International Journal of Engineering Technology and Management Sciences

2023, Volume 7 Issue 5

Availability of Reference Materials for Improving Quality of Life within Scientific and Industrial Framework

AUTHOR(S)

Dr. Remya NS, Leena Joseph

DOI: https://doi.org/10.46647/ijetms.2023.v07i05.025

ABSTRACT
Established metrological traceability to SI (system international) is the strength of any reliable quality management system. Accreditation of facilities and Good laboratory practices in conducting studies drives all measurement involved in the system with traceability either through calibration or by use of Reference Material (RM). Whenever the process of calibration become not convenient, RMs could take up the role for assuring reliability in results with stated level of confidence with minimum possible uncertainty in results. Standardizing clinical diagnostics, qualifying different developmental stages of bio-medical devices and biomaterials, development and constructive use of radio nuclear techniques, control of environmental pollution, etc invites special attention in improving quality of life. Onsets of pandemic conditions like SARS – CoV 2 (severe acute respiratory syndrome -Corona Virus 2) triggers emergencies for regulatory approvals. Availability of certified property values of RMs has significant role in qualifying such tests and evaluations. They may support quick release of products like medical devices into market for routine use. Property value of RMs could be quantitative or qualitative. Even though a large quantum of work has established RMs with quantitative property value, the other type still remains as minimally addressed in many countries. Remarkable efforts done at international research laboratories supplies RMs traceable to NIST (National Institute Standards and Technology, USA), USP (United States Pharmacopeia), NPL (National Physical Laboratory) India etc. RM requirements in critical application areas like healthcare are not sufficiently visible to the scientific community and hence do not satisfy global demands. This feature presents an overview of present status on the issue.

Page No: 212 - 218

References:

