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A responsible and challenging position in an organization that would enable me to augment my acquired knowledge, bring to forefront my skills and offer opportunities for growth based on achievements.
QUALIFICATION UNIV/COLLEGE YEAR OF PASSING % OF MARKS
---------------------- ---------------------- ---------------------- ------------------
M.Sc Micobiology St. Theresa’s College,
Eluru, AP, INDIA. Till rd Sem %
Chemistry) Pragathi Degree College,
Hyderabad, AP, INDIA. %
INTERMEDIATE Board of Intermediate,
AP, INDIA .%
Chattisgarh, INDIA %
Packages MS Office Suite
Operating Systems Windows ’//XP
Academic Project Details
Project Title : Microbial Limit Test of pharmaceutical products
Client : AUROBINDO PHARMA LIMITED
UNIT V PASHAMYLARAM
Description : This project work was done under the guidance of Mr. P. Anil Kumar in charge in Food and drug administration (FDA). The objective of this project work is to “Determine the total Aerobic Microbial Count of the Pharmaceutical products (non-sterile bulk drugs) and specific pathogens by using pour plate method.
Bioburden or Microbial limit test is performed on pharmaceutical products and medical products as a quality control measure .It is used to determine levels of organisms present and the bioburden is a reflection of how well the manufacturing process has performed with respect to the environment and quality system controls that are in place.
Validation of the test methods for devices may be performed by inoculating with known levels of bacterial spores and then subjecting to normal laboratory procedure – the results (obtained vs. expected) will then yield the correction to be used.
This methodology includes qualitative and quantitative evaluation of added specified organisms in the test samples that is recovery of challenged organisms when inoculated with validated quality of penicillinase to the test sample. This methodology comprises confirmation of neutralization property of penicillinase, Total aerobic microbial count and qualitative estimation of specific organisms.
Based on the qualitative and quantitative calculation, it was observed that the samples are complying with respect to all methodology used i.e. Total aerobic microbial count with added validated quantity of penicillinase and Total aerobic microbial count of specified organisms. Hence the methodology used for conducting the tests on regular basis by general test procedure and it was concluded that the sample produces less than cfu / ml.
Name S S K S Aparna