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

Hallie Forcinio

With the advent of COVID-19 vaccines that require ultra-cold storage, the demand for shippers with this capability has skyrocketed. One example from CSafe Global, a shipper equipped with double-wall vacuum-insulated panels, provides 10 days of protection at -70 °C and is used by BioNTech. The container can maintain the desired temperature indefinitely with the addition of dry ice as needed. Other features include a custom payload box with a built-in handle to simplify packing and unpacking of vial trays (1).

Another ultra-low temperature (ULT) shipper is being used by Pfizer for its COVID-19 vaccines. Designed by Softbox Systems to protect the vaccines through distribution to storage at point-of-use, the reusable shipper can maintain -90 °C to -60 °C for at least 10 days if unopened. High-performance insulation materials and dry ice ensure long-term ULT control. Based on current guidelines, the Softbox ULT Shipper can be opened twice a day for up to three minutes at a time. This allows clinicians at point-of-use sites to access the vaccine vials required for each day’s immunization clinics without exposing the remaining vaccine in the shipper to ambient temperatures (2).

When correctly managed and topped off with dry ice, the ULT Shipper protects vaccines for more than 30 days. Kevin Valentine, CEO of Softbox Systems, explained in a press release that the company worked with Pfizer during 2020 to develop the ULT shipper. In addition to establishing a fleet of reusable temperature-controlled parcel shippers, Softbox Systems set up two service centers to support ULT shipper refurbishment (2).

A dry-ice-free ULT option, the PC-21 shipper from Thermal Custom Packaging, maintains -21 °C. Reusable, nontoxic phase-change materials help maintain the required temperature, eliminate the need for dry ice, ice in general, or gel packs, and can make many trips. Three sizes of insulated reusable totes can transport between 350 and 2100 vaccine doses at a time (3). This same transport system with phase-change materials designed to maintain 0 °C can be used to store the Moderna vaccine for 30 days or the Pfizer vaccine for five days (4).

A recyclable/compostable cooler from Vericool also offers ULT performance. Designed to hold eight to 16 syringe doses, the shipper maintains temperatures of -70 °C (-94 °F) to -20 °C (-4 °F) for up to 96 hours (5).

Monitoring temperatures through the supply chain plays a vital role in ensuring ULT shippers are performing as expected and no temperature abuse has occurred. The iOn Xtreme Temperature Tag, a smart sensor tag from Cal/Amp, monitors temperatures as low as -270 °C and provides end-to-end supply chain visibility of pharmaceuticals, vaccines, biological materials, and liquid nitrogen. When affixed to an asset or container, the tag captures proximity location and ambient temperature readings at a user-defined logging rate, which is configurable from an intuitive user interface. A proprietary Bluetooth Low Energy signal transmits the data to CalAmp SC iOn gateway devices. The captured data is securely communicated to the Cloud in real-time from the warehouse, during transport, and from the final destination, making the information instantly available to confirm that temperature-sensitive products have been handled properly (6).

1. CSafe Global, “CSafe Global Providing Thermal Protection for COVID-19 Vaccine Shipments from BioNTech Facility,” Press Release, May 5, 2021.

2. Softbox Systems, “Softbox Successfully Supports Pfizer in the Global Cold Chain Distribution of COVID-19 Vaccines,” Press Release, March 10, 2021.

3. Thermal Custom Packaging, “As the Deadly COVID-19 Delta Variant Spreads, State Agencies, School Districts, and Major Hospital Groups Turn to Thermal Custom Packaging (TCP) Totes and Chemical Reactions to Maintain Refrigerated and Frozen Temperatures,” Press Release, Aug. 24, 2021.

4. Thermal Custom Packaging, “With Omicron Variant on the Rise, Thermal Custom Packaging (TCP) is Providing Secure Transportation of COVID Vaccine,” Press Release, Jan. 4, 2022.

5. Vericool, “Vericool Launching Vaccine Recyclable and Compostable Shipping Cooler,” Press Release, Nov. 20, 2020.

6. CalAmp, “CalAmp Releases New iOn Xtreme Temperature Tag to Monitor Pharmaceutical and Biological Shipments,” Press Release, Aug. 19, 2021. 

Articles

Protective external packaging ensures COVID-19 vaccines arrive safely. 

Sustainable Shippers for Ultra-Cold Conditions

Labeling equipment and materials continue to evolve with onboard serialization and inspection capabilities, adoption of radio frequency identification (RFID) technology, ever-improving performance and speed, and higher levels of connectivity that include remote access for troubleshooting, servicing, and training. Materials offer better performance as well as sustainability advantages.

Demand for labelers is strong for both new installations and line upgrades. “Labelers and Related Equipment” is among the top six categories of new equipment purchases for the pharmaceutical industry, according to a report published in November 2020 by PMMI, The Association for Packaging and Processing Technologies (1).

Forces driving purchases of labeling equipment include automation, growth in self-administration of medication and personalized pharmaceuticals, digitalized packaging that communicates directly to patients, the need for flexible production, and sustainability concerns (1).

