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Cell Culture Sampling (Bags)
The Challenge
A process engineer from an animal healthcare manufacturer faced contamination risks due to their open environment sampling procedure and desired a sterile closed system for microbiology analysis during cell culture. If cell culture was falsely identified as contaminated due to a poor sampling process then batch loss would result.
The Saint-Gobain Collaborative Design Services' Solution
The customer shared their current cell culture sampling requirements for their existing bioreactors with our Design Services Team. The goal was to develop a single-use system that supported (4) – (12) sample collections plus (1) effluent bag during cell culture. 150ml Saint-Gobain Bioprocess Bags constructed of 7mil multi-layer film (LDPE/EVOH/Nylon), C-Flex? 374 heat sealable and weldable tubing, Pure-Fit? SIB? Connectors and needle-free sample ports were assembled into a manifold assembly. Prototypes were built and confirmation of the cell culture sampling process efficiency resulted. The final product was delivered to the customer gamma sterilized with a sterility assurance level of (SAL) of 10-6.
Customer Experience
This newly implemented single-use sampling system has eliminated the customer’s contamination false positives as experienced with previous sampling process.