UPMRaflatac

Injectable Labeling: Pre-filled Syringes, Vials, Injection Pens, Cartridges and Ampoules Labels

 

Injectables drug delivery packaging trends

There are trends in the injectable packaging field which not only potentially impact how the drug or medicine is administered, but also the choice of label. One of these trends is the shift from traditional vial and syringe administration to user-friendly drug delivery systems such as pre-filled syringes and injection pens. One of the driving factors for this is the need to make the administration process as easy as possible for patients by enabling more convenient self-administration at home. Another 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 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.

 

Injectable labels must withstand extreme conditions and deliver vital information

Injectables packaging types such as pre-filled syringes, pens, cartridges, vials, and ampoules pose multiple challenging requirements for labeling. These small diameter containers require specialized label materials to ensure tight mandrel hold as well as extreme durability. They often need to:

  • Perform in changing harsh cold chain storage conditions even down to ultra-deep freeze
  • Withstand sterilization conditions
  • Provided excellent adhesive properties to remain intact
  • Fulfil regulatory obligations for product safety

Using a label which is not designed for small diameter container and intended application condition window can cause the label to become unreadable or peel off. This can lead to costly recalls or even compromise product safety.

 
 

High performance labels throughout the supply chain

Requirements for the label material for small diameter injectables

It is vital to understand the requirements and needs of versatile pharmaceutical packaging types.

1. The size and shape of the labelled container

Injectable containers with diameter of 7–23 mm (0,275–0,905 inches) and a volume of 1–50 ml we define as small diameter containers, as they pose higher risk for label edge-lifting. The most critical small diameter for label mandrel hold is from 7–12 mm (0,275–0,472 inches).

2. Label material construction with special properties

Adhesives must have good initial tack and a balance of peel and shear properties to offer superior mandrel hold and resistance against edge-lifting. Pairing these adhesives with thin and flexible label faces gives optimal performance, with the label tightly wrapping around the curvature of the container. Film labels must be conformable and flexible to wrap and contour to tight radius containers yet have some dimensional stability for high-speed dispensing.

 
  Pre-filled Syringes Vials Glass Ampoules Pre-filled Pens Cartridges
 
Typical diameter range (mm): 6,8—14,8 mm 13—16 mm 10,75—23 mm 15—20 mm, cylindrical or conical shape 11 mm
Typical diameter range (inches): 0.268—0.583″ 0.512—0.630″ 0.423—0.906″ 0.591—0.787″ 0.433″
Volume: 0,5—5 ml 2,5 ml and up 1—20 ml 0,5—5 ml 1,5—3 ml
Substrate: Glass, PP, COC, COP Glass, LDPE, HDPE, PP, COC, COP Glass PP or other high-performing plastic systems such as ABS Glass, PP, COC, COP

 

 
 

In addition to container size and diameter, other factors that can create additional challenges for label mandrel hold include:

  • Plastic substrates with lower surface energies where it is more challenging to develop adhesion
  • Surface is treated (slip-coated or varnished)
  • Surface is moist and cold when applying the label in lines
  • The product is stored in cold and extreme freezer conditions and possibly later exposed to freeze-thaw cycles
  • Various sterilization methods that can impact adhesive properties
 
 

Pre-tested label solutions to offer robust mandrel hold in various conditions

UPM Raflatac makes the selection of labels for injectable containers easy with a Selection Guide for pharmaceutical labeling materials. Our recommendations are based on decades of experience in the labeling industry, as well as extensive pre-testing done in our accredited research laboratory. Choosing pre-tested label solutions is made easier and more efficient, ensuring that you have the right label solution before starting your own qualification activities.

 
 

The label materials recommended for tight mandrel hold are pre-tested with the exact packaging types and in intended application conditions. Tests are done in varying storage conditions and with multiple different sterilization methods. We follow the FINAT test method for FTM24 mandrel hold.

 
 

Label materials designed and pre-tested

Diameter, substrate and shape

Low leachability

Fridge and freezer storage

Deep freeze and cryogenic storage

Sterilization conditions

Ultra-clarity for drug inspection

 

Hanger labels for IV bottles

Tamper-evident seal labels

Line speed and performance

Printability and legibility

Chemical and mechanical exposure

Label presence verification

 
 

Product safety with injectable packaging

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 is a crucial aspect of complying with pharmaceutical labeling requirements. The appropriate selection of a suitable adhesive is critical, as it is in direct contact with the primary packaging. Migration can especially pose a risk with non-solid form drugs (liquid, gel or aerosol) that are packed in a plastic container. The likelihood of packaging component interaction with the extractable and leachable risks can be especially high with plastic injectable packaging. Glass acts as a natural barrier and is often not so sensitive to migration concerns. However, with the increasing usage of plastics in novel injectable packaging, migration safety is a key focus area. EMA (European Medicines Agency) and US Food and Drug Administration (FDA) requires migration safe packaging, printing inks and labeling systems for liquid prescription drugs. This is important for containers made from polyethylene (PE), polypropylene (PP), cyclic olefin polymer (COP), and cyclic olefin copolymer (COC).

 
 
 

Drug delivery devices are a specialty area within the medical device industry. These are combination products that combine a medical device with a medicinal product (for example autoinjectors, or pre-filled pens or syringes) that may require review and approval by either device or drug agencies, or both. For drug-device combination products user safety is paramount. Per regulatory requirement, any packaging material within a device 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.

To ensure biocompatibility and migration safe labels, a pharmaceutical or medical device company should pay attention to the entire packaging solution and their chemistry before starting qualification activities. Thorough testing and evaluation of the label materials together with the packaging is always needed.

 
 

Adhesive support packages available for biocompatibility and migration studies

For UPM Raflatac’s low leachable label adhesives, RP31 Purus and RPMD, we have created comprehensive documentation packages that contain technical information and details of the formulation and extraction profiles of our adhesives. The information packages are provided upon request, only under a Non-Disclosure Agreement, and provided only directly to pharma and healthcare companies in supporting them conducting their own:

  • E&L (Extractable and Leachable) and shelf-life stability studies,
  • Biocompatibility assessments and toxicology evaluations for medical devices
 
 

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