According to the report, built-in connectivity is important, and remote troubleshooting is becoming a necessity. As requirements for traceability and serialization take hold, the need for efficient labeling operations grows. The report notes, “Facilities are increasingly leveraging the Internet of Things (IoT), connecting equipment with computers and devices to maximize productivity, control operations, and maintain quality. Companies are finding that they need these systems more within the serialization process, and this trend is expected to continue as more regulations get implemented and more tracking data is required throughout the supply chain” (1).

Speed, accuracy, quick changeover, and flexibility are important attributes for labelers on today’s pharmaceutical packaging lines. Designed for COVID-19 vac­cine packaging applications, the modular, servo-driven VR-72 labeler from WLS, a ProMach product brand, can run faster than 600 vials/min. The flexible, continuous-motion unit applies wraparound, pressure-sen­sitive film or paper labels to any cylindrical container and accommodates different code printing methods and inspection systems.

Products enter the labeler via a synchronized feedscrew and are held in place during label application by a vertical trunnion roller assembly for accurate, repeatable placement. A vacuum drum label dispenser holds each product at three contact points to minimize label skew. The continuous motion of the vacuum drum maintains tension on the label web to minimize web break and expand label and web material options. WLS’s patented label reconciler automatically tracks and removes out-of-tolerance labels from the vacuum drum before application. Options include redundant label heads to eliminate downtime and 

 21 Part 11 compliance with audit trail, domain authentication, and various types of data collection (2).

Maximizing speed and uptime for vaccine vial labeling is the goal behind an upgrade of the high-speed HERMA 132M HC wraparound labeler. Designed for efficiency, the wraparound labeler features digital position indicators and format sets that provide tool-less changeover and integrated control for the entire machine, including the camera and printer. The labeler now can operate continuously via retrofittable EasySplicer and EasyCutter modules, which make it possible to change or remove label and liner reels without stopping the machine and halting production, as shown in Figure 1. Considering that reels require replacement approximately every 10 minutes, the result is reduced downtime and significantly improved output.

The EasySplicer module arranges two label reels vertically, one above the other. The active label web is guided over a splicing table, where it is fixed at the end of the label web. Because the unit is equipped with a buffer, an operator can splice the new label web to the fixed web before the buffer runs out. Meanwhile, the EasyCutter module vacuums up the empty liner and chops it into shreds that are collected automatically and can be recycled. The add-on eliminates the need for manual removal of rewound backing paper (3).

As the deadline for unit-level serialization approaches, RFID is viewed as one way to carry data through the supply chain. RFID labels on vials, bottles, tubes, syringes, and devices can lock in select variable data while allowing other variable data to be updated through the life of the product. This technique simplifies inventory control and confirms product authenticity. However, applying RFID labels can be tricky. Label paths must be designed to prevent damage to tags or antennas to ensure readability for the life of the product. This challenge has been overcome, and pharmaceutical manufacturers have a growing number of equipment options so RFID labels can be adopted with minimal disruption.

For example, WLS offers three choices: RFID-Ready labelers, RFID-Enabled label application systems, and RFID-Ready print stands. RFID-Ready labelers apply pressure-sensitive labels with embedded RFID inlays. The RFID labels are read, written (encoded), locked or unlocked, verified, applied to the product, and re-verified as needed. Options include variable data printing with vision inspection, rejected label reconciliation, and rejected product removal.

RFID-Enabled label application systems consist of dual label heads that feed a single applicator. The first label head releases a standard pressure-sensitive label onto the vacuum drum while the second label head centers and releases an RFID tag onto the label, so the vacuum drum applies an integrated tag and label. Prior to being married with the label, the tags are read, written, locked or unlocked, and verified. Once applied, the RFID label can be re-verified.

RFID-Ready print stands are designed to digitally print pressure-sensitive labels embedded with RFID inlays, providing an off-line solution for incorporating RFID labels with variable data print-ing or whole-label printing. The offline, on-demand unit makes it possible to adopt RFID labeling without altering or upgrading existing labelers. The high-speed RFID-Ready print stands incorpo-rate full-label vision inspection with rejected label removal and verification and also verify the printed label and the encoded RFID tag (4).

1. PMMI, The Association for Packaging and Processing Technologies, “Pharmaceutical & Medical Devices Trends & Opportunities in Packaging Operations,” Report (November 2020).

2. WLS, “WLS Introduces VR-72 Labeler for COVID-19 Vaccine Packaging,” Press Release, Aug. 6, 2020. 

3. HERMA, “HERMA US Introduces Continuous Labeling Capabilities for Premium Pharma Wraparound Labeler,” Press Release, March 9, 2021. 

4. WLS, “WLS Introduces RFID Labeling Solutions,” Press Release, July 15, 2021.

New equipment meets needs for faster vial labeling and RFID for unit-level serialization.

