A new standard in clinical packaging: Tamper-evident innovation for secure and sustainable supply protection
Author: Philipp Georg Ab Egg, Director, Service Line Management, Thermo Fisher Scientific, Pharma Services
Category | Clinical trial services
In the world of biotech and biopharma, every aspect of drug packaging is critical to advancing patient care. One essential feature is the tamper seal, which provides an added layer of security and trust, ensuring that packaging remains intact and product integrity is maintained from production to patient use.
Across the industry, traditional tamper-evident seals have shown limitations, particularly in extreme conditions like ultra-low temperature storage, where labels can lift or fail. These issues can pose risks for maintaining product integrity.
Why traditional solutions aren't enough
Tamper seals play a crucial role in ensuring that clinical supplies arrive intact and uncompromised. However, adhesive tamper-evident labels, commonly used for security, are not always designed to withstand challenging storage environments. In extremely cold conditions, adhesive strength can weaken, causing labels to lift or detach—compromising packaging security and potentially falling short of regulatory requirements. Reworking products due to these quality issues can lead to significant trial delays, and in the worst cases, prevent patients from receiving the medications they need.
In response to these widespread industry challenges, Thermo Fisher Scientific’s in-house team designed an innovative packaging solution, patented in March 2024, that reimagines patient safety by integrating tamper-evidence directly into the carton structure.
Introducing the Tamper Evident Carton: Meeting industry needs with a holistic solution
Thermo Fisher Scientific’s patented Tamper Evident Carton provides a comprehensive answer to tamper-sealing concerns in clinical supply chains. This design eliminates the need for traditional tamper-evident labels by incorporating the carton, insert, and tamper-evident features into a single, unified package. By doing so, it significantly reduces the risk of tamper-related failures in various storage conditions.
Going beyond security: Sustainability and versatility
The design of the Tamper Evident Carton not only enhances security but also addresses environmental impact. The carton is both foam- and glue-free, supporting sustainability goals while maintaining robustness. Adaptable to a range of vial sizes from 2R to 20R and suitable for temperatures as low as -80°C, this solution caters to the diverse needs of today’s biopharma and biotech markets, offering peace of mind for both temperature-sensitive and ambient storage needs.
Strengthening confidence in the clinical supply chain
By delivering a reliable, tamper-evident packaging option, Thermo Fisher is helping to build trust and integrity within the clinical supply chain. With a clear indicator of tampering risk, teams can focus on what matters most: ensuring products reach patients safely and securely. The Tamper Evident Carton is more than a packaging innovation—it’s a response to the real challenges facing clinical supply teams, allowing them to advance their work with added security, confidence, and commitment to sustainability.
