system allows for the use of thinner Tyvek. This thinner material reduces the weight and cost without compromising sterility. Without the roll-fed system, a thinner or lighter weight pre-cut lid might curl or move during tray indexing and sealing. The roll-fed system fully removes these seal quality errors. As Kim Sanderson, marketing specialist at Sonoco Alloyd, explained in a product demo, “Advantages of using lighter weight lidding materials include less overall packaging costs, lower waste, and similar benefits to form/fill/seal without the high cost of integration.” The company has calculated cost savings start at around 10% on raw materials saved alone.Image #3 in the article text.
Both the infeed roller and opposite rewind roller are powered by dual servo-driven motors paired with a series of highly engineered breakers that keep the Tyvek taut and located above the package until the sealing operation is engaged. The system can accommodate rolls up to 14 in. in width. “This torque-applied pressure ensures a tight seal against your package and removes any swelling or extra material that would allow for product to move about,” said Sanderson.
Via the 10-in. HDMI touchscreen, Tyvek is programmed to auto advance at a predetermined length, by either a photo eye for printed materials (accurate to ± 1⁄16 in.) or linear indexing measurement for unprinted materials, such as for hand-labeled medical packages. The multi-lingual touchscreen features full color display and on-screen prompts were designed for ease of use.
Sealing and diecutting happen at once. When the tray fully engages into the machine, the Tyvek indexes, and the heat platen automatically comes down to seal and cut the Tyvek in the customized shape. Once the predetermined seal time has elapsed, the heat platen then comes up and the operator may bring the tray back out to remove the finished package.
On the other side of the system, scrap webbing is neatly and automatically rewound on the opposite roller. Sanderson said this excess material may be recycled or sold to regrind HDPE scrap facilities.Image #3 in the article text.
This automated system eliminates manual lid placement that takes time and can cause errors: • Operators no longer meticulously place the pre-cut lids over the trays using locating pins. (Pins are completely removed with this new integrated medical sealing system, saving on tooling costs.)
• Lack of locating pins eliminates the indents in Tyvek lidding.
• Upside down, doubled, or missing lidding is eliminated as well.
The roll-fed medical sealing system is designed to offer increased repeatability at approximately 2-6 cycles/min, depending on the application and operator pace. The Aergo 2 features a 12 in. x 18.5 in. seal area while the Aergo 2 Plus features a 14 in. x 28 in. seal area.
“When working with medical packaging, there’s little if any room for mistakes,” Sanderson explained. “With the integrated medical sealing system, operator error and misplacement of lidding is eliminated. Backwards lidding could cause a costly quality error further down the road If it were to ever reach your end customer. Upside down lidding has the ability to hold up production lines as activated coating buildup must be removed from the heat platens or any subsequent lids will stick to the tool. Misaligned lidding from atmospheric interruption during tray engagement wreaks havoc on seal accuracy and integrity. Trays sealed with lidding completely absent has even larger consequences of contaminating tools by melting raw plastic to the bare tool. Any contamination must be removed before further sealing operations can proceed again.”
Tooling is designed and manufactured at the same time as the machine and tray order. The system is compatible with various medical-grade roll supply materials including foil, paper, and clear sterile barrier film. Specialty tray materials such as direct seal technology may be incorporated. Additionally, multiple number-up seal tool configurations may be designed to maximize production and efficiencies.
There are a number of optional features that may be applicable to device manufacturers, including UDI printing, RFID tooling, power shuttle tray, validation ports, automatic product lift, ionizing bar, and ethernet ports.
Check out the many packaging solutions featured by Sonoco Alloyd at their PACK EXPO Connects Virtual Showroom, found at PE.show/136.
Blister machine’s vacuum system for reject/transfer Pharmaworks, part of ProMach Pharma Solutions, introduced at PACK EXPO Connects the TF1pro (3), the next-generation system in its TF1 family of compact blister machines. The system is particularly suited to small to moderate batch sizes and clinical trials for pharmaceutical and biotech manufacturers and contract packers that frequently change over. The fully servo-driven blister machine runs up to 100 indexes (200 blisters) per minute.
While smaller systems don’t always have the bells and whistles of high-throughput machines, Pharmaworks added many features to maximize product safety and ease of cleaning, while also achieving fast changeovers, accuracy, and versatility. Ben Brower, Director of Sales and Marketing at Pharmaworks, said, “Two years ago, a large pharmaceutical company approached us and asked us to develop a compact blister machine with the most advanced cGMP features. With their design input, we developed the TF1pro, the only blister machine on the market that offers this high level of product safety and sanitation in a small footprint.”
