Complete Transparency for

Sensitive Pharmaceutical Shipments

How Single Use Support enhanced product safety

with an integrated shipment monitoring solution


Safer Pharmaceutical Transport

High Standards for Transparency and Safety in the International Transport of Active Pharmaceutical Ingredients

For the international transport of active pharmaceutical ingredients, Single Use Support faced the challenge of providing a controlled, secure, and practical single-use shipper solution. The goal was to reliably protect sensitive single-use bags within their RoSS® shells while ensuring seamless monitoring of all relevant transport parameters throughout the entire transport period.

A key risk was the lack of a way to continuously record, track, and audit-proof document all critical transport parameters. Particularly for long international transport routes, this could have led to uncertainties regarding product integrity and process safety. Furthermore, at the time of the inquiry, there was no standard shipper solution available on the market that could fully meet all technical, quality, and operational requirements.

The planned solution therefore needed to meet several essential requirements: ensure the secure mechanical protection of the single-use bags in RoSS® Shells; reliably maintain defined temperature-controlled transport conditions; continuously record and document all relevant transport parameters; and provide a tamper-proof, traceable, and permanently storable database. At the same time, the solution had to be practical enough to integrate seamlessly into routine transport operations.

Adaptation of Existing Shippers and Integrated Shipment Monitoring

Following extensive technical and procedural coordination, a targeted, pragmatic approach was chosen: An existing shipper design from Single Use Support was specifically adapted to meet the transport requirements. The focus was on combining mechanical product protection with digital transport monitoring.

Specifically, a RoSS.SHIP single-use shipper was modified by integrating an additional mount for the Tec4med SmartHub. This mount is designed to utilize the magnets in the SmartHub, supported by a magnetic plate to ensure stable and secure positioning throughout the entire transport process. This ensures that the monitoring equipment remains securely in place even under real-world transport conditions.

The SmartHub is used in combination with a CryoBeacon, including a Pt100 probe, to enable precise measurements. This not only allows for continuous monitoring of the temperature inside the shipper but also provides a central tracking function. This combination enables end-to-end transparency throughout the entire transport process.

When designing the solution, great emphasis was placed on ensuring that the customized shippers could be seamlessly integrated into existing logistics and transportation processes. The focus was on a reusable, robust, and reliable solution that is suitable for routine use while also meeting the highest standards for quality and documentation.

From a Customized Approach to an Established Transport Solution

The modified shipper solution was initially implemented as part of an initial transport and used successfully. Already after this first application, the high practical suitability of both the customized shipper design and the integrated shipment monitoring was confirmed. Subsequently, the shippers were validated and have proven themselves to be a reliable solution that is still regularly used today for further international transports of sensitive active pharmaceutical ingredients.

By combining mechanical protection for the single-use bags with digital tracking via Tec4med technology, all relevant transport data can be seamlessly integrated into Single Use Support’s quality and documentation processes. This creates a flexible, scalable, and future-proof solution that meets regulatory requirements while ensuring complete transparency throughout the entire transport chain. In addition, the transition from a one-time custom solution to a standardized routine process was successfully implemented.

„The jointly developed shipment solution sustainably improves
process and product safety for the transport of sensitive goods
and builds trust in a controllable supply chain
through transparent, reliable data.“

Claus Exenberger, Technical Product Owner at Single Use Support

Both qualitative and quantitative metrics are used to evaluate the solution’s effectiveness. These include, in particular, verifiable compliance with defined transport conditions, complete recording and storage of all transport data throughout the entire duration, and a significant reduction in uncertainties and risks in the transport process.

In the long term, the solution creates additional value for sensitive international shipments by enhancing process and product safety and further increasing trust in the supply chain through transparent, auditable data. At the same time, it promotes efficient collaboration between shippers and tracking providers without the need to pool internal resources.