What to consider when selecting label materials for injectable packaging
Choosing the right label material for injectable packaging is critical to ensuring product safety, regulatory compliance, and performance throughout the supply chain. Below are seven essential questions to guide your selection process:
1. Is the label material designed for injectable packaging?
Labels for injectable products must adhere securely to small diameter containers and withstand cold chain storage. They must also meet regulatory requirements for product safety. As pharmaceutical technologies evolve, packaging and labeling solutions must adapt. For example, a change in storage temperature may require a completely different label material. Using a label not designed for pharmaceutical use can result in peeling or illegibility, leading to costly recalls or compromised patient safety.
2. Does the label material meet the needs of small diameter containers?
Containers with diameters below 23 mm / 0.91 inches require adhesives and materials that prevent edge lifting and peeling. The most critical range is 7 to 12 mm / approximately 0.3 and 0.5 inches. The right label material should:
- Adhere to moist and cold surfaces, including treated surfaces,
- Provide strong mandrel hold on glass and plastic substrates,
- Support high-quality, legible printing,
- Remain intact during storage and handling, and
- Resist moisture absorption and tearing, even after thawing.
Learn more about the requirements for label material for small diameter injectables
3. What labeling is required for secondary packaging?
Secondary packaging, such as cardboard or plastic logistics containers, also requires reliable labeling. It is essential to consider the entire cold chain packaging system to ensure traceability. For example, UPM Adhesive Materials and AJK Etiketten developed a labeling solution that performs in ultra-deep-freeze conditions, supporting vaccine transportation and storage down to -80°C / -112 °F.
4. Has the label material been tested and is change management in place?
Label materials for injectable packaging must undergo rigorous validation to ensure safety and performance. Pre-tested materials with a robust change management protocol are essential. Uncontrolled changes in label components or packaging can affect product stability, purity, and performance - posing risks to patient health and brand integrity. A strong change management process helps mitigate these risks.
Learn more about our pre-tested label solutions that offer robust mandrel hold in various conditions
5. Can the label material withstand sterilization processes?
Sterilization is a critical step in ensuring the safety and sterility of injectable products. Labels used on primary packaging (such as vials, ampoules, or syringes) must be capable of withstanding the chosen sterilization method without losing adhesion, legibility, or integrity. Common sterilization methods include steam autoclaving, ethylene oxide (EtO), gamma irradiation, and electron beam (E-beam) sterilization — each of which subjects label materials to different combinations of temperature, pressure, humidity, and radiation.
When selecting label materials for injectable packaging, it’s essential to verify:
- Adhesive and facestock compatibility with the sterilization process to prevent bubbling, delamination, or discoloration.
- Print durability to ensure critical information (e.g., dosage, lot number, expiry date) remains clear and traceable after sterilization.
- Resistance to sterilization-induced aging, which can affect adhesive performance and appearance during shelf life.
- Validation data from material suppliers confirming performance under the intended sterilization conditions.
Partnering with a label supplier experienced in pharmaceutical applications ensures that materials are pre-tested for common sterilization methods and compliant with regulatory expectations.
6. Does the packaging ensure product safety and compatibility?
A key consideration in injectable packaging is the safety of the entire system, particularly regarding chemical interaction with the drug or the patient. This includes minimizing the risk of leachables (substances that may migrate from packaging materials into the drug product) and considering biocompatibility for components that may come into direct contact with the patient.
These risks are especially relevant for non-solid drug forms such as liquids, gels, or aerosols, and for packaging made from plastic. Any packaging material used in a drug-device combination product, such as an injection pen, that may come into contact with the patient at any point during use should consider biocompatibility to ensure it does not release harmful substances or cause adverse reactions. Selecting adhesives and label materials with low leachable potential is essential to maintaining product integrity and patient safety.
7. Can label material selection help reduce the carbon footprint of the packaging?
The healthcare sector is responsible for around 5 percent of global greenhouse gas emissions, with nearly half coming from supply chains. As pharmaceutical companies work to reduce their environmental impact, packaging is under increasing scrutiny.
Labeling offers a practical opportunity to support sustainability goals without compromising safety or compliance. At UPM Adhesive Materials, we help customers reduce their carbon footprint by offering thinner label constructions and materials that include recycled or bio-based content. These options are evaluated using UPM Label Life, our life cycle assessment service validated by DEKRA, which provides reliable data on environmental impact.