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

Hallie Forcinio

Makers of parenteral products gained a new vial option with this summer’s launch of Viridian Vials by Corning. The vials serve as a drop-in replacement on fill/finish lines and combine performance and improved safety with sustainability (1), often a challenging objective for pharmaceutical manufacturers since packaging for parenteral products is likely to be incinerated and landfilled (2).

The improved sustainability profile can be attributed to a 20% reduction in glass material versus conventional glass vials, with no impact on the quality or safety of the vial. This reduction in glass material lowers manufacturing and transportation-related emissions (carbon dioxide equivalents) by up to 30% and decreases the total amount of glass entering the waste stream and ending up in the landfill (1). In addition, vials are produced using 100% renewable electricity (2).

Under development for several years, the Viridian Vial features a nanometers-thick coating, which reduces the coefficient of friction on the outer surface of the vial. It also reduces glass particulates in the fill/finish process by up to 96% (3). The proprietary polymer coating, which was developed for the company’s Valor Glass vial, introduced in 2017, ensures a low coefficient of friction before, during, and after filling to protect the vial and its contents (2). Viridian Vial’s external coating is capable of withstanding temperatures up to 360 °C and can maintain the vial’s strength during transportation, fill/finish, and delivery, helping to minimize cracks, breaks, and cosmetic rejects while substantially reducing tipovers and improving filling-line efficiency by up to 50% (1, 3). This increase in efficiency also has the potential to lower total product costs (3).

Extensive testing of the coated vial has shown the coating is robust under typical fill/finish conditions including machine-to-vial and vial-to-vial contact as well as when experiencing temperature extremes from the heat of depyrogenation to the cold of cold storage and lyophilization (4). “The tests indicate the coating remains where it is supposed to be, on the outside of the vial,” says Ron Verkleeren, senior vice president and general manager, Corning Life Sciences.

Commercial applications await FDA approval, but Verkleeren expects the approval process to move smoothly because the vials are made of Type I glass, an industry standard, and regulatory approval has been given to drugs packaged in Corning’s Valor Glass vials and Velocity Vials, which use the same external coating as Viridian Vials. “All elements of the process have been approved in one form or another,” he notes. “As a result, the regulatory approval process should be exactly the same if a customer is using Viridian Vials or a conventional Type I vial.”

The first product to use the vial could be almost any drug that is compatible with Type I glass, from a pediatric vaccine to a generic small-molecule formula. However, Verkleeren thinks a small-molecule drug is the most likely product to be first on the market in the Viridian Vial. “The validation process tends to be more straightforward for small-molecule drugs,” he explains. 

West Pharmaceutical Services serves as the exclusive distributor for Viridian Vials (1).

1. Corning. Corning’s New Viridian Vials Reduce Waste and Carbon Emissions in the Pharmaceutical Supply Chain. 

2. Forcinio, H. Phone interview with Ron Verkleeren, senior vice president and general manager, Corning Life Sciences. July 12, 2023.

3. Corning. Corning Viridian Vials. Brochure, 2023.

Articles

Corning launches a more sustainable glass vial. 

Vial Options Expand

The INTERPHEX Exhibitor Awards recognized several parenteral packaging and handling advancements at INTERPHEX 2023, which took place between April 24–26, 2023 at the Javits Center in New York, NY (1). The Best in Show award went to IMA Life North America for its INJECTA aseptic fill/finish system, which has evolved to integrate its gloveless module. Robotic technologies help achieve gloveless processing and eliminate human intervention at crucial stages of the process, such as the aseptic assembly of sterile components loaded using rapid transfer ports. The system does not lose the sterility guaranteed by the autoclave, does not come into contact with the operator, and is assembled entirely in aseptic conditions following isolator decontamination. The extensive use of robotics drastically reduces the number of manual operations, eliminating the need for productivity-sapping integrity checks and simplifying compliance with Annex 1, which views gloves and manual operations as major sources of contamination (2).

The award for Best New Product/Service went to the BoMa Dosing System from DEC Group, which recently established a Filling Solution Technologies Division. Judges selected the patented BoMa precision filling technology for its ability to precisely dose highly sensitive pharmaceutical products without the stress and shear associated with pumps and other conventional filling methods. The system harnesses the physics principles of Boyle’s Law, or pressure and volume of a gas have an inverse relationship with constant temperature, and uses a vacuum to smoothly and precisely handle tiny amounts of product and a wide range of fluid densities and viscosities (3).

