Innovative active ingredients such as mRNA, biologics, or cell and gene therapies not only bring progress—they also place the highest demands on their packaging. The situation becomes particularly critical when drugs are stored and transported at high sub-zero temperatures. In those cases, reliable tamper evidence truly poses a challenge. Schreiner MediPharm has developed a new solution exactly for that purpose: a transparent deep-freeze seal that reliably works even at temperatures down to -196 °C (-320 °F).

The special feature of the seal is that it will destroy itself when trying to remove it due to a dual security mechanism: the multi-tear effect. It means that not only the seal itself tears due to integrated security cuts that irreversibly destroy it (film tear) but that the cardboard surface of the folding box comes off as well (fiber tear). Any tampering attempt thus becomes immediately visible. In addition, the deep-freeze seal offers a guilloche as an integrated authentication feature. Further overt, semi-covert, and covert authenticity features can be added on request, resulting in a multi-level security solution tailored to the customer’s specific needs.

The transparent deep-freeze seal is suitable for storage temperatures down to -196 °C (-320 °F). Two variants of the seal are available: one for dispensing at 10 °C (50 °F) and a second one for application at temperatures down to as much as -50 °C (-58 °F). Both variants reliably adhere to the folding box across the entire supply chain—from production to final use.

With its many years of expertise in the development of security seals for the pharmaceutical industry, Schreiner MediPharm not only offers technical excellence but also comprehensive consulting support along the entire process chain. Every seal project is customized to suit the specific use case and threat scenario—naturally in compliance with the EU’s Falsified Medicines Directive and ISO 21976.

Digital solutions are key for enhanced inventory management and patient safety in hospital environments. At the same time, product integrity has to be ensured until the point of use. Schreiner MediPharm’s Cap-Lock Label with RFID functionality enables digital tracking of prefilled syringes on unit level as well as enhanced efficiencies along the supply chain.

The new Cap-Lock plus RFID is based on the proven principle of Schreiner MediPharm’s Cap-Lock Label and is combined with SCHOTT Pharma’s SCHOTT TOPPAC^® infuse COC syringes. Thanks to a special cap design that has the same diameter as the syringe barrel, the Cap-Lock Label wraps around the syringe and cap. A label-integrated irreversible first-opening indication is activated as soon as the cap is opened. The solution safeguards the integrity of the prefilled syringe until final use, thus replacing the usual blister pack by a sustainable alternative enabling considerable CO₂ reductions and cost savings. Additionally, due to optimized packaging and distribution processes as well as reduced space requirements during transportation and storage, it helps enhance efficiencies along the entire supply chain.

The special innovation of Schreiner MediPharm’s Cap-Lock plus RFID is its integrated RFID functionality. In addition to the analog first-opening indication, the chip embedded in the label offers a digital first-opening indication. In hospital settings, this enables automated tracking of the integrity of each individual prefilled syringe—up until the medication is administered. Consequently, there is no need to manually check if the syringe has previously been opened, resulting in optimized and reliable processes for healthcare staff. At the same time, clear identification on unit level is supported, which makes seamless tracking in the supply chain possible and facilitates automated inventory management in daily hospital settings. Expired drugs are automatically detected and unused prefilled syringes can be returned to inventory in a reliable process. Potential diversions and medication misuse can be monitored digitally.

Like all RFID solutions from MediPharm, the new Cap-Lock plus RFID features a particularly robust design. A special label construction reliably protects the integrated chip against mechanical stress and functional failure—even on the high-speed dispensing systems in pharmaceutical manufacturing. Thus, the readability and functional reliability of the label-integrated RFID chip is guaranteed from production to final use. As a result, pharmaceutical companies are provided with a reliable solution avoiding additional costs due to production downtimes and waste rates. At the same time, product and patient safety is enhanced.

Label applications at extreme temperatures, especially in the range of deep-freeze and cryogenic levels, are becoming increasingly important. They require reliable closure seals and labels performing perfectly even under harsh conditions. Schreiner ProSecure has taken up this challenge, developing solutions that meet even the most exacting demands.

Applications under cryogenic and deepfreeze conditions confront labels and adhesives with new challenges. Extreme temperatures—whether during storage or dispensing—result in special adhesion and performance requirements regarding a sealing function with first-opening indication. Traditional adhesives and film materials soon reach their limits under these conditions. Especially in gene therapy where active ingredients must be stored at temperatures below -150 °C it is essential that labels reliably adhere to the substrate and are tamper-proof. But even in the less extreme deep-freeze range starting at -15 °C, labels must deliver robust and reliable performance to ensure the safety and integrity of products.

