Packaging Formats Evolve

Forcinio,Hallie;

Packaging Formats Evolve

January 2, 2023

By Hallie Forcinio

Publication

Article

Pharmaceutical TechnologyPharmaceutical Technology, January 2023

Volume 47

Issue 1

Pages: 33-35

Manufacturers automate production lines and increase the use of third-party providers.

sveta - stock.adobe.com

The pharmaceutical industry registered $800 million in sales in 2020 and is forecast to grow at a 7.6% compound annual growth rate through 2026, according to 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 (1).

As the production of higher-value injectables and customized products grows, packaging formats and production preferences are evolving and pushing manufacturers toward more automated production lines, digitization of data, and expanded use of contract manufacturing and packaging organizations (1).

The report also notes manufacturers must adjust to steady growth in direct-to-consumer e-commerce channels and consumer preferences for sustainable practices (2). To meet sustainability objectives, 67% of pharmaceutical manufacturers are lightweighting packaging, 53% are increasing post-consumer-recycled content, 47% are seeking more energy-efficient equipment, and 40% are changing packaging formats (3).

Evolving packaging formats

As the demand for injectables grows, so does the need for ready-to-use (RTU) vials, cartridges, and syringes. As a result, suppliers are increasing capacity. For example, SCHOTT Pharma, a standalone company established in August 2022 by SCHOTT for its pharmaceutical business, started up a production facility in Germany for pre-fillable polymer syringes; is expanding cartridge production in Switzerland, China, and Hungary; broke ground on a pre-filled syringe operation in Hungary; and plans to triple its capacity for high-quality sterile vials in the United States (4,5,6).

The additional cartridge capacity addresses the demand for drugs that are self-administered via auto-injectors, which make it easy for a patient to self-dose safely and accurately (4). The pre-fillable syringe (PFS) operation under construction in Lukácsháza, Hungary, will add a second production hub to SCHOTT Pharma’s global manufacturing network. Scheduled for completion in 2024, it will feature fully automated manufacturing processes and cutting-edge machinery, as well as an advanced camera-controlled inspection system. “With this move, we are staying one step ahead in providing high-value solutions to store biologics, vaccines, and the latest generation of mRNA-based medications,” said Andreas Reisse, CEO of SCHOTT Pharma (6).

A high-quality PFS not only offers stable, long-term storage for drugs, but also a safe and convenient delivery system for patients and clinicians. “With our PFS system, we are eliminating almost all drug injection preparation steps and thereby reducing the risk of medical errors and contaminations. This plays a vital role in the safety of health care professionals and patients,” said Christian Helbig, vice-president for Prefillable Glass Syringes at SCHOTT Pharma (6).

Two other glass container producers, Stevanato Group and Gerresheimer, have joined forces to develop RTU glass containers that will run on standard fill/finish lines and accelerate the transition from bulk to RTU containers. The EZ-fill Smart product line, a next-generation addition to Stevanato’s EZ-fill family, will share the same secondary packaging, production process, and sterilization method to ensure consistent reliable double sourcing. “Through our collaboration . . . we expect to achieve another important milestone in creating a reliable ecosystem to support, accelerate, and de-risk the conversion from bulk to EZ-fill [RTU] vials,” said Mauro Stocchi, chief business officer at Stevanato Group. “The newly developed RTU vial platform stands out in terms of quality, total cost of ownership, and sustainability, and takes the use of RTU solutions like vials, and, in the future, cartridges to a new level,” added Dr. Lukas Burkhardt, member of the Gerresheimer Management Board (7,8).

Process and product improvements and increased automation throughout the manufacturing process boost productivity and reduce human errors. The optimized process eliminates glass-to-glass and glass-to-metal contact, which improves vial quality and integrity throughout the product life cycle. Redesigned secondary packaging further enhances quality by reducing particle risks during fill/finish operations. The new EZ-fill Smart line also eliminates traditional ethylene oxide (EtO) sterilization and is validating a safer, more environmentally friendly sterilization method, which meets guidelines given by regulatory bodies supporting the transition away from EtO sterilization (8).

Developed in close cooperation with major machine vendors, the EZ-fill Smart line seamlessly integrates with standard fill/finish operations and accommodates small- and large-batch production. Designed to automate the infeed process, EZ-fill Smart containers will be available in nest-and-tub and tray configurations. EZ-fill Smart containers in nest-and-tub arrays are scheduled to be available in mid-2023 for initial validation and by mid-2024 for commercial use. A tray configuration for high-volume applications is expected to be available during the first half of 2024. “The new platform will enable customers to optimize their processes, improve their quality and their carbon footprint. In addition, our customers can benefit from a significant reduction in the total cost of ownership,” said Burkhardt (8).

Stevanato is also partnering with DWK Life Sciences to distribute its RTU EZ-fill vials in nest-and-tub and tray configurations and EZ-fill cartridges in nest-and-tub arrays. The pre-sterilized containers streamline the fill/finish process, reduce total cost of ownership, and shorten overall time-to-market (9).

A potential alternative to glass containers, MSI-TX thin film, under development by Jurata Thin Film, stabilizes biologic materials (live virus and bacterial-based vaccines, as well as antibody-based therapeutics) in a film matrix for ease of shipment, storage, and administration (10). “All components of our thin film, except for one, are considered generally recognized as safe (GRAS) by the US FDA,” reports Megan Livingston, senior director of Business Development at Jurata Thin Film. She notes, “The one component that is not GRAS is undergoing toxicity studies now, the results of which will be submitted to the FDA in a Type IV Drug Master File. With that said, the amount of the novel excipient included in our formulations is so low that we do not anticipate any negative toxicity results.”