A robotic innovation, the bionically-inspired, energy-free ADHESO gripping technology from Schunk, captured the Editor’s Choice award. ADHESO end effectors grip without mechanical force, external energy supply, or residue generation enabling gentle product handling and compatibility with cleanroom requirements. Modeled on Van Der Waals adhesive forces used by animals, such as geckos, for locomotion, the grippers use gentle pressure to pick and one of four release options for placing: rotary movement, tilting movement, sliding movement, or pressing. Alternatively, it is also possible to equip the gripper with an active wiper, which prevents mechanical stress on the workpiece at the placing position. Four standardized ADHESO gripper pad sizes with matching ISO flange adapter serve a wide range of applications (4).

The Ready Pack system from West Pharmaceutical Services earned the Best Technologies award. The ready-to-use sterile packaging system provides all the components needed to fill/finish sterile products, including sterilized NovaPure stoppers, Flip-OffCCS (clean, certified, sterilized) seals, and Corning Valor ready-to-use vials utilizing Stevanato Group's EZ-fill tray or nest and tray formats. Available from stock in small order quantities, Ready Pack kits are particularly well-suited for R&D purposes or small filling operations and designed to support a smooth transition from early-stage pilot manufacture to larger commercial-scale operations and accelerate speed to market (5, 6).

West Pharmaceutical Services, which is celebrating its 100th anniversary, also took home honors for two poster sessions, a Third Place for Evolving Component Technologies to Meet the Needs of Large Volume Injections and a Fifth Place for Functional Assessment of Adeno-Associated Virus Stored in Daikyo Crystal Zenith Vials at Ultra-cold Temperatures(1). 

INTERPHEX 2024 will return to the Javits Center on April 16–18, 2024 (1).

1 RX (Reed Exhibitions). Pharmaceutical Manufacturing and Biotech Industries Showcase Latest Innovations throughout INTERPHEX 2023. Press Release. May 4, 2023.

2 IMA Life. IMA Life Wins Top Prize at INTERPHEX New York 2023. 

3 Dec Group. DEC Group Wins INTERPHEX Award for BoMa Filling Solution. 

5 West Pharmaceutical Services. West's Ready Pack™ Containment Solution with Corning® Valor® RTU Vials Utilizing Stevanato Group's EZ-fill® Technology Recognized for Best Technologies Award at INTERPHEX. Press Release. May 2, 2023.

6 West Pharmaceutical Services. West Ready Pack, Product Sheet. January 2023.

Parenteral packaging and handling advancements receive awards.

INTERPHEX 2023 Honors Packaging Innovations

Pharmaceutical manufacturers strive to address many concerns including cost and lead times in the supply chain. “Speed to market remains a top priority with our clients,” says Kristin Smith, client coordinator at Sharp. Other concerns include compliance with stringent quality control requirements and delivering on sustainability commitments.

Outsourcing operations, especially packaging, addresses these priorities and generates many benefits for pharmaceutical manufacturers. As a result, 60% of pharma manufacturers outsource at least a portion of their operations to a third-party contractor, according to 

2022 Pharmaceutical Manufacturing: Trends Shaping the Future

, a report published in March 2022 by PMMI Business Intelligence, a division of PMMI, The Association for Packaging and Processing Technologies. Driving forces behind the interest in outsourcing include the rise of injectables and personalized medicine and the accelerated pace of new product development, which has strained production capabilities for pharmaceutical manufacturers (1).

Packaging is often outsourced because of its complexity. Smith at Sharp explains, “Packaging involves a degree of technical, operational/process, and design complexity, which creates the need for ‘solutions’ providers … to manage packaging as a holistic process including design, engineering, packing, serialization and aggregation, foreign-trade zone, qualified person services and release, stability, and ID testing.” In addition, outsourcing can provide “a partner who can offer a breadth of regulatory and rapid launch requirements, including global regulatory requirements for multi-market launches.”

Contract packaging services provide numerous advantages for both clinical trials and commercial medicines. Contract packagers “can offer expertise, flexibility, and efficiency, while further mitigating risk and maintaining product quality and safety,” says Justin Schroeder, global vice-president of technical sales at PCI Pharma Services.