Schreiner ProSecure meets these requirements with a sophisticated modular system specifically developed for use in deep-freeze and cryogenic conditions. To perfectly address the specific demands of customers in terms of temperature and process, the portfolio encompasses a large number of adhesives and surface materials that have been comprehensively analyzed and tested by the company’s in-house research and development department. The focus is not only placed on adhesion at extreme temperatures but also on functions such as distinct first-opening indication or dispensing in the required temperature range. The combination of materials expertise and comprehensive know-how in terms of tamper evidence leads to tailored solutions delivering reliable performance even under the most difficult conditions.

Schreiner ProSecure’s extensive testing expertise is a significant success factor. To ensure that the labels work perfectly in the final application environment, many different tests are performed—both in the in-house laboratory and directly at the customer’s site. Factors like humidity, handling, and storage conditions are considered in order to test the labels’ functionality under realistic conditions. Thanks to this expertise, Schreiner ProSecure offers not only first-class solutions but also certainty that they fully satisfy the customers’ specific requirements.

A classic stamp that for a long time used to be the standard way of marking the documents can be faked—but what about a seal that reacts to heat? Due to the utilization of thermochromic ink, a simple test can confirm the authenticity of the seal. “One swipe with a finger is all it takes for the color to change,” explains Dr. Kai Schnapauff, Director, Schreiner PrinTrust. “That’s an unmistakable feature showing very quickly and easily whether or not a document is authentic.”

However, the adhesive seal was not only developed to prevent counterfeiting. “Thanks to the tab patented by Schreiner, using the seal is as easy as child’s play, fast, and precise,” says Manfred Hammerschmidt from Behördenverlag Jüngling, a publishing house for government forms. “Directly interfacing with the government agencies applying the seal it’s obviously important for us as a publishing house to deliver a high-grade product to our customers that’s easy to use as well,” Hammerschmidt adds. The seal is already in use by various counties and government offices including the Berlin state office for matters pertaining to citizens and public order.

The adhesive document seal, by the way, is not only used in conjunction with vehicle documents but increasingly also for other sensitive items such as official certificates, inspection documents, or for signatures.

 

Moving Forward with Counterfeit Protection

For Schreiner PrinTrust the further development of security solutions remains a central goal. Describing the current situation, Dr. Schnappauf says, “This is a very dynamic field we operate in and which constantly calls for new technologies and solutions to satisfy the growing security needs.” Going forward, a combination of digital and physical security features could deliver even more extensive protection especially in the case of the adhesive seal by combining several protection levels. With their expertise and innovative prowess, Schreiner PrinTrust and Behördenverlag Jüngling are already working on meeting the requirements today and continuing to ensure the security of documents on the highest level.

Schreiner MediPharm together with SCHOTT Pharma and Körber Pharma has developed an innovative packaging concept for prefilled syringes requiring no blister packaging. The new solution offers numerous benefits in terms of sustainability, security, and cost efficiency and met with strong interest at this year’s Pharmapack in Paris. The three partners are thus emphasizing their pioneering role in the field of pharmaceutical packaging.

The blister-free concept is based on the combination of a SCHOTT TOPPAC^® infuse COC syringe with an innovative specialty cap and the novel Cap-Lock Label from Schreiner MediPharm. Due to the new cap design, which has the same diameter as the syringe barrel, the Cap-Lock Label can be applied to the syringe barrel and cap in a reliable process, enabling tamper-evident first-opening indication. Opening the cap irreversibly damages the label so that users immediately see if the syringe has been opened before. “With this solution, we ensure maximum product safety and integrity—from manufacturing to final use,” explains Dr. Nadine Lampka, Senior Product Manager Pharma-Security at Schreiner MediPharm.

Moreover, the Cap-Lock Label performs other protective functions of the conventional blister and transfers them to the primary container. For instance, it can include a gas barrier and multi-level UV and light protection ensuring the stability of the active ingredients. In addition, the extended label area provides ample space for individual product markings and color codes. The integration of an RFID chip for automated tracking on unit level and for digital first-opening indication are possible as well. The combination of a COC syringe with a special cap and functional label with a seal function enables the utilization of a volume-optimized top-load cardboard box from Körber Pharma consisting of 100 percent mono-material. That optimizes packaging and distribution processes in pharmaceutical manufacturing and clearly reduces the space required for transportation and storage.

