Hallie Forcinio is packing editor for Pharmaceutical Technology and Pharmaceutical Technology Europe, editorhal@sbcglobal.net.

Hallie Forcinio

Temperature-sensitive pharmaceuticals and biologics depend on a variety of services and technologies to establish, maintain, and verify proper storage and transport conditions. 

 lists temperature ranges for frozen, refrigerated, and controlled-room-temperature (CRT) products. With regulations evolving regarding thermal protection of these products, proof of compliance is gaining attention. Fortunately, it is becoming easier to automate data collection, analysis, and compliance reporting for controlled-temperature shipping and storage. In addition, solutions increasingly offer sustainability attributes such as reusability, recyclability, or derivation from renewable materials.


Protecting temperature-sensitive products from point of manufacture to point of use typically involves integration of hardware such as insulated shippers and data loggers with software for management, data collection, analysis, and proof of compliance. Clinical Reference Laboratory, a provider of testing services for clinical trials, molecular diagnostics, and toxicology, relies on hardware and software from Cryoport for a major clinical trial being conducted in four European countries. Dry-vapor, liquid nitrogen shipping protects patient samples while a web-based logistics management portal tracks and documents all shipments.

Another option for clinical trials, the reusable BioCarrier courier transit case from Intelsius shown in 

, is specifically designed for local courier routes, multiple site sample collection, and “home visit” injectable transport. A rugged polymer outer with expanded polypropylene (EPP) liner maintains payloads at 2-8 C for more than 12 h (up to 18 h with dry ice). A clasp closure secures the lid, and cases can be stacked and locked together. All three sizes are regulatory compliant with preprinted UN3373 labels for the shipment of Category B biological samples. 

For greater distances and longer travel times, Intelsius offers its next generation ORCA 2.0 controlled-temperature shipper. It thermally protects the payload for at least 170 h. Like many temperature-controlled shippers, it relies on advanced phase change material (PCM) that extends the protective period in extreme hot or cold environments with simple preconditioning. A variety of PCM panel configurations increases the range of shipments served and reduces costs. To help optimize container configuration, ATMOS analytical thermal modeling software, also from Intelsius, quickly assesses the suitability of a design for the intended route and payload. 

To simplify specification, a number of suppliers have begun to offer prequalified temperature-controlled shippers. One recent introduction, the Aeris series from Sonoco ThermoSafe, maintains its payload at 2-8 ºC for at least 54 h. The shippers are developed specifically to address the European Union’s good distribution practice (GDP) guidelines, which took effect on Sept. 8, 2013 (1). Four sizes, ranging from 2.5 to 24 L, are optimized to minimize the number of components and shipping weight. The configurations simplify and expedite assembly and lower total cost of ownership.

Sonoco ThermoSafe also offers options for CRT shipments. “A regulatory focus on strict compliance to storage temperature limits has increased the demand for CRT shipping solutions,” explained Russell Grissett, vice-president, Sonoco ThermoSafe (2). To address this emerging market need, Sonoco Thermosafe designed the Certis Silver Universal CRT series. The expanded polystyrene (EPS) foam containers and PureTemp PCM reportedly maintain pharmaceuticals and biologics at 15-25 C for up to four days (for an 11-L payload), regardless of the season.

A Passive Vaccine Storage Device, designed to deliver vaccines in undeveloped areas, combines insulation technologies developed for space exploration and storage of cryogenic fluids with ice and data logging to overcome poor infrastructure and unreliable power supplies (see 

). Invented by Global Good, a collaboration between Intellectual Ventures and Microsoft founder Bill Gates to invent technology that improves life in developing countries, the system maintains 300 doses at the required temperature for more than 30 days. Vials can be retrieved as needed without jeopardizing the remainder, and the chamber can be restocked and redeployed in the field. An onboard data logger monitors location, internal temperature, and the number of times vaccines have been removed. These data can be communicated via daily text messages and downloaded via a USB port to help plan future vaccination campaigns. 

