Automated aseptic filling platforms, such as RoSS.FILL , enable accurate, fast and safe dispensing into small single-use bags. Introducing 21 CFR Part 11 and GMP-compliance paired with high filling accuracy help advance fluid management processes. IRIS single-use assemblies are customized off-the-shelf fluid transfer tubing sets to provide an aseptically closed system and qualified fluid path.

Before filling cells into single-use bags, it is important to ensure that the cell count is consistent from bag to bag. Homogenizing devices, like RoSS.PADL, ensure cooling of high density cells after DMSO addition and uniform cell count distribution during aliquoting.

Temperature control during freezing and thawing can be achieved through plate-based platforms, e.g. RoSS.pFTU, or controlled-rate blast freezers, such as the cryogenic freezer RoSS.LN2F. Both enable a 21 CFR part 11 compliant automated cold chain process that performs protocol-driven cell freezing at approx. -1°C/min, the optimal cooling rate to maximize cell viability and recovery.

Secondary packaging to protect single-use bags, such as RoSS.KSET, enables a safe cell freezing and storage. With optimal heat transfer, it is an efficient way to standardize scalable cell cryopreservation as a method for banking CHO cells as intermediates.