Expanded Production Capacity for Injectable Medicines

The establishment of this site effectively doubles the overall production capacity of Gerresheimer in China for primary packaging used for injectable medicines. The production line is currently operational, manufacturing specialized ampoules alongside pharmaceutical vials targeted predominantly at the domestic Chinese market. These expanded facilities ensure a reliable supply of packaging for critical injectable medicines.

The facility is equipped with automated logistics and production systems, as well as state-of-the-art glass forming lines. Operating under China’s good manufacturing practices for pharmaceutical packaging, the site manufactures borosilicate glass ampoules and pharmaceutical vials across multiple sizes and formats. To support these operations, the plant currently employs roughly 250 workers, with plans to add 50 additional roles over the next several years.

Strategic Partnership with Shuangfeng Glass

The launch of the Zhenjiang Dagang facility coincides with a 20-year operational partnership between Gerresheimer and Chinese enterprise Shuangfeng Glass. Through their established joint venture, Gerresheimer Shuangfeng Pharmaceutical Glass, the alliance with Shuangfeng Glass now operates four Tubular Glass plants across China. These include two sites located in Danyang, one facility in Zhenjiang, and the newly commissioned operation in Zhenjiang Dagang.

Gerresheimer tubular glass global senior vice-president Mehran Nilchian said: “With our new plant in Zhenjiang Dagang, we are responding to the dynamic market growth in China, particularly in the field of injectable biologics.” Nilchian added: “We are pleased that we can provide our pharma and biotech customers in China and the Asia-Pacific region with the best possible support through our expanded production capacity, excellent quality, and comprehensive service.”

By delivering high-standard glass primary packaging, the facility strengthens support for pharmaceutical and biotechnology operations throughout the region.

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Haruo Naito, CEO at Eisai, says: “This strategic investment reflects our long-term commitment to strengthening resilient supply capabilities for our innovative medicines and pipeline products, while further deepening our long-standing relationship with the UK. We value the opportunity to work with the UK government in strengthening life sciences manufacturing and healthcare resilience for the future.” The investment is aligned with the UK government’s objective of strengthening pharmaceutical manufacturing within the country. Eisai’s Hatfield facility is expected to operate as a regional manufacturing hub serving Europe, the Middle East, and Africa. The company noted that the project will expand the site’s responsibilities beyond oral solid dose production to include the packaging and supply of injectable and infusion medicines requiring controlled-temperature management. This expansion supports the growth of Cold-Chain Pharma Packaging capabilities within the facility.

The project also enables Eisai to reduce dependence on external contract manufacturers by bringing a greater share of packaging activities in-house. Planned developments include enhanced goods receipt and dispatch operations, new ambient and cold-chain warehouse facilities, dedicated packaging buildings, and additional packaging lines capable of handling temperature-controlled products. According to the company, the site’s ability to manage multilingual packaging requirements, small production batches, and stringent quality controls will further strengthen its global supply network. Lord Vallance, Minister of State for Science, says: “Building world-class manufacturing capabilities here in the UK will secure the supply of vital medicines, including treatments for Alzheimer’s disease, that can transform lives. Eisai’s government-backed investment will also support the creation of new skilled jobs in Hatfield and is another example of the benefits of international companies investing in the UK bolstering our reputation as a life sciences hub while growing our economy.”

Recent activity across the sector highlights continued investment in pharmaceutical packaging infrastructure. This month, Amcor expanded healthcare packaging production capacity through investments in Sira, Karnataka, India, and a US$35 million healthcare packaging coating facility in Subang Jaya, Selangor, Malaysia. Earlier this year, Sharp committed more than €20 million (US$21.6 million) to its European packaging facilities to meet growing demand for injectable products. Eisai’s latest project adds to this momentum while reinforcing its position in Cold-Chain Pharma Packaging operations.