The super-insulated device successfully completed field trials in Senegal in 2013 and will undergo additional field testing in Africa before broader manufacturing and distribution in 2014. Under an agreement announced in July 2013, AUCMA, a refrigeration company based in Qingdao, China, will manufacture and distribute the device to strengthen the vaccine supply chain in underserved regions. 


To reduce waste, Fairview Pharmacy Services has switched from EPS coolers to insulated shippers made of biodegradable, cornstarch-based Green Cell Foam material. The conversion to the compostable shipper from StarchTech will keep about 44,000 EPS coolers out of landfills in 2013. Because EPS is rarely included in curbside recycling programs, the shipper also simplifies disposal for the estimated 12,500 patients who receive temperature-sensitive medications from the pharmacy each year. 

Enhancing the sustainability of refrigerated truck trailers, Emerald Technology Partners has launched the patent-pending Wedway refrigeration power system. The system replaces fossil fuel with kinetic power and eliminates related emissions. A WedLink temperature monitoring and management system from InTouch Technologies makes it possible to view trailer location in real time and remotely manage all refrigeration and mechanical systems from any computer or mobile device equipped with an Internet connection.


It’s not enough to establish and maintain frozen, refrigerated, or CRT conditions; data must be collected to confirm parameters were met or provide a warning that a deviation occurred so a decision can be made about the viability of the product. Wireless devices are gaining popularity for this task. 

One example, the Automated Temperature Monitoring System (ATMS) from Cargo Data Corp., relies on radio frequency (RF) technology to automate collection, retrieval, and archiving of in-transit temperature data captured by the company’s data loggers. The ATMS automatically posts the data to Cargo Data’s website, where any interested party may view and print it, so that supply-chain partners do not need to manually download or distribute temperature-recorder data. 

Another wireless device, FreshLoc SA mobile temperature monitor from FreshLoc Technologies, works with a calibrated thermometer and text or email messaging to automate documentation of conditions in storage environments and support compliance with regulatory requirements. “Many of the people we have talked to have complained about the difficulty of staying compliant with manual temperature monitoring and inventory checks but are not ready to move to a fully automated system because they only have one or two refrigerators,” explained Dick Fettig, executive vice-president of FreshLoc (3). Once deployed, the FreshLoc SA software sends a phone or email message to remind the operator to record the temperature or make the inventory date check. The operator inputs the data on a Smartphone, tablet, or personal computer and sends it in real time to a server where it can be accessed at any time. Each entry is signed with an email or text-message address for 21 CFR Part 11 compliance. The reminders reduce the chance that scheduled checks will be missed or product will experience temperature abuse and become unusable. If the reading entered is out-of-specification, the system issues an immediate alert and suggests corrective action. 

A fully automated system, the VTMS vaccine temperature monitoring system from MadgeTech, shown in 

, provides continuous, remote monitoring of sensitive products such as vaccines or pharmaceuticals in refrigerators, freezers, and coolers. The system provides the tools needed to comply with the Centers for Disease Control and Prevention (CDC) guidelines for storage and temperature monitoring of refrigerated vaccines, which stipulates accuracy of +/- 0.5 °C and specifies use of a glycol-encased, detachable probe along with a digital data logger to provide temperature-buffered readings and prevent false alarms (4). MadgeTech’s VTMS consists of an NIST traceable RFTCTemp2000A data logger equipped with two-way wireless communication plus a thermocouple and glycol bottle. A liquid crystal display on the data logger displays minimum, maximum, average, and current temperature readings. Alarms light up and sound if temperature drifts above or below the safe range. E-mail or text alerts also can be sent so action can be taken before goods are compromised. Two-way wireless technology permits remote starting, stopping, and downloading of the device. Data can be transmitted in real time to a central personal computer or downloaded periodically. Accompanying MadgeTech 4 software preserves original records and includes customizable analysis and reporting tools. 