The new concept offers considerable economic benefits for pharmaceutical manufacturers—while clearly enhancing sustainability. The space-saving packaging reduces material consumption and enables more efficient logistics. “Due to eliminating the need for blister packaging, we can reduce plastics and plastics waste by up to 80 percent and significantly increase transportation capacity at the same time,” emphasizes Christoph Zauner, Head of Global Product Management for Polymer Solutions at SCHOTT Pharma. A sample calculation shows that the number of containers for one shipment of ten million 5 ml SCHOTT TOPPAC^® infuse syringes from Hamburg to New York can be reduced by 16 while avoiding around 87,400 kilograms of CO₂ emissions.

At Pharmapack, the three partner firms presented the solution as part of the Alliance to Zero Workshop “How to Build Sustainable Value Chains Together”. Lidia Smith, Sustainability and Product Manager at Körber Pharma, emphasizes, “The great response at the trade fair shows that sustainable packaging concepts are urgently needed. Our collaboration with Schreiner MediPharm and SCHOTT Pharma is an important step toward an eco-friendlier pharma supply chain.” Schreiner MediPharm underscores its commitment to innovative, sustainable solutions with further functional labels for pre-filled syringes including Needle-Trap Secu and Syringe-Closure-Wrap, both of which enable secure, blister-free packaging as well.

Counterfeit medicines pose a great risk to patients—and entail a loss of image and trust for the pharmaceutical manufacturers concerned. High-priced drugs and those in great demand are particularly attractive for counterfeiters. With its NFC labels, Schreiner MediPharm offers a particularly secure digital solution preventing counterfeits and enabling interactive patient support at the same time.

More and more patients are using pens and autoinjectors for self-medication. With seal solutions and overt authentication features, they can check if the devices are potential fakes but only digital security features provide higher levels of safety. That’s why Schreiner MediPharm has developed NFC-based solutions supporting patients in safely using the devices. With a smartphone and via the NFC label on their injection device, end users can quickly and reliably check if the product they’re holding in their hands is an original. The NFC labels from Schreiner MediPharm offer high-level security ensured by chips with an encryption function whose code cannot be counterfeit or tampered with.

The special design of the NFC label that wraps around part of the cap provides a clear digital seal function in addition to digital authentication. As soon as the end user scans the NFC label with a smartphone an automatic check is run to indicate if the product is intact or has been opened before. The digital solution not only enhances security but also provides pharmaceutical manufacturers with the opportunity to monitor gray market activities and to interactively support patients in administering their medication.

Thanks to its robust design and reliable integration in the manufacturing process, the NFC label can be easily included in the processing of pens and autoinjectors. The NFC functionality is ensured also on high-speed label dispensing systems so that the label enables reliable reading of the chip during the product’s entire lifecycle. The utilization of NFC technology helps prevent counterfeiting, enhance product and patient safety, and protect the supply chain.

Schreiner MediPharm’s novel RFID-Label features a unique integrated digital seal function which irreversibly indicates the first opening of a drug container, enabling automated tracking of its integrity on unit level. Thus, secure medication management in hospital environments is ensured. Due to its special label design, the integrated chip is reliably protected against functional failures from production till final use.

Digitalization is a growing trend in the healthcare sector for automating processes, enhancing product safety, and avoiding medication errors. Labels with an integrated RFID chip play an important role in this regard since they are used for product marking while simultaneously enabling clear digital identification of each individual medicine container. That is a decisive prerequisite for complete end-to-end tracking of the containers within the supply chain. However, in hectic daily hospital settings it must also be ensured that the integrity of the prefilled syringe or vial is intact before administering the medication.

This is exactly where the novel RFID-Label with an integrated digital seal function from Schreiner MediPharm comes into play. Thanks to its special design, it irreversibly indicates the first opening of the container, enabling automated tracking of its integrity. Consequently, a manual check if the container has been opened before is no longer necessary. That not only facilitates work for healthcare staff but also optimizes inventory management because unused drugs can be efficiently returned to stock. At the same time, possible diversions and abuse of medicines can be monitored.

