The demands made on product protection and brand security keep growing. Around the world, product counterfeiting is increasing, supply chains are becoming more complex, and consumers expect transparency and clear proof of authenticity. The international ISO 22383 standard defines security features as a component of a multi-level test concept and serves as a structured basis. The Schreiner ProSecure competence center offers various integrable security features that systematically engage with these standardized requirements and expand them in practice.

“Our claim is to develop a solution for every use case that not only meets but exceeds the framework of the standard,” says Dr. Oliver Weiß, Senior Development Manager at Schreiner ProSecure. This claim is the basis for a portfolio of 15 powerful security features that can be combined according to the application. They range from specialized layouts to high-security features requiring special testing equipment. This portfolio is supplemented by digital smartphone- readable security features.

Practical Application

ISO 22383 classifies security features into overt, semi-covert, and covert categories so that they can be reliably tested by various user groups along the entire product lifecycle—with or without technical tools. Overt security features are detectable and checkable with the human senses whereas semi-covert features require commercially available tools such as magnifying glasses, UV lamps, or hand-held microscopes. Covert security features on the other hand can only be checked with special equipment or even laboratory tests. This clear differentiation provides the basis for the development of tailored security concepts at Schreiner ProSecure—adapted to attack scenarios, user groups, and available testing equipment.

Economic Benefit

For companies, security features in their product labels offer clear economic benefits: Protection against loss of image and sales due to faked products, a reduction of liability risks, higher customer satisfaction, and a compelling cost-benefit ratio because economic losses due to counterfeiting and recalls are prevented. In addition, the standard-oriented design of the security concepts provides business with a high level of investment security. In combination with closure seals containing first-opening indication and tamper evidence features, this results in comprehensive product protection.

Whether brand owners, supply chain employees, customs inspectors, or consumers: Verifying security features can be equally relevant for all of them. Because not everyone has access to appropriate equipment Schreiner ProSecure emphasizes the aspects of practical suitability with special security features. “It’s decisive that all relevant testers can perform reliable authentication—regardless of what devices are available to them,” explains Dr. Oliver Weiß.

With the Quanta™ pen, SHL Medical has introduced a new injector platform that has been developed for weight management therapies. The multi-dose platform device addresses central requirements of modern long-term therapies. Schreiner MediPharm has complemented the Quanta™ pen with a multifunctional and perfectly fitting label solution.

Platform for Exacting Requirements
SHL Medical is a global leader in the development and manufacturing of self-injection solutions headquartered in Switzerland. The Quanta™ pen was developed specifically for cardio-metabolic long-term therapies and addresses key aspects such as intuitive handling, consistent dosing performance, efficient operational costs, and sustainability. The automatic spring-driven mechanism with fixed dose setting reduces injection preparation steps and supports a steady injection rhythm—an important prerequisite for medication adherence and patient safety in the case of weekly use.

Short Time to Market
To satisfy the rapidly growing demand for weight management medications, reliable system solutions are crucial. The combination of a platform pen and functional label offers precisely that advantage. Schreiner MediPharm developed a perfectly fitting label that adopts SHL Medical’s branding while integrating added functional value. An anti-slip varnish improves grip and supports safe handling while a holographic effect serves as an overt security feature and enhances the design. The pen plus label facilitates fast integration into pharmaceutical manufacturing thus supporting shorter time to market.

Connectivity and Differentiation
As a special feature, a label-integrated NFC chip enables a wide range of options for digital applications and easy interaction with the end user. Content such as product information, user guidance, or service offerings can be conveniently read via smartphone. In addition, the functional label provides further options for customized differentiation. Additional security, design, or functional elements can be integrated as needed to specifically adapt the pen to the brand, application, or market strategy.
This co-marketing project is a case in point showing how two leading experts pool their expertise to functionally and digitally extend platform devices in combination with specialty labels.

A booming market, high demand, and growing risk of counterfeiting—GLP-1 applications, often colloquially referred to as “weight-loss injections”, make new demands on packaging and on the device. Schreiner MediPharm has developed a multifunctional label for pens and autoinjectors combining safety, ease of use, and design. A closer look at the details reveals how this functional label sustainably strengthens product, brand, and patient protection.

Secure Supply Chain
GLP-1 refers to a class of active ingredients (APIs) that, among other things, is used to treat Type 2 diabetes and obesity and is frequently administered via self-injection using pens or autoinjectors. These drugs are particularly attractive targets for product counterfeiters. That’s why the functional label from Schreiner MediPharm with new design elements integrates analog and digital security features for reliable product authentication. Overt features such as ShiftSecure with a positive-negative effect depending on the viewing angle, semi-covert features such as microtext and InfraredSecure, as well as covert, smartphone-readable printed codes, or integrated NFC functionalities enable multi-level authentication—from the pharmaceutical manufacturer to
the patient.