To monitor air shipments, the wireless Sentry FlightSafe system from OnAsset Intelligence combines sensors for environmental conditions such as temperature, humidity, pressure, shock, and vibration with GPS, wireless transmitters, and analytical software to collect environmental data and track location in real time. Envirotainer is testing the Sentry FlightSafe system on its RKN e1 and RAP e2 air cargo containers, which are equipped with compressor-based cooling and electric heating. Successful tests will lead to commercialization of integrated systems and required approvals and certifications. Until now, data on shipment conditions were gathered continuously but not available for review until a container reaches specific destinations. With the patented, Federal Aviation Administration-compliant FlightSafe communications platform, the RKN e1 and RAP e2 containers transmit location, condition, and environmental information whenever the containers are on the ground. Immediate access to data provides peace of mind regarding product condition throughout transit and helps supply-chain partners take action if conditions drift out-of-specification or maintenance is needed. This knowledge also can expedite returns. 

Once fully deployed, The Sentry FlightSafe system will provide Envirotainer’s Active Container Data and Transport Evaluation services with position and sensory data for each shipment. These enhanced information services will help supply-chain partners verify supply-chain performance and confirm product quality.

UPS provides similar proactive shipment monitoring and risk management capabilities with its UPS Proactive Response Secure service. The service helps ensure temperature-sensitive shipments achieve timely arrivals at their destinations and guarantees up to the retail value, plus other costs, when unexpected events (including weather delays) occur. “This is the highest level of service we offer,” says Bill Hook, vice-president of UPS Global Healthcare Strategy (5). The 24-h/7-day service provides end-to-end visibility and is available throughout the United States and Puerto Rico and for outbound shipments to 12 countries in the European Union. Other service enhancements for temperature-controlled shipments include Next Flight Out expedited delivery from UPS Express Critical, installation of dry-ice replenishment and refrigeration infrastructure at more destination locations, and addition of UPS Proactive Response control towers in Europe and Asia.

SenseAware, a sensor-based logistics system from FedEx, uses sensors to detect temperature, light, humidity, barometric pressure, and location. The system communicates these data in near real-time so supply-chain partners can take action as needed.


As regulatory guidance and requirements evolve, so does the need for compliance reporting. However, data gathering and analysis can be cumbersome. The latest cold-chain technology platform from Dyzle BV not only automates the process, but documents the data to meet requirements outlined in the European Union’s GDP guidelines (1). 

The open, independent platform collects data from multiple sensors and monitoring systems, including proprietary and legacy devices, and provides automatic registration and interpretation of environmental parameters like temperature, humidity, carbon dioxide, and energy consumption in real time. “With one view, we provide complete end-to-end visibility of the cold chain on any Internet-enabled device, enabling automatic registration that is needed to meet the new GDP guidelines,” explains Bert Zandhuis, CEO of Dyzle (6). Another benefit of the software is its ability to organize data into dashboards customized for specific job functions. For example, the senior management dashboard might present the financial impact of any excursions in the cold chain. 

Guidelines on Good Distribution Practice of Medicinal Products for Human Use

 2013/C 68/01 (Brussels, Mar. 2013).
  2. Sonoco ThermoSafe, “Sonoco ThermoSafe Launches Certis Silver Universal CRT Design-Qualified Shippers,” Press Release, Mar. 14, 2013. 
  3. FreshLoc Technologies, “New Mobile Solution from FreshLoc Promotes Safety and Prevents Non Compliance,” Press Release, Jan. 15, 2013. 
  4.Centers for Disease Control and Prevention, “Guidelines for storage and temperature monitoring of refrigerated vaccines,” 

www.cdc.gov/vaccines/recs/storage/toolkit/toolkit-resources.pdf

, accessed Sept. 6, 2013.
  5.UPS, “UPS Launches Industry-First Service for High-Value Time- and Temperature-Sensitive Shipments,” Press Release, June 26, 2013. 
6. Dyzle BV, “Dyzle’s Latest Version of Proven Cold Chain Solution Sets the Standard for Global GDP Compliance,” Press Release, June 18, 2013.

Hallie Forcinio is Pharmaceutical Technology's packaging editor, editorhal@cs.com.

Articles

Temperature-sensitive pharmaceuticals and biologics depend on a variety of services and technologies to establish, maintain, and verify proper storage and transport conditions.

