February 10, 2020

Cold Chain Logistics with Single Use Bags

When it comes to the manufacturing and development processes in biopharmaceutics, single use bioprocess container exhibit a vast number of advantages: Handling is easy, costs – both for acquisition and storage – are low, and as opposed to bottles, single use bags require almost no space. They are easy to store, yet they offer a high degree of reliability.

This is not to say that there aren’t several phases during the cold chain logistics process that require closer inspection, as medical substances in various developmental stages are shipped around the globe. Some simple hacks can contribute to a safe journey to warrant the single use bag’s intact arrival at its final destination and keep its precious contents protected from biocontamination and other damages.

Protecting Single Use Bags The Right Way

Temperatures of -80 °C (-62 °F) can cause single use bags to rupture and materials to break, which can lead to an excessive waste of materials and resources, especially when it comes to high-quality substances. This is why it is imperative to protect the single use bag during its controlled freezing – and afterwards – from the outside.

For this reason, Single Use Support has developed a compact shell for the single-use freezing process. It ideally protects the single use bag during storage, shipping and the bag freezing process. The shell is made of high-quality stainless steel that offers protection against external impact, while on the inside the bag is bedded in specially developed soft 3D foam.

Each shell is tamper-proof so the bag contained in the RoSS Shell cannot be accessed during the entire controlled freezing and logistics process. The RoSS Shells are compatible with single use bags of all established brands and manufacturers.

Prior to their utilization, all bags should be tested on their integrity. The integrity test kit MITS.2D is based on helium and allows for the detection of microscopically tiny holes in the bags. Deficient single use bags pose a risk of contamination with bioburden and endotoxins, and in the worst case the entire content of the bag will be lost. As such, deficient single use bags not only pose a safety risk but the financial aspect plays a role too.

RoSS protecting single-use bags

High-quality Freezing

Most manufacturers use traditional freezers to freeze their valuable biopharmaceutical substances. However, the most logical solution is not always necessarily the best one. The slow freezing process of traditional freezers impacts the quality of the medical substance. It leads to the formation of large crystals that can cause friction and will increase cryoconcentration. As a result, up to 20% of proteins can get destroyed.

This can be countered with a fast freezing process. So-called plate freezer allows for a shock-like freezing effect that will maximize the quality of frozen biopharmaceutical substances.
Plate freezing leads to a speedy and at the same time controlled freezing of the valuable liquid solution contained in the single use bag.

During the freezing process, the bags are protected by stainless-steel RoSS single-use shell, with the stainless steel offering the best possible temperature transfer from freezer to bag to liquid.

The following curve illustrates the freezing speed during single-use freezing:

RoSS.pFTU - 16x 8200ml PALL bags

Special Shipping Containers maintain the Cooling Chain

As already mentioned, biopharmaceutical products cover enormous distances during development and production. In order to maintain the cooling chain during the entire frozen bag shipment and storage, specialized shipping containers are required.

That is why we have developed coolable shipping and ultra cold storage containers with minimum space requirements to keep the RoSS Shells and their contents cool after the bag freezing process.

The containers can carry up to 20 RoSS Shells and are, like the shells themselves, made from robust stainless steel. The cooling system inside the isolated containers is based on dry ice or so-called “Phase-Change Materials” (PCM).

The containers are equipped with GPS chips so they can be tracked and localized throughout their journey. At the same time those chips allow for a constant monitoring of the temperature inside the containers to guarantee for a reliable and safe frozen bag shipment.