Trends in Vial Labeling Equipment

Products enter the labeler via a synchronized feedscrew and are held in place during label application by a vertical trunnion roller assembly for accurate, repeatable placement. A vacuum drum label dispenser holds each product at three contact points to minimize label skew. The continuous motion of the vacuum drum maintains tension on the label web to minimize web break and expand label and web material options. WLS’s patented label reconciler automatically tracks and removes out-of-tolerance labels from the vacuum drum before application. Options include redundant label heads to eliminate downtime and US

21 Part 11 compliance with audit trail, domain authentication, and various types of data collection (2).

Maximizing speed and uptime for vaccine vial labeling is the goal behind an upgrade of the high-speed HERMA 132M HC wraparound labeler. Designed for efficiency, the wraparound labeler features digital position indicators and format sets that provide tool-less changeover and integrated control for the entire machine, including the camera and printer. The labeler now can operate continuously via retrofittable EasySplicer and EasyCutter modules, which make it possible to change or remove label and liner reels without stopping the machine and halting production, as shown in 

. Considering that reels require replacement approximately every 10 minutes, the result is reduced downtime and significantly improved output.

Figure 1. Modules on a high-speed wraparound labeler (HERMA 132M HC) make it possible to change or remove label and liner reels without halting production. Figure is courtesy of HERMA.

Digital label printing provides quick turnaround, production planning flex¬ibility, real-time variable data application, and inventory reduction, supports multilingual label printing, reduces waste, and decreases costs associated with ordering and maintaining an inventory of pre-printed labels. Digital printing can be integrated with the labeler to create a printer/applicator. An integrated system from United Automation combines an Epson ColorWorks C7500 on-demand color label printer with robotic automation. The desktop label printer/applicator prints standard matte or glossy labelstock on-demand in full color, and a high-precision robot performs feeding and application functions. The desktop system allows pharmacies to upgrade from black to color labels to highlight warnings, logos, and branding on prescription bottles (5).

“Color not only enhances safety by enabling the inclusion of photo identification, color-coded warnings, and color-highlighted information but also helps improve readability and reduce errors,” says Andrew Moore, product manager, Commercial Label Printers, Epson America.

Although targeted to pharmacies, the systems can be integrated on pharmaceutical packaging lines. “The process is very similar to our prescription labeling applications,” explains Jeff Runge, project manager, United Automation. “An on-demand, color label printing solution allows companies the flexibility to incorporate color for safety, reduce errors, and implement overall process improve-ments,” adds Moore.

The printer/applicator model with a six-axis robot offers expanded functionality: printing, loading, labeling, peel labeling, inspection, verification, and unloading. Capable of printing and applying up to 600 unique color labels/hr, the first-in/first-out flow and inspection and verification technologies ensure each bottle receives the correct label. The system is flexible enough to handle wraparound or folded labels and bottles of varying heights and diameters. Label height is adjusted dynamically based on bottle specifications, and label position is verified at two points in the cycle (5).

In many printing processes, color comes with an upcharge. However, Moore, says, “The cost of ink does not vary by color for Epson. So, there is no impact to cost, [which] makes using color even more attractive.” Durable pigment-based inks result in smudge-proof labels that can withstand exposure to gamma sterilization and chemicals such as hand sanitizers. “The [return on investment] is evident in a very short period of time,” concludes Runge.

Auxiliary equipment also must be considered. For cold-chain products like temperature-sensitive vaccines, serums, and tests, labeling can be a challenge because condensation affects adhesion. Yet conventional conditioning methods can mean hours sitting outside the freezer. An automatic vial dryer from Garvey removes condensation in as little as 15 minutes. The patented, pressure-less loop with a high-volume, laminar-flow accumulator dries lyophilized or liquid-filled vials ranging from 2 mL to 50 mL at rates up to 500/min and feeds them in single file into a labeler or inspection machine at up to 900/min. A space-saving, modular design and various infeed and outfeed options mean the system can be configured as needed (6).

With new materials and designs constantly arriving on the market, pharmaceutical manufacturers have an ever-growing array of labelstock options. To make it easier to identify the proper material, FLEXcon has organized its PHARMcal line according to application requirements, such as con-tainer diameter, cover-up capability, extreme storage conditions, tamper evidence, and secondary blood bag labeling (7).

Another application-oriented product, the Pharma-Tac Plus label for infusion bottles, 

Figure 2. A label that presents product information in various languages (Schreiner MediPharm, Pharma-Tac Plus) facilitates clinical studies. Figure courtesy of Schreiner MediPharm.

was devel-oped by Schreiner MediPharm to simplify international clinical trials. The label combines a mul-tipage booklet label with Schreiner MediPharm’s hanger label, creating ample space for compre-hensive product descriptions in multiple languages (see

). The paper booklet label firmly adheres to the base label and can be opened and reclosed via a tab. The customizable combination can be adapted to various vial and bottle sizes, and the number of booklet pages can be tailored to suit specific requirements (8).

Sustainability ranks as another important consideration, pushing the adoption of source reduction and use of recyclable, recycled-content, and/or renewable materials. Two paper-based release liners from Mondi offer a renewable material plus source reduction or recycled content. EverLiner labelite release liner is a lightweighted 47 g/m2 alternative to standard 58 g/m2 glassine. The Ever¬Liner M R release liner is said to be the first to use recycled base paper. The machine-glazed paper with 70% Forest Stewardship Council-certified recycled content reduces the amount of virgin fiber con-sumed. “Our aim is to create sustainable alternatives with no need to change the silicone system in order to offer products that are effective in usage, work for our customers, and ultimately help pro-tect the environment,” said Andrea Lackner, R&D director Release Liner at Mondi, in a press re-lease (9).