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Established in 1910 in Newark, New Jersey, O.Berk initially supplied bottles and jars to local chemical plants and food companies before evolving into a major packaging provider. The company later became family-owned and contributed to the commercialization of plastic bottles and closures. Led today by fourth-generation owners Marc Gaelen and Meryl Japha, O.Berk operates facilities in New Jersey, Connecticut, Maryland and Southern California. Its customer base spans beauty, personal care, pharmaceutical, nutraceutical, household, food and beverage sectors. Alongside its packaging offerings, the company manages BottleStore.com, an e-commerce platform serving small businesses and emerging brands. O.Berk also provides design and innovation services, custom tooling, decoration, warehousing, logistics management, quality assurance and regulatory compliance support.

The acquisition is expected to expand Berlin Packaging’s value-added service portfolio while increasing its North American footprint. O.Berk customers will gain access to the company’s global supply chain network, sustainability expertise, logistics capabilities, digital tools and Studio One Eleven design services. Berlin Packaging supplies billions of glass, plastic and metal containers and closures annually, combining manufacturing, distribution and value-added services for customers across multiple industries.

Commenting on the transaction, Rick Brandt, CEO, Berlin Packaging Americas, said: “We are excited to welcome O.Berk to Berlin Packaging. Like Berlin, O.Berk has a long history of supporting customers with packaging products and value-added services. This combination expands our industry-leading capabilities and strengthens our expertise in growing beauty, personal care, pharmaceutical, and nutraceutical markets.”

Marc Gaelen, President and CEO, O.Berk Company, stated: “We are proud to join forces with Berlin Packaging and excited for the opportunities this partnership creates. Berlin’s global supply chain, digital capabilities, sustainability expertise, logistics platform, and Studio One Eleven design services will enhance the solutions available to our customers and create new opportunities for our employees and suppliers.”

Bill Hayes, Global CEO and President, Berlin Packaging, added: “Family-owned businesses like O.Berk bring deep industry expertise, entrepreneurial spirit, and deep relationships with stakeholders. We are excited to bring our organizations together and build on that momentum for years to come.”

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As part of the system, the Product Navigator has been developed to simplify material selection across a growing range of packaging options. The tool allows users to assess suitable material combinations according to application requirements and sterilization methods such as steam, EtO, and gamma sterilization. The MedGuard portfolio includes flexible and rigid packaging systems, including thermoforming films as well as pouch and bag solutions. Dedicated lidding materials are produced under certified cleanroom conditions and are designed to support sterile packaging validation in accordance with ISO 11607 requirements. SÜDPACK Medica stated that it also works with suppliers of paper and lidding materials along with packaging machine manufacturers to configure and optimize sealing performance and opening behavior for industrial production environments.

The company additionally highlighted the role of its in-house laboratory facilities and Technology Center in Ochsenhausen in supporting packaging validation and process testing. Customers can conduct sealing trials using MedGuard films together with different lidding materials to evaluate sealing ranges, peel characteristics, and process robustness before commercial deployment. SÜDPACK Medica also noted that sustainability assessments form part of the MedGuard strategy, with screening life cycle assessments being used to generate environmental evaluations based on secondary data. The company said these analyses are intended to support packaging systems that balance sustainability performance with safety, functionality, and regulatory requirements. SÜDPACK Medica continues to position MedGuard Packaging as a system-focused approach for sterile barrier packaging applications across healthcare industries.

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Sustainable packaging solutions are increasingly replacing conventional materials such as non-degradable plastics, glass, and metal with recyclable, reusable, and biodegradable alternatives. Within the pharmaceutical industry, packaging remains a critical component for ensuring sterility, contamination prevention, and product shelf-life stability. The integration of environmental compliance with functional packaging performance is emerging as a key driver of long-term market demand.

Governments across major economies are strengthening regulations related to packaging waste and recyclability. The United Kingdom has allocated substantial public funding to accelerate sustainable plastic packaging innovation, while the United States introduced Extended Producer Responsibility (EPR) laws in July 2025 that require packaging producers to finance recycling systems based on packaging volume and recyclability standards. These regulatory developments are increasing the commercial viability of sustainable materials across the packaging value chain.

