In the pharmaceutical and healthcare industry, there are strict regulations as well as demanding conditions that set high technical requirements for labels, particularly for those found on Injectables packaging types such as pre-filled syringes, pens, cartridges, vials, and ampoules. These small diameter containers pose multiple challenging requirements for labeling and require specialized label materials to ensure tight mandrel hold as well as extreme durability.
One trend that is impacting the field of injectable packaging is fast-growing biologic medication, which typically requires cold chain storage. Biologic medication is increasingly being utilized for chronic diseases such as diabetes, heart disease, Alzheimer´s and cancer. Vaccines also frequently require cold chain storage as low as -80°C. The label material should perform with the specific injectable packaging type and in the conditions it is exposed to during its lifecycle. It is therefore more important than ever for label materials to meet the challenge that new disruptive technologies bring to packaging requirements.
Here are the 6 crucial questions to ask when choosing labeling for your injectable products/packaging
1. Is the labeling material designed specifically for injectable packaging types?
Pharmaceutical labels must adhere securely to small diameter containers. They often need to withstand cold chain storage and moist labeling conditions, whilst fulfilling regulatory obligations for product safety. In addition changes in novel disruptive medicine technologies or biologic drugs, for example, would mean that current packaging and label solutions that are in use today, will not necessarily meet the needs of the future. A critical change to storage temperature conditions may require a completely different labeling material, therefore it is important to ensure any major changes are also assessed from a packaging point of view. Using a label which is not designed for pharmaceutical requirements and intended temperature windows can cause the label to become unreadable or peel off. This can lead to costly recalls or compromise product safety.
2. Does the labeling material meet the requirements for small diameter injectable containers?
Small cylindrical containers below 23 mm in diameter require special materials and adhesives that stop the label from lifting at the edge and peeling off. The most critical small diameter for label material mandrel hold is from 7–12 mm. Make sure you choose the right label material that will:
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- adhere well even to moist and cold surfaces and their possible surface treatments,
- have optimal mandrel hold performance and suitability for glass and/or plastic substrates with lower surface energies,
- ensure legible printing,
- remain securely intact after harsh storage and handling, and
- will not absorb moisture or tear, even after thawing.
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Learn more about the requirements for label material for small diameter injectables
3. What labeling is needed for secondary logistic packaging?
An equally important consideration are the secondary packaging labels. For example, logistics packaging made from cardboard or plastic. Make sure you holistically consider the pharmaceutical cold chain packaging in its entirety to ensure traceability. Read more about how UPM Raflatac and AJK Etiketten provided a labeling solution that withstands the ultra-deep-freeze conditions in the temperature-controlled transportation of a vaccine in logistic packaging and in final storage down to -80°C.
4. Has the labeling material been tested and are changes controlled?
Injectable packaging materials require extensive product validation testing to ensure product safety. Thus, the importance of pre-tested materials with a change management protocol is crucial when choosing a pharmaceutical label solution for injectables packaging types. Unforeseen changes in label raw materials or the packaging of pharmaceutical products can potentially cause unintended effects on performance, purity and stability that create serious risks to patient health and brand security. With a robust change management process in place, these problems can be avoided.
Learn more about our pre-tested label solutions that offer robust mandrel hold in various conditions
5. Is the injectable packaging migration safe?
A critical consideration for injectable labeling is the product safety of the entire packaging solution, especially regarding migration safety (leaching of chemicals into the drug) and biocompatibility (leaching of chemicals to the patient via direct contact). Preventing toxic compounds from interacting with the drug and patient is a crucial aspect of complying with pharmaceutical labeling requirements.
Migration can especially pose a risk with non-solid form drugs (liquid, gel or aerosol) that are packed in a plastic container. As per regulatory requirement, any packaging material within drug-device combination product such as injection pen that could come in contact with the patient at any time must demonstrate biocompatibility. This is to ensure they do not leach chemicals to the patient and affect their health or cause irritation. The appropriate selection of a suitable low leachable characteristic adhesive is critical in those circumstances.
Learn more about product safety with injectable packaging
Learn more about low leachable label adhesive RP31 Purus
6. Are there sustainable pharmaceutical labeling options?
Although patient safety and regulations have been the key drivers for the design of pharmaceutical packaging materials, there is a growing need for the industry to ensure that packaging is also environmentally sustainable. Even though not all pharmaceutical packages can necessarily be recycled with today’s technologies and infrastructure, there is always a way to increase the sustainability of the package and cause less burden to the environment by choosing pharmaceutical labels manufactured from renewable or recycled raw materials, or solutions that are resource optimized and therefore use less raw materials.
Learn more about sustainable pharma packaging
Learn more about how to find the right pharmaceutical pre-tested label material for injectable packaging types in our Selection Guide.
UPM Raflatac collaborates with brand owners and joint industry stakeholders in various labeling related matters. From defining the right dedicated solution for your labeling application to supporting material specification and matching your application acceptance criteria, as well as helping reach joint sustainability targets.
We know it's not always easy to choose a label, which is why we are on hand to help you select the right labeling materials for your pharmaceutical product. Request a guide here.
Choose pharma-dedicated labels for your pharmaceutical product