The system accommodates tablets, capsules, softgels, vials, syringes, liquids, and more. The intermittent-motion TF1pro supports both thermoforming and cold forming applications and runs a wide range of base materials with a standard roll diameter of 500 mm, providing twice the production capacity of the TF1E blister machine. The usable forming area is 120 by 165 mm with a depth of 25 mm. Optional product vision inspection and print vision inspection are available, as well as full serialization if needed.Image #4 in the article text.
Processes and parameters—including temperature, pressure, and the timing of each step—are PLC-controlled and programmed as a unique recipe in the TF1pro’s large HMI. The TF1pro offers either Rockwell Automation or Beckhoff control systems.
As the base roll unwinds, an optional feature monitors roll diameter and alerts the operator when it’s time to add fresh material at the splicing station. Power-driven rollers form a loop in the material, while a sensor ensures that the material loop is in the correct area. This touchless feature helps prevent excess drag on the material, meaning less stretch, saving on costs by allowing the use of small width base rolls.
Next, a splice detector notifies the operator when there is a splice in the web, allowing the machine to track the splices and automatically reject that section of material.
The company reports that automated adjustment of heating plates, forming tools, and other change parts translates into a 30% reduction in changeover time versus other TF series machines. It features ergonomic components that slide in and lock, including the guide track on the feeding station. The heat area automatically retracts when not in use for operator safety and convenience during changeovers and maintenance.
Sloped surfaces throughout the system eliminate the chance of cross-contamination from trapped product or debris, which also speeds changeover by simplifying machine cleaning.
At the heating station, upper and lower plates apply contact heating to the base material. The heating station opens fully during machine stop to remove heat from the material. There are optional burnout detectors to determine that all heating elements are working correctly—these will stop the machine if an issue is detected.
The warmed material is then indexed to the forming station where upper and lower tools create blisters of predetermined shape, size, and depth. These are change parts that permit toolless changeover, depending on the blister dimensions needed.Image #5 in the article text.
Driven by a servo motor, the lower tool moves upward during the forming process and this travel can be changed and stored on the HMI to allow the most efficient motion for a given blister size. The blister cavity can be formed with air only or air plus plug assist (for cavities up to 25 mm deep).
The TF1pro is available with a wide variety of options, including selective forming that enables specific pockets to be turned on and off within the same tool. Pinhole detection for the lid material and/or the base material is available for cold forming. Additional options include a lid material splice table, a splitter, servo plug assisted cold forming, and both helium and nitrogen gas flushing.
Finished blister cavities are indexed to the feed area, a separate module on the TF1pro that can be tailored to almost any length needed up to 2,500 mm. Open access from the front and rear in combination with feed area length allows automatic feed systems to nimbly dock and undock as needed or allow operators to manually fill blister cavities.
Pharmaworks offers several feed systems for its blister packaging machines. The machine on show used the FA1 feeder (also common are the FF1 and FT320) with servo-driven technology to pick and place product into blister cavities. This next generation FA1 feeder is enhanced for more reliable pick motion and features that help speed cleanup and enable toolless installation.
At the feeding stage, product is conveyed across a vibratory sift tray, where dust and debris are removed and product is aligned in the feed track. The product populates each groove in the slanted track, enabling gravity to pull the product down the track. The end point of each groove is pre-engineered to match the blister cavity orientation on the web. (When feeding is done manually, operators can work from either side of the machine.)
Before the blisters arrive at the seal station, the TF1pro’s advanced vision system inspects the product shape and color, and checks for broken or missing product. The vision system logs this information on good and bad blisters into the blister tracking register (BTR). The position of bad blisters on the web is identified, and these products will be rejected later.
Lidding may be preprinted or printed online with the required lot and date codes. Several third-party printers are compatible with the system while a Scanware print vision system checks and logs print quality.
Image #6 in the article text.To ensure consistent and accurate seal integrity, a load cell provides real-time information on seal pressure. A secondary high-speed sensing system will detect any foreign object between upper and lower seal plates. If an object is detected, the sealing cycle will instantly stop and reverse plate travel. Another safeguard on the TF1pro is a retracting seal plate—if web motion stops, the upper seal plate retracts to the rear so that the web won’t be exposed to unnecessary heat.
The blisters are then perforated and die cut by the inverted die punch. The reject/transfer station uses a vacuum arm to lift the “good” blisters onto the outfeed conveyor while “bad” blisters simply drop down into the reject bin, which ensures consistent and accurate ejection. Positioning the die cutter in this way also provides space at the end of the web for direct coupling of a cartoning machine. Blisters can be manually packed as well.
