Withstanding Fluctuating Temperatures Along the Cold Spectrum

Schreiner MediPharm’s Gene Dul on the importance of sub-zero-capable pharma labels

Whether it be cryogenics or simply super-low temperatures, the preservation of labels on cold chain pharma products can be just as important as the care of the contents themselves. Advancing technology now allows labels to endure a multitude of conditions and maintain functionality of crucial additional features, such as detachability. Gene Dul, president of Schreiner MediPharm US, a specialty label developer, sat down with Pharma Commerce to further outline these capabilities.

Pharma Commerce: What is the state of the market for labels that can withstand sub-zero storage and transport temperatures needed for CGT medications or clinical trials?

Gene Dul: Due to the rise in biologics, biosimilars, personalized medicine, mRNA substances, etc., there is a growing need for low-temperature labels that can withstand challenging conditions without losing their functionality. Specialized label suppliers such as Schreiner MediPharm offer a variety of labels that can be applied at room temperature or cryogenic temperatures, depending on the specific use case.

Since this technology is also applicable to COVID-19 mRNA vaccines that have very specific and stringent temperature requirements, how has the demand for these types of labels been affected?

The demand for cryogenic labels for the mass market has skyrocketed due to COVID-19 mRNA vaccines and their extremely fast time-to-market. Usually, in commercial pharma production for mRNA vaccines, labels are applied at room temperature at conventional production lines before being placed in cryogenic conditions.

What challenges are presented with manufacturing such a label?

When manufacturing a cryo label for mRNA vaccines or other commercial medications, it must be considered that adhesives for sub-zero temperature applications tend to be a bit more oozy, so a temperature-controlled production environment and controlled processes are crucial. Also, printing quality is an important aspect to ensure readability of crucial product information up to the point of use. In addition, the label design must ensure strong adherence, even to small containers with narrow radii, and allow reliable functionality of additional features—for example, detachable documentation labels despite freezing temperatures.

Could you describe Schreiner’s Freeze-Lock label and the benefits it offers?

Schreiner MediPharm’s novel Freeze-Lock cryo label consists of two components: a bottom label and a top label. The bottom label layer has a specialty surface texture, and is applied to the empty, non-refrigerated container at room temperature. The container is filled with the drug and immediately cooled down for storage at sub-zero temperatures of dry ice (-78 °C) or liquid nitrogen (-196 °C). To mark the frozen container, it is removed from cold storage just before labeling. The top label layer is applied to it by firmly pressing it against the bottom label. The deep freeze adhesive of the top label combines with the texture of the bottom label and freezes within seconds and can then be returned into cryogenic conditions immediately afterward. This results in a permanent bond between the label construction and the container, which can be returned to storage and transported in frozen condition.

Freeze-Lock is the only labeling technology that allows adding the pharmaceutical label with product information at any point. What makes this technology especially unique is its label construction, which is resistant to condensation or iced layers, and enables reliable adhesion to frozen containers.

As it pertains to the cold chain sector, what future projects does Schreiner have in the works?

The continuous rise of cell and gene therapies, as well as mRNA technologies, will have a big impact on the future of pharma. As a supplier of innovative, highly functional labels for the healthcare industry, Schreiner MediPharm is proactively supporting its customers to find individual solutions for their specific challenges. We are well prepared to scale up our portfolio of cryogenic specialty labels to meet any future needs.