5. Epson, “Epson Partner United Automation Creates Print-and-Apply Label Applicators for Pharmacy Bottle and Bag Labeling,” Press Release, Jan. 26, 2021.

6. Garvey Corp., “Garvey’s Pharmaceutical Solutions Help COVID-19 Vaccine Makers Protect Potency, Increase Throughput,” Press Release, Jan. 29, 2021.

7. FLEXcon, “FLEXcon Announces Global Launch of New PHARMcal® Portfolio for Pharmaceutical Labeling,” Press Release, Aug. 24, 2021.

8. Schreiner MediPharm, “To Simplify International Clinical Trials, Schreiner MediPharm Equips Hanger-Label for Infusion Bottles with Booklet,” Press Release, Aug. 5, 2021. 

9. Mondi, “Mondi Expands Release Liner Range with Launch of Two New Paper-Based Sustainable Everliner Products,” Press Release, Feb. 11, 2021.


Vol. 45, No. 11
November 2021
Pages: 42–44

When referring to this article, please cite it as H. Forcinio, “Labeling Efficiently,” 

Machine and material innovations yield more efficient, sustainable processes for pharmaceutical packaging, including vaccine vials. 

Labeling Efficiently

With the pandemic remaining top-of-mind, parenteral products rank as a primary focus at INTERPHEX 2021 (October 19–21, Javits Center, New York, NY). Demonstrations throughout the show floor display fill/finish, labeling, and inspection systems for vials, cartridges, and syringes. Anticounterfeiting and serialization also garner strong interest.

To make the step up from manual filling, TurboFil Packaging Machines has introduced a benchtop syringe filling machine. Offering full control of filling parameters in single or dual operation, the TipFil unit handles up to 12 syringes/min. It can accommodate a variety of syringe sizes and fill liquid or viscous products through the tip. Infeed scenarios include hoppers and reservoirs, and an optional attachment for filling via bottles and vials. Suckback control helps heighten fill accuracy, and all product contact parts are fully disposable, single-use plastic. Filling occurs when a servo motor-driven piston mechanism draws the needle back via the plunger. The distance the plunger is pulled back dictates the amount filled. This design eliminates the need to clean a metering device and ensures precise, repeatable fill (1).

TurboFil also will display its SimpliFil syringe filling and assembly system. Suitable for small to medium batches, the unit accurately fills syringes via ceramic piston, peristaltic pump, or direct draw from a reservoir bag. Walking beam indexing provides intuitive operation and simple, recipe-based changeover. For heightened precision, TurboFil's TipFil technology allows syringes to be filled through the tip, which is a step-saving innovation eliminating the need to insert plungers post-filling. Rated at 36 syringes/min, the SimpliFil system smoothly handles syringes with tips outfitted for press-on caps and luer caps, as well as safety caps for oral syringes. An optional labeler can wrap syringes with pre-printed labels or print and apply labels for medications requiring variable marking. An automatic syringe loading system also is available, as is fill and label verification (1).

Another new filler designed for small batches, the Versynta FFP from Syntegon, features an integrated isolator. Suitable for potent pharmaceuticals, the modular and configurable system with 100% in-process control precisely fills liquid pharmaceuticals into vials, syringes, and cartridges at rates up to 60 containers/min, and it can be converted to different filling systems including single-use. The Pharma Handling Unit, a four-axis robot developed by Syntegon, safely and gently transports containers without glass-to-glass contact (2).

For combined products, Comecer and ATS have partnered to present a Comecer aseptic isolator equipped with SuperTrak Gen3 Pharma linear motion technology to handle ready-to-mix filling and assembly of combined products. The flexible system also can handle dry powders and pills as well as an array of rigid and flexible packaging formats. Linear motion offers faster speeds than walking beam or other transport systems and reduces particle generation due to minimal moving parts (3).

Labeling, printing, and inspection on show at INTERPHEX

Vial labeling is evolving to accommodate the high-speed glass vial lines producing COVID-19 vaccines and other products. The WL-1-RT wraparound labeler from MG America, the US subsidiary of Italy’s MG2, precisely applies labels at speeds of 600 vials/min. A trunnion system provides positive vial control. The machine can be integrated with thermal-transfer and laser coding and is preconfigured for onboard vision inspection with optical character recognition and verification. Non-conforming labels are rejected prior to application (4).

The AV print inspector from Antares Vision Group, a high-resolution vision system, integrates easily on new or existing labeling, printing, or packaging machines and provides 100% inspection for print-on-demand applications. According to the company, the system provides whole-label inspection at speeds up to 80 m/min and supports all major vision system tools for quality control across a wide array of layout features.

To automate parenteral product inspection, Stevanato Group has developed an artificial-intelligence-ready Vision Robot Unit. The autonomous module is capable of automatically inspecting both cosmetic and particle properties without human intervention. The robotic, human-like inspection system combines flexibility with automation efficiency to meet emerging smart factory needs and enhance control process reliability for biotech products such as monoclonal antibodies, vaccines, and lyophilized drugs (5).

