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

Hallie Forcinio

Medicine, Injection, vaccine and disposable syringe, drug concept. Sterile vial medical syringe needle. Glass medical ampoule vial for injection. | Image Credit: © ivandanru - Stock.Adobe.com

Prefilled products, particularly prefilled biologics, are a growing sector in the pharmaceutical industry. “Prefilled syringes and pens offer precise dosing, reducing the risk of errors during administration. They also eliminate the need for reconstitution, making them more convenient for patients and healthcare professionals,” explains Ward Smith, director of marketing and business development at Keystone Folding Box Company, a manufacturer of paperboard packaging. Prefilling also improves product/patient safety because less handling means less chance of contamination.

Prefilled biologics address the growing demand for personalized medicine, homecare, and self-administration options, as well as the desire for an improved patient experience. “This allows patients to continue their treatment in the comfort of their homes while reducing the costs for the healthcare system as fewer trips to a hospital or doctor are needed,” notes Tom Van Ginneken, product manager of polymer solutions at SCHOTT Pharma, a manufacturer of containers used for prefilled biologics and other pharmaceutical products.

The latest innovations for prefilled biologics, including pens, auto-injectors, and on-body delivery systems, accommodate higher volumes, more viscous fluids, a proliferation of longer-acting injectables with longer dosage intervals (weekly, monthly, or even longer), smaller batches, and the ever-present need to reduce healthcare costs. As a result, manufacturers are focusing on user-friendly device designs with features such as ergonomic grips, intuitive mechanisms for injection, and safety features to prevent accidental needlesticks. One example, the Aidaptus auto-injector, developed by Owen Mumford and Stevanato Group, can accommodate a variety of drug viscosities. For added flexibility, the two-step, single-use auto-injector is compatible with 1-mL or 2.25-mL prefilled glass syringes (1).

“Some prefilled biologics packaging now integrates digital technologies, such as Bluetooth-enabled devices or smartphone apps,” reports Smith. These connected devices can track dosing history, provide reminders, and transmit data to healthcare providers, improving adherence and patient monitoring.

Finally, sustainability is an increasingly important consideration. Therefore, manufacturers are exploring ways to minimize environmental impact by moving away from non-renewable materials, optimizing packaging size and weight, incorporating recyclable, recycled-content, or biodegradable materials, and maximizing reusability.

Primary packaging developments include ready-to-use (RTU) containers and designs to address higher viscosity products, larger syringe volumes to meet the dosing requirements of longer-acting biologics, cryogenic storage and distribution, greater focus on self-administration and patient comfort, and container enhancements that minimize the risk of product/package interactions. “This minimized interaction risk ensures that the biologics maintain their efficacy and safety profiles,” says Van Ginneken.

With sensitive substances and challenging environmental requirements, biologics place special demands on primary and secondary packaging. Many APIs are light-sensitive, and the large, complex molecules in many new molecular entities are sensitive to oxygen. Cell and gene therapies as well as messenger RNA (mRNA) substances must be stored and transported at extremely low temperatures. Thus, syringe development has focused on designs capable of withstanding low-temperature conditions without losing functionality or container closure integrity. One example, the TOPPAC freeze prefilled syringe from SCHOTT Pharma, is designed for drugs that require storage and transport at temperatures approaching -100 °C. Another option from SCHOTT Pharma, EVERIC freeze vials, are available in sizes from 2–30 mL and can be supplied RTU. Strength-optimized geometry, designed into the structure of the vials, reduces the risk of breakage (2).

As drug products have moved toward more complex proteins and longer intervals between injections, “primary packaging needs to evolve,” says Daniel Martinez, product manager at Stevanato Group, a global provider of drug containment and delivery solutions. This evolution requires higher levels of inertness to minimize chemical interactions, which can cause aggregation that could trigger an immune response in a patient.

Glass continues to dominate, but cyclic olefin copolymer (COC)/cyclic olefin polymer (COP) syringes are well-established alternatives due to their break resistance, lighter weight, lower chances of protein absorption, and compatibility with cryogenic conditions. Unfortunately, COC/COP’s barrier properties may not be sufficient for oxygen-sensitive biologics and

biosimilars. However, “… specialty labels with built-in barrier functions can overcome this challenge,” reports Corinna Endres, product manager drug protection solutions at Schreiner MediPharm, a Germany-based provider of functional labels. The company’s Gas-Protect-Labels can reportedly reduce oxygen transmission without changing processes or primary packaging. One Gas-Protect-Label design covers the syringe barrel. Another design, the Syringe-Closure-Wrap, enhances barrier protection by wrapping like a second skin around the syringe barrel and cap and sealing at the upper end. An integrated first-opening indication on the Syringe-Closure-Wrap also provides tamper evidence. Label structures can be customized for the barrier needs of the API in the syringe.