The RFID solution from Schreiner MediPharm additionally features a special label construction reliably protecting the integrated chip against mechanical stress and impacts during the pharmaceutical production process and on high-speed dispensing systems. Thus, the digital seal can be reliably read out from production to final use. That is an important aspect to ensure seamless tracking of the drug on unit level and enhancing product and patient safety.

90 percent recycled content–100 percent security: In January 2024, at Pharmapack in Paris, Schreiner MediPharm for the first time presented its sustainable closure seal that meets the requirements of the EU’s Falsified Medicines Directive as well as the PPWR targets for 2040. Extensive tests demonstrate the capabilities of the seal.

On April 24, 2024, the European Parliament adopted the Packaging and Packaging Waste Regulation (PPWR) that is intended to support the transition toward a circular economy. The regulation requires all packaging to be recycable and plastic parts of packaging to have a minimum recycled content obtained from post-consumer plastic waste by 2030. Schreiner MediPharm has risen to that challenge and developed a sustainable closure seal meeting the most exacting demands.

The Objective: Sustainability and Security Combined
The objective of the product development was to achieve a closure solution offering reliable tamper evidence, high transparency, and optimal printability. At the same time, the seal’s carbon footprint was to be significantly reduced and recycling of the cardboard boxes to be enabled without impairing the quality of the recycling paper. Due to extensive in-house as well as external testing, a film-based seal with up to 90 percent of recycled content was developed. It features a multi-tear effect for irreversible first-opening indication and tamper evidence. Integrated security die-cuts produce a film-tear effect while a fiber-tear effect causes the cardboard fibers to tear. Thanks to the highly transparent film material, it does not impair the packaging design—which is an important aspect for pharmaceutical manufacturers.

Best-in-Class: Seal Impresses in Testing
In addition to extensive in-house performance tests, an independent test institute conducted a standard recycling test. The objective was to ensure the compatibility of the seal based on a recycled film with the recycling process of a cardboard box. The results of the CEPI Recyclability Laboratory Test Method – Standard Paper Mill Version 2 showed that the seals made of recycled film achieved a best-in-class rating, i.e., that they do not affect the recycling process. In the macrostickies test that investigates sticky contaminations in the recycling process, the recycled film material even performed clearly better than paper-based seals.

Sustainable Seals Support the Pharmaceutical Industry
Schreiner MediPharm’s sustainable closure solution supports pharmaceutical companies not only in terms of regulatory compliance and achievement of sustainability goals but also in reducing Scope 3 emissions. All that is achieved without impairing the performance, functionality, and transparent look of the closure seals, which are crucial for the wide range of cardboard box surfaces and designs in the pharmaceutical industry.

The utilization of this sustainable label solution leads to a CO₂ reduction of approximately 28 percent in the face material compared to standard film materials. In addition, the switch from gas to heat pumps at Schreiner Group at the end of 2023 resulted in an additional 35-percent CO₂ reduction in label manufacturing operations. With its innovative seal Schreiner MediPharm sets a new standard for sustainable packaging solutions and actively contributes to reducing packaging waste and protecting our environment.

Tamper evidence and brand protection are of utmost importance—especially for pharmaceutical packaging. Therefore the Schreiner ProSecure Competence Center together with the Schreiner MediPharm Business Unit, the market expert serving the pharmaceutical industry, has developed a new solution exposing any tampering attempt like cutting through the closure seal. The special design enables particularly flexible and cost-efficient integration of the cut-through indicator function.

Tampering with a folding box is frequently done by cutting through the closure seal and subsequently resealing the box with a transparent adhesive tape. The new cutthrough indicator function clearly signals this type of tampering, thus effectively protecting the contents of the packaging.

Flexible and Cost-Efficient

Schreiner ProSecure did not develop the cut-through indicator function as a standalone standard label but specifically as an additional modular feature. This enables the integration of the innovative feature in existing closure seals for current products as well as in newly developed seals. The single-layer structure ensures that the new feature can be integrated costefficiently into a wide variety of materials and printing substrates.

The graphic design of the seals can be customized, for instance by integrating guilloches.

Tailored Security

The special graphic design of the cutting layout with thin, long, and highly movable bars ensures that lateral shifts and small defects catch the eye particularly effectively. In addition, raised structures and irregular outer contours can optionally be integrated into the label. These measures enhance the visibility of any attempt to reclose the package by taping over and make tampering attacks even easier to notice. Moreover, specific wishes in terms of graphic design can be considered, such as guilloches as an additional authentication feature. The cut-through indicator function thus offers attractive and effective protection against the exchange of medicines in folding boxes.

