Design and Implementation of a Track n trace 2D Multi Scanner Bulk Code Reader for Pharmaceutical Packaging

Pharmaceutical Science-Pharmaceutical Sciences

Authors

  • Vidyasagar Kasagani Research scholar, Department of Computer Science, GSS, GITAM https://orcid.org/0000-0002-9398-2431
  • Vanitha Kakollu Assistant Professor, GITAM Deemed to be University, Visakhapatnam, Andhra Pradesh, India.

DOI:

https://doi.org/10.22376/ijlpr.2023.13.2.P37-P50

Keywords:

Drug Traceability, Federal Guidelines, Barcoding, Bulk Code Reader, FDA, FMD, ANVISA, NADFC, DGFT, and TGA

Abstract

With various compliance initiatives surrounding the traceability of medical drugs coming into prominence and with federal regulations becoming more stringent, there is a need to efficiently manage the supply chain process involving drug packaging. To enable traceability of the drugs being packaged, many manufacturers are implementing barcoding of product labels which contains a minimum of the attributes namely GTIN, lot number, serial numbers, expiry date, manufacturing dates, etc., to enable traceability of the packaged item. Currently, manufacturers are looking for ways to keep their supply chain moving at an efficient and optimal process. One of the challenges was to build automated equipment providing a well-defined and properly structured framework for functioning, designing, and implementing of Track N Trace Counterfeit Risk Management (CRM) application to increase the speed of the aggregation with the child-to-parent aggregation and generation of online case labels after the required child's Quantity in Multi carton aggregation station. Track N Trace Counterfeit Risk Management (CRM) allows the manufacturers to establish the parent-child relationship during packaging their drugs. Also, various guidelines US Drug Supply Chain Security Act (DSCSA), EU regulation (Falsified Medicines Directive-FMD), Brazilian Health Regulatory Agency (ANVISA), Indonesia's National Agency of Drug and Food Control (NADFC), India’s Directorate General of Foreign Trade - DGFT, and Australia TGA will need to be integrated into one single source of equipment that can meet with their barcoding regulation for tracking of drugs packed. Machine Vision systems are finding themselves in use in the pharma machinery and the "multi-carton" equipment that has been built for implementation for pharmaceutical packaging uses the vision systems architecture. We aimed to build a counterfeit risk management software solution that ensures compliance with various regulatory agencies by building a common framework that can be extensible for any further changes to the guidelines and/or additional regulatory guidelines from other countries. Lots of design architecture work has been refined through continuous process improvement practices and we developed a software tool that improves efficiency and requires minimal changes to the current manufacturing/packaging supply chain lines. 

References

Blackstone EA, Fuhr JP, Pociask S. The health and economic effects of counterfeit drugs. Am Health Drug Benefits. 2014;7(4):216-24. PMID 25126373.

Michael White CM. Counterfeit drugs: A major issue for vulnerable citizens throughout the world and in the United States. J Am Pharm Assoc (2003). 2021;61(1):e93-8. doi: 10.1016/j.japh.2020.04.020, PMID 32471767.

Yang DS, Nan N, Ma LY, Niu JZ, Xu MD. A brief introduction to the application of repackage, relabel and private label distribution drug products in USA. Chin J New Drugs. 2019;28:1815-8.

Yang Y, Ma L, Niu J, Xu M. Brief introduction for application of the USA national drug code. JChinPharmSci. 2019;28(3):203-8. doi: 10.5246/jcps.2019.03.020.

Brechtelsbauer ED, Pennell B, Durham M, Hertig JB, Weber RJ. Review of the 2015 drug supply chain security act. Hosp Pharm. 2016;51(6):493-500. doi: 10.1310/hpj5106-493, PMID 27354753.

O’Connor AC, Kennedy ED, Loomis RJ, Haque SN, Layton CM, Williams WW et al. Prospective cost-benefit analysis of a two-dimensional barcode for vaccine production, clinical documentation, and public health reporting and tracking. Vaccine. 2013;31(31):3179-86. doi: 10.1016/j.vaccine.2013.04.073, PMID 23664988.

CDAC. Integrated validation of export of drugs and its authentication. Available from.

