Information normally included on a pharmaceutical label can include usage instructions, dosages, potential side effects and manufacturing dates. These labels can be found on pharmaceutical packaging, vials and test tubes, blood bags, cold and cryogenic storage, and sterilization products. These applications often have migration and temperature requirements too.
Pharmaceuticals often feature extended content labels, which will not find their way onto the newest craft beer. An extended content label (ECL) is a multilayer design that includes a bevy of information that will not fit on traditional packaging. Government regulations and requirements, along with multiple languages, will make their way into these booklets that function as part of the label.
“With many products and regions requiring multiple languages, the challenge for engineering is in developing label structures that can fit all of the information in readable text,” says Trevor Richardson, market development manager, Americas, at UPM Raflatac. “UPM Raflatac has a global team of compliance managers that stay current with legislation that impacts labeling materials and components. This is built into product design as a key factor when new product development is underway and is reviewed from an impact standpoint on existing products, as well.”
Luminer Converting Group, a printer with manufacturing facilities in Lakewood, NJ, USA, and Red Lion, PA, specializes in ECL labels. “Our largest growth segment is multi-ply labels for pharmaceutical use, and that’s because of content,” explains Tom Spina, president at Luminer Converting Group. “You need to put more information on a small space, and there are also quality requirements like orderability. You must be able to order it, you must be cGMP compliant and ISO-certified. In some cases, you have to be FDA registered, so the infrastructure around the quality department and around the facilities is critical.”
ECL labels provide certain challenges that are foreign to other markets. These labels are more complicated than single-ply labels on press. According to Spina, capital equipment is a necessity. Inspection is also more difficult because most cameras are designed to examine the top of the label. “The operator skillset is also different because you’re not just a press operator, you’re into folding, gluing, onserting, and inline web laminations,” he explains. “You’re dealing with a broader array of operator skillsets.”
As in other industries, customers are seeking quicker turnaround times at lower prices.
Pharmaceutical labels typically make use of pressure sensitive films, with the trend going to thinner and lighter. Thinner substrates also enable suppliers to more effectively create ECL labels. Printers can then increase the number of labels per roll at dispensing and improve tight mandrel wrap requirements on narrow containers such as pre-filled syringes and vials.
According to Richardson, over-the-counter pharmaceuticals often feature pressure sensitive papers with low basis weight, like Pharmagloss and Raflasilk. These materials provide excellent printability, gloss and mandrel wrap.
Avery Dennison offers a specialty portfolio of pressure sensitive label products dedicated to pharmaceutical applications. The Customer-Ready Pharmaceutical portfolio provides brand owners with high-quality, compliant paper and film constructions ranging from simple to complex needs. In addition to various facestocks, Avery Dennison provides a list of recommended adhesives and liners. The solutions are tailored to a multitude of applications such as blood and IV bags, cryogenics and syringe labeling.
The portfolio enables Avery Dennison to meet the growing need for quicker lead times and shorter time to market. It also provides brand owners with an added layer of security by reducing their risk of contamination and recalls.
“Traditionally, it’s been a lot of paper labeling, and we offer a lot of different paper facestocks, one being a cast gloss,” says Alison Schuitema, product and business development manager, pharmaceuticals, at Avery Dennison. “We also have a semi gloss and a lightweight pharma litho, which would be a paper solution for a tight mandrel situation, where it maybe needs to wrap around a small diameter vial or bottle. Over the past couple years, we’ve started to see some of the labeling shift toward film.”
Avery Dennison sees white and clear films being used. White is often utilized to replace paper applications, especially in a sterilization process. Films often offer better durability and hold up better in an atmosphere like an autoclave. Clear films will be utilized with products like syringes and vials, where someone wants to see how much liquid is left.
Richardson emphasizes that the technology has significantly improved, even though the market features materials that were initially designed 10 to 15 years ago. “Film, paper and adhesive products have evolved significantly since then,” he says. With major improvements in efficiency, performance and cost, it’s a challenge for the industry to define ‘what are the actual performance requirements in a given application?’ versus remaining locked in on legacy specifications. Once the variables are defined, it is quite easy to implement an evaluation and validation protocol.”
Given the evolving technology, there are several trends in the pharmaceutical labeling market. UPM Raflatac has noticed growth areas, such as increased biological and cold chain storage (cryogenics), and increased usage of pre-filled syringes and vials as a method of treatment (for diabetes health management, vaccines). The company also continues to see requests for global product solutions with regional service to printers.