Investor activity and manufacturing expansion are also supporting market momentum. Over the last five years, sustainable packaging companies collectively secured more than USD 13 billion in funding activity. In March 2026, a major packaging manufacturer announced plans to establish a 468,000-square-foot sustainable packaging facility in Mississippi to address rising long-term demand for environmentally compliant packaging formats.

Key Market Drivers

• Regulatory enforcement and EPR frameworks are accelerating adoption of recyclable and reusable packaging materials across pharmaceutical and consumer industries.
• Sustainability commitments from pharmaceutical and biotechnology companies are increasing pressure on suppliers to provide eco-friendly packaging formats.
• Expansion of pharmaceutical drug pipelines is driving additional demand for primary and secondary packaging solutions.
• Strategic partnerships and material innovation initiatives are improving recyclability, fiber-based packaging adoption, and sustainable closure technologies.
• Advancements in material science are helping reduce performance limitations traditionally associated with biodegradable and sustainable packaging materials.

Market Segmentation Analysis

Recyclable and reusable packaging currently accounts for approximately 90% of the total sustainable packaging market due to established manufacturing infrastructure, availability of recyclable raw materials, and extended product shelf life. However, biodegradable packaging is projected to expand at a faster pace, with an estimated CAGR of around 7% through 2035 as environmental regulations become stricter.

Primary packaging, including bottles, syringes, cartridges, ampoules, and vials, represents the largest segment by packaging type and is expected to maintain market leadership throughout the forecast period. In secondary packaging, boxes and cartons continue to dominate due to their scalability and compatibility with diverse product sizes and shipping requirements.

Pharmaceutical and biotechnology companies remain the largest end-user segment, driven by high-volume packaging demand and sustainability compliance mandates linked to greenhouse gas reduction initiatives.

Regional Outlook

Asia-Pacific currently holds nearly 50% of the global sustainable packaging market and is expected to maintain its leading position through 2035. The region’s growth is supported by population expansion, rising healthcare consumption, and increasingly strict regulations targeting plastic pollution. Countries including Japan, South Korea, and Thailand have implemented restrictions on conventional plastics while encouraging adoption of sustainable packaging alternatives.

Europe and North America continue to represent major market centers due to established regulatory frameworks and high concentration of packaging solution providers. Europe remains a key innovation hub supported by advanced environmental policies and packaging regulations, while the United States market is benefiting from new EPR legislation introduced in 2025.

Latin America is forecast to be the fastest-growing regional market, with a projected CAGR of 6.9% through 2035. Growth in the region is being supported by rising consumer preference for environmentally responsible products, stricter plastic waste regulations, and expanding retail and e-commerce sectors requiring scalable sustainable packaging solutions.

The post Global Sustainable Packaging Market to Hit $19.19B by 2035 first appeared on Packaging World Insights.

Tjoapack brings more than 35 years of experience in delivering primary and secondary packaging services to the pharmaceutical sector. Its operations span packaging and labelling for oral solid dose products such as blister packs and bottles, alongside sterile injectables including vials, pre-filled syringes and auto-injectors. The company runs facilities in Clinton, Tennessee, and Etten-Leur in the Netherlands, employing over 400 people while serving more than 40 commercial markets globally.

Commenting on the development, Tjoapack CEO Dexter Tjoa said: “This transaction represents an important next chapter for Tjoapack. Partnering with Alcami allows us to accelerate our growth ambitions while staying true to what has made Tjoapack successful – quality, reliability, and a strong focus on our customers.

“Together, we create a more integrated transatlantic platform that enables us to support our partners more effectively as they scale and expand globally.”

Following completion, Alcami will expand its packaging and labelling capacity in the US, while also adding Qualified Person release and associated services in Europe. Customers of Tjoapack are expected to gain access to a broader set of Alcami capabilities, including pharmaceutical testing laboratories, sterile and oral solid dose drug product manufacturing, and GMP pharmaceutical storage.

Alcami CEO and chairman Patrick Walsh said: “This acquisition marks our first European expansion, which is an essential element of our investment strategy to expand our presence in the global market.