Schreiner Medipharm also offers a label for prefilled cell and gene therapies and mRNA substances stored and transported under cryogenic conditions. The Freeze-Light-Protect label reliably adheres to COC syringes at sub-zero temperatures and provides customizable light protection ranging from blocking pure ultraviolet (UV) rays, to blocking UV rays and blue light, to providing a total light barrier. Freeze-Light-Protect labels can be equipped with integrated functionalities such as detachable documentation labels, an inspection window for checking the syringe content in true color, and a graduation for exact dosing when performing the injection. “With the help of this multi-functional label solution, product and patient safety can be enhanced,” says Endres.

Although 1 mL remains the most common volume for auto-injectors, the range of prefilled syringe and cartridge sizes is expanding to include 2.25-, 5-, 10-mL, and greater volumes needed to handle more viscous products, higher volume injections, and products that can’t be concentrated and are destined for on-body delivery systems. SCHOTT Pharma, for example, has added a 5.5 mL size to its syriQ BioPure glass syringe family. Applications include larger volume medications for treating cancer and autoimmune diseases.

It’s also been necessary to optimize mechanical performance to accommodate higher impact forces without breakage. “More viscous products require higher injection forces,” explains Martinez.

The development of device platforms, like the two-step YpsoMate injector from Ypsomed or the Molly auto-injector from SHL Medical, is streamlining the introduction of combination products. Instead of performing Phase I and II clinical trials in vials and moving to a prefilled syringe for Phase III and commercial product, developers are adopting prefilled syringes as early as Phase I or II. “This … allows for earlier data gathering for the prefilled syringe presentation, and perhaps even more importantly, one can obtain valuable stability information at a much earlier stage,” says Justin Schroeder, global vice president, technical sales at PCI Pharma Services, a contract development and manufacturing organization (CDMO). Being able to include real-world data in regulatory filings can expedite regulatory approvals and shorten time-to-market.

The earlier transition to a prefilled syringe also helps ensure the patient self-doses properly, prevents medication errors, mitigates potential risks, improves patient adherence and persistence, and increases patient education and health literacy. “Well-orchestrated and integrated device, packaging, and labeling strategies can succeed on all [these fronts] if planned and executed synchronously,” explains Schroeder.

A customizable on-body delivery system, the Vertiva platform developed by Stevanato and Thermo Fisher Scientific, consists of a single-use pod with prefilled and pre-loaded 3-mL cartridge and a multi-use, smart controller. Stevanato supplies pre-sterilized EZ-fill cartridges and assembly equipment, while Thermo Fisher provides fill/finish and final assembly services (3). The highly flexible programmable device can deliver micro-precision basal doses or full-content bolus injections and is suitable for a wide range of therapies. It also accommodates volumes greater than 3 mL and offers Bluetooth connectivity for digital health applications. Reusability helps address sustainability concerns (4).

The primary trends on fill/finish lines for biologic products are the growing adoption of RTU containers, higher levels of automation and flexibility, and increased reliance on CDMOs.

RTU containers result in a more flexible, leaner operation and improve contamination control. For example, EZ-fill Smart containers from Stevanato now rely on thermally welded polymer film tray lidstock. The change from traditionally used Tyvek lidstock requires minimal modification of the fill/finish line and eliminates any fiber or glue residue contamination associated with the removal of the Tyvek material.

Flexibility, especially to handle the smaller batches needed for clinical trials or personalized medicine, is becoming an essential attribute of the fill/finish process. One filling system installed at PCI Pharma Services, the SA-25 aseptic filling workcell from Cytiva, handles vials or syringes. “These advanced robotic isolator systems are Annex 1-compliant and offer very small line losses, [and] are attractive for those developing high-value drug substances such as biologics and antisense oligonucleotides,” reports Schroeder.

When automating, some companies transition to fully automated systems, while others take a semi-automated approach. One semi-automated example, a custom-built benchtop draw filler from Turbofil Packaging Machines, offers a system that is more accurate and less labor-intensive than manual filling. Plus, it fits under a laminar flow hood, making it suitable for aseptic filling. The machine fills the syringes through the tip directly from intravenous bags via a disposable fluid path. This “saves time and resources while reinforcing sterility,” explains Deborah Smook, vice-president of marketing and business development at TurboFil Packaging Machines. Draw-filling not only enhances accuracy but also improves operator safety, simplifies changeover, accommodates a variety of syringe sizes and product types, and eliminates the need to clean a metering device.