For serialization needs, WIPOTEC-OCS plans to demonstrate two checkweigher-compatible traceability modules: the TQS-SP serialization unit and the TQS-CP aggregation unit. The TQS-SP serialization unit applies track-and-trace data to individual cartons and can handle up to 600 cartons/min. A specially designed, double-guided, top-band system ensures stable positioning. The TQS-CP aggregation unit provides semiautomatic aggregation of manually repacked folding cartons to provide a reliable parent-child relationship. ConfigureFast software controls all components including camera, printer, and transport system and expedites setup and changeover (6).

1. TurboFil, “At INTERPHEX NYC, TurboFil to Showcase Module for Simplified, Automated Syringe Filling and Assembly,” Press Release, Oct. 8, 2021.

2. Syntegon, “INTERPHEX 2021: Syntegon to Showcase New Laboratory and Small Batch Solutions for Solid and Liquid Pharmaceuticals,” Press Release, Sept. 23, 2021.

3. Comecer, an ATS company, “Comecer at INTERPHEX 2021 for Pharma Automation,” 

4. MG America, “At INTERPHEX NYC, MG America to Premier Precision Wraparound Labeler for Vials, and Robust 10-Lane Capsule Checkweigher,” Press Release, Oct. 8, 2021.

5. Stevanato Group, “At INTERPHEX NYC, Stevanato Group to Demo Robotic Inspection Unit, Present Modular Assembly Solutions and Recent After-sales Expansion,” Press Release, Sept. 9, 2021.

6. WIPOTEC-OCS, “At INTERPHEX NYC, WIPOTEC-OCS to Demonstrate Serialization and Aggregation Units Compatible with Its End-of-Line Checkweighing Modules,” Press Release, Sept. 22, 2021.

Back in person at the Javits Center, exhibitors present containers, components, equipment, and services to fill, ship, protect, and optimize the packaging process. 

INTERPHEX Features Pharma Packaging Innovations

Serialization plays an essential role in maintaining supply chain integrity, discouraging counterfeiting, and meeting regulatory requirements. In the United States, manufacturers are preparing for the Nov. 27, 2023 aggregation deadline to meet requirements of the Drug Supply Chain Security Act (DSCSA). “Aggregation is the process of ensuring that each unique serialized item is associated to its packaging and that packaging also includes a unique serial number,” explains Marta Schaefer, pharma account specialist at Videojet Technologies.

Europe, Asia, and Latin America have similar objectives for serialization. “It’s a global initiative,” says John Wirthlin, industry principal for Manufacturing, Transportation, and Logistics at Zebra Technologies. He adds, “The whole supply chain is affected. But the US deadlines are a little more aggressive. We are working with a couple of major pharmaceutical companies, who are looking at 10–12 months to implement a process so they will be ready 10–12 months ahead of the deadline. Global companies are looking to identify solutions and test in the US so they can finalize their process and harmonize it across the globe. The feeling is if they start here and meet US requirements, they will be able to address most requirements globally. They want a solution to be as standardized as possible so it can be rolled out to their facilities and third-party providers.” 

One third-party provider that is ready to meet aggregation requirements, Reed-Lane, started up its second track-and-trace-ready cartoning line late in 2020 (see 

). The line can serialize individual cartons and aggregate at multiple levels: cartons to cases, cartons to bundles, bundles to cases, and cases to pallets. It also can rework previously serialized items (1).

Figure 1. A cartoning line (Reed-Lane) meets track-and-trace requirements for unit-level serialization and multi-level aggregation. Figure is courtesy of Reed-Lane.

The November 2023 deadline also involves requirements for the interoperable exchange of data between entities transferring ownership of product. This system includes a secure, interoperable, electronic system between authorized trading partners through which Transaction Information (TI), such as name of the product, strength, and dosage form; National Drug Code; and Transaction Statement (TS), such as paper or electronic attestation by the business transferring ownership of the product. “In this system, for each pharmaceutical product transaction, an authorized trading partner provides TI and a TS to another authorized trading partner ‘in a secure, interoperable, electronic manner’ in accordance with standards established by guidance,” explains Steve Wood, president and CEO of Covectra.

FDA is running pilot programs involving industry standards groups such as GS1, wholesalers, and distributors. In addition, pilot programs are evaluating the use of blockchain and other communal databases. In July 2020, the Partnership for DSCSA Governance released the first version of its blueprint for the 2023 system. It focuses on interoperability standards and implementation.

Wood says, “A lot of progress has been made on the setup of the verification router service network. The focus is now on a secure way of verifying the authorized use of these systems to only allow authorized trading partners to request and respond to verification requests.”

With the US deadline for aggregation approaching, many stakeholders are creating processes and tools to improve post-serialization packaging line efficiency.

Julien Faury, solutions lead for Antares Vision Group, reports, “Everywhere we see large companies, early adopters of serialization, and contract packaging organizations upgrading their systems to meet looming aggregation mandates. Not only will this make packaging operations easier to control, but also will help supply chain partners.” However, Faury believes outside help will be needed to optimize these tools. “Many solutions are teetering on obsolescence in terms of support viability; for example, many pharma companies need to upgrade from Windows 7,” he explains. He also notes, “with trends toward switching or significantly diversifying hardware and software solutions, we need more open, transparent communication between vendors. The initiative with Open SCS [Serialization Communication Standard] is a good way to standardize such mission-critical interactions.”

