STERILITY CHECK IN FERMENTOR OPERATIONS

One of the most important aspects before and while running a fermentation study using a fermentor is to monitor whether that fermentor is effectively sterilized and/ or that during the whole fermentation run that the fermentor maintain its aseptic integrity. It is indeed very sad in my personal experience meeting with various fermentation technologists especially those trained from an engineering background that the question of sterility and contamination have never been seriously considered. What is important to them that the fermentor is 'functioning mechanically' and is yielding growth of microorganisms or producing tons and tons of data. Did they ever think for all the efforts, time, energy and costs that their data could be wrong or useless? In fermentation studies, wrong experiments can still yield data....wrong and error filled data!!?? And to make things worst they send their students on a wild goose chase analyzing these wrong data and reaching definitive conclusions? This must be the case of abuse of statistics and computer! After all if its rubbish data coming in you will get rubbish data or conclusions coming out

Most fermentation technologists take lightly to the concept of microbial contamination. This is not so in the stringent pharmaceutical fermentation industries where cGMP are always applied and validation of sterilizations and aseptic conditions are sustained as routine procedures. Any contamination would be a very heavy consequence in such industries.

Most fermentation technologists in universities, colleges and research institutes I met seemed to be in the state of denial thinking that:

1 Their fermentors are 100% sterile or can maintain aseptic integrity
2 They dont bother doing blank sterility test runs periodically to check if their fermentors are up to the sterilty validation
3 They do not periodically remove samples during fermentation runs to check for microbial contaminants

It is true that those fermentors before they are delivered are tested for sterility check for about 5 days equivalent of fermentation run. But these fermentors must be continually checked by conducting blank runs using rich broth and operated without any organism inoculated

It is impirtant to know if contamination occurs to determine whether it is due to:
1 Fermentor structural weakness
2 Operator failure
3 Feed or what ever