For fully automated operations, a servo-driven, intermittent-motion TipFil monoblock model loads, fills, caps, inspects, and labels syringes and prints lot number and expiration date and other information such as QR codes or usage instructions at up to 50 pieces/min. Interchangeable pucks accommodate syringe sizes from 1–60 mL, and the machine can handle a wide range of product viscosities (5).

However, Smook warns, “… automation is rarely as simple as devising a machine to replace a manual process. Adjacent issues such as sterility and inspection, which can become more challenging at higher line speeds, also must be addressed.”

Automated inspection needs can be met by the high-speed Visual Rotating Inspection (VRI) series from Antares Vision Group. Capable of checking liquid-filled glass or plastic containers at speeds up to 400 containers/min, the machines combine sophisticated particle and cosmetic detection with closure integrity verification. VRI units can inspect liquids with viscosities from water-like to gels and emulsions, as well as lyophilized and powder products. Vials also are inspected for cosmetic defects related to crimping quality, flip-off color, neck-shoulder sidewall flaws, and stopper position (6).

Overall, drugs are becoming more complex and thereby more sensitive. Thus, “… the prefilled biologics packaging industry is characterized by ongoing innovation aimed at enhancing safety, convenience, and patient experience, while also addressing regulatory compliance and sustainability concerns,” says Smith.

“It is therefore essential for pharma companies and containment suppliers to work hand-in-hand from the beginning to ensure that the medication is stored and administered safely,” concludes Van Ginneken.

1. Stevanato Group. Aidaptus Manufacturing. 

 (accessed March 4, 2024).
2. SCHOTT Pharma. Protecting Drugs at Deep-Cold Temperatures: SCHOTT Pharma Launches New Vials for mRNA and Gene Therapy. Press Release. Jan. 24, 2024.
3. Stevanato Group. Stevanato Group Collaborates with Thermo Fisher Scientific to Bring Its Innovative On-Body Delivery System Platform to Market. Press Release. March 21, 2023.
4. Stevanato Group. Vertiva. www.stevanatogroup.com (accessed March 4, 2024).
5. TurboFil Packaging Machines. TurboFil Introduces Fully Automatic Version of Popular Syringe Filling System. Press Release. Dec. 5, 2023.
6. Antares Vision Group. At INTERPHEX, Antares Vision Group to Showcase Automatic Inspection Machines for Vials, Pre-filled Syringes, and Other Small-Volume Containers. Press Release. Feb. 13, 2024.


Vol. 48, No. 4
April 2024
Pages: 24–27

When referring to this article, please cite it as Forcinio, H. Innovations in Prefilled Biologics. 

Articles

Packaging and packaging line innovations are addressing the industry’s growing use of biologics.

Innovations in Prefilled Biologics

Secondary packaging for pharmaceutical products must navigate global and local challenges and address a myriad of demands with sustainability at the top of the list. Other secondary packaging trends stem from the need for more complex carton designs, kitting, and the incorporation of child-resistant, serialization, anticounterfeiting, or smart features. These needs are generating advances in coding, marking, and printing. There’s also a growing reliance on suppliers for design assistance so cartons, labels, and leaflets run efficiently on the packaging line, protect the product throughout the supply chain, and meet the requirements of regulators, drug makers or contract manufacturing/packaging organizations, caregivers, and patients.

Consumer preference is a driving force in the attention given to sustainability. Erwin Klünder, head of Sales, Healthcare & Flexibles at Graphic Packaging International (GPI), says, “Consumers want to make more sustainable purchasing choices, a sentiment shared by patients in the pharmaceutical industry (1). Those patients expect companies to help them achieve that goal by providing the right products—including the packaging.”

In line with this sustainability focus from the consumer as well as increased pressure from regulators to reduce waste, “brand owners are trying to showcase their commitment to sustainability,” reports Ward Smith, director of Marketing & Business Development for Keystone Folding Box.

Marga Romo, head of Marketing at MM Packaging, a division of MM Group, notes as new products are developed, “… pharma businesses must have absolute awareness of the product’s total environmental footprint, before the product hits the market. This includes an assessment of the full supply chain for Scope 3 emissions. … we factor this into our manufacturing operations by prioritizing resource-optimized production and recyclability … and moving toward a true circular economy.”

Sustainable packaging involves reducing or eliminating plastic, lightweighting and downgauging, transitioning to more-recyclable packaging materials to achieve a circular economy, adopting renewable paper-based options, rightsizing (cube efficiency), and minimizing the number of packaging sizes and configurations, adds John Lackner president/COO of Colbert Packaging.

