Articles
Tighter pH Control In Biopharmaceutical Applications
November 13, 2008
•Application Note: Tighter pH Control In Biopharmaceutical Applications
By Emerson Process Management, Rosemount Analytical Liquid Division
In fermentation and cell culture, one of the most critical process challenges is to maintain the optimal pH level. Fermentation process utilizes a living organism such as a yeast, bacteria, or fungus strain to produce an active ingredient. Fermentation process is normally shorter in duration (2-7 days). Cell culture is a process in which a mammalian cell is grown to produce the active ingredient. The cell culture process is typically longer (2-8 weeks).
One big challenge for the pH measurement is the cleaning process. The fermentor or bioreactor has to be sterilized prior to the start of either process to ensure no cross batch contamination or any unwanted growths are present. In addition, pH sensors undergo a 2 point calibration using buffer solutions. The residual buffer chemicals must be removed prior to start of the batch. The Clean In Place system (CIP) consists of Steam in Place (SIP) and sometimes additional chemical cleaning steps. Exposure to high temperature steam and rapid thermal shock significantly affect the sensor's life.
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