Detection of Tampering
A key feature of the label’s design is its irreversible first-opening indication. Since the label partially covers the pen cap, any attempt to open it becomes clearly visible—with the naked eye or also optionally by digital means via NFC plus a smartphone. Tampering attempts, unnoticed recapping, or illegal reuse of the label are clearly detectable. The label’s construction with reverse-side printing permanently protects all product information against abrasion and additionally prevents reutilization of the pen because in the case of an unauthorized removal of the label parts of the printing layer remain on the surface.

 

Ease of Use And Security of Supply
Enhanced convenience when using the device was another focus of the development. The label surface that has been enlarged due to the included use of the cap offers space for larger font and better readability as well as for customized design with high recognition value. The integration of an NFC chip provides additional options for interactive user support. Scalable production capacities at Schreiner MediPharm and smooth integration of the labels into high-speed labeling of pens and autoinjectors contribute to an agile and secure pharmaceutical supply chain.

Guilloches are some of the oldest security features in printing—and even so, are very current. The delicate, interlaced line patterns have their origins in the 17th century and are still an integral component of high-end security solutions today. Schreiner ProSecure has now raised them to a new level: with an extensive design catalog, an internal design guide, and many customizable design options.

Time-Tested Technology—Reimagined

Guilloches deliver compelling performance as an anti-counterfeiting feature particularly due to their design diversity, elegance, and resulting recognition value. The complex, mathematically generated lines pose a true challenge to scanners and printers. Unauthorized reproduction results in visible blurs or moiré effects—a clear indication of tampering attempts. Especially in the case of closure seals, guilloches are frequently positioned along the edge of the cardboard packaging to make unauthorized opening and resealing more difficult.

Flexibility in Every Detail

Guilloches are more than a security feature—they’re also a design element with countless variation options. That’s exactly where Schreiner ProSecure’s new offering comes into play: A comprehensive catalog of examples offers many fully created, sophisticated guilloche designs serving as the basis for customized solutions. The catalog is complemented by a design guide that systematically explains all design parameters—from the shape of the outer contours to the alignment, density and thickness of the lines, and the integration of microtext.

 

Tailored to Suit Any Application

Thanks to this preliminary work, the design phase of customized guilloches in new projects can be significantly shortened—without sacrificing the level of security or freedom of design. Together with the respective customer of the business units, a desired design is selected, modified, and optimized for the relevant application and printing technology.

Customers profit from Schreiner Group’s decades of experience with security features using sophisticated printing technologies—and can rely on top quality and functionality, no matter what printing technology is used.

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.

Inkjet printing is a megatrend permeating the entire printing industry—especially label printing. This technology offers not only maximum precision but also the opportunity to integrate sophisticated security features. As a result, the Schreiner ProSecure competence center can also implement proven methods such as microtext by means of inkjet printing.

Inkjet printing enables a contactless printing process in which the artwork is digitally transmitted. That makes fast adjustments and various consecutive printing processes possible. Microtext and guilloches are some of the security features that can be integrated in this process. Serialization, i.e., issuing of individual serial numbers, enhances security further, as repeated queries or feedback of the same serial number in an online feedback system detects fakes.

According to the FINAT Digital Press Index, the utilization of inkjet printing presses in narrow-web printing has been overtaking conventional printing presses for several years. This trend shows that inkjet printing has become firmly established in label production. That’s why it’s crucial to integrate security features directly in inkjet printing. Hybrid machines combining flexographic and inkjet printing can be used more efficiently in that way.

Microtext has been used in flexographic printing for a long time and experienced continuous evolution over the years. Now microtext is possible in inkjet printing as well. Serialization of microtext enhances security further because individual counterfeits are practically impossible. Guilloches, complex graphic patterns, can be used in serialized form in inkjet printing too. Every pattern is individually adapted around the serial number, which raises security to yet another level.

In total, inkjet printing offers a versatile and effective means of integrating security features such as microtext and guilloches into labels. By combining precision and digital flexibility this technology provides a wide variety of possibilities in security printing.

They shimmer in holographic colors, have tiny, barely visible text elements, or look like any ordinary label: integrated security technologies—overt, semi-covert, covert, analog, and digital. They are used in labels to enable authentication of a product that has been marked with them. They can be verified either with the naked eye or by using specialty readers. The Schreiner ProSecure competence center knows which authenticity feature is ideally suited for a specific application and which reader to use with it. It provides individual advice regarding the suitable technology and as a systems supplier provides the appropriate reader as well.