With the need to upgrade initial systems that are five to 10 years old and the cost of major updates likely to be as much as a replacement, many pharma companies are identifying shortfalls and exploring the possibility of changing packaging equipment, software, and cloud serialization providers. “Amid this landscape,” Faury says, “more innovative providers are offering end-to-end coverage and digital solutions enabling value beyond compliance.”

To meet these needs, suppliers are consolidating. Systech is now part of Markem-Imaje and Antares Vision Group has made a series of acquisitions including Rfxcel and Adents to grow its cloud track-and-trace capabilities. Faury says this consolidation “will help the industry have more uniform and therefore replicable global solutions, introducing a standardization that aligns with the maturation of track-and-trace. We’re seeing more and more GS1-compliant regulation, indicative of a trend toward easier implementation and supply chain simplicity.”

Another trend is the addition of a “helper code” that is added to the bottom or top of round bottles. Schaefer explains, “When round bottles are bundled or packed into a case, helper codes allow for a vision system to easily identify the product and assign a unique serialized code to that case or bundle, which is associated with the serialized code on the bottle’s label.”

Currently, these codes tend to be applied by continuous inkjet printers. However, Videojet offers an ultraviolet (UV) laser system, which produces a high-quality permanent code on high-density polyethylene. UV laser marking creates a photochemical reaction at the surface of the material that resembles ink printing but offers higher resolution and therefore fewer false rejects and better overall equipment effectiveness. Another trend, says Schaefer, is the automation of case and pallet labeling with systems like the Videojet 9550 print-and-apply labeler.

Wirthlin reports a shift in interest from barcoding to radio frequency identification (RFID) for serialization because it offers high levels of accuracy and efficiency. Plus, tag and equipment costs have declined. “There is a big push to explore RAIN RFID,” he says. The RAIN Alliance is a global group that promotes the adoption of ultra-high frequency (UHF) RFID technology using the GS1 UHF Gen2 protocol, which ISO/IEC has standardized as 18000-63 (2). Pharmaceutical products provide a large enough target for tags to be readable at a useful distance and sufficiently high volumes for RFID to be cost-effective. If the primary container is source tagged, capturing its information offers benefits throughout the supply chain. As a result, Wirthin reports, “there is some effort to figure out how partners might share tag costs.” For example, a wholesaler saves labor time and expense if it receives tagged product and doesn’t need to do the tagging.

WLS, a ProMach product brand, also sees growing use of RFID. RFID labels can provide two points of identification per label—the chip ID plus the encoded serial number—compared to a single point of identification with a printed serial number. “RFID labels are readable without orienting the product for a direct line of sight as is needed for a printed label, facilitating tracking at the point of use,” says Peter Sarvey, director of Business Development at WLS.

With the initial serialization learning curve scaled, pharmaceutical manufacturers have more resources available and are well positioned to work with new partners and enter new markets. The serialization and aggregation technology itself also is more mature, offering capabilities that exceed industry needs.

The T60 Integrated 360 Series from Mettler-Toledo PCE reads and verifies small product or serialization codes printed directly on round containers from 10 to 110 mm in diameter or on bottle or vial labels. The compact systems integrate easily over existing conveyors. Six image sensors capture a 360-degree image, confirm the codes are machine-readable, and identify quality issues such as smears, misprints, or skew, so only authenticated product serialization is recorded in databases. Mettler-Toledo PCE Line Manager software provides preconfigured serialization and aggregation functionality (3).

Printing codes directly on bottles and vials, instead of cartons, saves time and reduces costs by minimizing the number of labeling processes and systems on the packaging line. Manufacturers may choose either the T63 Integrated 360 Serialization system or the T65 Integrated 360 Aggregation system. The T63 unit serializes directly on the applied label instead of the traditional “label-on-web.” The T65 model obtains a full 360-degree view of products on the conveyor before insertion into secondary boxes and cases, which eliminates the need for top-down printing of helper codes and the extra processing associated with it (3).

NJM, a ProMach product brand, has introduced the Bottle Tracker and the Cumulus semiautomatic case packer. The Bottle Tracker accommodates a large range of bottle sizes and shapes in a compact machine footprint. “It provides secure code association of the actual serialized code on the label with the helper code to facilitate downstream automated aggregation of bottles in bundles and/or shipper cases,” says Omar Azam, inside sales manager at NJM.

Less expensive and smaller than fully automatic case packers, the Cumulus semiautomatic case packer supports automatic aggregation of bottles in shipper cases. Its smaller footprint allows it to fit on packaging lines currently relying on manual aggregation, where space often isn’t available for a fully automatic case-packing system.

New products from WLS include the capability to print serialized codes on labels off-line on its Autonomy digital label printer, the integration of RFID tag application on some of its labelers, and the ability to match the bottle helper code to the label serialized code (i.e., commissioning) on its RL-420 rotary labeler. The off-line printing “can replace the need for serialized code printing on the labeler itself, thus simplifying line integration,” says Sarvey. Integration of RFID tag application (either prewritten or written at the labeling station) eliminates the need for a standalone commissioning station. The company also offers RFID-ready labelers for online configurations.

