2023-06-15

The global demand for pharmaceutical products is rising, and new medications are being introduced to the market at an accelerating rate. The German pharmaceutical market, which is the largest in Europe and the fourth largest in the globe, generated approximately 53.6 billion euros in sales alone in 2022. According to Statista, the volume has more than doubled in the past fifteen years, and nearly 100 billion counting units (tablets, capsules, injections, etc.) have been sold as of the most recent estimate. They must all be packaged hygienically and securely in accordance with stringent legal requirements. This places demanding requirements on packaging materials, filling processes, and packaging machines.

Since the pandemic, the significance of protective packaging for vaccines, medications, disinfectants, and other medical products has become apparent. As demonstrated by the Corona vaccines, vaccine development alone is insufficient. To protect millions of people from the virus, a number of players along the complete supply chain had to work in concert. For the vaccine, billions of tiny glass vials were required, as well as special cooling cases for transport and storage.

When the packaging industry gathers in Düsseldorf from 4 to 10 May 2023 for interpack, innovations in the manufacturing, packaging, and logistics of pharmaceutical products, including new solutions to the problem of product piracy, will also be on the agenda. The pharmaceutical industry is uniquely afflicted by counterfeiting. With the expansion of online commerce, the lucrative business of selling counterfeit medications, which at best contain less active constituents but can also be laced with unknown, harmful substances, has regained momentum. The World Health Organization estimates that more than half of the medications purchased from illicit websites online are counterfeit. The estimated annual market value of counterfeit medications is approximately $75 billion USD.

Protection Against Counterfeit Through Security Features

In addition, the complexity of global supply chains is increasing. Frequently, active constituents are produced in one country, processed and packaged in another, and then distributed and marketed across international borders. With EU Directive 2011/62/EU, the European legislator took up the fight against counterfeit medications years ago. The 2019 directive prescribes several safety features for prescription medications. For instance, each package of a pharmaceutical product must bear a Unique Serial Code (USC) along with the article number (GTIN), the lot number (LOT), the expiration date (EXP), and the manufacturer's name. All information is encoded in a 2D data matrix code, which is then printed in ordinary text with a specified minimum print quality on the packaging. In addition to the unique code, each container must also contain tamper-evident characteristics.

There are various companies that have spent years devising coding and labeling solutions for pharmaceutical packaging that comply with the EU directive for counterfeit-resistant packaging. This includes laser or inkjet coders, thermal transfer printers, labeling systems, and the appropriate software. For instance, the drug-coding-specific Integra One inkjet labeler produces unique identification codes, barcodes, or data matrix codes on a variety of pharmaceutical packaging.

UV laser marking is also a well-established labeling method. Domino introduced in 2022 a new UV laser system that is appropriate for marking plastics as well as current sustainable packaging materials, such as recyclable, flexible monomaterial films. Without impairing the barrier properties of the material, the system can be used to mark both white and colored substrates. Due to a photochemical reaction, the novel laser for marking does not require laser-activating pigments, additives, or specially-prepared coding fields.

Advantages Of Labels

Anti-counterfeiting measures may also include security labels with first opening indication and incorporated overt, covert, and digital anti-counterfeiting features that indicate a tampering attempt irreversibly. For outer packaging, void seals that leave visible effects when the label is first removed are optimal. Numerous security features are frequently paired with or supplemented by additional features. In addition, digital identifiers with NFC technology and track & trace systems guarantee the full traceability of pharmaceutical products.

Labels are an essential component of pharmaceutical packaging and serve multiple purposes, including counterfeit protection. Depending on the application on primary packaging such as bottles, blisters, syringes, and vials or on secondary packaging such as folding boxes, they must adhere to a broad range of specifications: They contain general information, offer first-opening protection, and can be partially detached for affixing to patient records or vaccination certificates. Large quantities of information can also be accommodated by multipage labels, which are frequently a combination of label and package insert. And for refrigerated products, temperature-resistant labels are required to maintain legibility during storage and transport.