Maintaining and Verifying the Cold Chain

The counterfeit drug problem shows no signs of disappearing. In fact, since January 2012, FDA has issued warnings about fake Adderall (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate), Avastin (bevacizumab) and Altuzan (bevacizumab) (1-3). Fortunately, even as counterfeit products are discovered in marketplaces worldwide, drugmakers have added weapons to their anticounterfeiting arsenal. 

 One way to authenticate product involves a syringe label with overt and covert security features. These features include a security printing-image and a 23-digit, encrypted KeySecure code overprinted with a removable scratch field (see Figure 1). The KeySecure technology from Schreiner Medipharm is already commercial in China where Q-Med AB adopted it in 2012 to protect prefilled syringes of its Restylane gel (an injectable hyaluronic-acid-based product). 

“Our customers rely on a product that has been subjected to years of research and testing,” said Lars Carlson, head of purchasing at Q-Med, a Galderma division (4). “This makes it all the more important for us to prevent [customers] from suffering undesirable side effects and health problems by counterfeit products.”  

For further quality assurance and documentation, a barcode referencing the security code is integrated into the label. In addition, a customized adhesive and security slits in the substrate make it impossible to remove the label without destroying it. 

To authenticate the product, the doctor or therapist exposes the encrypted code by scratching off the overprinted ink with a coin or fingernail, dialing the phone number on the label, and entering the security code on the phone’s keypad or touch screen. Confirmation of authenticity is almost immediate. “The KeySecure tracing system allows products to be tracked anywhere in the world…web-based queries are possible too,” said Gene Dul, president of Schreiner MediPharm US (4). The telephonic code queries not only authenticate product, but also provide Q-Med with data about user behavior and alerts about potential threats, such as a rising number of false codes received from a particular region. 

Another authentication technology applies microparticle barcodes to solid dosage forms using inert silicon dioxide, which is a commonly used excipient with GRAS (generally recognized as safe) status from FDA. Invisible to the eye, the barcode, developed by TruTag Technologies, is readable via a Portable Authentication Reader, also from TruTag. The scannability enables both verification and product tracking at the dosage level and can reveal product information such as dosage strength, batch number, site of manufacture, and expiration date.

Another barcode technology combines widely used logistic symbols, such as a two-dimensional GS1-DataMatrix or QR code, with polymorphic, nonmathematical technology from Six Degrees Counterfeit Prevention. Common readers and SmartPhones read the hybrid barcode to obtain item identity, serial number, lot number, and expiration date. The encryption technology is impervious to cryptanalysis and other attacks and enables authentication without referring to a database. Since the code can only be authenticated once, any copies on counterfeit product would raise an alert. In addition, the unique encryption prevents counterfeiters from reverse engineering the algorithm and producing new codes. “Six Degrees Counterfeit Prevention will enable mass serialization for the pharmaceutical, biotech, and medical device industries; ensure brand protection and prevent counterfeiting, providing end-to-end e-pedigree, recall control, and ensure hack-proof security for all data without requiring special hardware or readers,” said Reid Graves, senior pharmaceutical advisor at Six Degrees (5). 

Other labeling technologies also can thwart counterfeiting. Thinfilm Memory electronic labels from Thin Film Electronics ASA provide an electronic signature that is virtually impossible to replicate. A handheld reader tests the label and verifies the product’s authenticity. Customized signals can be dedicated to a specific product line or manufacturer. On the packaging line, the Thinfilm Memory labels handle just like conventional labels. 

Randomly placed micro- and nano-particles create a unique fingerprint on tamper-evident labels applied to product packaging. The nonClonableID technology from Bilcare Research (see Figure 2) cannot be copied and provides instant authentication, as well as secure track-and-trace and e-pedigree data. Authentication occurs in seconds through a commercially available reader that checks a scanned fingerprint against an online database. Confirmation information also can be sent to a SmartPhone.

FDA, “FDA warns consumers about counterfeit version of Teva’s Adderall,” Press Release, May 29, 2012. 

FDA, “Avastin (bevacizumab): Counterfeit Product - FDA Issues Letters to 19 Medical Practices,” Safety Alerts for Human Medical Products, Feb. 14, 2012.  