For example, “using a contract development and manufacturing organization (CDMO) allows companies to benefit from the expertise and specialized knowledge gained through handling a wide variety of products with varying parameters, such as ultra-low temperature handling,” says Harry Lindenmuth, vice-president operations at Almac Pharma Services, who oversees the company’s Audubon, Pennsylvania, site.

Smith at Sharp agrees, noting third parties often are chosen for therapies that require more complex handling, assembly, packaging, and storage requirements (e.g., cold chain, frozen storage, or high-value small-batch drugs). In addition, contract packaging organizations maintain a broad network of suppliers, including those who will collaborate on sustainable packaging efforts.

Reduced costs are a major benefit of outsourcing because manufacturers don’t need to purchase, install, and validate new equipment and lines, thereby freeing up capital and personnel for use elsewhere in the operation (1). Eliminating the need to invest in packaging equipment, labor, materials, and floorspace allows pharma and biotech companies to focus on their core competencies (drug development and manufacturing). This not only lowers costs but “also provides greater flexibility and scalability, enabling them to grow quickly and adapt easily to changes in demand,” says Lindenmuth. The outcome is improved supply chain efficiency and inventory management and reduced lead times.

Josh Goolcharan, director of sales and marketing at Reed-Lane, agrees, noting, not only are packaging activities outsourced but these partners are asked to manage the procurement of all necessary components. He says, “This allows customers to focus efforts more on marketing existing products and developing additional ones.”

Speed to market may be the biggest benefit of outsourcing pharmaceutical packaging. Outsourcing can deliver rapid launch support and/or launches in multiple markets across the globe and reduce risks by providing a deep understanding of up-to-date regulatory and compliance guidelines in multiple countries.

Outsourcing also can strengthen the supply chain and provide production redundancy. “Single sourcing is no longer a viable strategy when material and labor shortages persist in many countries,” explains Schroeder. He adds, “PCI and other CDMOs are organized and structured with flexible assets complemented by a network of locations around the globe to move quickly and operate with agility. [Service providers can also] increase speed by serving in a consultative advisory capacity, helping clients streamline their approach and avoid unnecessary steps.”

Engaging an experienced CDMO expands packaging options and enhances quality and efficiency because it provides access to knowledgeable teams, who routinely handle various types of pharmaceutical packaging. “Companies are provided with the surety that their packaging is performed correctly and consistently, and that processes, such as serialization, are performed to the highest level of compliance,” says Lindenmuth.

In short, “the right contract packaging organization can offer the experience, expertise, and technology to handle various packaging complexities,” says Smith. Wide-ranging expertise includes:

technical expertise, which accommodates a range of formats and environments such as precise vial labeling, assembly of pre-filled syringes and autoinjectors/pens, cold-chain/frozen storage, and protection for products with light/temperature/humidity sensitivities

operational expertise, which addresses speed-to-market requirements, strict quality control needs, and process efficiencies for multi-country launches, as well as scalability for growing or fluctuating volumes

design expertise, which balances functional and aesthetic design that addresses safety, end-user instructions, product sensitivities (light, temperature, humidity), and tracking and anticounterfeiting requirements.

Whatever services are provided, the manufacturer and CDMO must forge a collaborative relationship. Fully understanding the product, patients, and target markets ensures all criteria are met and the product reaches the patient on time and in the optimal format.

To meet rising demand, service providers are expanding their capabilities. For example, PCI Pharma Services has added new facilities in Bedford, New Hampshire; Bridgewater, Massachusetts; and Rockford, Illinois; to serve customers in key geographies. These expanded capabilities, which include innovative packaging and manufacturing methods, have been implemented in recognition of the need to get treatments to patients quicker than before, emphasizes Schroeder.

The company also has invested in software and expanded service offerings. Its pci | bridge digital supply chain management platform provides customers with a direct look into their systems and network of locations. “This digital supply chain management platform … gives clients access to real-time updates and information like production and order management status, inventory, batch release, global distribution, and invoicing,” says Schroeder.

PCI’s new consultative offering, SpeedSolutions, complements core manufacturing, clinical trial, and commercial packaging services. “SpeedSolutions allows PCI to shape and guide successful outcomes … by accelerating client molecules across the various phases of drug formulation and process development, analytical development, clinical trials, and ultimately, global commercial supplies,” reports Schroeder.

