Monday, January 10, 2011

ASEPTIC TRANSFERS IN STRINGENT FERMENTATION INDUSTRIES

Microbial contamination of fermentation processes could be serious and even critical in some fermentation industries. The presence of unwanted microbes could not only jeorpadise the safety and quality of the fermentation products as in the production of pharmaceuticals but also cause product spoilage and short shelf lives of the products with serious consequence in terms of economy and time wasted.
Strange it may seemed but quite a number of people sees the problem of contamination only at the level of mid stream fermentation and ignoring the input of microbial contamination at both levels of upstream and downstream activities. They are in the belief that once a fermentation product is formed microbial contamination is no longer a problem.
In reality, the seriousness of microbial contamination occurs at all levels and at all times. In fact it is even more critical if traces of microbial contaminations occur upstream as the microbial contaminants will have time to amplify over space and time. And you will find yourself dealing with a bigger problem of contamination if steps are not taken to minimize the contamination problems earlier.
Finished fermentation products are attractive as substrates to microbial contaminants downstream. To the microbial contaminants these finished fermentation products are good food sources to support their growth
Everytime microbial contaminations occur in the fermentation industries it becomes a nightmare for the operators. The consequence of such contaminations would often mean the rejection of the complete process in terms of fermentation products, fermentation media which have very serious economic consequence. Costly steps are taken not only to terminate the fermentation but in washing, cleaning and eliminating the source of contaminants. Labour, downtime loss is part of the price they have to pay!
This situation is even more critical in pharmaceutical fermentations.
One of the main sources of introducing microbial contaminants occur during the transfers from one stage of the fermentation process to the other. We will now discuss the problems of aseptic transfers or aseptic fillings of the finished fermentation products in detail
The most significant word which we must contend and understand clearly here is ASEPTIC. Aseptic describes the condition where the environment is free from the presence of microorganisms which might cause the contamination. In a way it almost describes a sterile environment or zone where the desired activity takes place.
This situation of being absolutely free of microorganisms is almost quite impossible to achieve, especially in the environment of the factory floor or the fermentation plant. At best we can control only a certain volume of space as being free from microorganisms where aseptic transfers can be quickly carried out
It is of importance to use a smaller room for aseptic transfers in terms if economy and efficiency
Surfaces in the aseptic room must always be clean sterilized or disinfected as a matter of routine procedure
Microbes being microbes are very ubiquitous and microscopic. They are not easily seen and are easily transferred by air, water and other medium. A slight turbulence will easily dislodge and transport them from one point to another. Thus sudden or lots of movements should be avoided in areas where aseptic transfer are being carried out.
This is especially important when supplying air into the aseptic filling room.
Additionally the air introduced into the aseptic filling room should be sterile and filtered using a suitable size filter that meet HEPA standard
Cutting the air movements and turbulence is an important step in preventing microbial contaminations. The use of laminar flow is very strongly recommended to avoid turbulence
One of the greatest source or reservoirs of microns are the workers themselves. The human body carries a lot of microbial flora especially on the skin and our respiratory system. A sick or infected worker will even harbor more unwanted microbes and a source of disease and infections
The more workers you have the more risks you will face with microbial contamination. Keeping the number of workers to a minimum during aseptic transfer is important in reducing microbial contamination
The use of clean sterile protective clothing and guard help in preventing transfers of microbial contaminants from workers to the products
If possible most of the aseptic transfers should be automated or semi automated to prevent contamination from the operator



Type rest of the post here.

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