VallyDroid® - AUTOMATED THERMAL QUALIFICATION SYSTEM FOR STORAGE CHAMBERS (Vaccines, Medicines And Blood Products)

• Grant number: 23/10894-0
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: November 01, 2024
• End date: July 31, 2025
• Field of knowledge: Engineering - Biomedical Engineering - Medical Engineering
• Principal Investigator: Anderson Carlos Rodrigues
• Grantee: Anderson Carlos Rodrigues
• CNAE: Fabricação de aparelhos e equipamentos de medida, teste e controle ; Suporte técnico, manutenção e outros serviços em tecnologia da informação ; Serviços de engenharia
• Principal investigators: Francisco Rodrigo Moreni dos Reis

Abstract

Given the publication by ANVISA of RDC430/2021 in the midst of the global pandemic scenario, Brazil is in line with the international directives of the World Health Organization (WHO) and the FDA, with regard to the Cold Chain (logistics chain of vaccines, blood products and drugs from manufacture to point of use).Within what the international norms and the aforementioned RDC recommend, the requirement to carry out the Thermal Qualification of the Equipment used in this chain is established, from refrigerated warehouses, trucks and chambers for the conservation of drugs and vaccines themselves.This Thermal Qualification is carried out by simulating the conditions of use of the equipment, from its Installation, Performance and Operations, requiring an accurate and inviolable documented record of the conditions found with regard especially to temperature and humidity over time and in all parts of the equipment.It is observed, however, that in Brazil, only a small part of the hospitals (sentinels) carry out the correct Thermal Qualification of their equipment, given that many Health Units have not even been, at this moment, already audited based on the recent standard RDC430/2020 or even already aware that they will be audited based on such regulations from 2024 onwards.The correct performance of a Thermal Qualification requires the use of calibrated and certified measuring instruments that are inserted in the Conservation Chamber at strategic points and monitored by a qualified professional (pharmacist, clinical engineer or quality technician) and subsequently the collected data are compiled in reports, graphs and tables that record and show that that equipment performed adequately and can actually be used for storing vaccines, etc.The set of measuring instruments needed to carry out each Thermal Qualification can vary from R$20,000.00 (sets of standalone dataloggers) to R$200,000.00 (Amphenol's integrated qualification solution), including the most used solution in Brazil: a DAQ device (data acquisition) with input for around 20 temperature sensors, costing around R$25,000.00. - because it is a high cost, hospitals in general choose to outsource the Thermal Qualification service at a cost of approximately R$2,500.00 per chamber to be qualified annually.Our solution, called VallyDroid®, consists of a computational system that performs the Thermal Qualification in an automated way through a cell phone application, a set of wireless sensors based on open-hardware, a signal concentrator hub and a cloud application that performs all calculations, evidence collection and issuance of paperless Thermal Qualification Reports, while guiding the user through the qualification process by a Virtual Assistant on the cell phone. At the moment, we have already filed a patent for part of the hardware that behaves as a certified measuring instrument and we are developing software in an alpha version.The manufacturing cost of our solution is estimated at U$1,900.00 and, according to the defined business model, it can be sold for around R$20,000.00 or even rented for a fraction of that. (AU)