CDAC. Pharmaceutical Export Promotion Council [internet]. IVEDA: integrated validation of export of drugs and its authentication; 2020 [release date: 26.08.2020]. Available from: https://www.iveda-india.in/IVEDA/download/Manuals_iveda/User%20Manual_for_iVEDA_v1.1.pdf.

Cavendish R. Industrial vision system inspects parts at high speeds. Pharm Technol. 2012 May 1;36(5):28-9.

Kumar GP, Prasad PB. Machine Vision based Quality Control: importance in Pharmaceutical Industry. Int J Comput Appl;975:8887.

Lin JA, Fuh CS. 2D barcode image decoding. Math Probl Eng. 2013;2013:1-10. doi: 10.1155/2013/848276.

Winter W, Huber L. Getting a handle on access security for 21 CFR Part 11. Biopharm Int. 2004;17.

Alli SM. Bar coding an automatic identification and data capture system in healthcare settings. Available from: https://www.thepharmajournal.com/archives/2021/vol10issue1/PartC/9-12-67-816.pdf.

Winter W, Huber L. Implementing 21 CFR part 11 in analytical laboratories: Part 2: Security aspects for systems and applications. BioPharm. 2000;13:44-50.

Kephart JO, Chess DM. The vision of autonomic computing. Computer. 2003;36(1):41-50. doi: 10.1109/MC.2003.1160055.

Dedić N, Stanier C. Measuring the success of changes to Business Intelligence solutions to improve Business Intelligence reporting. J Manag Anal. 2017;4(2):130-44. doi: 10.1080/23270012.2017.1299048.

Haji M, Kerbache L, Sheriff KMM, Al-Ansari T. Critical success factors and traceability technologies for establishing a safe pharmaceutical supply chain. Methods Protoc. 2021 Nov 22;4(4):85. doi: 10.3390/mps4040085, PMID 34842786.

Khan A, Laghari AA, Awan SA. Machine learning in computer vision: a review. EAI Endorsed Trans Scalable Inf Syst. 2021;8:1-11. doi: 10.4108/eai.21-4-2021.169418.

Breckenridge A, Eichler HG, Jarow JP. Precision medicine and the changing role of regulatory agencies. Nat Rev Drug Discov. 2016;15(12):805-6. doi: 10.1038/nrd.2016.206, PMID 27739512.

Epstein J, Seitz R, Dhingra N, Ganz PR, Gharehbaghian A, Spindel R et al. Role of regulatory agencies. Biologicals. 2009;37(2):94-102. doi: 10.1016/j.biologicals.2009.01.004, PMID 19230707.

Krishna ST, Kalluri HK. Deep learning and transfer learning approaches for image classification. Int J Recent Technol Eng. 2019;7:427-32.

Ashmore R, Calinescu R, Paterson C. Assuring the machine learning lifecycle: desiderata, methods, and challenges. ACM Comput Surv. 2022;54(5):1-39. doi: 10.1145/3453444.

Glass BD. Counterfeit drugs and medical devices in developing countries. Res Rep Trop Med. 2014;5:11-22. doi: 10.2147/RRTM.S39354, PMID 32669888.

Kritchanchai D, Krichanchai S, Hoeur S, Tan A. Healthcare supply chain management: macro and micro perspectives. Logforum. Forum. 2019;15(4):531-5444. doi: 10.17270/J.LOG.2019.371.

Bansal D, Malla S, Gudala K, Tiwari P. Anti-counterfeit technologies: a pharmaceutical industry perspective. Sci Pharm. 2013 Mar;81(1):1-13. doi: 10.3797/scipharm.1202-03, PMID 23641326.

Connolly C. Part‐tracking labelling and machine vision. Assembly Autom. 2005 Sep 1;25(3):182-7. doi: 10.1108/01445150510610881.

Naughton BD, Vadher B, Smith J, Smith G, Chapman S, Dopson S et al. EU Falsified Medicines Directive mandatory requirements for secondary care: A concise review. J Generic Med. 2015;12(3-4):95-101. doi: 10.1177/1741134316643358.

Gonzalez JE. Deployment of a traceability system by a pharmaceutical wholesaler leveraging GS1 Standards. GS1 Healthcare Reference Book. 2012;2013:19-22.

