 In this module which is the continuation of the previous module which is fermented design but particularly in this module we will talk about aseptic operation and containment. What is containment and what is aseptic operation? So, as we have studied in our previous modules that while talking about the basic requirement of any good fermenters. So, we have discussed 13 different requirements are a basic characteristics of a good fermenter. The first characteristics of a fermenter so the fermenter that can be maintained aseptic conditions for a long term when the fermentation process is going on as well as that is able to maintain the containment level regulations. So, what is containment level and this that? So, aseptic operation involves the protection against the contamination and the containment involve the prevention of escape of viable cells from a fermenter or during the fermentation process or when there is a as we have studied that upstreaming process and as well as the downstreaming processes. So, it is very easy to understand that aseptic operation refer to that there will be no more contamination inside the fermenter and the containment that there should be no release of the viable cells from the fermentation process or later on in the downstreaming equipment. So, first of all the containment guidelines were initiated during 1970s. So, in order to establish the appropriate degree of containment which will be necessary to grow a microorganism so it and in fact the entire process must be carefully assessed for potential hazards that could occur should there be accidental release. But when we say that when there is a fermentation process is going on and the microorganism which are we are using for the mass culturing that can be a pathogens. So, there are so many miss happens during this fermentation process so in such cases that we have to assign some hazardous levels so that basically deal with that that how we can have some hazardous group that is only based upon the processes so the different assessment procedures are used depending on whether or not organism contain the foreign DNA mean genetically engineered organisms. So, once the hazard are assessed then an organism can be classified into the hazard group for which there is an appropriate level of containment be awarded. In general speaking there are four different levels in common sense when we called about biosafety levels there are four different biosafety levels which we can also called as the hazard levels. So, before giving the level to any organisms that we have to assess that what level of the risk is involved by culturing of that organism colon 1992 report 8 point risk assessment criteria according to that criteria the first criteria that is that we should know about the pathogenicity of the microorganism which we are going to use in fermentation process. We should be very clear about the type of that organism either that it pathogen or that is non pathogen mean environmental friendly. As an example that if we are using scaromyce servici I mean baker yeast that is non pathogen on other hand if we are using bacillus anthrox or any other such kind of the pathogen salmonella etcetera. So, we should clear about the our organism which we have to use in the fermentation process that either that is pathogen or not pathogen. But as concerned the second criteria if we know that our organism is a pathogen we should know about the virulence mean the level of pathogenicity. So that either the disease caused by that microorganism that is that will be the mild or very serious either that is not very much serious. So that is the second criteria. So first if the organism is pathogen then second is the level of pathogenicity and the third is that how much number of the organisms required to initiate an infection. So if that organism is pathogen and the level of virulence is very serious then we should know that how much amount of the cells required to initiate the infection. It is very clear that we are talking about the salmonella type of organism. So even one or two number of cells are sufficient to start the disease. And the fourth criteria that is the root of infection. So what is the root? Either that is direct intact blood contact either that is by air inhaling or by some food items and etcetera. So we should know about the root of infection of that organism by which that caused the disease. So the fifth criteria that the known incidence of that infection in the community. So where we have to run the fermentation process in that area is there any case of such disease is reported already. Very clear example with reference to Pakistan that in if we go behind 10 years we have no any report case of the dinghy. So that was the first chance in Pakistan community that we have the dinghy problem. So but now if we are dealing with the dinghy then almost we have some incident and then we have some precautionary measures. So if we are using such pathogens in our fermentation process we should know about that the disease caused by that organism either there is already case reported in our society in our community or not. So that and the sixth that the amount or the volume of the organism used in fermentation process. That means that what scale of the fermentation we are using. Either we are using on a laboratory scale or on a pilot scale or on an industrial scale. So another hand that is also as well as the volume of the fermentation we have to look about that what kind of the process we are using either solid state fermentation either the submerged fermentation. So we should clear about the volume and the type of the process in fermentation we are using. So that is very related to know the risk factor in associated with that organisms which we called as process organism. The seventh criteria that is the technique which I have already mentioned while expressing the sixth criteria that what kind of the techniques we are using. So there are number of techniques in fermentation process. So how that either that is exative sterilization, in-sative sterilization and then how what are the techniques we are using for handling the up steaming and the down steaming along with that either solid state fermentation, submerged fermentation or surface culture fermentation. So that is very critical. So the last criteria for the risk assessment that is the ease of prophylaxis and treatment that meant that is there any precautionary measures either there is vaccine or such kind of treatment which we called as prophylaxis kind of actions are already we know or not. If that organism is known pathogens and we have some prophylaxis and then that is the major part of that by which we can know the assessment level the hazardous level. So by using this eight point criteria we can determine the assessment then we can give a level to that organism in a fermentation process.