  1. EA - 4/14 The Selection and Use of Reference Materials, EEE-RM working group, February 2003.
  2. Report from NPL, India on Bharatiya Nirdeshak Dravya:India Reference Materials January 5, 2021.
  3. Meškuotien?, A., Dobilien?, J., Raudien?, E. et al., A Review of Metrological Supervision: Towards the Common Understanding of Metrological Traceability in Legal and Industrial Metrology. MAPAN, 2022, 37, 693-701.
  4. Wandelburg, K., Reference materials in the Federal Institute for Materials Research and Testing. Official and information bulletin of the Federal Institute for Materials Research and Testing (BAM), 1987, 17 No. 3.
  5. JCGM-WG2-CD-01, International Vocabulary of MetrologyFourth edition - Committee Draft (VIM4 CD) 11 January 2021.
  6. Recknagel, S., Bresch, H., Kipphardt, H. et al., Trends in selected fields of reference material production.,Anal Bioanal Chem, 2022, 414, 4281-4289. https://doi.org/10.1007/s00216-022-03996-7.
  7. Sio CK, Parsons-Davis T, Lee E, et al., Additive manufacturing of platinum group element (PGE) reference materials with a silica matrix. Rapid Commun Mass Spectrom, 2020, 34(7): e8627. https://doi.org/10.1002/rcm.8627.
  8. Allen AJ, Levin I, Witt SE., Materials research & measurement needs for ceramics additive manufacturing. J Am Ceram Soc, 2020; 103(11): https://doi.org/10.1111/jace.17369.
  9. Shankar, S., Gadi, R., Sharma, S.K. et al., Identification of Carbonaceous Species and FTIR Profiling of PM2.5 Aerosols for Source Estimation in Old Delhi Region of India. MAPAN, 2022, 37, 529-544. https://doi.org/10.1007/s12647-022-00575-0.
  10. Natarajan, S., Mukhopadhyay, K., Thangaswamy, D. et al., Characterisation of Indoor Volatile Organic Compounds and Its Association with Respiratory Symptoms Among Children Living in Solid Fuel Using Households in Tamil Nadu, India. MAPAN, 2022, 37, 565-578. https://doi.org/10.1007/s12647-022-00588-9].
  11. Ali, S., Kullayappa, G.R., Saritha, V. et al., Design and Development of Wireless Meteorological System for Measuring Air Pollutants at Indoor and Outdoor Environments. MAPAN, 2022, 37, 611-623 . https://doi.org/10.1007/s12647-022-00560-7.
  12. Sasi, R., Nimi, N., Sasikala, T.S. et al., Measurement Uncertainty of Chromatographic Analyses: A Comparative Study on the Role of Reference Materials. Journal: MAPAN, 2022, 37, 625-629, DOI: 10.1007/s12647-022-00595-w.
  13. Resch-Genger U, DeRose P., Fluorescence standards: classification, terminology, and recommendations on their selection, use, and production (IUPAC Technical Report). Pure Appl Chem., 2010, 82, 2315-2335.
  14. Rindhatayathon, P., Koonkana, K., Rungseesumran, T. et al., Development of the Primary Standard for IAEA TRS-457 at OAP, Thailand. MAPAN, 2022, 37(3):641-652, https://doi.org/10.1007/s12647-022-00584-z.
  15. Remya Devi, P.S., Ajith, N., Chavan, T.A. et al., Preparation of In-House Calibration Standard Solutions for Mn, Co and Their Assay Using Nuclear Analytical Techniques. MAPAN, 2022, 37, 631-640,  https://doi.org/10.1007/s12647-022-00571-4.
  16. Joseph, L., Ramesh, P., Remya, N.S. et al., Significance of Metrological Tools in an ISO 17025 Accredited Quality System for a Biological Evaluation Facility. MAPAN, 2022, 37, 683-691. https://doi.org/10.1007/s12647-021-00517-2.
  17. Halamoda-Kenzaoui,  B, Holzwarth, U, Roebben, G, Bogni, A, Bremer-Hoffmann, S., Mapping of the available standards against the regulatory needs for nanomedicines. Wiley Interdiscip Rev Nanomed Nanobiotechnol. 2019 11(1): e1531. https://doi.org/10.1002/wnan.1531.
  18. Andrew D. Maynard., Exploring Boundaries Around the Safe Use of Advanced Materials: A Prospective Product-Based Case Studies Approach. In Micro and Nano Technologies, Nanotechnology Environmental Health and Safety, (ed. Matthew S. Hull, Diana M. Bowman.),William Andrew Publishing, 2018, pp.  427-452.
  19. Wang M, Chu Z, Meisel TC, Guo J.,  Determination of Re, Os, Ir, Ru, Pt, Pd Mass Fractions and Os-187/Os-188 Ratios of Organic-Rich Geological Reference Materials Geostand Geoanal Res, 2022, 46, 333-349. https://doi.org/10.1111/ggr.12423.
  20. Srinath, K., Kiranmayee, A.H., Bhanot, S. et al., Detection of Palm Oil Adulteration in Sunflower Oil Using ATR-MIR Spectroscopy Coupled with Chemometric Algorithms. MAPAN, 2022, 37, 483 - 493. https://doi.org/10.1007/s12647-022-00558-1.
  21. Singh KA, Rai R, Nair SS., Review on development of assigned value microbiological reference materials used in food testing. Food Microbiol., 2022, 102: 103904. doi: 10.1016/j.fm.2021.103904.
  22. Emteborg H, Florian D, Choquette S, Ellison SLR, Fernandes-Whaley M, Mackay L, McCarron P, Panne U, Sander SG, Kim SK, Held A, Linsinger T, Trapmann S., Cooperation in publicly funded reference material production. Accred Qual Assur. 2018;23, 371-377.
  23. Krishna, A., Tripathy, S.S., Vinod et al., Futuristic Role of Bhartiya Nirdeshak Dravya an Indian Reference Material on Safety and Quality of Food Products. MAPAN, 2022, 37, 511 - 516. https://doi.org/10.1007/s12647-022-00539-4.
  24. Greg Miller, W., Greenberg, N.; Budd, J., Delatour, V., Traceability, I. W. G. o. C. i. M. The evolving role of commutability in metrological traceability. Clin. Chim. Acta , 2021, 514, 84- 89,  DOI: 10.1016/j.cca.2020.12.021.
  25. Sangji Woo, et.al., Development of Certified Reference Material for Amino Acids in Dried Blood Spots and Accuracy Assessment of Disc Sampling, Anal. Chem., 2022, 94, 10127-10134.
  26. Bijoy, R., Kasoju, N. ., & Nandkumar, M., SARS-CoV-2 Detection by Quantitative PCR: A Technical Note on Concepts, Practical Considerations and Safety Aspects for Beginners. Trends in Biomaterials & Artificial Organs, 2022, 36, 68-76. https://biomaterials.org.in/tibao/index.php/tibao/article/view/518.

  27. How to Cite This Article:
    Dr. Remya NS, Leena Joseph . Availability of Reference Materials for Improving Quality of Life within Scientific and Industrial Framework . ijetms;7(5):212-218. DOI: 10.46647/ijetms.2023.v07i05.025