Meeting the Demands of Medical Grade Labels
- Published: November 25, 2024
High-performance Materials Key in Demanding Industries
By Amy Donato, PPG Global Platform Director, TESLIN® Products
Labels used in medical and pharmaceutical applications have a very important job: They communicate a wide range of essential information that help to keep patients and providers safe. High-performance materials are key in these demanding industries where labels need to withstand harsh conditions including sterilization procedures and fluctuating temperatures.
Flexible packaging formats and specialized medical containers like blood bags and IV bags require labels with exceptional adhesion, conformability and print durability to stay attached and readable through every stage of transportation and utilization.
Known for their durable characteristics, synthetic papers made from polymers or polymer blends are a common choice for medical grade labels. Even among synthetics, however, there are many different material options, and each type has its own unique specifications from printing processes to chemical vulnerabilities.
Achieving the right combination of substrate, ink and adhesive can be challenging in the highly-regulated medical industry and requires a thorough understanding of the regulatory landscape, label production technologies and the finished product's possible exposures.
By leveraging relationships across the value chain, converters and label suppliers can facilitate knowledge sharing that helps bridge these gaps and solve difficult problems. Collaboration throughout the design, testing and pro duction stages accelerates product development to meet the demands of hospitals and medical manufacturers for effective label solutions.
Environments and Exposures
Medical pouches and bags need specialized labels because of their non-rigid shapes and their exposure to a variety of harsh environments. Labels may face demanding processes such as ethylene oxide or gamma sterilization, cryogenic storage at below-freezing temperatures, and abrasions from handling and laboratory operations.
The PVC used in blood bags is a low-energy surface, making primary label adhesion more difficult at the outset. Secondary labels may be applied to frozen or damp bags. The bags are subjected to autoclave steam sterilization, freeze-thaw cycles and immersion in water throughout their journey from collection to transfusion.
Performance Considerations
In order to design labels that withstand these conditions, converters and label suppliers must consider how each label element functions and how they work together on specialized medical containers.
First, the labels must be compliant with all relevant guidelines such as the U.S. Food and Drug Administration's (FDA) guidelines for the Uniform Labeling of Blood and Blood Components.
Each synthetic substrate is suited for different printing processes and inks. Some will display better printability with certain methods, while others are completely incompatible; for example, the heat of laser printing can cause some synthetic substrates to melt. A substrate with strong ink adhesion that is resistant to abrasion and scuffing is important to consider for labels that include tracking lot numbers, bar codes and identifying information.
Conformability is crucial for these medical applications. The structure of the label substrate determines its flexibility and dimensional stability, and some synthetics are prone to cracking or melting at extreme temperatures. Many synthetics also require coatings, which can affect how they bond with both inks and adhesives. In varying conditions, the adhesive's interaction with the coating can fail and result in peeling.
The finish must also be resistant to UV light, water and chemical exposure from cleaning and testing. Converters should work with label suppliers to find the right substrate with the appropriate durability and bond performance for maximum printability and flexibility.
Benefits of Collaboration
There are many factors at play when designing medical labels. Label technologies and materials are being developed and adapted every day to create better labels that remain legible under stress, such as microporous substrates, digital printing and traceability markers. Partnerships between converters and label suppliers enhance the understanding of both parties, allowing for more efficient product design and testing, and innovative new approaches.
When choosing a label supplier, converters should look for partners who have relevant expertise and extensive industry connections. If a face stock supplier or a pressure sensitive material supplier - or a company that does both - have worked with other suppliers, such as an ink manufacturer or coating service company, the converter can benefit from that breadth of collective knowledge when designing a medical-grade label product.
Converters and suppliers can also work together to develop structures that work with specific printing processes and fit into the converter's capabilities. When it is time to test a new design, suppliers can assist with commercial scale trials to prevent interruption to the converter's operations. This collaborative approach helps both parties stay up to date on requirements for labels, adhesives and packaging materials that meet industry standards.
Flexible and medical packaging requires labels that provide printability, adhesion and conformability. In this rapidly-evolving and highly-regulated industry, increased collaboration throughout the label manufacturing process will help converters meet the needs of hospitals, laboratories and pharmaceutical companies.
About the Author
Amy Donato is PPG's global platform director for TESLIN® substrate — a synthetic facestock for printed labels. She has nearly two decades of experience in marketing and sales for consumer and B2B industries. She earned a B.S.B.A in marketing from the University of Pittsburgh and an M.B.A. from West Virginia University.
