Full Gauge Controls and Fiocruz guarantee the quality of COVID-19 vaccines

Fundação Oswaldo Cruz (Fiocruz), an agency of the Ministry of Health, is the entity responsible for keeping the integrity of the doses of North American vaccine Pfizer/BioNTech which have been arriving in Brazil since the end of March, mainly regarding the strict temperatures required for their conservation.

Fiocruz has prepared to receive them through the acquisition of cooling chambers equipped with the Full Gauge Controls temperature controllers and the Sitrad Pro remote-management software, ensuring the -25°C temperature required for the conservation of the drugs and, therefore, meeting the rules issued by Anvisa (the Brazilian health control agency).

The company SmartMonit Brasil, from Rio de Janeiro, was responsible for installing the controls and the software. The Full Gauge Controls products selected were MT-512E Log (refrigerator and freezer control), MT-530E Super (ambient acclimation control) and MT-543E Log (freezer control for -8°C temperatures).

Additionally, the installations have also been essential in the production of the active pharmaceutical ingredient (API) of the COVID-19 vaccine, approved on April 30, 2021, by Anvisa. Thus, Fiocruz is authorized to start the production of pilot batches of the vaccine, on a commercial scale, using the API produced in Brazil. The technical approval has occurred after an inspection which has verified the good manufacturing practices of the production line at the Instituto de Tecnologia em Imunobiológicos Bio-Manguinhos (a Fiocruz immunobiological technology institute).

Roberto Simonal and Guto Castro, partners of SmartMonit Brasil, state that the installations at Fundação Oswaldo Cruz have been possible thanks to the partnership with Full Gauge Controls. “I have no doubt that the quality of the controllers, along with the expertise of those involved, have been essential for closing this contract of such major relevance to the Brazilian population”, reinforces Roberto Simonal.

As for the remote management service, Roberto praises the speed of the reading and of the prompt warnings issued by the Sitrad Pro system. Regarding the technical support offered by Full Gauge Controls, he said that the agility of the service always provided to them gave the impression that there was no physical distance between the teams.

In addition to the vaccine sector, the Full Gauge Controls products have also been installed in labs and freezers assigned for the storage of the drug cocktail distributed to the population carrying the human immunodeficiency virus (HIV).