From its European Centre of Excellence, Almac Pharma Services offers specialized ultra-low temperature packaging that enables advanced, lifesaving medication to be packaged, labeled, and distributed in temperatures between -20 ºC and -80 ºC. “Our team works closely with clients to define … a tailored, robust, and commercially scalable process which takes into consideration the temperature requirements, allowable time out-of-condition, conditioning time requirements, final pack-out configuration, level of serialization aggregation required, temperature-controlled distribution, and global supply chain needs,” says Lindenmuth. With this capability, the CDMO has “processed and QP [qualified person]-released over 1000 batches, enabling them to be transported direct to the patient within as little as 20 hours.”

Almac Pharma Services also has invested in stick pack and sachet capabilities across all of its facilities. Installation of a triple-head dosing module has boosted capacity. “This key investment was in response to the increased demand from our clients in commercial packaging for pediatric formulations such as powders, granules, and mini-tablets,” reports Lindenmuth. Specialized packaging such as stick packs and sachets enables accurate dosing of drug products by offering pre-measured amounts, reducing over- or underdosing, and providing increased portability and convenience for patients. Sachets also can be customized with printed instructions and branding.

At Sharp, investments are focused on secondary packaging services for injectables and gene therapy. For gene therapy products, which typically involve small volumes and requirements for time- and temperature-sensitive handling, a dedicated 1000 ft2 packaging suite at its facility in Bethlehem, Pennsylvania, includes dedicated high-efficiency particulate air-filtering systems with full redundancy and an emergency power generator. Two ante-rooms at entry maintain positive pressure to ensure the cleanliness of the suite. An automated system constantly monitors temperature, humidity, and dew points and sends emergency alerts if a deviation occurs. Dedicated -80 ºC freezers also are monitored 24/7 (2).

Although Sharp specializes in secondary packaging for injectable formats, it also can provide isolator-based sterile filling and lyophilization services via its 25% stake in Berkshire Sterile Manufacturing. Semi-automated and automated, isolator-based filling lines offer the flexibility to handle syringes, cartridges, vials (either ready-to-use or bulk), and lyophilized products. On the fully automated line, robotics and multiple vision systems minimize the need for intervention by human operators (3).

Goolcharan concludes, as packaging experts, contract packagers offer cost-effective processes, the flexibility to address low- and high-volume requirements, and familiarity with multiple packaging styles (e.g., vials, pouching, bottles, blisters, carding, secondary operations, and kitting).

PMMI Business Intelligence, a division of PMMI, The Association for Packaging and Processing Technologies. 

Sharp Services. Supporting Commercial Gene Therapies–Transforming to Patient-Led Demand Model. SharpServices.com, accessed April 24, 2023.

Sharp Services. Creating Flexibility and Efficiency in Isolator-Based Filling with Robotics and Automation. SharpServices.com, accessed April 24, 2023.

When referring to this article, please cite it as Forcinio, H. Generating Benefits with Outsourced Packaging. 

Third-party contract packaging service providers can help save time and money. 

Generating Benefits with Outsourced Packaging

Whatever your product – parenteral, solid dose, inhalable, liquid, transdermal – you will find packaging innovations at INTERPHEX 2023 (April 25-27, Javits Center, New York, NY). Quality control is always strongly represented, but labelers, containers, filling lines, and systems that support traceability and sustainability also will be displayed across the show floor.

A high-speed x-ray inspection system checks pharmaceutical blister packs and pouches at speeds up to 400 ft (120 m)/min. The compact X34C x-ray inspection system from METTLER TOLEDO Product Inspection measures only 28 in (700 mm) long to occupy minimal space and simplify integration on the line. A checkweigher and combination checkweigher vision system also will be demonstrated. The Starweigh checkweigher checks the weight of small, unstable, lightweight products at up to 300 parts/min with accuracies of +/- 5 mg. The integrated CV35 checkweigher/vision system features a compact footprint, detects over- and under-filled products, and performs side, top, and bottom inspection (1).

Another inspection system, the Visual Rotating Inspection (VRI)series from Antares Vision Group, confirms closure integrity at rates up to 600/min using high-voltage, vacuum, and headspace gas analysis. It also detects cosmetic defects and particles and checks fill level. The VRI unit can inspect liquids in viscosities ranging from water-like to oily, suspension, gel, and emulsion. The system also checks crimping quality, flip-off color, neck-shoulder sidewalls, and stopper position. Optional add-on features include code verification, optical character recognition/optical character verification, and serialization (2).

