Drug Protection Labels for Sensitive APIs

Typical applications include the packaging of biologics, biosimilars, mRNA-based drugs, ADCs, cell and gene therapies, and other sensitive active ingredients. They are particularly relevant for transparent primary containers such as pre-filled syringes or vials. Pharmaceutical companies and CDMOs use such solutions when product protection and process reliability are required, whether in commercial applications or clinical trials. The key is always precise customization regarding the active ingredient, container, and supply chain.

Many modern pharmaceuticals are very sensitive to UV radiation, visible light, or oxygen. Even minor exposures can compromise their stability, shelf life, and efficacy. For highly sensitive formulations in particular, additional protection is therefore advisable when using transparent primary containers. Functional labels provide an application-specific solution that is flexible and offers customized protection.

Light protection is achieved using specially developed Light-Protect-Labels, which are customized by Schreiner MediPharm for each specific syringe or vial. Depending on the level of protection required, several options are available—ranging from UV protection to full protection against the visible light spectrum. At the same time, inspection windows can be integrated so that the contents of the container can still be visually checked. In the case of vials, Light-Protect-Labels offer the option of replacing amber glass with transparent glass. This not only enables customized light protection but also allows the liquid medication or lyophilisate to be inspected in its original color.

Schreiner MediPharm’s solutions are available in three protection levels. Level 1 protects against UV radiation and features a transparent inspection window; Level 2 extends protection to visible blue light; and Level 3 offers protection against both UV and visible light. Levels 2 and 3 are also equipped with a resealable inspection window. This allows the protection to be precisely tailored to the active ingredient, container, and application. Pharmaceutical companies’ individual needs and process requirements can thus be specifically addressed.

COC syringes are lightweight and break-resistant but offer a lower barrier to oxygen compared to glass. For oxidation-sensitive drugs, Schreiner MediPharm’s Gas-Protect-Labels can therefore be used, which significantly reduce oxygen permeation. Depending on the label design, these solutions cover a large area of the syringe body or even additionally enclose the cap. This allows the gas barrier function to be enhanced without having to forego the advantages of COC as a primary container.

A Syringe-Closure-Wrap is a labeling solution that covers both the syringe body and the cap. It combines an irreversible first-opening indication feature with light protection or a gas barrier function. This enhances product safety and makes tampering attempts visible. For sensitive pharmaceuticals in pre-filled syringes, this is an efficient solution when multiple requirements must be met simultaneously.

The Cap-Lock Label combines a first-opening indication, light protection, and/or a gas barrier in a single design. It encloses the syringe body and cap and provides an irreversible indication of opening. Additionally, it can help transfer protective functions from the blister packaging to the primary packaging. This opens up opportunities for space-optimized and sustainable packaging concepts, reduced material usage, and more efficient logistics.

Yes, special Freeze-Light-Protect Labels are available for temperature-sensitive pharmaceuticals. These labels are designed for applications involving extremely low temperatures and maintain their adhesion and functionality even under demanding conditions. At the same time, they can be combined with light protection, graduations, or detachable documentation labels. This is particularly relevant for mRNA substances, cell and gene therapies, and other frozen applications.

The labeling solutions can be adapted to various syringe formats made of glass or COC. They can be customized for systems with staked-in needles or Luer-Lock adapters and tailored to the specific geometry. Depending on the protection concept, it is also possible to cover both the cap and the syringe body. As a result, the solutions are suitable for a wide range of pharmaceutical packaging requirements.

All label formats can be applied without the use of heat, unlike shrink solutions. This is a significant advantage for heat-sensitive pharmaceuticals and existing pharmaceutical packaging lines. At the same time, customization options regarding format, protection requirements, and additional features remain feasible. This allows for efficient integration into existing processes.