Label printer/applicators from Zebra have been capable of encoding RFID tags for some time but now offer expanded functionalities to accommodate mixed pallet loads. Zebra also is testing tags with a more sensitive proprietary antenna. The tests, in partnership with two major pharmaceutical companies, examined tag performance on hard-to-read products involving liquid or metal. Four products (540 cases each) were tested for readability. Wirthlin reports, “We were able to successfully read case-level RFID labels for the majority of pharma product tested under industry-controlled processes. We achieved 99% accuracy for hard-to-read product that included dry tablets, liquid vials, prefilled injectables, and foil blister packs. The cases were tagged with Zebra’s ZBR4000 inlay and loaded onto pallets. The pallets were loaded onto a truck via forklift at normal speeds and read by our Zebra Transition RFID Portal at the dock door.”

Covectra recently introduced a modular Serialization Packaging Platform, which can be located anywhere in the supply chain—manufacturer’s warehouse, contract manufacturing organization, third-party logistics provider, wholesaler, or distributor. The Serialization Packaging Platform is designed on GS1 general specifications and is extensible and modular. “The same platform can be configured for manual, semi-manual, and completely automated environments,” says Abhijeet Bhandari, Director of Software Engineering at Covectra. It also supports scenarios where existing aggregation hierarchies are reworked while maintaining data integrity.

For repackagers, Covectra has added the Atlas Repackaging System component to its Atlas Serialization Platform. It enables cost-effective relabeling of previously serialized products and rework products, and it accounts for products removed after packaging for quality-control processes. Targeted toward small and mid-size pharma companies and designed according to good manufacturing practices, the Atlas Repackaging System complies with 

CFR) 21 Part 11, GS1, and Healthcare Distribution Alliance specifications as well as DSCSA barcoding guidelines for serialized products at manufacturing or packaging operations. The agnostic system connects to commonly used printers, vision systems, and barcode scanners and provides complete reporting features on reworked or relabeled orders (4).

Noting that reconciliation remains a manual process in many organizations due to the absence of a standardized process, Bhandari believes, “exception handling and reconciliation of serialized product with the data still needs work on the packaging lines and within systems exchanging serialized data information.” The lack of these checks inevitably leads to exceptions where the physical serialized product and the data with the identifiers for those products do not match, generating “Product/No Data” or “Data/No Product” exceptions. Bhandari says, “We believe more validation checks need to take place by communicating standardized volume information along with the standard [Electronic Product Code Information Services] data formats for this purpose.”

The key to addressing the latest DSCSA requirements is digitizing and sharing information. “We need to connect partners and eliminate silos,” concludes Wirthlin.

1. Reed-Lane, “Reed-Lane Adds 2nd Carton Track & Trace Line with Aggregation Capabilities, and Expands Injectables Kitting Operations,” Press Release, Dec. 3, 2020.

2. RAIN Alliance, “RAIN RFID Technology,” 

3. Mettler-Toledo PCE, “New T60 Integrated 360 Series Reduces Cost and Complexity on Liquid Pharma Packaging Lines,” Press Release, June 28, 2021.

4. Covectra, “Covectra Enhances ATLAS Serialization Platform to Simplify the Repackaging of Pre-Serialized Products,” Press Release, June 22, 2021.

Hallie Forcinio is packaging editor for Pharmaceutical Technology, 

Vol. 45, No. 9
September 2021
Pages: 34–38

When referring to this article, please cite it as H. Forcinio, “Moving Forward with Serialization,” 

Stakeholders work to meet deadlines, maximize benefits, and close gaps. 

Moving Forward in Serialization

The pharmaceutical industry is focused on making documented, measurable strides to meet goals related to environmentally friendly business practices. “Many large pharma companies have initiatives in place to become carbon neutral in the coming decades,” notes Jay McHarg, CEO at AeroSafe Global, a supplier of cold-chain services for the biopharma industry. So, sustainable packaging is receiving a lot of attention, particularly for temperature-controlled packaging. Sought-after attributes include reusability, recyclability, and renewable content.

Many firms are looking for alternatives to expanded polystyrene (EPS), a cost-effective material that is commonly used for temperature-controlled packaging and performs well. Recycling EPS, however, poses some challenges.

Reducing carbon emissions and the amount of EPS going into landfills was the goal set by New England Biolabs, a provider of reagents for life science researchers. “Cold-chain shipping has always been a challenge from an environmental standpoint,” recalls Deana D. Martin, PhD, associate director, Marketing Communications, New England Biolabs. She explains, “Most of our products require shipment on ice, and maintaining shipping temperature conditions is critical, particularly when shipping long distances or to warmer climates.”

Martin notes, “…when we heard about the ClimaCell Cooler, we were excited to be able to implement a more environmentally-friendly solution…. The majority of our shipments now use the ClimaCell Cooler.” The paper-based ClimaCell insert, developed by TemperPack, can maintain the required temperature for the duration of the product’s transit time. After unpacking, the entire box, which is based on renewable content, is recyclable with other corrugated.

