Schreiner MediPharm, a manufacturer of functional labels for the healthcare industry, has developed a transparent deep-freeze seal that reliably adheres in deep-freeze conditions while enabling irreversible first-opening indication. As a result, packaged drugs that must be stored and transported at extreme sub-zero temperatures can be provided with reliable tamper evidence.

Since the enactment of the EU Falsified Medicines Directive and ISO 21976, tamper-evident packaging for prescription drugs has been mandatory. Innovative medications such as mRNA substances and biologics, as well as cell and gene therapies, are frequently processed, stored, and transported at extreme sub-zero temperatures. In such frigid conditions, the adhesion of conventional seals may be impaired. Nonetheless, to ensure product integrity and patient safety, reliable tamper evidence is essential.

Schreiner MediPharm’s new transparent deep-freeze seal has been designed specifically for these requirements, and is suitable for storage temperatures as low as -196 °C (-320 °F). It features a multi-tear effect as a double security mechanism: Any attempt to remove the seal results in the film irreversibly tearing due to integrated security cuts and — depending on the cardboard surface — in fibers tearing on top of the folding box, making a tampering attempt and first opening immediately visible. An integrated, sophisticated guilloche serves as an additional authentication feature, and further overt, semi-covert, or covert security features can be added to suit various threat scenarios.

The deep-freeze seal is available in two versions, each of which maintain adhesion in temperatures as low as -196 °C (-320 °F). One is designed for dispensing at 10 °C (50 °F), and another for application down to -50 °C (-58 °F). Both variants meet the requirements of the EU Falsified Medicines Directive and ISO 21976 “Packaging – Tamper Verification Features for Medicinal Product Packaging.” They reliably adhere to folding boxes and secure product integrity across the entire supply chain.

Schreiner MediPharm supports pharmaceutical manufacturers with comprehensive consulting along the entire process chain, and tailors each solution individually to the specific use case and threat scenario.