Sound technical content, curated with aloha by
Ted Mooney, P.E. RET
Pine Beach, NJ
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for Metal Finishing since 1989
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Cleaning of a 50L fermenter
Q. Hi:
I am conducting a cleaning process and cleaning validation on a 50L 316L stainless steel fermentor. I inquired from several of my friends in the industry regarding any established protocols on 50L (or smaller) fermentor cleaning and cleaning validation. No one has any information for me. I would highly appreciate if any one could give some insight of how to clean 50L fermentor without talking the head plate off and how to validate the cleaning process.
Thank you,
Prabo WijetungeBiotech - Columbus, Ohio, USA
2004
A. The home brewers use sodium percarbonate for cleaning. It's also one of the major constituents of dishwasher detergent, and as an "Oxygen Bleach" [link is to the product at Amazon] in laundry detergents. Some products advertise FDA (Food and Drug Administration) approval for use in food plants. I've seen prices from about $1.80 to $10 per pound in small quantities (a few pounds).
As for a cleaning procedure without disassembly, try the method used on tank trucks. A spray head in a ball shape is inserted into the tank on the end of a hose and the pump is turned on. With a high enough pressure (around 150 psi for the ones I've seen), the spray head whips around rather violently inside the tank, doing a good job of dispersing the spray.
Tom Gallant- Long Beach, California, USA
2004
Q. We are a new Biopharmaceutical company, We have 20 L and 500 L fermenters and after each fermentation we have to open the fermenters and use mechanical force (like smooth brush) to remove the sticky mass present on the inner side, on shaft and on the impeller of the fermenter.
If we use CIP technique and use detergent without open the fermenter, is it enough to remove sticky mass?
What is the guarantee that there is no traces of detergent material which may affect the next fermentation process?
- Cairo, Egypt
2006
A. Look for gradual improvements rather than looking for miracles, and guarantees on those miracles, Sohair :-)
The fermentor tanks, shafts, and impellers should be highly polished mechanically, and then electropolished. This will reduce their "tooth" and reduce the sticking. Then you can try the cleaning with detergent that was proposed, then open the fermentor and see what you have. The improvement may be marginal and not worth the effort, or the improvement may be quite impressive but still imperfect, indicating the need for more design work. It's unlikely that the improvement will be spectacular on the first attempt. Good luck!
Ted Mooney, P.E.
Striving to live Aloha
finishing.com - Pine Beach, New Jersey
2006
A. AS YOU HAVE ASKED ABOUT THE CLEANING WITHOUT OPENING THE LID OF THE FERMENTOR,YOU CAN USE THE SPRAY BALL SYSTEM AND ALSO AS YOU ARE CLEANING WITH BOTH ACID AND ALKALI DURING CIP SO THERE WILL BE NO PROBLEM FOR YOR NEXT BATCH.
IF YOU WANT AN CONFIRMATION REGARDING THE BATCHES TAKE THREE CONSISTENT BATCHES WITH SCD MEDIUM OR NUTRIENT BROTH SO THAT YOU CAN VALIDATE THE PROCESS.
- Visakhapatnam, India
2006
Q. We are doing sterility for fermentor. we have tried every option like with additions through ports, checked the mechanical seal for leakage, checked for air contamination but still it is failing. can any one suggest for the improvement.
Rajesh Konathalaproduction - Hyderabad, Andhrapradesh, India
2007
A. Check for the air line leak check,and also inoculate the scd medium through 0.2 micron filter
and then also if it fails sterilize the fermentor with formalin and leave over night and then try for the sterility batch.
- Visakhapatnam
2007
December 26, 2008
A. I think you should check to eliminate the contamination..
1. the air supply
2. Lumps in the media
3. Humid air (Wet air filters)
4. Clean all the process valves thoroughly if necessary change gasket etc.
5. Clean thoroughly your fermentation area and use disinfectant while cleaning.
6. Hydro-statically check any loss in jacket pressure or coil pressure.
- New Delhi
Q. What are the suggested chemicals to clean the 2 kl fermenters?
- Hyderabad
March 28, 2012
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