Packaging, coding and labeling technologies play a vital role in protecting pharmaceutical product and brand integrity. As pharma manufacturers and OEM partners face growing complexity in packaging products for health care and consumer markets, they need solutions that can support regulatory compliance while keeping pace with evolving trends.
The pharma industry is utilizing more environmentally friendly packaging materials to support sustainability strategies, while governmental regulations continue to raise the bar on packaging coding requirements to improve traceability and mitigate rampant global counterfeiting. At the same time, manufacturers are striving to achieve greater customization to meet the needs of health care distributors, pharmacists, medical providers and patients.
Today’s pharma manufacturers need modern printing, marking and coding solutions not only to assure compliance but enable them to stay ahead of trends and thrive.
Driver #1: Sustainability
Global manufacturers are leading the charge to incorporate more eco-friendly packaging, printing and other consumable materials in the pharma supply chain as the regulatory climate grows increasingly complex. Government and industry initiatives regarding packaging reduction, recycling and material requirements are widely recognized as more than guidelines; they signal a significant pivot toward a future where sustainability and transparency are integral and expected. Leaders in the packaging sector are navigating these regulations as catalysts for change and innovation.
Regulations such as the EU Packaging and Packaging Waste Directive specifically target packaging recycling and restrict the use of nonrecyclable materials. Additionally, U.S. Food Contact Materials Regulations and EU’s REACH restricts the use of harmful chemicals in packaging materials. In the EU, Canada and, increasingly, the U.S., Extended Producer Responsibility (EPR) holds producers of packaging products responsible for managing packaging waste throughout its life cycle. Meeting these and other environmental requirements requires organizations to have the right solutions and processes in place.
The sustainability push has sparked growing interest in everything from plant-based materials and compostable fiber-based substrates to recyclable plastics and rigid paper packaging. Although implementation of new substrates — requiring extensive testing and validation first — always lags behind interest, companies need to keep an eye on the horizon for innovative substrates and anticipate stricter regulations promoting circularity and waste reduction.
Sustainability demands a level of commitment by pharma companies and their partners to holistically assess products and packaging, from raw materials throughout the full life cycle of the product.
Driver #2: Traceability
The trade of counterfeit and illicit drugs represents a serious worldwide public health issue, costing millions of dollars annually and threatening patient safety. Over 6,000 pharma crime incidents involving counterfeiting, illegal diversion and theft were reported globally in 2022, representing an increase of over 50% (4,344 incidents reports) since 2020.
Due to the increasing number of counterfeit medicines and unauthorized supply chains, most countries — both industrialized and in emerging markets — have implemented serialization regulations for drugs and medical devices to protect patient safety. In the U.S., the Drug Supply Chain Security Act (DSCSA) underscores the need to ramp up serialization compliance sooner rather than later. Enforcement is due to begin on November 27, 2024, at which time pharma companies need to be ready for full interoperable electronic unit-level traceability for all stakeholders.
As governing bodies enact stringent serialization and traceability legislation and guidelines, manufacturers are reacting and changing the way they code products and packaging to meet requirements.
In the context of the pharma supply chain, serialization is typically achieved by assigning a unique serial number to each saleable unit and conferring it with a distinctive identity that enables chain-of-custody tracking back to the manufacturer at virtually any point during its life cycle. Many companies are implementing aggregation to track individual products through the distribution chain. Aggregation refers to the grouping of individually serialized packaging into larger units such as bundles, cases or pallets. These units bear a code containing information correlated directly to the serialized products contained within the package. This approach requires a coder that can communicate with machine vision solutions and packing equipment.
For code legibility, measures must be taken to protect against condensation, light exposure and other environmental influences that may cause an ink code to smudge or fade. Consideration is given to each package and code’s exposure to damaging elements and conditions over the life cycle of the product. In the selection of coding technology, finding the optimal coding and marking solution combined with line speed, installation requirements, consumables and substrate is key to achieving legible and fully compliant codes. Thorough testing of a coded product or packaging can determine a code’s durability and help prevent traceability problems.
