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Pune University - SY BSc (Sem - II) VOC INDUSTRIAL MICROB : Paper - II, April 2010

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Total No. of Questions : 4] P520 [Total No. of Pages : 2 [3717]-249 S.Y. B.Sc. (Vocational) INDUSTRIAL MICROBIOLOGY VOC-IND-MIC-222 : Quality Assurance in Industrial Products (Theory Paper - II) (Sem. - II) (2008 Pattern) Time : 2 Hours] [Max. Marks : 40 Instructions : 1) All questions are compulsory. 2) Figures to the right indicate full marks. 3) All questions carry equal marks. 4) Draw neat labeled diagrams wherever necessary. 5) Use of scientific calculators is allowed. Q1) Answer each sub-question in one or two lines; Fill in the blanks; State whether the statement is true or false. [10] a) Define "Quality Control". b) Define "Sterile". c) Give the full form of "AGMARK". d) Give the full form of 'ISO'. e) State whether the following statement is TRUE / FALSE. All injectables should only be sterile. f) State whether the following statement is TRUE / FALSE. Gel diffusion microbiological assays are more sensitive than turbidimetric microbiological assays for testing antibiotics. g) State whether the following statement is TRUE / FALSE. The LAL test was first designed for Gram positive bacterial pathogens. h) State whether the following statement is TRUE / FALSE. Allergen testing is an important test for packaged drinking water. i) State whether the following statement is TRUE / FALSE. All heat sterilized products are pyrogen-free. j) Name any one medium used for testing for sterility of a product. P.T.O. 1 Q2) Answer any two of the following. [10] a) Explain the advantages of the 'Modified Ames Test'. b) What is the difference between the tests used for pyrogen testing using animals and LAL test? c) Describe the test for 'undue toxicity'. Q3) Answer any two of the following. [10] a) Briefly explain the role of pharmacopeias in quality assurance. b) State the name and the role of the dye used in the medium used for checking the presence of anaerobic bacteria in a sterilized product. c) Explain the role of the FDA in controlling the quality of products. Q4) Answer any one of the following. [10] a) With the help of a suitable example, explain the standardization required before any microbiological assay can be performed. b) Enlist the quality assurance tests carried out for 'packaged drinking water. Explain why only these tests are required. [3717]-249 2 -2-

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Additional Info : S.Y. B.Sc. Industrial Microbiology (Semister - II), VOC - IND - MIC - 222 : Quality Assurance in Industrial Products (Paper - II) (New Course 2008) (Vocational), Pune University
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