An exception to adopting a more-recyclable material like paperboard is products destined for surgical areas. For this environment, pharmaceutical manufacturers want a material that looks clean. “It’s all about appearance and cleanliness,” says Paul Glintenkamp, vice-president Sales at Aphena Pharma Solutions, a contract pharmaceutical manufacturing and packaging company. Some drug makers have overcome this concern by specifying paperboard that is coated on both sides.

Advances in coding, marking, and printing

Increasing regulation is spurring demand for enhanced coding, serialization, and pre-serialization technologies to provide product security and fight counterfeiting. This has prompted innovations in carton design as well as coding, marking, and printing functions on packaging lines.

Keystone Folding Box frequently provides guidance about graphic changes to optimize laser or inkjet printing of serialization, lot, and expiry information. In some cases, Smith says, customers are requesting the addition of QR codes that direct patients to additional information or instructions about the medication.

Aphena Pharma Solutions, which offers three levels of serialization, assists customers with package and carton design to ensure serialization will not disrupt packaging line efficiency. This means designing the cartons so codes will be readable without extra manipulation. “Marketing professionals and graphic designers don’t always think about how internal packaging systems or bundling requirements may complicate online code reading,” explains Glintenkamp.

Additionally, concern about code clarity and smudge-free readability is expanding interest in laser coding. “[Aphena] recently added laser coders on two lines and is doing shipping studies to verify the laser-printed code is less prone to scuffing than an inkjet-printed code,” says Glintenkamp.

Laser coding, which is considered to be cleaner, faster, and more efficient than alternative technologies, is the focus of MM Packaging’s Clear Code pre-treatment coating that enables precise and durable high-contrast patterns to be applied using carbon dioxide, fiber, or yttrium aluminum garnet laser energy.

GPI’s highly flexible serialization service meets the demands of the most recent drug traceability specifications and can accommodate longer or more complex coding requirements, including compliant European Union (EU) codes, Chinese C128 codes, veterinary codes, and more country-specific formats, such as Italian Bollini labels.

Colbert Packaging also can address an array of coding needs including item-level identification and traceability based on country of origin and helps ensure folding cartons are ready to receive serialization codes on the packaging line.

Furthermore, coding, marking, and printing technologies enable the late-stage customization needed as lot sizes shrink to address the growing availability of patient-specific drugs and treatments for rare diseases. “Packaging processes need to ensure individual information can be printed in highly efficient and automated ways (for example, specific language versions for countries with lower volume demands),” says Klünder.

New folding carton designs and the evolution of wallet packs address the demand for sustainable, child-resistant, and smart packaging options. Sustainability can be enhanced by changing materials to incorporate fiber-based content that can meet performance requirements while increasing the circularity of the package. “These materials can be used alone or combined with barrier coatings or films to create hybrid solutions,” reports Klünder. Additionally, print finish advances using metallic effects or water-based inks can replace metallized polyethylene terephthalate/paperboard laminates with a more-recyclable paperboard.

Adoption of wallet packs, which help patients take each dose correctly, will continue to grow particularly for products that involve complex dosing regimens or serious warnings about proper use and contraindications. For example, the Key-Pak F1 wallet card from Keystone Folding Box holds blister packages of solid dosage forms, provides child resistance, and allows for the integration of smart technology that monitors and records data related to dosage removal.

One smart, child-resistant design integrates the Key-Pak wallet with electronics from Schreiner Medipharm to provide a real-time e-diary for dosing history. The integration of conductive trace-patterns linked to each of the cavities generates data the instant the patient removes a dose. Details, such as time and date of removal and cavity location, are stored within the onboard electronics and can be transmitted by near-field communication (NFC) or Bluetooth technology for precise patient compliance tracking. It’s also possible to send medication dosing reminders to patients and to adjust therapy plans. When used in combination with special software, central tracking as well as data documentation and analysis are possible. The design accommodates virtually any dosing regimen by customizing the number, arrangement, and shape of the blister cavities. The improved data quality can expedite the clinical trial process and accelerate the approval of a new drug (2).

Another design from Keystone Folding Box, the Ecoslide-RX blister pack wallet, provides a child-resistant alternative to high-density polyethylene vials and amber polypropylene prescription vials, which are rarely accepted in US recycling streams. According to Smith, the package is engineered to use the least amount of film and foil, maximize manufacturing efficiencies, and run at high speeds on existing equipment. He reports, “The switch from a bottle/vial to an Eco-slide-RX blister package results in significantly reduced plastic—in some case up to 75%. Even more sustainable benefits are achievable by utilizing newer recyclable blister materials.”