FDA, “Altuzan (bevacizumab): Counterfeit Product - Contains no Active Ingredient,” Safety Alerts for Human Medical Products, April 3, 2012.

Schreiner MediPharm, "Q-Med and Schreiner MediPharm Partner to Secure Medical-cosmetic Products in China through Telephonic Authentication," Press Release, June 13, 2013. 

Six Degrees Counterfeit Prevention, "Six Degrees Counterfeit Prevention Announces Release of Revolutionary Hybrid Barcode," Press Release, Oct. 4, 2012. 

Hallie Forcinio is Pharmaceutical Technology's packaging editor, 

New weapons in the anticounterfeiting arsenal include authentication and labeling technologies.

New Tools Fight Counterfeiting

Packaging and packaging equipment displayed at INTERPHEX (April 23-25, 2013 at the Javits Center in New York, NY) play a significant role in protecting product quality and patient safety. 


To prevent injuries and deaths related to unintentional ingestion or accidental overdose of children’s liquid medicines, the DoseGuard Valved Bottle Adapter System from Comar allows access to the product only when a specially modified oral syringe (also from Comar) is connected to the container. Inserting the syringe until it clicks into place opens a valve in the vented adaptor, thus allowing the proper dose to be withdrawn. When the syringe is removed, the valve closes, which prevents leaks, evaporation, and contamination. Four interlocking ridges on the recessed adaptor prevent it from being pulled out or pushed into the container. Comar molds medical-grade low-density polyethylene (LDPE) and slits the friction-fit component in one operation. Standard diameter is 20 mm. The valve-opening oral syringe may be ordered in 0.5, 1, 3, 5, 10, and 20-mL sizes. 

The new Shaker Single-Dose System from Bormioli Rocco keeps sensitive ingredients separate until it is time to mix a dose. The polyethylene terephthalate (PET) bottle holds the liquid. A medium-density PE plug contains powder ingredients and resides in a high-density PE cap with a polypropylene plunger. For moisture-sensitive ingredients, a desiccant can be incorporated. Turning the cap breaks a tamper-evident band and activates the plunger, which has a cutting edge to release the dry ingredients. Shaking the container mixes the dry and liquid ingredients. After opening, the plunger and plug remain in the cap. A Bormioli Roco partner in Kansas fills the liquid and powder ingredients and assembles the finished package. Containers are available in amber in sizes from 25 to 60 mL. Active ingredient capacities include 0.334, 0.660, and 1.0 cc.

Quality assurance, a perennial concern of pharmaceutical manufacturers, encompasses many technologies, including checkweighing. The SSV checkweigher, a compact unit from Anritsu Industrial Solutions USA, a first-time INTERPHEX exhibitor headquartered in Japan, can be integrated with a metal detector to provide dual functionality. At less than 1 m in length, the combination unit often fits in the space occupied by a metal detector alone. A range of SSV models address different weight ranges and aperture sizes and perform with an accuracy of +/- 0.01 g. The model SSV 6412 BP60 features an aperture with a usable product pass-through height of 180 mm. 

Another compact design, the SL-M-FS checkweigher from Wipotec, separates the weigh cell from the electronics with a 3-m cable. As a result, the unit occupies a footprint smaller than most laptop computers. The checkweigher comes in five models covering weights from 20 to 1000 g and features a washdown option. Operating on electromagnetic force restoration technology, the self-damping units minimize measuring time and maximize resolution. Potential applications include filling and packaging machines, multitrack weighing systems, in-process control, and cleaning in place. 

INTERPHEX returns to the Javits Center in 2014 (March 18-20). Meanwhile, an opportunity to view pharmaceutical packaging innovations will occur at PACK EXPO Las Vegas (September 23-25, 2013, at the Las Vegas, Nevada Convention Center) where a portion of the show floor is dedicated to a Pharmaceutical Pavilion.

Containers, components, and quality control equipment help safeguard product quality and patient safety.

INTERPHEX Introduces Packaging Safety and Quality Innovations

Packaging machines displayed at INTERPHEX (April 23-25, 2013, at the Javits Center in New York, NY) rely on advanced technology to handle solid-dosage forms or parenteral products. 