A serialization-readycombination system from Wipotec integrates three functions: traceability, checkweighing, and tamper evidence/anticounterfeiting. The TQS-HC-A-TE machine offers precision weight monitoring, tamper-evident labeling, and serialization support such as in-line printing of batch or unique product identifiers, print verification, and the ability to add sensory data to a product’s unique identifier. Tamper-evident labeling systems seal folding cartons or apply additional anticounterfeiting vignettes (3).

Automated line clearance software, powered by artificial intelligence (AI), will be introduced on a machine from Marchesini Group. The system, developed by SEA Vision Group and ARGO Vision, relies on AI algorithms along with cameras and sensors to automate line clearance. Digitizing the clearing and cleaning phases and automating the checking phase prevents errors, reduces downtime, boosts product safety, and increases the line’s overall equipment effectiveness. Part of the Industry 4.0 software suite yudoo, smart clearance technology AI algorithms analyze the inspected scenes in-depth and in real-time, immediately identifying any mispositioned machine parts, foreign objects, or products passing through the unit (5).

SEA Vision also will demonstrate vision hardware and software combinations to inspect injectables. ChecKIT360 and ChecKITassembly kits can be installed on any vial or syringe filling and capping machine, as well as on syringe assembly machines. The systems can check for vial crimping defects, flip-off presence and color, stopper/cap presence and position, correct syringe assembly, and syringe label presence (4).

BellatRx has introduced the Notaris Plus pressure-sensitive labeler. The all-servo machine offers 100% speed-synchronized labeling, fast changeover, and ease of use. Capable of labeling up to 100 containers/min, the unit features integrated lot code and expiration date printing and visual inspection of labels and printing. A serialization package is available for track and trace requirements (5).

NJM, a ProMach product brand, plans to display its Courser 230 labeler. It can be configured to handle an array of containers including vials, syringes, bottles, ampules, cartridges, centrifuge tubes, auto-injectors, and other small or unstable packages. Design features include a trunnion starwheel for positive handling and a vertical label spool dispenser, which improves ergonomics and labeling accuracy. An optional thermal-transfer or laser printer can be installed to print variable data, including serialized data, on pre-printed or blank labels before application. Other options include a print inspection system, a label removal system that ensures incorrectly printed labels are reconciled on a separate web, and a label placement inspection system that identifies packages with missing labels and triggers a downstream reject device (6).

Sustainability is one of the topics at the INTERPHEX Technical Theater. The session, Sustainability Packaging and Contemporary Cartoner Design, is sponsored by Rotzinger Pharmapack.

1. METTLER TOLEDO Product Inspection. METTLER TOLEDO to Demonstrate Its Product Inspection Systems at Interphex 2023. Press Release. March 28, 2023.

2. Antares Vision Group. Antares Vision Group to Showcase Automatic Inspection Machine for Liquids in Glass Containers. Press Release. March 24, 2023.

3. Wipotec. At INTERPHEX, Wipotec to Showcase 3-in-1 System with Traceability, Tamper-Evident & Checkweigher Functionality. Press Release. March 24, 2023.

Smart Clearance Technology for the First Time in the US. Press Release. March 14, 2023.

5. BellatRx. Introducing Notaris Plus Labeler. E-Newsletter. March 2023.

6. NJM, a ProMach product brand. NJM Introduces the Enhanced Courser 230 Vial/Syringe Labeler. Press Release. Jan. 29, 2020.

7. INTERPHEX. Presenting the INTERPHEX Technical Theater. Email. March 16, 2023.

INTERPHEX Returns to NYC

The market for sustainable pharmaceutical packaging is projected to grow at a compound annual growth rate (CAGR) of 15.4% to $146.3 billion by 2027 (1). Primary packaging is forecast to register the strongest CAGR. Sustainable primary packaging materials such as eco-friendly bioplastics and biodegradable materials like paper or cellulose minimize environmental impact, reduce waste, and conserve resources. At the same time, innovative packaging designs reduce waste and carbon footprint through lightweighting and downgauging. Pharmaceutical companies also are exploring the feasibility of reducing waste by adopting reusable or refillable packaging (1).