Colbert Packaging also offers paper-based alternatives to plastic packaging. Its water- and agri-based One Clean Carton offers low migration, low odor, and low levels of volatile organic compounds. Like many secondary packaging suppliers, the company embraces sustainable practices across its supply chain, using wood fiber from certified sources. In addition, “investment in wind RECs (renewable energy credits) supports [Colbert’s] sustainability program, and [its] participation with the EcoVadis sustainability ratings platform enables [the company] to continually address and improve overall sustainability efforts,” says Lackner.

Stakeholders predict the demand for sustainable packaging will intensify in 2024–2025 as the sector grapples with evolving legislation, including the EU’s proposed Packaging and Packaging Waste Regulation (PPWR), United Kingdom Green Claims Code, EU Green Claims Directive, and extended producer responsibility schemes being introduced around the world.

Regulations and national and international collaborations will propel efforts to be more sustainable. For example, the US Plastics Pact is bringing together the plastics value chain to reconsider the design, use, and reuse of plastics. “The overarching objective is to diminish plastic waste in our environment and establish a circular economy for plastics,” says Smith.

Sustainability will take on even greater urgency when the PPWR is approved because it brings the recyclability of pharmaceutical packaging under the scope of packaging waste legislation for the first time. Klünder explains, “This means healthcare packaging must be designed to facilitate efficient recycling and be easy to collect and sort into separate waste streams. It must also result in secondary material that is of sufficient quality to substitute for primary material. Paper-based materials, used in cartons and corrugate, are the obvious choice to help the industry rethink its secondary and tertiary packaging. They are already capable of being recycled at scale—figures show 82.3% of fiber-based packaging is recycled in Europe (3), along with 81% in the USA (4)—and can easily meet Design for Recycling criteria.”

“We believe that the initial emphasis will be on reducing the overall plastic content in pharmaceutical packaging, [and] … transitioning to easily recyclable cartons,” says Romo of MM Packaging, which is developing paperboard options with recycled content with the help of sister company, MM Board & Paper.

Beyond sustainability, other growth areas include a continued emphasis on quality with broader use of vision systems at all stages of secondary packaging production and the continued adoption of smart packaging technologies. Increasingly based on radio frequency identification and NFC technology, smart packaging can turn individual packaging units into traceable data points, unlocking new heights of transparency and enabling pharma businesses to make data-driven decisions regarding the supply chain. “The … pharma sector will see smart, connected packaging playing a more central role in preserving patient safety,” predicts Romo.

Anticounterfeit and security features will continue to evolve to protect products, brands, and consumers. Layered overt and covert anticounterfeit technologies will be needed to discourage counterfeiting of rapidly growing, high-value products like anti-obesity treatments.

Growth in self-administered products will impact packaging design and supply chain processes. “A patient-centric approach to packaging design will be key to enhancing the patient experience and enabling accessibility for people with different physical needs or reduced motor capabilities,” says Klünder.

With all this activity and the expanding development of biosimilars and new drugs, Glintenkamp predicts contract manufacturing and packaging capacity will tighten. As a result, contract manufacturing and packaging organizations will need to boost their workforce and, in some cases, add capacity.

1. Shorr Packaging, The 2022 Sustainable Packaging Consumer Report. White Paper. July 20, 2022.
2. Schreiner MediPharm. Schreiner MediPharm Enables Digital Adherence Monitoring with New Child-Resistant Smart Blister Wallet. Press Release. Nov. 28, 2023.
3. 4evergreen. A Journey through Recycling of Fibre-Based Packaging. 

. Accessed Dec. 7, 2023.
4. Two Sides North America. Paper-Based Packaging Is Recycled More than Any Other Packaging Material. 


Vol. 48, No. 1
January 2024
Pages: 22–25

When referring to this article, please cite it as Forcinio, H. Navigating Trends in Secondary Packaging. 

Designers adopt value-added features, different materials, and enhanced coding technologies.

Navigating Trends in Secondary Packaging

To streamline the fill/finish process, Datwyler has introduced ready-for-sterilization (RFS) combiseals for cartridges used in pens and autoinjectors. RFS combiseals for cartridges arrive ready for immediate sterilization, eliminating the need for drug manufacturers to prep packaging components for sterilization, install washing equipment, and validate washing processes on fill/finish lines. The RFS combiseals adapt to existing lines, save time, and cut costs while complying with FDA and European Union regulations (1).

Because combiseals contact the contents of the cartridge directly, cleanliness is imperative to comply with regulatory requirements and prevent any risk to patients. Before shipping to a sterile drug manufacturer, the RFS combiseals undergo Datwyler’s water-for-injection washing process and are packed in a controlled environment. The steam-sterilizable bags, which hold the RFS combiseals, ensure a controlled state of microbiological cleanliness that meets regulatory requirements (1).