Check out the many packaging solutions featured by Pharmaworks at their PACK EXPO Connects Virtual Showroom, found at PE.show/211.
Pharma security label with RFID technology Schreiner MediPharm is a global provider of functional label solutions for the healthcare industry. At PACK EXPO Connects, the Germany-based firm discussed its enhanced tamper-evident specialty label, Cap-Lock, with a special RFID inlay (4).
Developed to help hospitals expand digitization initiatives, the label-and-cap security concept for prefilled syringes now also enables automated inventory and supply chain management, as well as digital first-opening indication. In doing so, the new Cap-Lock plus RFID solution offers efficient and reliable product authentication and enhanced patient safety.
Equipping syringes containing liquid medications with RFID-Labels poses a challenge, as both the container material and the composition of the liquid may impair reading of a UHF RFID Label. Flag labels protruding from the container are frequently used for this purpose; however, these typically require additional space, are prone to being torn off, and must be applied manually. As Paul D’Adamo, sale director, North America, at Schreiner Medipharm, explained, “Flag labels need to be manually applied by hospital staff. This offers separation between the RFID label and the liquid, but it’s not necessarily a very user-friendly application.”
With Cap-Lock plus RFID, the RFID chip is integrated in the label. Cap-Lock is a combination of a cap adapter and label. The adapter is placed on top of the syringe’s primary closure and interlinked with it to equalize the diameter differences of the syringe body and closure. The label wraps around the syringe body and cap adapter and—once opened—provides irreversible tamper evidence due to an integrated perforation.
The new label-and-cap security concept offers a less labor-intensive application process. “With Cap-Lock, you’re able to incorporate the RFID into the cap, which is creating distance from the actual liquid. From a machine application standpoint, it can be applied when you’re labeling the actual syringe, taking that burden off the healthcare worker,” said D’Adamo.
One major benefit of RFID for busy healthcare staff: a direct line of sight is not needed to record inventory, meaning a whole drawer of tags can be read at once without spinning each syringe to view a barcode.
Check out the many packaging solutions featured by Schreiner MediPharm at their PACK EXPO Connects Virtual Showroom, found at PE.show/489.
Robotic inspection for vials, syringes, and more Featured at PACK EXPO Connects by the Stevanato Group was the Vision Robot Unit (VRU), which is designed for accurate and flexible inspection of vials, syringes, cartridges, and more (5). One machine accommodates a range of products including monoclonal antibodies (mAbs), vaccines, and lyophilized drugs. The system, which is being delivered to its first customer toward the beginning of 2021, inspects both cosmetic and particle properties without human intervention.Image #7 in the article text.
With the recent growth of cell therapies, biopharmaceutical companies are in need of flexible machines with fast changeover for small, high-value batches. Giacomo Girotto, Vision Inspection Project Manager at Stevanato Group, said, “We want to release the full flexibility of human-like inspection, together with the repeatability and scalability of automated inspection equipment. The system allows some of the flexibility of a ‘human-like inspection’ including the capability to rotate and tilt the containers as they are being inspected, allowing for new inspection possibilities.”
With standard vision inspection machines, there may be different format parts to accommodate an array of products, but with the VRU, the robotic gripper means the setup time passing from one format to another is greatly reduced. Its no glass-to-glass inspection process significantly mitigates the likelihood of product damage or breakage for fragile containers.
Flexibility is a key benefit of the machine. Whether the end user is a brand owner or contract manufacturer, they are likely to be processing very small batches (some thousands per year) or personalized batches based on a patient’s own cells, where a product may have different attributes—such as varying viscosity—depending on the patient and treatment.
This is where AI technology comes in; the VRU is able to improve its inspection performance as data is collected. The unit can quickly react to changing product characteristics—including active ingredient variations, differing fill levels, and different containers—even throughout a single batch.
It is also adaptive, exhibiting continuous learning from both production and operator stimuli. It learns to look at the necessary part of the image and isolate the defect. The result is an improvement in the reduction in both costly false rejects and, even more important, false positives. In one trial focusing on reducing the False Rejection Rate (FRR) due to bubbles misclassified as particles, the inspection system viewed 30,000 product images and the false reject rate dropped to 0.21%.
The VRU’s island design, for which there is a patent pending, comprises a versatile “plug & play” concept with a freely configurable infeed and outfeed. It is also scalable, so multiple vision inspection units can be added to increase throughput as needs dictate.
