Bioburden Study: Do RoSS Single-Use Bag Shells Affect Cleanroom Sterility?

RoSS shells contain 3D foams to protect and immobilize the filled and frozen bags while transporting. Usage of foams is uncommon in the biopharmaceutical industry resulting in concerns that may arise in this regard.

In this study we thoroughly tested RoSS shell on how it has an influence on the sterility on ISO cleanrooms. The goal of this study was to investigate if the foam absorbs condensate during thawing and thereby could promote microbial growth. Additionally, the surface bioburden of the foam was analyzed.

In detail the following questions have been fact-checked:

• Do RoSS shells expose particles when in use in cleanroom environments?
• Do foams of RoSS pose a microbial contamination source in general or by absorbing condensate during thawing?