Data about the washing process will be filed in Datwyler’s Drug Master File so customers can reference it for drug submissions to FDA. The RFS combiseals also undergo 100% camera inspection to identify and eliminate seals with visual defects and minimize rejects on fill/finish lines. A concurrent development, DuraCoat lamination technology, reportedly minimizes particle generation and shows less abrasion than standard aluminum seals (1).

The RFS combiseals join other RFS components on the market such as Westar RS stoppers, plungers, and seals from West Pharmaceutical Services (2,3) and 13-, 20-, and 30-mm vial stoppers from QCVIALZ. Cleanliness of the QCVIALZ RFS13, RFS20, and RFS30 series vial stoppers is assured by bioburden and endotoxin testing conducted in an FDA- and ISO 17025-certified facility. Lot traceability and documented testing results accompany each shipment to drug makers (4).

“… pharma companies want to focus mainly on their core activities—drug manufacturing. Washing and sterilization of rubber materials are more and more done by the rubber manufacturers,” said Carina Van Eester, global platform leader, Prefilled Syringes and Cartridges at Datwyler, in a press release (1). “Combiseals are the final product in our portfolio to supply in RFS format,” she added.

To further simplify the preparation of components for fill/finish lines and complement the expanding use of pre-sterilized, ready-to-use (RTU) vials, syringes, and cartridges, Datwyler is developing RTU combiseals. The pre-washed and pre-sterilized seals are expected to be available in 2024 (1) and join RTU components from suppliers such as West Pharmaceutical Services (3), Aptar (5), and makers of glass vials, syringes, and cartridges.

The usage of RTU components is expanding because it further streamlines the fill/finish process. A report from Research and Markets predicts the global pre-sterilized RTU pharmaceutical packaging market will grow at a compound annual growth rate of 6.62% through 2035 from an estimated value of $9 billion in 2023. The integration of RTU packaging containers meets the growing demand for aseptic fill/finish processes, minimizes human intervention and reduces chances of contamination, enhances product quality and safety, streamlines the fill/finish process, supports regulatory compliance, and enables faster product launches (6).

1. Datwyler. Datwyler Introduces Ready-for-Sterilization Combiseals to Enhance Efficiency in Drug Filling and Packaging. Press Release. Oct. 17, 2023.

2. West Pharmaceutical Services. Westar Stoppers. 

Westar® Stoppers for Pharmaceutical Packaging Solutions (westpharma.com)

3. West Pharmaceutical Services, Cartridge Systems and Components. 

Cartridge Plunger, Systems & Components for multi-use pen or injectors (westpharma.com)

4. QCVIALZ. Benefits of Using Ready to Sterilize Vial Stoppers. 

Benefits of Using Ready to Sterilize Vial Stoppers (qcvialz.com)

5. Aptar. Advanced Parenteral Closure Solutions. 

Advanced Parenteral Closure Solutions | Aptar

Pre-Sterilized/Ready to Use Pharmaceutical Packaging Market (3rd Edition): Distribution by Type of Container, Type of Closure, Material of Fabrication and Key Geographical Regions: Industry Trends and Global Forecasts, 2023-2035

Washed seals save drug makers time and money. 

Seal of Approval: New Technology Is Streamlining Sterilization

Medicine injection vial and blister pack | ©khuntapol - stock.adobe.com

The global pharmaceutical packaging market is projected to expand at a compound annual growth rate (CAGR) of 9.7% from 2023 to 2030, according to a study by Grand View Research (1). The growth in pharmaceutical packaging reflects the growth in the sector, due to expanding usage in developing nations and an aging population and reshoring in the United States, the world’s largest market for pharmaceuticals (2).

Analysts predict the strength of the US market will make the pharmaceutical sector one of the strongest performers in 2023–2024, even if a recession occurs, which many economists think is likely to happen especially if the Federal Reserve continues raising interest rates. A weaker economy would yield at least one positive; it would help retain personnel because employees are less likely to change jobs in uncertain times. It won’t, however, help hiring challenges, which are expected to continue for the remainder of the decade. As a result, automation is viewed as a good investment with growing interest in artificial intelligence (AI), digitalization, and robotics (2).

A report published by Connect in Pharma notes, that although not yet widely used, AI is no longer a future concept. Of the companies engaged in adopting AI, almost all recognize the important role digital tools are playing to improve data collection and reduce manufacturing downtime. AI and machine learning support continuous manufacturing practices, a key trend to reduce waste, improve efficiency, and increase line speeds. Digital tools also can reduce human error and improve precision fill/finish, workflow integration, and anticounterfeiting (3).