For medical devices sold in the U.S., the FDA’s UDI (unique device identification) standardized identification system was established to set rules for the consistent, unambiguous and globally harmonized tracking of medical devices during distribution and use. This UDI system facilitates the device’s traceability, significantly increasing the effectiveness of recalls and enabling better surveillance by authorities
Similar UDI regulations are being adopted and phased in by the EU and other countries, requiring that the device itself and all higher levels of packaging be marked with a unique code in machine-readable (barcode) and human-readable format.
Driver #3: Customization
Personalized, tailored medicine is gaining traction among consumers and health care providers, resulting in a higher number of smaller batches being produced. Lower volume manufacturing in any industry needs flexibility and efficiency while being cost effective, and modern packaging and coding solutions can help achieve this.
Fully integrated companies that manufacture and market a range of pharmaceutical preparations in various dosage forms must be able to customize for diverse therapeutic categories, across various geographies. Rather than opting for fully pre-printed packaging materials and labels, many companies are printing on demand. On-demand, variable-data package coding technologies support smaller production batches and enable drug tailoring while reducing packaging inventories. Performed on the production or packaging line, these agile technologies provide greater flexibility for customization while managing critical, complex coding to adhere to regulatory and traceability requirements.
Exploring packaging substrates
Packaging materials and production processes must align with global regulations and support an efficient, cost-effective supply chain while addressing sustainability, traceability and customization trends. But not all coding and marking solutions are the same, and the ideal system must be carefully matched to the packaging substrate.
For example, folding cartons are one of the most widely used packaging materials for drugs and medical devices because of their versatility in form and function. Unit-level, variable-data printing and marking technologies like thermal inkjet (TIJ), continuous inkjet (CIJ) and laser marking systems perform well on most carton types.
Flexible packaging such as pouches and stick packs are handy, user-friendly options for many pharmaceutical and medical device manufacturers. Pouches, often made of Tyvek, medical paper, metal foil and plastic, can be coded with thermal transfer overprinters (TTO), CIJ printers, and even laser marking systems.
White HDPE (high-density polyethylene) bottles are a very common choice for pharmaceutical products, especially in North America. Until recently, it has been a challenge to deliver the high resolution, high contrast codes required for machine readability on these bottles. Now, innovations in laser marking technologies leverage UV wavelengths to create crisp, indelible black marks including serial numbers and 2D bar codes on HDPE. Laser marking can also achieve high-resolution codes on the side, bottom, shoulder or cap of HDPE bottles.
Supporting patient safety and security by protecting drugs from contaminants, blister packs are another leading packaging format. TIJ, CIJ and lasers are all suited to applying codes in the small areas available on blister packs while meeting line speed requirements.
Vials, syringes and ampules are inherently challenging for coding, given the small size and radius of the packaging. Integrating a coding solution into OEM equipment can provide improved product control, leading to high quality human- and machine-readable codes.
Vial coding has unique challenges due to internal processes like bright stocking, sterilization and refrigerated storage. Vials can be directly coded with CIJ printing, while vial caps can be marked with both lasers and CIJ printers. Covert coding is achievable with special invisible UV CIJ inks that are readable when illuminated with UV light. Fast illumination response times allow these codes to be read and captured on high-speed production lines.
Proven coding solutions
The need for high resolution printing and serialization has fueled the continued development of coding equipment and technologies. As a result, packaging specifiers and pharma manufacturers now have a choice of solutions to choose from to meet their needs:
Thermal inkjet
Offering high-resolution coding at high line speeds, TIJ is generally used to print traceability information on pharmaceutical packaging such as cartons, labels, blister packs, pouches, bottles and barrier materials.