“Furthermore, this increased scale aligns with our growth and expansion in pharmaceutical testing lab services, drug product manufacturing and pharma storage service offerings at Alcami.”

The Tjoapack acquisition is expected to close in the second quarter of this year, pending the fulfilment of standard conditions.

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Established in 1983 and headquartered in Istanbul, SEM Plastik is a leading regional plastics manufacturer with a strong legacy as one of Türkiye’s pioneers in sustainable packaging and, more recently, advanced medical manufacturing. SEM Plastik continues to expand its global presence, building on more than 25 years of engineering excellence.

To support this transition into medical manufacturing, SEM Plastik selected Husky as a long term supplier, recognizing the value of the company’s ICHORTM integrated medical system technology platform, and comprehensive service offering. As an early adopter, SEM Plastik invested in a complete solution designed to deliver consistent quality, operational efficiency, and regulatory compliance from day one.

High End Quality and Regional Impact

Through its SEM BIOTECH division and under its Vacusem brand, SEM Plastik has entered the medical components market and operates one of the most precise and high-capacity vacuum blood collection tube production lines in the world, with an annual production capacity of 500 million tubes, delivering the highest quality standards in Türkiye.

Vacusem tubes are fully automatically manufactured in an ISO 8 cleanroom environment and packaged under the highest hygiene standards, using best-in-class chemical formulations and components. The production is designed to meet European Union market standards, with a strong focus on export-oriented growth. This investment makes a strong contribution to Türkiye’s high value-added and high-technology exports.

“Diversifying into medical manufacturing required a trusted supplier and a proven technology platform. We are proud to serve the region with best in class blood collection tubes, and Husky’s support as an early adopter partner was essential in helping us turn this ambition into a successful and sustainable operation”, said Yavuz Eroğlu, SEM Plastik’s Owner-Chairman and President of PAGEV, the Turkish Plastic Packaging Manufacturers Association.

The collaboration supports Türkiye’s emergence as a reliable producer of high quality blood collection tubes, strengthening local supply chains while establishing a foundation for continued innovation and market expansion.

System Level Solution Enables Rapid Market Entry

Husky’s solution combines the ICHOR™ integrated medical system, advanced Schöttli Medical Molds, and Advantage+Elite™ proactive monitoring support, enabling SEM Plastik to establish a scalable, high performance production platform for blood collection tubes. The integrated system approach reduces operational complexity while delivering enhanced throughput, reduced material waste, and consistent part quality.

“We are proud to support SEM Plastik’s growth with the deployment of the ICHOR™ system, the fastest platform solution to produce blood collection tube in the market. By combining speed, precision, and full system integration, we are helping SEM Plastik establish a world class medical production platform in Türkiye”, said Thomas Bontempi, Husky’s General Manager Medical Business.

Husky’s advanced technology contributes to reduced cycle times and improved efficiency, while full traceability and process stability support compliance with stringent international medical standards. Additionally, dedicated training programs for running the system have been delivered to support medical injection molding and process optimization, enabling long-term operational excellence.

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This growth trajectory underscores the increasing strategic importance of packaging within the global pharmaceutical value chain, where compliance, product integrity, and supply chain efficiency are becoming central operational priorities.

Market Expansion Driven by Production and Compliance Needs

The continued rise in global pharmaceutical output remains a primary growth driver. Expanding production of generic drugs and biologics particularly across Asia Pacific and North America is increasing demand for high-performance packaging solutions capable of meeting stringent regulatory requirements.

At the same time, regulatory frameworks are tightening. Serialization mandates, track-and-trace systems, and anti-counterfeiting measures are being enforced across major markets, prompting pharmaceutical companies to upgrade packaging formats. These compliance-driven shifts are not only increasing baseline demand but also accelerating replacement cycles for legacy packaging systems.

As Packaging World Insights observes, the convergence of regulatory pressure and production scale is positioning packaging as a critical interface between manufacturing and market access.

