Robust Storage And Shipping: Secondary Packaging For Every Single-Use Bag

The RoSS® shell is composed of a stainless-steel top and bottom lid, a robust plastic frame, and 3D foam inlays (see Figure 1). These components provide unparalleled advantages in the handling of liquids in single-use bags. The composition of elements that embed the bioprocess containers is simple, easy to recycle, validated for use in a cleanroom environment, and it offers significant cost-efficiency and process flexibility.

Validated Robustness

All RoSS® shells manufactured by Single Use Support undergo rigorous testing and validation to ensure robustness in cold chain operations. The aim of the tests is to simulate real-life handling under standardized conditions, thereby verifying the shells‘ protective ability in cryogenic conditions. Drop tests and also bioburden validation tests in cleanroom environments are performed to optimize handling of single-use bags. As a result, the RoSS® shell has been proven to reduce bag rupture down to 0 %1 . The robustness of this secondary packaging helps to protect frozen single-use bags when frozen down to -80 °C. Its equivalent for smaller bags, RoSS.KSET, is qualified down to -196 °C.

Full Immobilization Of Single-Use Bags

While the outer shell is constructed from durable stainless steel and robust plastic elements, the interior is lined with specialized foam inlays that provide additional stabilization. The 3D foam offers a protective enclosure for the single-use bag and its assemblies. But it also absorbs the bag’s/liquid’s expanding energy caused by the density drop during freezing. At sub-zero temperatures, when the bag is already frozen, the foam hardens. The bag is fully immobilized in the hardened foam setup, making it safe to handle during storage and shipping

Enabling Plate Freezing

The RoSS® shell enables plate-based freezing of single-use bags, which is an advanced method for cooling biologics. The stainless‑steel lid enables direct, conductive freezing and thawing which ensures an efficient heat transfer between the bag and the cooling plates. Controlled freezing from the top and bottom allows for uniform freezing of the RoSS® shell, with a defined ice‑front growth rate that minimizes the effects of cryoconcentration.

One Shell To Advance Cold Chain Management

Manufacturers and CDMOs can greatly benefit from using a robust secondary packaging: Robustness, full immobilization of the single-use bag and the option to perform plate-based freezing are prerequisites to equip the pharmaceutical industry to handle liquids more effectively. The RoSS® shell provides unprecedented advantages for biomanufacturers, such as

• Minimized product loss
• Maximized product integrity
• Free choice of type of single-use bag
• Limitless scalability
• Integration in end-to-end process