Forces driving interest in sustainable pharmaceutical packaging include laws and regulations and a shift in consumer preferences toward recyclable and eco-friendly packaging materials (1). “Stakeholders throughout the value chain—employees, healthcare professionals, patients, policymakers, and investors—expect every business to be working toward and reporting on how they are impacting sustainability,” says Søren Tulstrup, president and CEO, Hansa Biopharma.

Lon Johnson, vice-president of Sales and Marketing at Colbert Packaging, has noticed this attitude too, especially among large pharmaceutical companies. He says, “There is a significant trend toward decarbonization and net zero goal setting, and they are encouraging supply chain participation in the effort. These North American companies are taking their cues from European counterparts who have led the charge to sustainability. We have seen an increase in supplier sustainability surveys from our customers in recent years. More and more, they are looking to work with suppliers who are committed to the same goals and vision for sustainability that they have.”

Committed suppliers are a requirement for Hansa Biopharma. Tolstrup reports, “All supplier agreements ensure that every effort is made to integrate sustainable practices into all aspects of these businesses. We work closely with our suppliers to ensure they are looking for ways to reduce waste and maximize recycling opportunities for manufacturing residuals. For instance, our supplier agreements require that partners have systems and procedures in place to safely handle waste and discharge, and to optimize the use of all relevant resources sustainably, including but not limited to, energy, water, and materials.”

Many pharmaceutical manufacturers are working toward improving the sustainability of their packaging and their operations in general. Since October 2021, when Astellas Pharma introduced a biomass-based plastic blister package in Japan for Irribow Tablet 5 µg (ramosetron hydrochloride) to treat diarrhea-predominant irritable bowel syndrome, it has expanded the use of plant-derived materials for its blister packaging. The blister package is made of polyethylene (PE) derived from sugarcane, as 50% of its raw material. A spokesperson for Astellas Pharma, reports, “This is the world’s first use of biomass plastic for blister packages for drugs. It is an environmentally friendly packaging that agrees with the concept of ‘carbon neutrality,’ which is the idea of balancing greenhouse gas emissions and absorption.” Emphasizing renewability rather than recyclability provides a blister package that can contribute to a reduction in greenhouse gas emissions.

To expand its efforts, Astellas Pharma began a collaboration in December 2022 with Eisai, Daiichi Sankyo, and Takeda to reduce the environmental burden posed by pharmaceutical packaging. Based on the agreement, Astellas Pharma will promote the use of more environmentally friendly packaging for pharmaceutical products by sharing knowledge about technologies such as biomass-based blister packs, compact packaging, recycled-content packaging materials, and recyclable packaging materials. “In doing so,” the spokesperson notes, “Astellas, Eisai, Daiichi Sankyo, and Takeda aim to ensure that society benefits from this collaboration to harmonize corporate activities with the global environment.” Moreover, the partners hope to eventually expand their collaboration to other manufacturers.

Packaging suppliers also are working to provide more sustainable options. Johnson explains, “The sustainability story is no longer a footnote or ‘nice to have.’ It has been moved to front and center in terms of corporate social responsibility. As a paperboard packaging manufacturer, we are committed to developing new and better ways to utilize paper in packaging as a 100% alternative to plastic, or as a means to using less plastic in a more environmentally friendly way.”

So, Colbert Packaging is focused on developing paperboard packaging that uses less material and offers increased recyclability. Tactics include the adoption of water- and agri-based inks, coatings, and adhesives as well as the design and engineering of lightweight, right-sized cartons. The company also practices responsible sourcing with 100% of its paperboard derived from certified, responsibly managed forests. Forest Stewardship Council and Sustainable Forestry Initiative certifications mean the firm can provide chain of custody documentation to buyers of its paperboard cartons.

“Downstream, we know that our secondary packaging materials are 100% recyclable, and most are compostable,” says Johnson. “We use various grades and types of paperboards … including 100% recycled board and other paperboards that contain post-consumer recycled content,” he adds.

More sustainable options for blister packaging include the EcoLam mono-PE family of recyclable laminates from Constantia Flexibles. Based on oriented PE in duplex or triplex structures, metallization and aluminum oxide can impart barrier properties that yield a material that can compete with aluminum foil laminates. These barrier materials are present at such low levels that recyclability of the PE is unaffected, according to RecyClass, a Europe-based nonprofit, cross-industry initiative facilitating the transition toward a circular plastic future (2).