“For the minority of products that require shipment on dry ice, we are still using EPS coolers,” reports Martin. However, the EPS coolers are recycled via a program established by the company more than 40 years ago. Customers simply use the enclosed return label to return the EPS cooler to New England Biolabs for free. “We estimate that 25–30% of the EPS coolers we ship are returned,” concludes Martin.

Humana Pharmacy has taken a different approach toward EPS. It has transitioned to a molded and biodegradable EPS package for temperature-sensitive medications. Shipments began in May 2021. “The biodegradable EPS is designed to decompose more than 90% by the end of four years in most landfills,” reports Michael Taday, president of Prescription Home Delivery, Retail Pharmacy, and OTC, Humana Pharmacy. Also new are long-lasting refrigerant gel packs, which are filled with a non-toxic, biodegradable gel, which can be washed down the kitchen sink. 

Kemp Proteins, a provider of gene-to-protein and monoclonal antibody development services, has also chosen a biodegradable EPS for its cold-chain shipments, Envirocooler-EVG insulation from Lifoam Industries. Its thermal and structural properties are equivalent to traditional EPS, but a bio-based additive causes the material to break down in a bioreactive landfill without leaving microplastics. The result is an 83% reduction in packaging going to the landfill. “This simple change will result in an immediate and significant reduction of our overall environmental footprint,” said Michael Keefe, CEO of Kemp Proteins (1).

Lifoam also offers other sustainable options. Its latest innovation, Bioffex polylactic acid, is 100% bio-based; it is derived from renewable plants and contains no petroleum-based content. Compostable in industrial facilities, the material’s sustainable manufacturing process consumes up to 50% less water and less energy (due to steam reduction) than traditional EPS, thereby lowering greenhouse gas emissions (2).

Another renewable option, the EOS line of temperature-controlled packaging from Sonoco ThermoSafe is produced from 100% post-industrial, pre-consumer paper fiber. With no non-recyclable components, third-party testing has confirmed its recyclability in curbside programs (3).

Also recyclable in curbside programs, the TRUEtemp Naturals Line from Packaging Technology Group (PTG). The line’s newest member, the extra-small PTGS-515-CEL shipper, offers payload dimensions of 7x3x5 inches. Designed to handle small bulk and direct-to-patient shipments, the thermal shipper maintains 2–8 ºC for 48 hours. The same pack-out has been qualified for summer and winter, with a small change to the refrigerant material’s preconditioning. Eliminating the need to switch packouts depending on season and shipment conditions simplifies training and daily decision-making and reduces the chance of the payload experiencing temperature excursions. TRUEtemp Naturals shippers decrease waste potential by 85%, water use by 90%, fossil fuel use by 78%, and mineral resource use by 83% in comparison to a standard EPS shipper (4).

The TRUEtemp Naturals Line also includes a dual temperature shipper that allows products with different temperature requirements to travel together (e.g., one frozen and one refrigerated). The ability to dual ship reduces shipping costs and assembly training (5).

The latest product developed by va-Q-tec, the non-returnable va-Q-pal pallet shipper, uses the same technologies as its va-Q-tainer such as vacuum insulation and temperature storage elements to maintain a constant temperature inside for several days without an external power supply or refilling with dry ice. The va-Q-pal shipper “is nevertheless very light and can be used several times on-site for regional transports, even continental logistics via truck are possible several times,” says Dr. Joachim Kuhn, CEO and founder of va-Q-tec.

Suppliers of temperature-controlled packaging also are offering services related to environmental monitoring, shipment and asset tracking, and inventory management. PTG can pair its shippers with an inventory management system for full traceability and asset tracking.

A real-time sustainability metrics portal, developed by AeroSafe Global, provides access to the latest data about how much water, energy, and waste savings has resulted from adopting reusable cold-chain shippers. “As one example, a customer that migrated from single-use to reuse reduced its carbon footprint by 5%—across its enterprise,” reports McHarg. He adds, “We are also launching a cold chain control tower to provide actionable data back to customers around efficiency, delivery insights, lane analysis, and more for improved decision-making.”

In partnership with Cloudleaf, Cold Chain Technologies has launched a Smart Solutions digital platform to provide 24/7 supply chain visibility, including product location and condition, to ensure on-time delivery and maintenance of appropriate temperatures throughout the shipping process.

1. Lifoam Industries, “Kemp Proteins Selects Lifoam’s Envirocooler as Prime Packager,” Press Release, Sept. 16, 2020.

2. Lifoam Industries, “Envirocooler bioffex,” 

3. Sonoco Thermosafe, “Sonoco ThermoSafe Launches EOS Line of Curbside Recyclable Temperature Controlled Parcel Shippers,” Press Release, Nov. 5, 2020.

4. Packaging Technology Group, “Packaging Technology Group (PTG) Expands Its TRUEtemp Naturals Line with a Universal, Extra-Small 2-8 Solution,” Press Release, March 16, 2021.

5. Packaging Technology Group, “Packaging Technology Group (PTG) Expands Its Line of TRUEtemp Naturals Products with a First of Its Kind, Dual Temp Thermal Packaging Solution,” Press Release, April 23, 2020.

Consider tactics to meet sustainability objectives for temperature-controlled packaging.