November 19, 2021

Bioburden Study: Does RoSS affect cleanroom sterility?

RoSS® is the safety standard for any single use bag. “Robust Storage and Shipping” is an innovation from Single Use Support providing a protection for single use bags to avoid product loss of highly valuable biopharmaceuticals. It can be applied in different areas of manufacturing in Biopharma, be it cell & gene therapies or liquid transfer of large bulk drug substances, such as blockbuster vaccine production.
Despite its short time on the market, RoSS shells are of high demand. The scalable protective system supporting single-use technologies is well-established in numerous Big Pharma companies and is in use worldwide proving its effectiveness in real-life every day.

Testing particles when using RoSS

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. 
We thoroughly tested RoSS shell on how it has an influence on the sterility on ISO cleanrooms. 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?
Frozen bag in RoSS shell

Elisabeth Haas-Karagiannidis

Director of Quality Management & Operational Excellence