Hansa Biopharma works to ensure its packaging is recycled and that partners understand and follow local requirements regarding packaging waste and recycling. “For instance,” says Tulstrup, “in Austria we contract with Alstoff Recycling Austria to ensure compliance with the Austrian Waste Management Act. At Hansa, we strive to make sustainable decisions across the entire value chain. Our lead molecule, imlifidase, is a cold-chain product—meaning it is temperature-sensitive and must always remain at a specific temperature. Therefore, we work with suppliers to ensure appropriate packaging and shipping are used while maintaining the temperature and protecting the integrity of the product. We also continue to investigate how to reduce the packaging required to provide the correct environment for the product given the cold-chain requirements.”

Stumbling blocks to adopting more sustainable packaging include technical issues, cost, and environmental awareness. From a technology perspective, multi-material structures make recycling difficult. Even if alternatives to foil and multi-material laminations exist, the infrastructure to cost-effectively recycle the materials must be developed and be widely available to make recycling a feasible disposal option for this type of packaging.

Cost is always part of any sourcing discussion. “There is a perception that … a more sustainable solution means added cost. Sometimes it is more costly, but it is not a given,” says Johnson. Indeed, some premium for sustainable packaging may be warranted. “Eco-friendly packaging is not always cheap, but we believe that it is a responsible investment considering the importance of the global environment,” reports the spokesperson for Astellas Pharma.

In many regions, there still isn’t enough recognition of environmental issues. “For instance,” says the spokesperson, “not everyone is aware of the carbon footprint of the packaging process or takes concrete actions to address environmental matters.”

Packaging is not the only area where pharmaceutical manufacturers and their packaging suppliers are taking steps to be more sustainable. Astellas Pharma, for example, also focuses on reducing greenhouse gas emissions.

In 2021, Hansa Biopharma assessed its business to understand priority areas for sustainable business operations and formalized its commitment to Healthy Patients, Healthy Business, and Healthy Planet. “To advance our commitment to Healthy Patients, we work closely with patient advocacy groups and healthcare decision-makers to ensure equitable access to our medicine,” says Tulstrup.

Operating a Healthy Business means focusing on the well-being of employees including safeguarding laboratory staff, eliminating gender pay gaps, and maintaining a low turnover rate.


Tulstrup explains, “We also have a robust governance structure and Employee Code of Conduct to instill a high level of integrity and value-driven behaviors throughout the organization. Additionally, we require that all vendors, partners, and suppliers sign a Supplier Code of Conduct that focuses on fair labor, ethical business practices, and health, safety, and environment practices. Underscoring our commitment to Healthy Planet, nearly two-thirds of the energy used in our operations in 2021 was completely renewable.”

At Colbert Packaging’s facility in Kenosha, Wis., it is pursuing zero manufacturing waste-to-landfill status. Johnson says, “We are proud to say that no paperboard waste from our operations goes to a landfill. Working with companies like River Valley Paper, we are recycling approximately 3000 tons of paper and production-related material in a typical year.”

Colbert Packaging also participates in alternative energy programs such as wind energy, through renewable energy credits. “By supporting Green-e Energy certified wind power, we are taking action against climate change, improving our overall environmental footprint, and having a direct impact on renewable energy projects,” concludes Johnson.

MarketsandMarkets. Sustainable Pharmaceutical Packaging Market Worth $146.3 Billion by 2027—Exclusive Report by MarketsandMarkets. News Release. Feb. 17, 2023.

Constantia Flexibles. What Is the Future of Flexible Film Packaging in a Circular Economy? Webinar. Feb. 21, 2023.


Vol. 46, No. 4
April 2023
Pages: 36–38, 49

When referring to this article, please cite it as Focinio, H. Packaging Becomes More Sustainable. 

Manufacturers and suppliers join forces to reduce the pharmaceutical industry’s carbon footprint. 

Packaging Becomes More Sustainable 

All product labeling that carries the National Drug Code (NDC) will need to be updated if FDA finalizes its proposed rule to expand the number from 10 to 12 digits. In some cases, labels also may need to allow more space for the code. The goals for the proposed rule, Revising the National Drug Code Format and Drug Label Barcode Requirements (/docket/FDA-2021-N-1351), are to standardize the format of the NDC, expand the pool of available codes, and increase the number of acceptable barcodes. Lengthening the code is necessary because the supply of five-digit labeler codes will be exhausted in 10 to 15 years. Comments on the proposed rule were due by Nov. 22, 2022 (1).

