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kumar, Birendra
- Investigation on the Performance of a Cylindrical Parabolic Concentrating Solar Water Heater
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Authors
Affiliations
1 Department of Mechanical Engineering, Indian Institute of Technology (ISM), Dhanbad - 826004, Jharkhand, IN
1 Department of Mechanical Engineering, Indian Institute of Technology (ISM), Dhanbad - 826004, Jharkhand, IN
Source
Indian Journal of Science and Technology, Vol 9, No 48 (2016), Pagination:Abstract
Background/Objectives: The objectives of the present work are focused to investigate the theoretical heat gain, heat loss and instantaneous collector efficiency of cylindrical parabolic concentrating solar water heater over a clear day. Methods/Statistical Analysis: The performances of a cylindrical parabolic concentrating solar water heater fitted with copper absorber tube, using water as working fluid are investigated theoretically. The theoretical investigations are studied for water flow rates 0.1 kg/s and 0.15 kg/s between 8:0 h and 16:0 h over a sunny day. Findings: The theoretical results are showed that intensity of solar beam radiation with respect to time much more at noon than that calculated at 8:0 and 16:0 hours. Theoretical solar beam radiation data obtained are compared and validated with that of experimental based published data. The instantaneous efficiency, useful heat gain, hourly energy collected and heat loss are influenced by water mass flow rate. Application/Improvements: The theoretical study consumes less time than analytical and experimental studies. The initial capital investment is must to procure the experimental setup, whereas for theoretical work not required neither capital investment nor procurement process.Keywords
Absorber Tube temperature, Heat Loss, Rate of Heat Gain, Solar Beam Radiation.Full Text
- Quality Assurance of Rituximab (Anti-CD 20) Antibodies by Potency Testing:Determining the System Suitability Criteria and Sample Acceptance Criteria
Abstract Views :254 |
PDF Views:81
Authors
Affiliations
1 National Institute of Biologicals (Ministry of Health and Family Welfare), Government of India, Plot No. A-32, Sector-62, Institutional Area, Noida 201 309, IN
1 National Institute of Biologicals (Ministry of Health and Family Welfare), Government of India, Plot No. A-32, Sector-62, Institutional Area, Noida 201 309, IN
Source
Current Science, Vol 114, No 12 (2018), Pagination: 2513-2518Abstract
A validated and robust bioassay is of paramount importance in the various stages of biosimilar development to ensure efficacy, quality and potency. The complement-dependent cytotoxicity assay was validated over six simulated potencies and found specific for rituximab-like antibodies. The bioassay was found robust with linearity parameter R2 = 0.99, %GCV for precision and accuracy was less than 20% for >40 individual performances. Detailed set of system suitability and sample acceptance criteria was determined. The study may play a key part in the development of written and physical potency reference standards for incorporation in different pharmacopeia for effective biosimilar development and regulation.Keywords
Complement-Dependent Cytotoxicity, Geometric Coefficient of Variation, Quality Assurance, Rituximab.Full Text
References
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- Jacobs, I., Ewesuedo, R., Lula, S. and Zacharchuk, C., Biosimilars for the treatment of cancer: a systematic review of published evidence. Biodrugs, 2017, 31(1), 1–36.
- Misra, M., Biosimilars: current perspectives and future implications. Indian J. Pharmacol., 2014, 44(1), 12–14.
- USFDA, FDA guidance: guidance for industry, bioanalytical method validation. US Food and Drug Administration, 2013
- Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues, European Medicines Agency, 2014.
- CDSCO, Guidelines on similar biologics: regulatory requirements for marketing authorization in India, Central Drugs Standard Control Organization, New Delhi, 2016.
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- Clatworthy, M. R., Targeting B cells and antibody in transplantation. Am. J. Transplant., 2011, 11(7), 1359–1367.
- Weiner, G. J., Rituximab: mechanism of action. Semin. Hematol., 2010, 47(2), 115–123.
- Boross, P. and Leusen, J. H. W., Mechanisms of action of CD20 antibodies. Am. J. Cancer. Res., 2012, 2(6), 676–690.
- Harjunpaa, A., Junnikkala, S. and Meri, S., Rituximab (anti-CD20) therapy of B-cell lymphomas: direct complement killing is superior to cellular effector mechanisms. Scand. J. Immunol., 2000, 51, 634–641.
- USP/MC; Rituximab Summary Validation Report, Report, USP Medicines Compendium, 2013.
- Reed, G. F., Lynn, F. and Meade, B. D., Use of coefficient of variation in assessing variability of quantitative assays. Clin. Diagn. Lab. Immunol., 2002, 9(6), 1235–1239.
- Biological Assay Validation. United States Pharmacopoeia, 35–NF 30, 2012.
- Dafale, N., Semwal, U., Agarwal, P., Sharma, P. and Singh, G., Development and validation of microbial bioassay for quantification of levofloxacin in pharmaceutical preparations. J. Pharm. Anal., 2015, 5(1), 18–26.
- Coffey, T, Grevenkamp, M., Wilson, A. and Hu, M., Biological assay qualification using design of experiments. Bioprocess. Int., 2013, 11(6), 42–49.
- Tsiftsoglou, A. S., Ruiz. S. and Schneider, C. K., Development and regulation of biosimilars: current status and future challenges. BioDrugs., 2013, 27(3), 203–211.
- ICH harmonised tripartite guideline, ‘Validation on analytical procedures: text and (methodology)’, International Council for Harmonisation, Q2 (R1), Step 4, 2005.
- Design and development of biological assays, United States Pharmacopoeia, 35–NF 30, 2012.
- Effect of Coating Thickness on Si Engine Performance
Abstract Views :78 |
PDF Views:0
Authors
Affiliations
1 Department of Mining Machinery Engineering, IIT/ISM, Dhanbad, Jharkhand, 826 004., IN
1 Department of Mining Machinery Engineering, IIT/ISM, Dhanbad, Jharkhand, 826 004., IN
Source
Journal of Mines, Metals and Fuels, Vol 66, No 4 (2018), Pagination: 256-262Abstract
Present work is intended to investigate the stress and temperature distribution for a partially coated spark ignition (SI) engine piston. For comparison purpose analysis was also made on uncoated piston and results were compared to the temperature and stress distribution obtained from the application of different coating thickness and width on the piston. It is found that increase in coating surface temperature with coating thickness is in a decreasing rate. From the analysis of bond coat surface, it is found that with the increase in coating thickness decrease in normal stress is steady while rise of maximum shear stress is in decreasing rate.Keywords
Ceramic coating; spalling; bond coat; piston; coating thickness, crevices
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- Muchai, Jesse G., Kelkar, Ajit D., Klett, David E. and Jagannathan, Sankar (2002): Thermal– Mechanical Effects of Ceramic Thermal Barrier Coatings on Diesel Engine Piston, Mat. Res. Soc. Symp. Proc., Vol. 697, Materials Research Society, 2002.