The regulations are a changin’
In the pharmaceutical market, the rules and regulations are anything but static. As government mandates change, suppliers and converters must adapt.
“It’s a very lengthy process in the pharmaceutical world to qualify and validate any change to the label that some might think is a small part of the package system,” explains Schuitema. “It is a lot of work that goes into ensuring that the change is going to be approved in your package system.”
Avery Dennison’s pharmaceutical portfolio meets a host of different regulations. “We put a lot of work into making sure the labels are compliant with the different directives and regulations that are a part of the pharmaceutical industry,” says Schuitema. “Our labels have been tested to standards, including ISO 10993, which is biocompatibility. They’ve also gone through testing for FDA 175.105 for indirect food contact, and they are of course compliant with CONEG, RoHS, and some of the other pretty standard regulations for pharmaceutical labels.”
Avery Dennison tests its labels for migration, where adhesive could migrate through a package and come into contact with a drug product. Therefore, the adhesives have proven to be safe with the various substrates the company uses for pharmaceutical labeling applications. The company gives customers an added resource, as well. Avery Dennison Advantage is a global technical and customer service platform that can assist with compliance testing.
As part of its pharmaceutical portfolio, Avery Dennison gives customers change protection that ranges anywhere from 3-12 months. “We give advanced notification of any component change to one of our raw materials or process change that might affect the function of the product itself,” says Schuitema. “We will notify up to a year in advance and give up to a year of safety stock to facilitate any requalification or revalidation that has to be done at the end user level.”
According to Spina, changing regulations require additional text in a confined space. “Regulation change often means the need for more information in less space,” he says. “That allows us to use our products, and we’re integrated to do that. We make labels from a single page to 54 pages. We run the full gamut.”
Schuitema says that the Drug Supply Chain Security Act (DSCSA)and Unique Device Identification will be two new pieces of legislature coming into effect within the next two to five years. DSCSA is designed to protect against tampering and provide track-and-trace features through the supply chain. Unique Device Identification will initially impact medical devices, but Schuitema believes it will eventually impact pharmaceutical and drug packaging.
“The biggest challenge is keeping up with the regulations and industry trends, and trying to stay in front of them,” adds Schuitema.
A secure future
Security continues to become a bigger concern throughout all levels of the supply chain. The developments in smart technology have opened up a new realm of possibilities for this market. In its most basic form, tamper evident labels can help users identify if a product has been opened prior to patient use. The possibilities, however, extend to medication management and doctor alerts.
“We also see many companies embracing authentication and tamper evidence in track-and-trace or serialization projects or to prevent grey market diversion,” explains Richardson. “There is a wide array of products that can be supplied to fit these needs. It is really key to look at the value-add that can be done on-press, as well as the functionality of the base label materials. These points drive the solution that is actually needed and can be used to measure a return on investment for implementing authentication features.”
Avery Dennison’s DirectLink technology creates many of the same possibilities. DirectLink allows users to generate digital content by tapping an NFC-enabled device to packaging containing the requisite antenna. This technology allows brands to directly connect with customers, providing information like surveys, coupons, reviews, tutorials and user manuals.
“DirectLink is something that we’ve seen success with in the food and beverage space with consumer interaction,” says Schuitema. “I could see how that would make its way into pharmaceuticals, as well. It can add some depth to a patient information card or an instruction manual for a medical device. Pharma is very slow moving, in general, but I think in a few years we’ll start to see more smart technology pop up within the pharmaceutical space.”
According to Bill Cummings, vice president of marketing and communication, Thinfilm, the possibilities extend far beyond tamper evidence. In a partnership with Ypsomed, an NFC tag used with an auto-injector can provide a patient with adherence history, injection reminders, usage guidelines, refill instructions and authentication. With the information available in custom apps via smartphones, a doctor can monitor his or her patients and whether or not they are adhering to daily self-medication requirements. These auto injections could be used with patients suffering from rheumatoid arthritis, diabetes or cardiovascular diseases.
“Most likely it’s going to be a scenario where a doctor, at any point, can go in and take a look at this particular patient’s injection history to see that they are adhering to the regimen or complying to the treatment schedule that’s been prescribed,” says Cummings. “There are some other scenarios where, if a patient is not sticking to that schedule, doctors could be sent alerts that this patient has not taken their injection the last two scheduled times, for example. It would give the doctors intelligence of information that they may be able to reach out to the patient directly and follow up.”