Abstract: A method and apparatus of aseptic processing and production of cells in a non-sterile enclosure apparatus without chemical biocides is disclosed, by controlling the level of humidity throughout the enclosure to 25% relative humidity (RH) or less, and preferably 20% or 15% or less RH. In addition, the temperature is controlled to 37° C., and consistent gas flow is maintained the enclosure. Colony forming units from microbial contamination detected by environmental monitoring within the enclosure are significantly reduced in this method.
Abstract: During growth of tissue culture in a controlled atmsophere incubator the oxygen (another environmental gas) is dynamic controlled according to an oxygen profile (or other profile). Gaseous oxygen concentration is deliberately changed over time in a precise and reproducible way, with other parameters being held constant, or with other controlled parameters being changed simultaneously or sequentially. Oxygen profile is developed based on the amount of gas phase oxygen needed to maintain the dissolved gas in the culture medium at a desired level. A gas controller is programmed with the gas profile, and the oxygen is dynamically controlled according to the oxygen profile. The specific sequence and timing of changes in gaseous oxygen concentration that best indirectly regulate the desired dissolved oxygen concentration in the culture media inside open culture vessels that are placed inside the incubator.