Packaging equipment for solid-dosage forms tends to be integrated. BellatRx, for example, displayed a compact Packaging Cell designed to handle batches of less than 50,000 units. The flexible system consists of a container infeed turntable, infeed conveyor, counter, desiccant inserter, cotton inserter, and capper. A low-level vibratory bowl presents caps to the capper and can be equipped with an elevator for replenishment (see Figure 1). The Packaging Cell also may include an induction sealer, retorquer, bander, labeler, inspection modules and outfeed turntable. Rated at 60 bottles per minute, the cell can run up to 100 bottles per minute with the addition of a feedscrew. It also can be configured to handle liquids or powders. 

Expanded functionality also is commonplace as demonstrated by the US introduction of the MV-11 Outsert System from G&K–Vijuk International. A patented, three-knife process increases insert size to 266 panels in response to regulatory requirements for more product and patient information. Operating at 14,000 cycles per hour, the unit folds printed sheets measuring 40 x 20 inches into 1 1/8 x 1 1/8-inch outserts. 

  Compact, integrated systems also rule parenteral-product packaging. One example, the Da Vinci Loading/Unloading System from IMA Life North America, moves groups of vials in and out of lyophilization chambers using a battery-powered gear box and caterpillar drive system that recharges when parked (see Figure 2). An aluminum track and belt made of a material with a low coefficient of friction minimizes wear and particulate generation, enabling the unit to function in a Grade A (Class 100) cleanroom environment and move up to 600 vials per minute. Eliminating the actuating mechanisms usually found on the front and back of the machine shrinks the space required for loading and unloading and improves operator access. Patent-pending wireless communication eliminates cables between battery and programmable logic controller and further simplifies the design of the machine. Laser technology precisely controls positioning.  

Many aseptic filling lines begin with washing. The GW24 Batch Washer from Cozzoli Machine cleans ampules and vials ranging from 1 to 500 mL with 180 

F water for injection (WFI) and jets of air. A programmable logic controller stores nine wash recipes with up to 18 steps each. 

For low-volume and start-up applications, the RW-250 Vial Washer from PennTech Machinery operates the same way as its rotary RW-500 except the operator pushes vials into the cassette manually. Containers ranging from 1 to 100 mL are inverted to clean with WFI and sterile air and reoriented to exit the machine. Dwell times can be set as needed, and maximum output is 100 vials per minute. 

A compact monoblock system from Chase-Logeman includes modules to fill, insert droppers, torque, label, and apply date and lot codes. The rotary, 12-station unit fills containers ranging from microtubes to 4-ounce bottles at rates of up to 60 per minute. A checkweighing option tares the container and weighs it again after filling. Peristaltic pump or other filling technologies can be specified. Other options include a disposable fluid pathway and disposable filling needles. 

The all-electric ASEP-TECH Model 628 machine from Weiler Engineering blows, fills, and seals containers ranging from 0.5 to 500 mL. Standard features include a patented, electronically controlled fill system, automatic sterilization system with integral data collection, and filter integrity test system. A HEPA air shower maintains a Class 100 environment in the nozzle shroud area. A two-piece stepped base simplifies maintenance and product discharge.  

Solid-dosage forms and parenteral products benefit from next-generation packaging machines.

INTERPHEX Showcases Machine Innovations

Integrated serialization systems topped the agenda of many exhibitors and attendees at this year’s INTERPHEX show (Apr. 23&ndash25, 2012, at the Javits Center in New York City). With California’s 2015 e-pedigree deadline rapidly approaching, serialization technology providers presented integrated solutions and emphasized retrofit capabilities. Serialization and collection of code data at each stop in the supply chain serve as the foundation of pedigree records. 

Serialization depends on a complex interaction between packaging line hardware and software to apply a unique code at the item level; confirm code quality and correctness; aggregate code data and label bundles, cases, and pallets; communicate with line-, plant- and enterprise-level software; handle manual operations and rework; and decommission codes on rejected packs. 

Seidenader Maschinenbau GmbH displayed its T&TSolutions hardware and software integrated into a serialization-capable line from primary-container marking to pallet-label generation. 