The proposed rule specifies a 12-digit NDC with three segments, a six-digit labeler code, a four-digit product code, and a two-digit package code. The effective date would be five years after publication of the final rule followed by a three-year transition period to convert existing 10-digit NDCs to 12 digits. During this period, all stakeholders would need to run systems that are capable of handling both 10- and 12-digit NDCs (1). The code change also would require updated software and employee training. FDA estimates the change will cost the industry between $43.1 and $136.3 million (2).

Many commenters agreed with the need to lengthen the NDC but raised concerns about the timeline; the number of stakeholders that rely on the NDC; the scope of the packaging, software, and system changes required; cost projections; the potential for confusion and misdosing as the longer codes are adopted; impact on the Global Trade Item Number (GTIN) code used for serialization; and the advisability of going beyond 12 digits to delay the next depletion of numbers (1). “Expanding the proposed new NDC code length to 13 digits, in a single uniform, 7-4-2 format, for example, may provide a more enduring solution,” noted Ryan Kaat, general counsel of Pharmaceutical Research and Manufacturers of America (PhRMA), in its comments (3).

If finalized, the change will reverberate across the value chain. Due to the number of parties, systems, and processes affected, GS1 US likened the impact of the change to an industry-specific Y2K (Year 2000), which necessitated updating systems to ensure a successful transition from 1999 to 2000. GS1 US noted, “There are three categories of systems impacted by the change in the NDC format: the barcoding system; the systems used by organizations within the healthcare industry; and the interfaces between organizations. The industry will no longer be able to use the linear UPC barcode due to the increased length of the NDC to 12 digits as it exceeds the maximum character allowance … This will result in a greater need to use the 2D DataMatrix barcode to carry the five product data elements (with capacity for others if necessary) within a certain space (4).”

Josh Goolcharan, director of sales and marketing for Reed-Lane, a privately held company specializing in pharmaceutical contract packaging, explains, “The logistics for implementing the changes will need to be managed to ensure there are no disruptions to the supply chain. Contract packagers like Reed-Lane will need to work closely with … their customers to see that required artwork revisions are implemented accurately and efficiently, ensuring that customer inventory levels are maintained.”

He adds, “Any of our in-house print systems currently printing either human-readable or barcode-based NDC numbers will need to be reviewed to determine compatibility with the revised format. These assessments include whether a software revision is required and whether a print system will need to be replaced to meet the new requirement.”

The potential for supply chain disruption is not limited to the availability of pharmaceutical products. Goolcharan notes, “As all packaging operations will be meeting the same implementation deadlines, the vendors that support the production of printed packaging components and serialized packaging lines may face a surge of orders, resulting in long lead times to meet the demand for the changes associated with the revised NDC format.”

Currently, each serialized package level is assigned a GTIN-14 number, and the NDC number is part of this GTIN number. The GTIN is printed in a human-readable format and included in the symbology printed on serialized packages. This scenario does not accommodate a 12-digit NDC. According to GS1 US, “The new NDC format amplifies the need to associate an NDC with a GTIN to uniquely identify a product at every packaging hierarchy. While the NDC can no longer be embedded in the product GTIN, the association of a GTIN to an NDC remains critical. The association of the GTIN to an NDC is achieved by defining NDC as AI (Application Identifier) (715) (4).”

Goolcharan observes, “Additional real estate on some packaging components may be required to accommodate expansions of printed information stemming from the revised NDC format.” In addition, he says, “…any required revisions to the software on serialized lines, or when transferring serialized data, would need to be developed, installed, and qualified so the serialized process can cooperate with the revised NDC format.”

1. FDA. Revising the National Drug Code Format and Drug Label Barcode Requirements. Proposed Rule,

Revising the National Drug Code Format and Drug Label Barcode Requirements. 

Preliminary Regulatory Impact Analysis,July 27, 2022.

Re: Docket No. FDA-2021-N-1351; Revising the National Drug Code Format and Drug Label Barcode Requirements,

 comment from ThePharmaceutical Research and Manufacturers of America. Nov. 23, 2022.

 GS1 US Comment to the United States Department Food & Drug Administration Regarding: Revising the National Drug Code Format and Drug Label Barcode Requirements Docket No. U.S. FDA-2021-N-1351, 

The change would impact every package and hundreds of systems. 