The thermostable nature of the film maintains the therapeutic efficacy of its payload, eliminating the need for lyophilization and cold-chain logistics and enabling a transition from temperature-controlled cargo containers to a sterile envelope, which can travel through normal mail channels (10). Livingston says, “For our pilot line, we are utilizing in-blister manufacturing, so our thin films will be dried within their primary packaging. This primary packaging will be labeled and put into secondary packaging for shipment/distribution.”

The thin film is adaptable to a variety of biologics, processes in about three hours, and is easily transferable to industrialized and developing countries. It has been validated with several active pharmaceutical ingredients, including influenza and Ebola vaccines, as well as live bacteria at room temperature
(20 °C) for extended periods (six months to three years). Juarta can provide the technology to pharmaceutical companies for in-house use or serve as a contract manufacturer using bulk API as a starting material (10). “We typically require about four weeks to optimize the formulation of a new vaccine or biologic,” explains Livingston.

MSI-TX thin film can deliver vaccines and therapeutic payloads through buccal or sublingual routes or be rehydrated to recover the therapeutic payload in an aqueous solution to be administered intranasally or parenterally. These routes of administration can improve the potency of biologics without using needles, for non-invasive vaccine and drug delivery. Juarta Thin Film also is optimizing the MSI-TX thin film for rapid and/or continuous release of therapeutic payloads, further increasing potential applications (10).

Automation and digitization of data

Pharmaceutical production lines are becoming increasingly automated to boost production, offset labor shortages, and minimize human interaction with parenteral products. Automation also is key to the flexibility and quick changeover today’s lines need to efficiently run multiple products, packaging formats, and sizes, as well as address the requirements of the direct-to-consumer channel. As a result, the use of robotics, increasingly supported by vision technologies and artificial intelligence, is growing (11). In fact, according to the PMMI report, Pharmaceutical Manufacturing Trends Shaping the Future, nearly three-quarters of respondents use robotics now and 53% plan to expand deployments for secondary and tertiary packaging applications (12).

Even quality control systems are becoming more automated. For example, PTI has introduced the modular E-Scan RTX model, a fully-automated container/closure integrity tester for pre-filled syringes. Its adaptable robotic design relies on micro-current high-voltage leak detection, which is compatible with delicate biologic liquids, including those with extremely low conductivity. The test yields a pass/fail result in seconds. Listed in United States Pharmacopeia Chapter <1207> as a recommended method for parenteral liquid package inspection, the system offers a good signal/noise ratio between good and defective products. Low-voltage exposure reduces the production of ozone (13).

Meanwhile, the pace of digitization is accelerating to meet regulatory requirements, address cybersecurity concerns, achieve operational visibility, and support blockchain product tracking (12).

Reliance on third parties

The global pharmaceutical contract packaging market reached US$18.44 billion in 2021 and is forecast to expand at a compound annual growth rate of 8.07% through 2027, according to a market study available from Research and Markets (14). This forecast tracks with information in the PMMI report, which notes three out of five pharma manufacturers outsource at least a
portion of their operations to a third-party contractor (12).

Contract manufacturing and packaging organizations help pharma manufacturers address the growing demand for injectables and personalized medicine. Benefits of hiring a third party include access to formats and production methodologies that are not available in-house, accommodating spikes in demand, and cutting costs by eliminating the need to source, install, and validate new machines and lines. This also frees up capital for use elsewhere in the operation (12).

References

1. PMMI, The Association for Packaging and Processing Technologies, Pharmaceutical Industry Increases Automation, Digitization. Press Release. Aug. 15, 2022.

2. Forcinio, H. Consumers Seek Sustainable Products. PharmTech, 46 (11)November 2022.

3. PMMI, The Association for Packaging and Processing Technologies, Pharmaceutical Manufacturing, The Future Ahead. Infographic. Undated.

4. SCHOTT, SCHOTT Establishes Stand-Alone Company for Its Pharma Business to Promote Further Growth. Press Release. Aug. 1, 2022.

5. SCHOTT Pharma, Simplifying Self-medication: SCHOTT Pharma Expands Cartridge Production in China and Hungary.Press Release. Sept. 22, 2022.

6. SCHOTT Pharma, Driving Growth for Prefillable Glass Syringes: SCHOTT Pharma Breaks Ground for Cutting-edge Production in Hungary. Press Release. Oct. 27, 2022.

7. Stevanato Group, Stevanato Group and Gerresheimer AG Together to Develop an Innovative RTU Vial Platform. Press Release. Sept. 7, 2022.

8. Stevanato Group, Stevanato Group and Gerresheimer AG Present EZ-fill Smart, a New and Innovative Ready-to-Use Vial Platform. Press Release. Nov. 1, 2022.

9. Stevanato Group, DWK Life Sciences and Stevanato Group Sign Non-Exclusive Distribution Agreement for EZ-fill Platform Products. Press Release. Oct. 27, 2022.

10. Juarta Thin Film, Our Technology, The MSI-TX Thin Film. www. juratatf.com/our-technology, accessed Nov. 30, 2022.

11. PMMI, The Association for Packaging and Processing Technologies, The Future of Automation in Packaging and Processing. Report. October 2022.

12. PMMI, The Association for Packaging and Processing Technologies, Pharmaceutical Manufacturing Trends Shaping the Future. Report. March 2022.

13. PTI, PTI Launches E-Scan RTX Automated CCI Solution for Pre-filled Syringes at PACK EXPO International. Press Release. Oct. 17, 2022.

14. Research and Markets, Global Pharmaceutical Contract Packaging Market Report (2022 to 2027) - Industry Trends, Share, Size, Growth, Opportunity and Forecasts. Press Release. June 7, 2022.