Supplier reliability, spec consistency and ordering predictability determine whether your validated processes stay on schedule or face costly disruptions.

What Pharmaceutical Packaging Teams Need From a Single-Use Tubing Supplier

Pharma manufacturing processes get validated against a specific tubing spec. The exact material, inner diameter, wall thickness and sterilization method used during process validation are the only versions of that tubing allowed in production without triggering a review.

Pharmaceutical packaging and procurement teams can’t treat tubing as a commodity purchase the way a facility might treat gloves or wipes.

A supplier switch or even a minor spec substitution forces the quality team to determine whether the change is significant enough to require requalification, additional testing or a filing update. That review process can take a long time, depending on the product and regulatory pathway.

Because of this, the supplier relationship potentially matters more than the per-unit price. A cheaper tubing source that can’t guarantee the same spec, lot after lot, often costs more in requalification time and production delay than it saves on the purchase order.

Why Repeat-Order Availability Shouldn’t Be a Gamble

Single-use tubing is often made to custom or semi-custom specs rather than pulled from generic stock. A supplier without a stocking program manufactures each purchase order rather than shipping from inventory. That turns routine reorders into new production runs with their own lead times.

Running out midprocess is a production stoppage. A batch that’s already underway can’t simply wait for restock without affecting hold times, environmental monitoring windows and, in some cases, the validity of the batch itself. Pharmaceutical equipment distributors like Sentinel Process Systems address this through dedicated stocking programs that align inventory levels with customer production schedules and forecasted demand.

This maintains safety stock to buffer against allocation shortages and unexpected volume increases.

How Delivery Delays Throw Off Your Production Schedule

Clean room time, equipment availability and trained staff are all scheduled in advance in most pharma manufacturing environments, because resources are shared across products and shifts. Tubing arriving late pushes the batch entirely out of its allocated production window.

Rescheduling a batch means rebooking a clean room suite that’s already committed to another product, reassigning qualified operators or re-executing environmental qualification if enough time has passed since the last clean room certification. The pharmaceutical industry faces significantly longer lead times than other industries, jeopardizing timely delivery.

The financial impact compounds past the missed date itself. A delayed batch can push back the next one in the same suite. For companies with clinical trial timelines or committed delivery dates, that ripple effect is often the costliest part of the delay, not the tubing itself.

The Importance of Consistent Tubing Specifications

A spec change covers more than swapping brands. Other factors include using alternative silicone or thermoplastic elastomer formulations, modifying the inner diameter or wall thickness, or adopting a new sterilization method, such as gamma, ethylene oxide or autoclave. Even moving production to a new manufacturing site for the same nominal product would be considered a change that needs to be assessed.

Under the FDA’s framework for disposable manufacturing material changes, buyers are expected to assess whether a change is significant enough to require reporting. In some cases, prior approval is required before it’s implemented in a validated process.

Changes involving disposable manufacturing materials may require different FDA reporting pathways depending on their potential effect on product quality. This ranges from annual reporting to prior approval before implementation.

A supplier that changes raw material sources or manufacturing sites without proactively notifying customers puts that evaluation burden on the buyer afterward, often after the product has already shipped or been used. This is a much worse position than knowing about a change in advance.

Sentinel Process Systems emphasizes consistency and documentation to support regulated manufacturing environments, helping procurement and quality teams maintain more predictable sourcing for recurring orders.

Solving the Inventory Forecasting Challenge

Tubing demand is driven by batch schedules that shift constantly. It’s tied to clinical trial enrollment pace, manufacturing yield and regulatory approval timing, which suppliers can’t see. Buyers forecasting against future production plans are often working with assumptions that will shift before orders arrive.

On the supplier’s side, buyers typically don’t have visibility into actual lead times, safety stock levels or how close a given stock-keeping unit (SKU) is to a reorder point. That means a buyer’s forecast is built on assumptions about supplier capacity rather than real data.

Both sides plan around incomplete information, a structural feature of pharma supply chains. Limited transparency in supply chains makes it difficult to calculate lead times and maintain correct inventory levels. Suppliers who share more of their own inventory and lead time data directly reduce that gap.

What to Look for in a Supplier That Scales With You

Breadth of inventory means how many SKUs, sizes and material types a supplier actually holds ready to ship versus how many require a custom manufacturing run. A supplier can appear comprehensive on a catalog page while stocking only a fraction of the items, so confirm this directly.

Distributors with direct relationships with multiple raw material and component manufacturers have more rerouting options than those reliant on a single upstream source.

Documentation support means whether lot traceability, certificates of analysis and change notifications are provided as standard practice or only on request after something has already gone wrong. The difference between those two models often determines how quickly a buyer’s quality team can respond to a supply disruption.

Sentinel Process Systems offers access to over 100,000 products from more than 30 manufacturing partners and has served as a strategic partner since 1950. It provides the breadth and longevity worth evaluating for recurring single-use tubing suppliers.

Frequently Asked Questions

Here are some common concerns for procurement and quality teams.

What makes a single-use tubing supplier reliable for repeat orders?

A reliable supplier maintains consistent stock levels, provides predictable lead times, and communicates proactively about any changes to product availability or specifications. Stocking programs aligned with your production schedule reduce the risk of allocation shortages during periods of high industry demand.

Why do tubing specifications need to stay consistent across orders?

Validated processes are locked to specific tubing specs, including material formulation, dimensions, required packaging, and sterilization method. Any deviation from that spec can trigger a quality review, requalification testing or regulatory filing updates, all of which delay production and increase costs.

Building a Tubing Supply Strategy That Grows With You

Scalability means more than finding suppliers who ship larger quantities. It’s partnering with a distributor who understands the regulatory constraints you operate under, maintains the inventory depth to support repeat orders and provides the documentation your quality team needs to respond quickly when conditions change.

Choosing a supplier with the infrastructure to scale alongside your production needs protects your validated processes and packaging and manufacturing timelines.

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A Single-Material Design Built for Recycling

The revised blister pack is constructed entirely from polypropylene, making it a mono-material format that still meets the product protection, safety, and quality standards required for consumer health products. Talcid, which is used for heartburn and other acid-related symptoms, continues to be delivered with the same user experience despite the packaging change.

The recyclable blister pack has received RecyClass Design for Recycling certification, achieving a Recyclability Class A rating and a recyclable plastic content score of 98.86%. Bayer stated that the format is intended to support recycling in markets where the necessary collection, sorting, and processing infrastructure is already in place.

Planned Expansion Across European Markets

Bayer plans to extend the new blister format to 11 additional European markets during 2026 and 2027. The German launch marks a significant step in that rollout, building on the earlier introduction in Slovenia.

The Talcid launch also follows Bayer’s broader work on mono-material blister packaging solutions. In 2024, the company introduced a PVC-free polyethylene terephthalate (PET) single-material blister for Aleve in the Netherlands, reflecting a continued direction across its Consumer Health packaging portfolio toward materials that are more compatible with recycling systems.

Bayer’s Position on Scalable Packaging Innovation

Bayer Vice President Chris Padain commented on the development: “The promise of this mono-material polypropylene design is that it can improve compatibility with recycling processes where appropriate systems exist, while continuing to provide a strong consumer experience. Its push-through performance supports intuitive use, while the mono-material structure simplifies the packaging design. This is the kind of practical, scalable innovation that can make a meaningful difference across our portfolio.”

Bayer confirmed that the mono-PP Talcid blister forms part of its wider Consumer Health packaging plans, with the RecyClass-certified design offering a format the company sees as both practically functional and compatible with evolving recycling capabilities across European markets.

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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.

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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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