Furthermore, digital tools enhance the ability to record and share supply chain data with regulators and make it easier to comply with regulations like Annex 1, which sets requirements to minimize the risk of contamination of aseptically filled products. “Automation in fill/finish can help to address some challenges in meeting these requirements, while at the same time providing better efficacy in production,” said Andreas Raabe, CEO of Adragos Pharma, a Munich-based contract development and manufacturing organization. Despite the benefits of digitalization, multiple barriers exist including ensuring data integrity and security, identifying the right software, cost, and a lack of corporate leadership (3).

Usage of robots, which offer precision, efficiency, speed, compatibility with customized packaging, and the potential to minimize human interaction on sterile product lines, is expected to expand dramatically through 2032, according to a report from Global Market Insights. Adopting robots for picking and placing products conserves floor space, simplifies inspection, and supports tracking and tracing functions (4).

Stäubli Tec-Systems, for example, offers validated robotic systems designed to work in aseptic areas and withstand rigorous cleaning. Systems include the Stericlean range for aseptic environments and the new Stericlean+ models for use in isolators. The TX2-60 Stericlean+ robot with a hollow wrist option features an enhanced hygienic design, higher cleanability, a new FDA-compliant surface coating, and dynamic joint seals. Telemanipulation of the robot via joystick minimizes human interventions and offers the potential for a closed system (5).

Sectors poised for the strongest growth include inhalable biologics, long-acting injectable formulations, and connected devices. Exactly half of the Connect in Pharma survey respondents confirmed that their company is or will be developing, manufacturing, or packaging drugs that are inhaled (3).

“Nasal delivery is becoming increasingly prevalent across a variety of pharmaceutical niches,” said Deborah Smook, vice-president of Marketing & Business Development at TurboFil Packaging Machines, which introduced the Mini-Monoblock MDN-50 system to streamline packaging of multi-dose nasal products. The system fills, seals, and caps nasal spray containers at a rate of up to 50 pieces/min, occupies a compact footprint, and can be integrated with a checkweigher and wraparound labeler (6).

The likelihood of strong growth for inhalable drug delivery devices can be attributed to the potential for fast absorption and the high bioavailability of biologics delivered via the nasal passage or lungs. Dry powder inhalers and nasal delivery devices rank as the most popular primary packages. Interest is particularly strong in developing more sustainable reusable inhalers and inhalation devices for vaccine delivery (3).

Suppliers already are working on more sustainable designs. For example, Aptar Pharma has developed the APF (advanced preservative-free) Futurity metal-free nasal spray pump for nasal saline and other over-the-counter products. When used in combination with a high-density polyethylene (HDPE) or polypropylene container, a product with the APF Futurity pump can be conveniently recycled as one piece when empty, with no need to separate or detach any parts or materials before disposal. The result is a streamlined recycling process and higher quality recyclates. Class AA certification from 

 confirms the recyclability of the metal-free nasal spray pump (7).

Hurdles to more widespread adoption of inhalable biologics include patient safety, satisfactory bioavailability, the shorter-acting effects of inhalable drugs, ease of use, and an evolving regulatory environment. The new EU Medical Device Regulation, for example, creates significant regulatory challenges for drug-device combination product manufacturers that will delay the approval and launch process, including increased demands for manufacturers to document their manufacturing flow (3).

New delivery systems for injectables are another growth area. Half of the survey respondents reported that their company is or will be developing,
manufacturing, or packaging injectable formulations (3).

Another projected growth area, connected devices, opens doors to personalized care. Benefits include increased patient adherence and compliance, support for remote monitoring and data collection, improved patient outcomes, and the potential to reduce waste from expensive therapies. Hurdles to adoption of connected devices include who controls the data, how/where the data are shared, and whether devices should be single-use or reusable. Manufacturing costs, cybersecurity, patient hesitancy, and regulations also pose challenges to developers (3).

Faced with growing consumer and regulatory pressure to reduce its environmental impact, the pharmaceutical industry is taking steps to adopt more sustainable manufacturing and packaging practices. Although one-third of Connect in Pharma survey respondents have yet to embark on sustainability improvements, the industry is seeing increasing use of recycled materials in secondary packaging, the implementation of energy-efficient technologies, and the development of more eco-friendly drug delivery systems (3). Interest in compostable materials and polyethylene terephthalate (PET) containers made from renewable, plant-based materials also is growing (1).

