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

Hallie Forcinio

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.

Articles

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.

Beyond Reusability in Cold-Chain Shippers

Sustainability concerns rank high with biopharma companies. According to the 2020 Biopharma Cold Chain Logistics Sustainability Survey by Pelican BioThermal (now known globally as Peli BioThermal), the biopharma industry is increasing its pace to prioritize sustainability in business and operational strategies. Nearly half of all respondents say that they always factor sustainability into cold-chain purchasing decisions, and 53% indicate that it’s very important to choose cold-chain packaging options that advance their organization’s sustainability profile. According to the survey, attributes that address sustainability needs include recyclability, weight reduction, and energy-efficient designs (1).

Many pharmaceutical products must be maintained at room, refrigerated, frozen, or deep-freeze temperatures. Preventing temperature excursions during distribution depends on maintaining the product within the required temperature range for the time it is in transit. Temperature-controlled packaging (TCP), or thermal shippers, typically consist of a coolant, insulating material, and outer shell. Designs can be one-way or reusable. Both formats are growing rapidly.

Kelly Cinelli, director of Marketing at Packaging Technology Group, reports, “We are finding the demand for single-use, curbside-recyclable shippers for direct-to-patient medication is at an all-time high.” However, she adds, “Reusable shippers also are in high demand due to the COVID-19 pandemic and supply-chain constraints.” 

A study of the pharmaceutical industry by Precedence Research estimates reusable packaging constitutes 74% of the market, and demand for it is growing faster than for single-use units (2). This demand for reusables is “due to the additional protections pharmaceutical products need including more robust packaging [and] stronger temperature control as well as the need for verification of temperature using a data logger or other temperature recording device,” says Mark Sawicki, president and CEO of Cryoport Systems.

Several suppliers cite sustainability as the major reason reusables are gaining market share. Ranjeet Banerjee, CEO of Cold Chain Technologies, reports, “A lot of customers have a very clear goal around reducing their environmental footprint. Reusables go a long way toward meeting that goal.”

“One easy way to reduce carbon footprint is to reduce materials,” explains Emilio Frattaruolo, vice-president of Innovation–Passive Systems at CSafe Global. Because reusables make multiple trips, less packaging waste is generated.

Reusable TCP also can offer cost and performance benefits. Although initially more expensive than a single-use unit, “the cost per use is equal or less,” says Frattaruolo. In addition, leasing programs can eliminate the capital investment required to buy shippers. Leasing also makes it easier to accommodate market growth or seasonal variations. “Our market research indicates that reusable TCP is significantly increasing its use of rental models,” reports Sean Austerberry, group research and product development director for Softbox Systems. He notes, “10% of spending was rental in 2020, and we estimate 25% of spending will be rental in 2024.”

Despite strong interest in reusables, there is ample demand for single-use TCP. “Single-use shippers are often a cost-effective solution in situations where a return/reuse program is either impractical or impossible,” explains Banerjee.

The decision between reusable and single-use depends on the application. Questions to consider include:

How many shipments go to that destination? How often?

How long will the shipment be in transit?

What temperature conditions will be experienced?

What preconditioning of refrigeration is required?

How is the shipment monitored and tracked?

What inventory management software is available?

For reusables, what percentage will be returned?

Is the end customer prepared to play its role in the return process?

Is there sufficient space and manpower available to prepare shippers for reuse?

What is involved in preparing the shipper for reuse (i.e., cleaning, inspection, and repair)?

For single-use, are end customers agreeable to disposing of the shippers?

How easy is the disposal process and how long will it be available?

Will the shipper chosen meet current and short- to medium-term needs?

Frattaruolo recommends mapping out the supply chain as the first step in deciding between reusable and single-use shippers. It is likely to be easier to recover shippers from distribution centers or intra-company operations. “Some remote areas don’t have the infrastructure to get reusables back … or won’t be receiving shipments [frequently] enough to justify a reusable,” explains Alex Arabea, marketing manager at Lifoam Industries, a business segment and subsidiary of LifeMade Products. Single-use also makes sense for many direct-to-consumer scenarios.

During the decision-making process, “It is important to understand that a reuse approach affords pharma manufacturers the ability to utilize higher-performance, more durable packaging material than is typically used in single-use shippers,” explains AeroSafe Global CEO Jay McHarg. He adds, “And since total cost is amortized over many turns, the investment in reuse can be quite comparable to single-use alternatives. Other cost factors to consider include possible fees, from shipper recovery to refurbishment. Conversely, there are cost items that reuse eliminates or reduces, such as stickers (printing and application), warehouse space, and sometimes even usage of freezers since, in the case of AeroSafe Global, we can supply preconditioned thermal material.”

If the decision is made to adopt reusables, time will be needed to plan and implement the recovery and refurbishment process. “A reuse model only works if the shippers are retrieved,” says McHarg. Another important consideration is that the buyer of the packaging usually is not the final recipient. “As such,” he advises, “retrieval programs must be tailored to the needs of the end user—clinician or patient—in both ease and simplicity.”

In situations where retrieval is not practical logistically or economically, a hybrid solution might be the answer. Dr. Joachim Kuhn, CEO and founder of va-Q-tec, explains: “va-Q-tec’s disposable solutions are manufactured for non-return, but due to their stability, they can be qualified for reuse. For example, our lightweight box, the va-Q-one, can be used several times for temperature-controlled transports when shipped to Africa. It only has to be requalified on-site.” 

Other important considerations in the review of reusable vs. single-use shippers include timing, product value, and stability range. Thus, a single-use design can provide adequate protection for a commodity product with a wide stability range and short hold time, but a higher performance reusable TCP is likely to perform better for an expensive, sensitive product with several days to travel. 

Consider the following pros and cons for reusable shippers in pharmaceutical packaging applications.

Equal or lower cost per trip if return rate is good

Can help meet corporate sustainability goals

Often consist of higher-performing materials

Tend to be more durable and resistant to damage

Costs increase if shippers or components are not returned

More work on the front end is needed to justify and identify the impact on internal and end-user processes

Must establish a practical process for return and preparation for reuse

End customer must be willing to participate in the returns process

Can be difficult to recover from direct-to-consumer applications

Requires inventory management system to prevent traceability and tracking issues

Custom configurations take longer to develop

Standardized sizes may not suit some payloads

Doesn’t generate costs/carbon emissions associated with return and refurbishment

Potential for on-site requalification at destination

Components can be environmentally friendly

Quick scale-up because no molding or tooling is required

Frequent decision making to determine correct packout for day/origin/destination/weather

Users must consider the specifics of their application when deciding whether the best option for TCP is a single-use or reusable model.

1. Pelican BioThermal, “Pelican BioThermal Survey Reveals Biopharma Companies’ Focus on Sustainability in Cold Chain Partnerships,” Press Release, July 28, 2020

2. Precedence Research, “Pharmaceutical Temperature Controlled Packaging Solutions Market Size, Share & Trends Analysis Report by Type (Reusable Solutions and Single Use Solutions), Application (Temperature-Sensitive Pharmaceuticals, Vaccines, Others) By Region, and Segment Forecasts, 2020–2027,” Market Report, www.precedenceresearch.com/pharmaceutical-temperature-controlled-packaging-solutions-market, accessed June 30, 2021.

Manufacturers seek more sustainable options for temperature-controlled packaging. 