Decisively influencing a sustainable supply chain requires rethinking the design of packaging. To do so, three founding members of the Alliance to Zero have pooled their expertise: SCHOTT Pharma, Körber Pharma, and Schreiner MediPharm. As representatives of the three partnering companies, Christoph Zauner, Lidia Smith, and Nadine Lampka explain the novel approach in an interview.

What are the key benefits of prefilled syringes compared to vials?

Christoph Zauner (CZ): Prefilled syringes are immediately ready for use and contain the correct dose. That enhances the efficiency of administering medicines and helps avoid medication errors. In addition, contaminations of the active ingredient during the preparation of the injection are avoided and drug wastage in the event of unneeded doses is reduced.

Aside from product safety, sustainability and costs play an important role in the pharmaceutical supply chain. Where do you see further optimization potential in packaging design?

Nadine Lampka (NL): To minimize the environmental impact and to maximize efficiency, it is necessary to question traditional packaging methods. For instance, what is the benefit of a blister pack? It is currently the standard for prefilled syringes because it comes with a variety of features. It serves as first-opening indication, protects the syringe against mechanical stress and contaminations, or can provide oxygen or UV protection. However, it also entails disadvantages in terms of sustainability, costs, and process complexity.

How can blisters be dispensed with?

Lidia Smith (LS): Due to a novel “dress code” for prefilled syringes, we can transfer the functionalities of the blister pack to the primary container, achieve additional benefits, and, in combination with a special type of secondary cardboard packaging, become sustainable.

What does the new dress code look like and what are the various elements?

CZ: For our SCHOTT TOPPAC® infuse COC syringe, there will be a new cap design covering a variety of syringe sizes. The syringe is delivered in ready-to-fill form, requiring no cap assembly after filling. Thanks to a pre-tested system of the syringe and label, pharmaceutical manufacturers are provided with a solution ensuring a reliable process.

NL: The label is the part where we come into play. Because the specialty label wraps around the syringe and cap like a second skin it serves as an irreversible first-opening indication and performs the functions of the blister up until final use. The integration of a gas barrier is possible as well as customized UV and light protection. The enlarged label area also provides more space for product information or drug color codes. Additionally, digital first-opening indication and automatic RFID-based tracking on unit level can be integrated.

LS: Due to the combination of a COC syringe with a special cap and a functional label with sealing function, the prefilled syringes can be packaged in a volume-optimized cardboard box consisting of 100 percent mono-material. Our top-load boxes with integrated dividers for reliable retention of the product are compact and eco-friendly. The system of the prefilled syringe featuring a new cap design plus the label and cardboard box has already successfully passed an ISTA (= International Safe Transit Association) 3A transportation test.

What are the benefits of the new dress code along the value chain?
NL: The benefits are enormous, encompassing optimized and more cost-efficient packaging and distribution processes in pharmaceutical production, clearly less space required during transportation and storage, and more efficient handling processes of the prefilled syringe in hospital settings up to and including disposal, with clearly reduced and more eco-friendly packaging waste. Last, but not least of course, increased patient safety as well.

Are concrete figures available in terms of optimization potential?
CZ: Using the example of the 5 ml SCHOTT TOPPAC® infuse, we calculated how many syringes with and without blisters can be packaged per pallet. Thanks to the 25-percent reduction in packaging size, an additional 1,260 syringes can be shipped per pallet, equating to 126 additional boxes of 10 syringes each. The more compact packaging size impacts the container space as well. In the case of 10 million syringes, 16 fewer containers are needed, which naturally means considerable logistics cost savings too.

LS: In this specific case, avoidance of the blister also results in major, 80-percent reductions of plastic materials and plastic waste. Assuming that 1 kg of plastics corresponds to twice the amount of CO₂, 68,200-kg reductions of CO₂ can be achieved in a single haul of 10 million 5 ml syringes from Hamburg to New York, and adding the logistics savings, 87,400 kg of CO₂ in total.

NL: Impressive figures emphasizing the value of our joint approach of pursuing new pathways along the supply chain and significantly reducing the carbon footprint in terms of a sustainable pharmaceutical supply chain.