What are environment isolates, their identification, methods of identification and their use in different validation studies?

Environment is fully loaded with the microorganisms. In environment some microorganisms are pathogenic and some are non pathogenic. In pharmaceuticals, controlled environment is used for manufacturing of drugs in which viable and non viable contamination must be controlled and monitored regularly. In pharmaceutical manufacturing areas, different types of microorganism could be present which we detect by using different methods of environmental monitoring programme like active air sampling, passive air sampling, surface monitoring and personnel monitoring. Environment isolates are the microorganism which we isolate form the environment like air, water, personnel etc. They are isolated from the environment that's why they are called environment isolates. 

                                                                    In pharmaceutical, it is important to identify environment isolates and they could be easily identified form environment, water, personnel or product etc. Identification of environment isolates is very important and mentioned in different guidelines and USP chapter no. 1116 (Identification of microbial isolates). In manufacturing environment these environment isolates are the main source of product contamination which could be introduced in the product through air, water, personnel or any other means. Environment isolates are the major tools for investigation in case of any product contamination or failure. If library of environment isolates is maintained then these environment isolates could be easily traced and if any previous history or outcome is there then it could be easily identify with the major source of contamination. Environment isolates should be properly isolated and library should be maintained with complete record. If any positive outcome or any product failure occurred then thorough investigation is required which includes identification of microorganisms, major source of contamination etc. As per pharmacopoeia and different regulatory guidelines microorganisms should be identified up to the species level. Different instrument and methods are available for the identification of microorganisms up to species level. DNA sequencing is one of the best method to identify microorganism up to species level. For example in case of identification of A.niger and A.brasiliensis both have same morphology on media plate but very small difference is there. So, DNA sequencing is the best method to identify closely related microorganisms up to species level. Once environment isolate identified then we can give right direction to the investigation and could identify root cause. 

Environment isolates should be preserved and used in different validation studies like disinfectant validation and Sterility validation etc. In disinfectant validation we use different reference microorganism strains mentioned in the pharmacopoeia but we should also check the effectiveness of different disinfectants against these environment isolates. If disinfectant is not effective against environment isolates then there is no need to use that disinfectant. Change of disinfectant is required in that case. In sterility validation we should also include environment isolates to check any bacteriostasis or fungistasis properties. Environment isolates should be properly recovered in the sterility media during sterility validation because failure to recover the microorganism can cause for false negative results. Environment isolates should be also used in the growth promotion test of the media in order to prove that particular media is suitable for recovery of microorganisms form the manufacturing or testing areas. So, identification of environment isolate is very important and major tool in investigation.


Thanks and have a nice day!