Mettler-Toledo ran demonstrations on a line capable of handling up to 400 packs per minute. The integrated line consists of the DataMatrix Station (DMS) XMV marking and verification system, the Advanced Bundle Station, and the Shipping Case Station, plus a manual pallet-labeling station (see Figure 1). For less automated lines, there is provision for a manual case station. Pilot Line Manager software manages the serialization function from the operator interface on one machine (including code printing, verification, and aggregation). The software also typically communicates with the Pilot Site Manager software, which oversees multiple packaging lines and transmits serialization data to the enterprise system. Another function is grading the quality of the serialized human-readable information and DataMatrix codes. If print quality does not meet specifications or the code itself is incorrect, the pack is rejected.

Serialization can generate valuable data beyond the information needed to track and trace product through the supply chain. For example, the Integrated Bottle Center from Uhlmann Packaging Systems LP embeds production and quality details, such as cap torque and number of desiccants, in the serialized code on each container.  

Other serialization news at INTERPHEX included the US introduction of the Traceable Quality System from OCS Checkweighers. This modular system provides single-point control, sends code data to the printer and camera at the same time, and includes Line Manager software, as well as unit- and bundle-level systems. A TQS-HC-A module combines serialization with checkweighing to ensure packaging is not only coded properly, but also complete. 

With thousands of lines in operation, implementing serialization frequently depends on retrofits. To meet this need, MG America has engineered coding and verification modules, which can be added to cartoners, bundlers, and case packers already in the field. The hardware- and software-agnostic technology makes it possible to configure systems with the coding, vision system, or serialization software options preferred by the end user. 

Retrofits also are supported by a turnkey serialization solution from Acsis. Serialization in a Box consists of Acsis Site Management and Line Management Software, printers from Domino North America, and vision components from Cognex. 

Moving beyond the packaging line to the warehouse, Optel Vision relies on track-and- trace technology from ROC IT Solutions to handle rework and shipping of serialized products. Working in conjunction with Optel’s TrackSafe platform, the ROC IT Track & Trace hardware and software prints, applies, captures, verifies, aggregates, decommissions, and submits serial numbers on products being shipped. 

A case-packing cell that supports serialization for track-and-trace requirements integrates the TaskMate Robotic Case Erector/Loader from ESS Technologies with the Xyntek-Antares Turn-key Serialization solution from Xyntek. Although shown with a FANUC LR Mate 200iC/5L multi-axis robot with ESS-designed end-of-arm tooling, the case packer can be built with other robot models to meet payload needs. During the show floor demonstration, bottles were conveyed through the Xyntek-Antares Omnivision 360° Bottle Tracking System, which captured and aggregated codes on the label and base of the container. The robot picked up a four-by-three collated group of 12 bottles. Before placing the bottles in the case, a high-resolution smart camera from Cognex read the codes on the bottom of the bottles and the Xyntek-Antares Tracking System software confirmed the serial numbers and printed a case label. The robot then pushed the loaded case onto an exit conveyor for manual or automatic sealing. Capable of handling up to five cases per minute, the system provides an alternative to manual case packing. 

Another serialization-ready machine and a first-time exhibitor, the entry-level Compact 4 Vertical End Load Cartoner from ADCO prints and inspects DataMatrix codes on tablock or glued cartons and verifies the code on any leaflet. Light-curtain guarding and automatic indexing help operators manually load products and/or leaflets at speeds of up to 40 cartons per minute. However, loading can be automated if higher throughput is needed. A patented eight-pocket, quick-size-adjust starwheel and quick-adjust levers and scales expedite changeover. Other features include stainless-steel construction and standard or washdown configurations. Carton sizes range from a 25 x 18-mm (1 x 0.71-inch) opening with a 60-mm (2.36-inches) depth to a 120 x 90-mm (4.72 x 4.54-inch) opening with a 180-mm (7.09-inch) depth. 