In a study conducted by Aptar Pharma in 2022, 77% of respondents indicated that it was “important” or “very important” that the products they buy are recyclable (7). This often is accomplished with monomaterial designs like the Polyfoil MMB 545/645’ tube from Neopac, which is approved as fully compatible with the European rigid HDPE recycling stream. The tube structure replaces the typical ethylene vinyl alcohol barrier layer with a thin film barrier layer, which does not affect recyclability. The tests, performed by the Institut für Kunststofftechnologie und -recycling using the RecyClass Recyclability Evaluation Protocol for HDPE containers, show recycled tube material can be used in high-end or closed-loop applications at levels up to 25% (8).

Another desirable feature, recycled content, supports circularity and is likely to become more important in pharmaceutical packaging if the European Commission’s proposed amendment to its Packaging and Packaging Waste Directive is approved. The amendment would make the directive a full-fledged regulation and set elevated sustainability standards for packaging materials. Although it’s likely the pharmaceutical industry would be granted longer deadlines, this regulatory change would push the industry toward greater use of recycled materials to meet the more stringent sustainability rules (9). Post-consumer recycled content is found in glass containers, as well as some PET containers and secondary packaging (1).

However, increasing recycled content depends on improved collection, better sortation techniques, and greater capacity for end-of-life reprocessing, according to a report published by PMMI, The Association for Packaging and Processing Technologies, and AMERIPEN. Policy changes will be needed to meet these objectives and achieve a circular economy. According to the report, success will depend on the establishment of:

extended producer responsibility programs

universal access to recycling and composting services

standardized definitions to lessen consumer confusion and ensure stakeholders communicate a consistent message

alternatives to material bans so the optimum packaging option can be chosen for each application

federal investment into programs focused on more efficient packaging design and waste management

data collection to measure and benchmark the performance of a circular packaging economy

Reusables, particularly for secondary and distribution packaging, look like a promising element of a circular economy. However, infrastructure is lacking, and investment is needed to establish reverse logistics systems, which provide consumers with convenient, safe, and hygienic collection points. Production lines also must be equipped for cleaning and reuse of packaging. The costs to develop and scale an infrastructure for reusables pose a significant hurdle. A wide range of stakeholders will need to develop a collaborative strategy that incentivizes innovation (10).

Despite a strong interest in sustainability, the cost of sustainable materials and practices poses a major barrier. However, some survey respondents believe digitalization across the manufacturing line can support sustainability efforts. Fausto Artico, global R&D tech head and product director of Innovation and Data Science at GSK, explained, “As more processes become automated, it’s easier to make green optimizations. …when you use data science to monitor and log everything happening in systems, you finally have an idea of what the waste is, how much there is, and where it’s happening” (3).

Grand View Research. Pharmaceutical Packaging Market Size & Share Report, 2030, 

. Market Study (accessed Sept. 28, 2023).

PMMI, Business Intelligence, a division of PMMI The Association for Packaging and Processing Technologies. Guidance in an Uncertain Economy–Gauging the Risks Going Forward 2023-2024. Market Study. June 2023.

Connect in Pharma. The Future of Pharma Production, Manufacturing and Packaging Trend Report.

Global Market Insights. Pharmaceutical Robots Market Size, Share and Industry Analysis Report, Regional Outlook, Growth Potential, Competitive Market Share & Forecast, 2023–2032. Market Study. Pharmaceutical Robots Market Growth | Forecast, 2023-2032. 

Stäubli Tec-Systems GmbH Robotics. Robots with a Laser Focus on Pharma. Press Release. Sept. 18, 2023.

TurboFil Packaging Machines. TurboFil Introduces Inline Filling & Capping Machine for Multi-Dose Nasal Dispensers. Press Release. July 29, 2023.

Aptar Pharma. Aptar Pharma Launches First Metal-Free Highly Recyclable Nasal Spray Pump, Press Release. Jan. 20, 2023.

Neopac. Neopac’s ‘Polyfoil® MMB 545/645’ Tube Receives a RecyClass Recyclability Approval. Press Release. Feb. 23, 2023.

TekniPlex Healthcare. TekniPlex Healthcare to Lecture on Pharma-Grade Recycled Plastics at Pharma Packaging & Labeling Innovation Forum. Press Release. Sept. 7, 2023.

PMMI, The Association for Packaging and Processing Technologies, and AMERIPEN (the American Institute for Packaging and the Environment). 

2023 PACKAGING COMPASS: Evaluating Trends in U.S. Packaging Design over the Next Decade and Implications for the Future of a Circular Packaging System.


Vol. 47, Number 11
November 2023
Pages: 22-23, 31

When referring Forcinio, H. Market for Packaging Continues to Expand. 

Interest grows in AI, digitalization, robotics, and sustainability. 

Market for Packaging Continues to Expand

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.

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.