Brand owners, consumers, or customs officials—the users of readers vary. Consequently, the requirements of the different user groups need to be considered in the selection of the security technology and the corresponding readers. For example, ease of use and the procedures to be followed in an inspection, the duration of an inspection, and the requisite training play a role. A consumer, for instance, needs to be able to confirm a product’s authenticity very easily and without a longer learning process. By contrast, for forensic authentication in a laboratory, a brand owner’s employee needs a complex system in which he or she must be trained.

There are several criteria to be considered in the selection of a suitable reader:

• Legal compliance
• Selection of trustworthy equipment manufacturers
• Availability in individual markets
• Suitability for the desired user group
• Suitability of the technology for authentication in the specific use case

There are some security technologies for which only few manufacturers offer corresponding readers. The selection is limited even further by the fact that many manufacturers are not domiciled in the relevant jurisdictions or, in the case of small volumes, are not willing to comply with the statutory requirements in individual markets like Germany because they are too complex. That makes the selection and purchase of readers a complex task requiring specialized knowledge for every jurisdiction. Schreiner ProSecure offers an extensive portfolio of security technologies and provides advice on selecting the appropriate reader, resulting in an ideal authentication system from a one-stop shop.

More than 1.5 billion units produced and recognized with ten international awards: That has been the success story of the Needle-Trap needle protection system from Schreiner MediPharm since its market launch in 2009. Now the label with an integrated needle trap for protection against needlestick injuries has been complemented by a new feature: A security seal reliably indicates if the syringe has previously been opened. Needle-Trap Secu is a clever combination of needle and product protection that provides users with a double dose of safety and protects the integrity of the prefilled syringe that is important for the pharmaceutical manufacturer.

A secure supply chain and the integrity of medicine packaging are essential for pharmaceutical manufacturers. Regulations such as the EU Falsified Medicines Directive support that need but only address secondary packaging. Primary containers, however, require more specialized solutions for tamper evidence and first-opening indication. Due to its integrated plastic trap, Needle-Trap poses special challenges concerning first-opening indication. Smooth processing of the label on dispensing systems in pharmaceutical manufacturing environments and ease of use in healthcare settings must be considered.

Easy Process Integration–Safe Use

Needle-Trap Secu features a closure seal integrated into the syringe protection label with a tab ending on the syringe cap. Prior to the injection the needle trap is folded sideways as usual. While the cap is being pulled off a perforation triggers the activation of the first-opening seal. Security cuts additionally prevent undetected removal of the seal. The closure seal can also be complemented by overt authentication features, such as a guilloche, or covert security features for authenticity verification. Pharmaceutical manufacturers are provided with a multifunctional and cost-efficient solution that can be integrated easily into existing production processes and enhances product and patient safety. The integrated seal secures the integrity of the prefilled syringes on unit level until the drug is administered. Thus, it eliminates the need for a blister pack, reducing space and waste. Healthcare staff benefit from the efficient and reliable needle protection as well as from convenient first-opening indication that is irreversible and detectable at first glance.

Schreiner MediPharm’s Security Concepts Are Based on Three Categories

Addressing Diverse Threat Scenarios

Development of a Customized Security Concept

Assessment of the current situation, e.g. the threat to which a pharmaceutical is exposed and who will be involved in the verification process, is the first step in the development process of a customized security concept. Following an in-depth analysis by our Pharma-Security experts, we will develop an effective security concept together with our customer, verify its feasibility in a pilot stage, and implement the concept after a successful test phase.

All concepts are based on tailored solutions that have been developed by an experienced security team. The various security features can be combined and integrated into any kind of customized functional labels. They result in effective, multi-level security solutions that consider the relevant stakeholders along the supply chain, from informed experts to final users. As a strategic partner, Schreiner MediPharm supports pharmaceutical manufacturers from the analysis and concept stage through to successful implementation.

RFID technology can help protect manufacturers and users against counterfeits. Schreiner ProTech’s Item Match Control solution provides a holistic approach to such protection. It is based on secure communication between a machine, the related consumables, and protection of the material chain. The lock-and-key principle is the crucial success factor of this solution.

For a renowned customer in the printing industry, Schreiner Group’s experts recently developed a complete security concept that was implemented shortly afterward in the company that stands for top manufacturing quality. Protecting its proprietary materials against counterfeiting was a key deliverable for this customer. The utilization of a novel type of encryption technology, known as NXP iCode DNA, made tampering with the material practically impossible.