Automated Processes

As pharmaceutical product safety is of the utmost importance, the requirements for packaging machines are also stringent. For instance, R.Weiss, a manufacturer of machines, employs modular picker lines in which Delta robots pack products at maximum speed. The company has recently developed an intelligent UniRob turnkey system for packaging diagnostic products that automates the manual insertion of folding cartons for Siemens Healthineers. Multipacks of various pack sizes are now also packaged in eco-friendly cardboard inserts, which have replaced the plastic previously used. A six-axis robot removes the blanks from the magazine, unfolds them, and inserts them into the carrier conveyor, which can be adapted to the respective formats in a flexible and entirely automatic manner.

In the Healthcare industry, Multivac has introduced a new carrier system that ensures controlled, gentle product transport from pre-filled glass or plastic syringes to the packaging equipment. In order to accomplish this, the syringes are separated in an upstream procedure and oriented in a workpiece carrier. Then, at the packaging machine, a robot removes the items from their carriers and positions them individually or in predetermined groups into the packaging cavities. Multivac Marking & Inspection's vision system is utilized to verify the integrity of the packages. Even at high throughput, it verifies that each product is accurately positioned in its designated cavity. If not, the corresponding pack is discharged automatically.

Filling liquid pharmaceuticals requires specialized expertise. For this purpose, Syntegon has developed the modular Versynta FFP (Flexible Filling Platform), a machine designed specifically for the aseptic filling of small quantities. The new filling solution accomplishes production rates of up to 3,600 vials, syringes, or cartridges per hour with 100 percent simultaneous in-process control. The platform consists of several pharmaceutical handling units, each equipped with a four-axis robot that transfers containers from one station to the next without glass-to-glass contact, thereby reducing product loss.

Additionally, Romaco has devised a new liquid filling line. Macofar E is a solution for aseptically filling vials with injection fluids. The technology satisfies all EU GMP requirements for the manufacture of sterile pharmaceutical products. Additionally, Romaco is committed to more sustainable production and reducing CO2 emissions: Through inventive process control, for instance, production times can be significantly shortened, resulting in targeted energy and material savings. In addition, all of the manufacturer's devices are available in a climate-neutral configuration and feature energy monitors for sustainability reporting.

User-Friendly Software

The security of software solutions that capture data along the pharmaceutical supply chain is enhanced. With the Pexcite software platform from Uhlmann Pac-Systeme, users can collect, collate, display, and analyze data from all areas of the production and packaging process, enabling them to accomplish a variety of tasks: implementation of track & trace specifications along the entire process chain, monitoring of the productivity of machines and processes, digital tool management, and central control and management of the entire production processes. The platform is compatible with all digital devices, including desktop computers, tablets, and mobile phones. "Visually appealing design, as well as a friendly, light appearance and feel, reduce complication for Pexcite users. People must appreciate working with our product and have no fear of making mistakes or breaking it "Director of Development and Operations for Digital Solutions at Uhlmann Pac-Systems, Thomas Kreutle, states the following. The software framework was thus awarded the Red Dot Award 2022.

Sustainable Pharmaceutical Packaging

Still, the pharmaceutical industry is hesitant to utilize recyclable materials. However, modern consumers also expect this industry to demonstrate a greater commitment to sustainability. Already one step ahead, pharmaceutical packaging manufacturers have devised numerous recyclable solutions for the primary and secondary packaging of medications. In the past year, for instance, the introduction of a recyclable paper blister caused a stir, and a recyclable mono material barrier tube in pharmaceutical quality won an award for packaging. Recently, a bio-based polymer PLA tubular film that is industrially compostable and can be used as a sterile barrier system for diagnostic flow-pack applications was introduced to the market.

In the area of primary packaging, i.e., where medications are directly packaged, it will likely take some time for recyclable mono materials to gain traction. In contrast, secondary packaging is already exhibiting a trend toward recyclable solutions, according to specialists. Korber Pharma GmbH, for example, was granted the Pharmapack Sustainability Initiative Award 2022 for developing secondary packaging made from grass paper as an alternative to packaging made from recycled paper and cardboard. Half of the cellulose in grass paper is replaced with grass fibers, requiring substantially less water and energy. The nearly unrestricted regional availability of grass shortens transportation routes, reducing CO2 emissions by nearly 95 percent. Korber Pharma has already conducted test and development projects with a number of pharmaceutical companies for safe secondary packaging made of grass cardboard, demonstrating that the costs for the new packaging material are comparable to those of conventional cardboard while offering the same level of product protection.