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 Career Episode 2 A Introduction1.0   This career episode talks about one of my pre-final year mini project during my Bachelor’s degree.The details of the project are given below:Project Title: Harmonized Microbial Limit Test Method Validation for “Val ganciclovir” Hydrochloride.

Duration: 1 Month (August – September, 2012).Geographical Location: Bellary, Karnataka – IndiaName of Organisation: Bellary Institute of Technology and Management Position Title: Team Member.  B Background 1.1 The project “Harmonized Microbial Limit Test Method Validation for “Val ganciclovir” Hydrochloride” was an analysis project undertaken as a part of my course during the pre-final year of my Bachelor’s degree.

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2 students including myself from the Department of Biotechnology Engineering worked on this project under the guidance of a senior lecturer from the department. The primary objective was to prepare microbiological validation report of Microbial Limit Test using harmonized method for “Val ganciclovir Hydrochloride”.  The project reporting and timeline strictly followed the specification rules and regulations rolled out by the department and the university.

Final evaluation of the project was done by a panel including the head of the department and a set of other senior lecturers from the department. The final evaluation included demonstration of a power point presentation and report submission.  1.2 Personal Workspace Statement of Duties       My duties during the course of the project involved: –          Assisting in research to analyse Harmonized Microbial Limit Test Method.-          Assisting in technical part and Research. –          Developing a project plan-          Assisting in the development and formatting of the project report and power point presentation. –          Demonstration of the complete project to the DOH with live results.  C Personal Engineering Activity TECHNICAL AND MANGERIAL PROJECT 1.

3 Reporting Structure of the Project  1.4 Objective: To demonstrate the TAMC (Total Aerobic Microbial Count) & TYMC (Total Yeast and Mound count) average count of colony forming units recovered from the challenged test preparation must not differ by a factor greater than 2( 50% to 200%) from the calculated value for Standard inoculum. Colony characteristics of the respective strain of specific microorganism obtained in test preparation should be similar to that of inoculum control of the approved medium.  1.5 Harmonized Microbial Limit Testing Validation of Finished Products. Harmonized Microbial Limit Test (HMLT) was made effective in May 2009.

Obtaining TAMC & TYMC colony forming units of finished products is tricky and important. The finished product we used for this mini project is “Val ganciclovir” Hydrochloride. This method makes use of Microbiology Engineering technology where we add the finished products into a solution and then plating the aliquots to determine the CFUs (Colony forming units)/g (or mL) of initial material. The method of platting can be pour plate, spread plate (or) material filtration and then placing the membrane filter on an agar plate surface. The membrane filtration method should only be used when few CFUs are found in the material to be tested.

The harmonisation method provides details in terms of selection of method suitability and media for growth promotion.  1.6 Assisting in Technical part and Research.  Since it is a mini project we had shortage of man power and time. I had taken the responsibility of research and contributing around 50% on technical part.

Microbial Limit Test using Harmonization method is one of the routine tests performed in all the Pharmaceutical Industries on finished products which are non-sterile which we made use of ours subject knowledge i.e., Microbiology Engineering Techniques.

My research included a visit to Pharmaceutical Industry to collect the data, finished product sample, Microorganisms cultures and to understand the process of experiment. This test will determine the total number of aerobic organisms as well as total yeast and mould count on finished products. Microorganisms can affect the health of the patients and hence knowing the amount and type of microorganisms in finished product is important for patient safety. This quantitative phase of a microbial limits test is known as the Test for specified Microorganisms which are designed to determine the presence or absence of specific objectionable organisms in a product.

 1.7 Working of Harmonized Microbial Limit TestThis is the flow chart I prepared to carry out the experiment. I collected finished product “Val ganciclovir” from a Pharmaceutical company and used it for my experiment.                       After validations are complete, the colonies obtained from the experiment on the finished product were analysed to identify the number of Colony forming units, the type of microorganisms with Advanced Microscope and its effects to check if they are objectionable microorganisms.     1.8 Developing Project PlanDuring the duration of the project, the regular classes are still going on and we need to spare more time for the project analysis. Time and Man power was a crucial factor. We had very less time to run the experiment and research at the same time.

I had prepared a project plan using excel that helped us to sort out things equally. This is the Gantt chart which I prepared and we followed it until our project completion.   Activities Week 1 Week 2 Week 3 Week 4 Week 5 Approval of Proposal           Data collection from secondary resources           Microorganism collection from  collection centre           Experiment/ Technical Part           Result Analysis           Report Preparation           PPT preparation and presentation            This helped us a lot in understanding the task dependencies and also scheduling time for most important task first and then doing the small events later which made the process very easy for us at the end.1.9 Assisting in the development and formatting of the project report and power point presentation.As mentioned above I was involved in research as well, I analysed the data through many resources and mentioned the same in my project Report.

I made a deep analysis about the different microorganisms and its affects to patient’s health. Even I got a clear view of the environmental situations like weather conditions, temperature etc. which promote the growth of these microorganisms in the environment. I prepared a validation report on the results we found out of the experiments and prepared a detailed project report which included every single information regarding the project. I also prepared a PPT for our final presentation and during the presentation; we demonstrated the results with live results we obtained from the experiments and explained how Microbiological techniques have helped us through the project.

I have also shared my experience of working with the employees of the pharmaceutical industry who helped me in understanding the technicalities of this project. The presentation went really well. D Summary 1.10 This project gave me a real-time experience of how to analyse issues and make detailed report out of it. I have learnt about team work and how to handle things within the timeframe. We completed the analysis within the timeframe. My deep analysis of the Microorganisms has helped us to make a great presentation and give an excellent demonstration during the final presentation.

My experience at a Pharma industry was exciting as I got to see how this mini project is carried out in a huge scale to check the quality of the finished products.  E Resources     

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