Technology and Biologics Reshape Packaging Requirements

The growing prominence of biologics and specialty drugs is redefining packaging specifications. These therapies require advanced containment systems such as vials, prefilled syringes, and temperature-controlled formats to maintain stability and efficacy.

This shift is also driving the integration of cold-chain logistics into packaging design, elevating the role of packaging from a passive container to an active component of drug delivery infrastructure.

Simultaneously, technological advancements are transforming the market landscape. Smart packaging solutions incorporating RFID, IoT-enabled monitoring, and real-time tracking are improving supply chain visibility and reducing risks associated with counterfeiting and product degradation.

Material innovation is another key area of development, with high-barrier films and biodegradable plastics gaining traction as manufacturers seek to balance performance with environmental considerations.

Segment Dynamics Highlight Primary Packaging Dominance

Across product categories, primary packaging continues to account for the largest share of the pharmaceutical packaging market, driven by its direct interaction with drug products and its role in ensuring safety and stability. Bottles, vials, ampoules, and blister packs remain foundational to pharmaceutical distribution systems.

• Primary packaging leads due to contamination prevention and regulatory requirements
• Injectable packaging is the fastest-growing segment, supported by biologics and vaccine demand
• Oral drug packaging retains dominance due to high global prescription volumes
• Contract packaging organizations are expanding, reflecting increased outsourcing trends

From a materials perspective, plastics maintain a dominant position due to cost efficiency and versatility, while glass remains essential for injectable and biologic formulations. Meanwhile, sustainable materials are emerging as a high-growth segment amid regulatory and environmental pressures.

Regional Shifts Reinforce Asia Pacific Growth Momentum

Regionally, North America continues to hold the largest share of the pharmaceutical packaging market, accounting for approximately 38–40%, supported by advanced pharmaceutical infrastructure and strict compliance standards.

However, Asia Pacific is the fastest-growing region, driven by expanding pharmaceutical manufacturing hubs in China and India, alongside increasing healthcare investments and export activity. Cost-efficient production and supportive government initiatives are further strengthening the region’s position in the global supply chain.

Europe remains a mature market with steady growth, characterized by strong regulatory alignment and a growing emphasis on sustainable packaging practices.

Operational Constraints and Market Pressures

Despite strong growth fundamentals, the industry faces several operational challenges. The high cost of advanced packaging technologies continues to limit adoption, particularly among small and mid-sized pharmaceutical companies. At the same time, navigating diverse regulatory frameworks across regions increases complexity and operational costs.

Supply chain vulnerabilities ranging from raw material price volatility to logistics disruptions are also impacting production efficiency. In parallel, the transition toward sustainable materials presents both an opportunity and a challenge, requiring significant investment in new technologies and manufacturing processes.

Competitive Landscape and Strategic Positioning

The pharmaceutical packaging market remains moderately fragmented, with competition centered on innovation, regulatory compliance, and cost optimization. Leading players such as Amcor plc, Gerresheimer AG, West Pharmaceutical Services Inc., and Schott AG are advancing capabilities in high-performance materials, containment systems, and smart packaging technologies.

Strategic collaborations, mergers, and technology partnerships are becoming increasingly common as companies seek to expand geographic presence and strengthen product portfolios.

Strategic Outlook for the Pharmaceutical Packaging Market

Looking ahead, the pharmaceutical packaging market is expected to remain closely aligned with broader pharmaceutical industry trends, particularly the expansion of biologics, increasing regulatory oversight, and the push toward sustainable operations.

As packaging evolves from a supporting function to a strategic enabler of drug safety and supply chain integrity, its role within the healthcare ecosystem is set to deepen further. In this context, Packaging World Insights highlights that innovation, compliance readiness, and material advancement will remain central to competitive differentiation across the market.

