VALIDATION OF PROCEDURES IN FERMENTATION STUDIES

In carrying out any fermentation studies using any type of fermentor, it is of utmost importance that we carry out the studies properly so that there will be no unwanted errors and that the results obtained are proper and truthful. We do not want at the end of our fermentation studies ending up with wrong and erroneous data which in their true value are useless.

In the process of carrying out the fermentation we need to look closely at the following points

NEED TO CALIBRATE THE ELECTRODES
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In carrying out fermentation studies we are dealing with fermentors which often come with various sensors and electrodes to monitor the fermentation process. The electrodes need to be examined closely in terms of its structure and functionality. It is important to calibrate the electrodes before every use in the fermentation studies

Most forget that every electrode have its life time expectancies especially in the fermentation studies where the conditions are harsh and demanding and the lifespan of the electrodes are short

It is ad to note in certain incidence fouled, broken and dried electrodes are used to monitor the fermentation process

NEED TO ESTABLISH ASEPTIC INTEGRITY OF FERMENTOR
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Before the use of the fermentors close examinations must be carried out on the various components of the fermentors from tubings to air filters. Blank run using rich medium should be used to detect if the fermentor is fit for operation.

NEED TO STERILIZE PROPERLY
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The autoclaves used to sterilize the fermentors should be validify in terms of their efficacy in sterilizing the fermentor. The inner chamber temperature of the autoclave should be calibrated to ensure that the temperature shown outside is the same as shown inside. This is similarly applied for the pressure check.

There is the need that the autoclave is not over loaded with materials to be sterilized, if not the sterilization cycle need to be adapted

NEED TO USE UNCONTAMINATED PURE CULTURES
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It is bad to assume that the microbial cultures used for the fermentation to be pure. Microbiological checks are need to be carried out up stream before the culture is used. Failure to do this would be a disaster to the fermentation studies as amplification of contaminants could occur with time length and temperature


NEED TO CARRY OUT PROPER ASEPTIC TECHNIQUES
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Proper aseptic techniques during inoculation and sampling should be effectively carried out and confirmed or validated. The sampling line is one of the most common portals for the introduction of contaminants into the fermentor.

NEED TO USE CORRECT OR APPROPRIATE VOLUME OF BROTH
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The volume of fermentation broth should be calculated to take into account of possible loss through samplings and dehydration. It is important that the volume filled must not enter or use up the headspace to avoid contaminations

Wrong volume of broth used could affect the results of the fermentation studies. We must be efficient and economical in determining the right volume for the fermentor

DON'T ASSUME
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In most of the procedures above we must not assume or live in the belief that everything is proper and assuming that the fermentors are effectively sterilized, or that the cultures are not contaminated or the ph probe is working well as specified. There is the need to validate that all the procedures are correct and the probes are in 100% tip top conditions.

Studies or validation procedures must be carried out to confirm all the above steps. Validation of equipments or methods constitute part of HAACP procedures and cGMP mechanisms. It is sad to say that these very important and fundamental objectives are often not carried out especially if the fermentation process involves engineers.

This condition would not be acceptable in stringent and demanding industries such as in pharmaceutical fermentation industries

RESPONSE FROM FERMENTOR USERS
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I have expressed my concern to a number of fermentator users in the local colleges and universities and inquire of the status or procedures carried out in their respective plants or laboratories. Sad to say the response have been very very poor from no response to a one word answers. This attitude does reflect the sad attitude of not willing to learn or scared of being criticised