Check out the many packaging solutions featured by the Stevanato Group at their PACK EXPO Connects Virtual Showroom, found at PE.show/527.
Intelligent technologies At Syntegon’s PACK EXPO Connects showroom, the latest intelligent and efficient technologies were being featured, including advanced customer services and a variety of digital solutions.
An especially timely feature in the showroom was a suitable solution for the use of Syntegon’s SVP process system for the production of potential COVID-19 vaccines. The equipment from the modular construction kit is available for delivery within a short time and can be ramped-up immediately.
Solutions for Syntegon liquid pharmaceutical filling systems ranged from small and micro batch sizes to high-performance machines including the MLD cartridge filling equipment. Combined with more than 25 years of experience in isolator technology, Syntegon offers everything from a single source, including bio-decontamination and air-handling technology as well as the qualification and validation.
This line competence is rounded off by advanced inspection technology, like Syntegon’s AIM 3000 series, which utilizes high-resolution CMOS cameras with high-speed interfaces to detect particles and cosmetic container defect, while an optional module offers 100% Container Closure Integrity Testing (CCIT).
When it comes to Oral Solid Dosage forms, Syntegon showed the TPR 500 tablet press, which combines high productivity and quality with usability. Its hygienic design reduces maintenance and cleaning requirements and offers fast and easy changeovers.
Syntegon’s medical device packaging solution handles products safely thanks to the integrated Fanuc robot arm. The products are protected by locked guards until they are fed into the Pack 202 flow wrapper.
Syntegon also presented the remote service assistant – a hands-free solution that enables remotely located experts to guide maintenance technicians using augmented reality (6).
Check out the many packaging solutions featured by Syntegon at their PACK EXPO Connects Virtual Showroom, found at PE.show/307.
Line for pharmaceutical powder sachets On show at PACK EXPO Connects was Universal Pack’s Synthesis Theta AR (7). The back story is that a multinational pharmaceutical company sought a complete packaging line to produce four-side-seal sachets of laxative powder and automatically insert them into pre-glued cartons. It was key that the line allow maximum production flexibility, high output, and compliance with pharmaceutical market requirements, while maintaining a compact footprint.
Image #7 in the article text.The company selected a four-side-seal Theta machine from Universal Pack due to speed and compact size—the vertical machine model can reach horizontal machine outputs, while reducing footprint and maintaining flexibility.
Beyond output, the company selected the Theta machine for sachet integrity and aesthetics. Seal integrity is enhanced by a new horizontal sealing concept and a liquid cooling system for sealing parts, which help avoid film and product stress during dosing.
For high precision with pharmaceutical powders, the packaging line was equipped with a multi-lane checkweigher whose load cells have direct feedback to the single lanes of the dosing unit. There is also a station for manual reintegration of rejected sachets. The extractable dosing system can be placed at ergonomic height to facilitate cleaning operations and format changes.
The Theta line offers companies flexibility in both sachet and carton size, making it well-suited to contract manufacturers and brand owners managing several production batches. With the goal of simplifying operations, the system features toolless adjustments and format changes.
The machine was released previously, but the complete line for the laxative powders is a new innovation. As Alex Leardini, Marketing Executive at Universal Pack, explained, “The real innovation is the R80 Counting and Stacking Unit. We usually package sachets using intermittent motion, and this is our first unit designed for continuous motion.”
The line features four modules: • Theta Sachet Machine
• R80 Counting and Stacking Unit
• SC80 Seamless Transfer Unit
• Cartoning Machine
The system can compact the stacks of sachets before transferring them to the cartoning machine—this process allows for greater stability and enables the company to insert more sachets into each carton. Next is the SC80 Seamless Transfer Unit. “The robot can independently move depending on the rhythm of the machine and the counting and stacking unit, for seamless transfer that maintains the speed and the output of the complete line. At the end we have a Universal Pack continuous motion cartoning machine,” said Leardini.
For the laxative powder line, Universal Pack provided a customized assistance and maintenance plan, including training, on-site and remote assistance, and predictive maintenance. Installation of the system depended heavily on remote assistance.
The turnkey line means the pharmaceutical company eliminated concerns over integrating components from multiple equipment suppliers. Leardini said that controls and motors are supplied by Allen Bradly, and all other components are produced in house by Universal. “This is important to us and allows us to be very flexible during development.”
Check out the many packaging solutions featured by Universal Pack at their PACK EXPO Connects Virtual Showroom, found at PE.show/492.
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