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The Regulatory Evolution of EU GMP Annex 1

The latest revision of EU GMP Annex 1 has introduced significant changes to the way sterile products and their components are handled. This updated guidance emphasizes a holistic approach to contamination control, moving away from a purely reactive model of testing toward a proactive strategy of risk management. For manufacturers of bulk APIs, this means that every stage of the packaging process must be meticulously validated to ensure that sterility is maintained. The concept of a contamination control strategy (CCS) is now a central requirement, demanding that companies provide a comprehensive overview of all technical and organizational measures in place to prevent contamination. This includes the selection and qualification of sterile barrier packaging materials, which must demonstrate their ability to withstand the rigors of sterilization processes such as gamma irradiation, ethylene oxide, or steam, without compromising their physical or chemical properties.

Material Science and the Performance of Barrier Systems

The choice of materials for sterile barrier packaging is a critical decision that directly impacts the stability and shelf life of bulk APIs. These materials must provide an absolute barrier against microbial penetration while also offering resistance to moisture, oxygen, and light, which can degrade sensitive chemical structures. Commonly used materials include high-density polyethylene (HDPE), various fluoropolymers, and multi-layer laminate films. Each of these materials offers distinct advantages in terms of mechanical strength, transparency, and chemical compatibility. For example, some highly potent APIs may require the use of specialized liners that prevent the leaching of plasticizers or other additives into the product. The interaction between the API and the packaging material must be thoroughly investigated through extractable and leachable (E&L) studies, ensuring that the container-closure system does not adversely affect the quality of the ingredient.

Maintaining Aseptic Integrity During Transfer and Handling

One of the most challenging aspects of using sterile barrier packaging for bulk APIs is the transfer of the product between different cleanroom environments. The “bag-in-bag” or “nested” packaging configurations are often used to facilitate this process, allowing for the outer layers to be removed as the product moves into progressively higher grades of cleanroom. This technique is essential for preventing the introduction of environmental contaminants from the warehouse or transport areas into the aseptic processing zone. Additionally, the use of rapid transfer ports (RTPs) and split butterfly valves has become standard practice for the sterile transfer of bulk powders. These mechanical interfaces allow for a closed-system transfer, where the sterile barrier packaging is connected directly to the processing equipment without exposing the API to the surrounding atmosphere. This level of containment is not only necessary for product sterility but also for the protection of operators handling highly potent or hazardous substances.

Validation and Integrity Testing of Barrier Systems

The reliability of sterile barrier packaging is dependent on a rigorous program of validation and routine integrity testing. Manufacturers must demonstrate that the packaging system can maintain its barrier properties throughout its intended lifecycle, including during the stresses of shipping and long-term storage. This validation process often involves a combination of physical and microbial challenge tests. Physical tests, such as bubble point testing, pressure decay, or high-voltage leak detection, provide a non-destructive way to verify the seal integrity of the packaging. Microbial challenge tests, on the other hand, involve exposing the packaging to a high concentration of microorganisms to confirm that it remains impermeable. For bulk APIs stored in large-format bags or containers, the validation must also account for the potential for pinholes or tears that could occur during handling. The transition to the new Annex 1 requirements has placed an even greater emphasis on the use of validated integrity testing methods that are sensitive enough to detect micro-leaks that could compromise sterility.

Environmental Monitoring and Cleanroom Compatibility

The performance of sterile barrier packaging is intrinsically linked to the environment in which it is used. Under EU GMP guidelines, the filling and sealing of sterile APIs must take place in a Grade A environment, typically within an isolator or a restricted access barrier system (RABS). The packaging materials themselves must be introduced into these environments through validated sterilization or decontamination cycles. For materials that cannot be autoclaved, such as certain plastic films, surface decontamination using vaporized hydrogen peroxide (VHP) is a common method. However, it is essential to ensure that the VHP does not penetrate the packaging or react with the API within. Continuous environmental monitoring, including the sampling of air and surfaces for microbial and particulate levels, provides the necessary data to confirm that the cleanroom is operating within its specified limits. The synergy between a well-designed sterile barrier system and a strictly controlled cleanroom environment is the only way to ensure the ongoing quality of bulk APIs.