Developments in TIJ printers and inks have unlocked the ability to code nonporous and semi-porous packaging such as films, foils, plastics and coated stocks. Some solutions provide complex data handling and high-resolution printing of linear bar codes, text, logos, GS1, DataMatrix and QR codes.
Boasting excellent adhesion and contrast, TIJ is an ideal fit for applications where traceability, high quality printing and ease of use are essential. It has been selected by pharma companies for years due to its ability to deliver consistent, high resolution codes at industry standard line speeds; simple and clean cartridge changes; no-wear parts for reliable production; and flexible configurations for integration into complex machinery.
Continuous inkjet
Highly versatile CIJ printers allow for the printing of dates and codes on both flat and curved surfaces and almost any substrate in any shape. CIJ offers fluids-based, non-contact printing of alphanumeric text, linear bar codes, and 2D bar codes on cartons, bottles, labels, vials and ampules, tubes, blister foils, pouches, barrier materials and stick packs.
Laser marking
Laser marking systems are designed to mark sharp, complex codes at high speeds. Depending on the substrate, UV, fiber and CO2 laser marking can produce permanent codes that are resistant to abrasives, chemicals and sterilization processes. Lasers can produce variable text, human-readable codes, and machine-readable linear and 2D bar codes on cartons, blister packs, bottles, HDPE bottles, labels, tubes, syringes, pouches, stick packs, and a variety of Tyvek materials.
High-contrast, permanent codes help to enable lifetime track and trace security for pharma products. Additionally, laser marking meets pharma’s demand for marking more data on products and packaging while requiring no consumables — aside from fume extractor filters — to align with sustainability initiatives.
Thermal transfer overprinting (TTO)
TTO printing is a digital technology used to print high-resolution, variable-content codes on thin, flexible packaging such as plastic film, pouches and labels. TTO systems, available in a range of speeds and with printheads of varying widths, can also provide excellent sensitivity and compatibility with porous substrates such as medical grade paper and Tyvek.
Technologies for serialization
Both laser and TIJ technologies can operate in continuous and intermittent (stop-and-go) packaging applications. An advantage of laser marking is its ability to print on either moving or stationary packaging. By comparison, a TIJ printhead requires the substrate to traverse across the front of the printhead to apply a code. Alternatively, a TIJ printhead can be physically traversed across a stationary substrate, but this adds some mechanical integration to the packaging line.
Both laser marking and TIJ printing provide the high-resolution detail required for multi-line printing and linear bar codes, as well as DataMatrix codes — the standard code carrier for serialization in many regions. Laser markers use a focused beam of light to inscribe or physically alter the top layer of a substrate. In contrast, TIJ printers fire tiny ink drops onto a package as it passes by the printhead.
Substrate, speed, installation considerations and capital costs are factors to evaluate when selecting a packaging technology. A coding and marking specialist with knowledge of the available technologies can provide a customized cost comparison of suitable printing solutions, taking into consideration the unique requirements of a given application and making application-optimal recommendations.
GAMP compliance
Good automated manufacturing practice (GAMP) is a set of guidelines and principles for manufacturers of automated systems in the pharma industry developed by the International Society for Pharmaceutical Engineering. The guidance aims to safeguard patient safety, product quality and data integrity when using GxP computerized systems.
Experienced coding solutions providers can help pharma manufacturers comply with GAMP by commenting on and supporting the draft of the technical reference document needed for the purchase of capital equipment, known as user requirement specification (URS), and providing installation and operational qualification (IQ/OQ) documentation. Providers can also modify standard printer configurations to satisfy the URS.
An integral role
Ultimately, coding and serialization solutions for pharma packaging protect patients, manufacturers, supply chains and brand integrity. Optimal coding solutions are part of a sound approach to pharma manufacturing, with the printer or laser playing a deceptively small but integral role in addressing industry regulations, trends and safety.
In navigating the complex landscape of packaging regulations, companies must strive to stay informed and proactive in addressing regulatory challenges and industry trends to better seize opportunities for growth in global markets