INTERPHEX is always a great place to see packaging innovations. Next year the show returns to Javits Center in Manhattan, but is scheduled a bit earlier than in recent years, March 18-20, 2014. In the interim, the Pharmaceutical Pavilion at PACK EXPO Las Vegas (Sept. 23–25, 2013 at the Las Vegas, Nevada Convention Center) provides an opportunity to address packaging needs.

Integrated serialization systems keep pace with industry demand.

INTERPHEX Highlights Serialization

Avive’s personalized, multi-medication 30-day dosing system won the 2012 Compliance Package of the Year award in an annual competition organized by the Healthcare Compliance Packaging Council (HCPC). HCPC also recognized a pharmacy seal pack from Information Mediary Corp. as first runner-up, and a 30-day dose pack from Eli Lilly as second runner-up. Awards were presented at the association’s RxAdherence 2013 meeting, on March 12, 2013, in Florham Park, New Jersey.

The winning Avive package was developed by MWV Healthcare and LTCPCMS, its pharmacy innovation partner, with input from patients and pharmacists.  Each Avive package features a month’s supply of prefilled medication packets, labeled with medication names and dosing instructions. The container also holds patient education information. The Avive service is designed to increase medication adherence and consumer convenience, allow more time for pharmacist–customer counseling, and reduce medication errors.

The Avive system synchronizes a person’s medications, so all prescriptions are picked up on the same day each month from one pharmacy. The system also creates a customized regimen, which consolidates dosing times consistent with universal medication schedules and aligns with the consumer’s daily habits. A central-fill location dispenses medications via a robotic system and pharmacist oversight. At the local pharmacy, the pharmacist makes a final inspection prior to pickup. 

The multi-medication packaging format delighted the judging panel. One judge noted the Avive dosing system “truly brings us to a personalized medication approach.” Another judge commented that the dosing system “…seems to be tailor-made for elderly patients, who often have multiple drugs to take, while assisting them in maintaining compliance.” 

The first runner-up in the competition, the Med-ic 21 Dose Multi-Med Pharmacy Seal Pack from Information Mediary Corp., was initially developed for a study to monitor Hepatitis C. The package provides large blisters for multiple dosages, is easily filled at the pharmacy, and can be heat- or cold-sealed. An electronic content monitor (ECM) and grid hidden inside the paperboard records when the patient breaks through the package. This information is stored on the ECM tag and can be read when the empty package is returned to the pharmacy. It also can be read via Smartphone, near-field communication terminal, or radio-frequency identification reader.

One judge commented, “This package is quite unique—especially with a way to transmit information about adherence to the pharmacist straight from the packaging. The ECM tag is a great feature that does not require a patient report of behavior….The blister packs are easy to push through, which is good for individuals with arthritis. This can allow pharmacies to send a reminder call or text and interact with the patient to figure out ways to improve adherence. This design also allows for pharmacists to package multiple medications per day in one blister pack for the patient.”

Second runner-up honors were earned by a MWV Dosepak for an Eli Lilly Strattera Physician Sample, copacked by AndersonBrecon. Eli Lilly Strattera treats attention-deficit/hyperactivity disorder in children, teens, and adults and is prescribed (based on the weight of the patient) in a titrating regimen to reach the target dose. The 30-day Strattera Physician Sample Dosepak features a color-coded, calendarized format that identifies the starting dose of 18 mg for the first five days of therapy and progresses to 25 mg for the second five days, 40 mg for the third five days, and 60 mg for the remaining 15 days. Other versions present 10/18/25/40 mg or 25/40/60/80 mg regimens. 

To further support patient compliance, the Strattera design incorporates dosing instructions that include tips to avoid side effects. The pack also directs patients to a supporting website for further information and possible discounts. A patient medication guide is included in the cover panel of the Dosepak sleeve.

“This package is ideal for individuals beginning a new medication regimen,” noted one judge, adding, “The color-coded sections for each increasing titration of medication helps the patient know what they are taking and also be able to pinpoint side effects to specific dosages. The opening design is great for preventing medication overdose and child resistance. Additional pluses are the easy-to-read instructions included on the inside panel.”


An annual Healthcare Compliance Packaging Council competition recognizes innovative pharmaceutical packages designed to improve patient adherence.