Huaiyuan S, Chenjie S, Yuehua L. The detection system for pharmaceutical bottle-packaging constructed by machine vision technology. In2013 Third International Conference on Intelligent System Design and Engineering Applications. IEEE Publications; 2013 Jan 16. p. 1423-5.

Rawashdeh NA, Abu-Khalaf JM, Khraisat W, Al-Hourani SS. A visual inspection system of glass ampoule packaging defects: effect of lighting configurations. Int J Comput Integr Manuf. 2018 Sep 2;31(9):848-56. doi: 10.1080/0951192X.2018.1447145.

Forcinio H. Packaging. Innov Pharm Technol. 2003 Aug;27(8):18-.

Ueno R, Mitsugi J. In: Proceedings IEEE World Forum on Internet of Things, WF-IoT. Institute of Electrical and Electronics Engineers Inc, vols. 2018-January; 2018. p. 416-20.

Golnabi H, Asadpour A. Design and application of industrial machine vision systems. Robot Comput Integr Manuf. 2007 Dec 1;23(6):630-7. doi: 10.1016/j.rcim.2007.02.005.

Cleland-Huang J, Gotel O, Zisman A. Software and systems traceability. London: Springer; 2012 Jan 31.

Ramík DM, Sabourin C, Moreno R, Madani K. A machine learning based intelligent vision system for autonomous object detection and recognition. Appl Intell. 2014;40(2):358-75. doi: 10.1007/s10489-013-0461-5.

Lopes-Martínez I, Paradela-Fournier L, Rodríguez-Acosta J, Castillo-Feu JL, Gómez-Acosta MI, Cruz-Ruiz A. The use of GS1 standards to improve the drugs traceability system in a 3-PL Logistic Service Provider. DYNA. 2018 Sep;85(206):39-48. doi: 10.15446/dyna.v85n206.69616.

Lachman P, van der Wilden E. Use of barcode technology can make a difference to patient safety in the post-COVID era. IJQHC Commun. 2022;1(1):lyab014. doi: 10.1093/ijcoms/lyab014.

Neuenschwander M, Cohen MR, Vaida AJ, Patchett JA, Kelly J, Trohimovich B. Practical guide to bar coding for patient medication safety. Am J Health Syst Pharm. 2003 Apr 15;60(8):768-79. doi: 10.1093/ajhp/60.8.768, PMID 12749163.

Klein K, Stolk P. Challenges and opportunities for the traceability of (biological) medicinal products. Drug Saf. 2018 Oct;41(10):911-8. doi: 10.1007/s40264-018-0678-7, PMID 29721822.

Sarkar S. Digital Traceability of pharmaceutical drugs in supply chain [international journal]. 2022 Feb;10(2).

Amaral P, dos Santos MV, Costa L. Porposal for EPCIS system implementation to control drugs in pharmaceutical sector in Brazil. In 2015 IEEE Brasil RFID. IEEE Publications; 2015 Oct 7. p. 1-4.

Heydrich J. Implementing GS1 datamatrix at Moinhos de Vento Hospital: ensuring drug traceability and patient safety. GS1 Healthcare Reference Book. 2012;2013:15-8.

Datta PK, Majumdar S. Role of Regulatory Agencies in India’s governance. Indian J Public Admin. 2018;64(3):427-41. doi: 10.1177/0019556118785426.

Silva RBD, Mattos CA. Critical success factors of a drug traceability system for creating value in a pharmaceutical supply chain (PSC). Int J Environ Res Public Health. 2019 Jun;16(11):1972. doi: 10.3390/ijerph16111972, PMID 31167350.

Bonetto R, Latzko V. Computing in communication networks: from theory to practice. Elsevier; 2020. p. 135-67.

Axicon. Bar-code verification [internet]; 2022. AXICON: what is a bar-code verifier? and how to check bar-code quality. Available from: https://www.axicon.com/what-is-a-barcode-verifier.html.

Published

2023-03-01

How to Cite

Kasagani, V. ., & Kakollu, V. . (2023). Design and Implementation of a Track n trace 2D Multi Scanner Bulk Code Reader for Pharmaceutical Packaging: Pharmaceutical Science-Pharmaceutical Sciences. International Journal of Life Science and Pharma Research, 13(2), P37-P50. https://doi.org/10.22376/ijlpr.2023.13.2.P37-P50

Issue

Section

Review Articles