The Role of Traceability and Documentation

In the pharmaceutical industry, the mantra of “if it isn’t documented, it didn’t happen” remains as relevant as ever. The use of sterile barrier packaging for bulk APIs requires a comprehensive trail of documentation that tracks the material from the point of manufacture to its final use in a finished drug product. This includes certificates of analysis (CoA) for the packaging materials, records of the sterilization process, and the results of all integrity and validation tests. With the increasing complexity of global supply chains, the ability to trace the history of a sterile barrier system is essential for investigating any potential quality issues. Many manufacturers are now adopting digital solutions, such as blockchain or advanced track-and-trace systems, to enhance the transparency of their packaging logistics. This not only aids in regulatory compliance but also provides an additional layer of security against the introduction of counterfeit or substandard materials into the supply chain.

Economic and Operational Impacts of Compliance

While the implementation of high-performance sterile barrier packaging and the associated regulatory requirements represent a significant investment, the cost of non-compliance is far higher. A single contamination event can lead to the loss of an entire batch of expensive API, not to mention the potential for regulatory fines, product recalls, and damage to the company’s reputation. Beyond the financial risks, there is an ethical obligation to ensure that the medications reaching patients are safe and effective. By investing in the latest packaging technologies and adhering to the principles of EU GMP, manufacturers can achieve a more robust and reliable production process. The operational efficiencies gained from reduced waste, fewer batch failures, and more streamlined regulatory inspections provide a clear return on investment over the long term. In a market where quality is a primary differentiator, the excellence of a company’s sterile barrier strategy is a key indicator of its overall commitment to manufacturing excellence.

Future Trends in Sterile API Packaging

The future of sterile barrier packaging for bulk APIs is being shaped by the rise of personalized medicine and the growing importance of biopharmaceuticals. These new classes of drugs often involve smaller batch sizes and more sensitive molecules that require specialized handling and storage conditions. We are likely to see the development of “smart” packaging that can monitor and report on its own integrity and environmental conditions in real-time. There is also an increasing focus on sustainability, with researchers looking for ways to reduce the environmental impact of pharmaceutical packaging without compromising on safety or sterility. This includes the exploration of bio-based polymers and more efficient recycling programs for cleanroom materials. As the regulatory landscape continues to evolve, the pharmaceutical industry must remain agile, embracing new technologies and methodologies to ensure that the sterile barrier remains an unbreakable link in the chain of patient care. The pursuit of perfection in contamination control is an ongoing journey, and sterile barrier packaging will continue to be at its forefront.

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ISO 13485:2016 outlines specific requirements for quality management systems in the medical device sector, including structured risk assessment processes, regulatory alignment, and operational efficiency. The transition from ISO 9001:2015 reflects a higher level of compliance and closer alignment with expectations from medical device manufacturers. This certification supports the site’s role in delivering healthcare packaging that meets defined safety, compliance, and quality benchmarks.

During the certification process, the Winterbourne team implemented several operational improvements. These included strengthening risk management practices, enhancing supplier standards, clarifying internal procedures, and reinforcing focus on customer requirements and patient safety. These adjustments were introduced to support consistent performance in healthcare packaging production and quality management.

“Our customers recognize ISO 13485:2016 as a key quality standard for the medical device industry”, said Jon Cowgill, General Manager at Amcor Flexibles Winterbourne. „With this, we are reinforcing our commitment to a quality management system that prioritizes and protects the end patient. Gaining this certification is a huge achievement for the Winterbourne team.”

With ISO 13485:2016 certification in place, the site is positioned to support a broader range of healthcare programs, including Class I and, in time, Class IIa medical devices. This includes EU Medical Device Regulation (MDR)-compliant products and CE-marked applications. The development aligns with Amcor’s broader healthcare roadmap, which aims to have all healthcare packaging production sites across Europe, Middle East, and Africa certified to either ISO 13485:2016 (Medical) or ISO 15378:2017 (Pharma) by the end of 2027.

The site’s Quality Management System is aligned with FDA’s Quality Management System Regulation requirements, enabling it to support regulated markets in both Europe and the USA while contributing to Amcor’s healthcare packaging portfolio.

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