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Controversy over the system that maintains the cold chain of the Sputnik V vaccine in Tucumán

Failure in the system that maintains the cold chain in the Sputnik V vaccine in Tucumán (TN)

Advances in the country Russian vaccine distribution so that tomorrow you can start applying, and on Monday morning, the last conditioned trucks left the Avellaneda logistics center for the different provinces with the 300,000 doses of the Sputnik V vaccine.

During a note in TN, from the local warehouse that protects the vaccine in Tucumán, the process of reception, conservation and subsequent distribution of the inoculant was explained, recently approved by ANMAT. While the operator showed how the process of temperature control and the cold chain works and how the device that records the history of the different temperatures during the entire transfer in a special log works, One detail immediately caught the attention: a message was displayed on the screen warning about a fault, an error in the status, and a maximum temperature recorded of -5.5 ° C when must always be below 18 ° C.

The company in charge of transportation throughout the country, Andreani, used a specially conditioned cold room at a temperature of 20 degrees below zero, according to a statement. The company indicated that the vaccines “They were placed in 60L capacity cold freezers, refrigerated at a temperature below 18 degrees below zero, through a combination of eutectic plates and dry ice”.

“Each conservator wears a DataLogger to certify that the appropriate temperature conditions have been maintained throughout the logistics process ”, it was added.

Capture of the failure in the system that maintains the cold chain in the Sputnik V vaccine in Tucumán (TN)
Capture of the failure in the system that maintains the cold chain in the Sputnik V vaccine in Tucumán (TN)

At the time of the “failure event” shown in the note, highlighted that they would show traceability in the temperature in which the vaccines came. “It is precisely on 12/26 at 11:55 pm, it says that the vaccine was at minus 5 degrees and the minimum temperature at minus 40. Clearly there was a problem here, in fact the technician was exactly setting an alarm: the vaccine should be kept at minus 18 degrees and the alarm referred to this issue that the vaccine could not have been any, the cold chain was broken “, said the company’s technician. “We have been told so far that no lot will be returned. Saying it’s a thermometer reading failure”He added.

The failure event warned that the vaccine had been at -5 ° C, when it should always be below -18 ° C
The failure event warned that the vaccine had been at -5 ° C, when it should always be below -18 ° C

The technician justified himself at that time saying that “it could be due to the bad Internet connection of the place” or a “technical failure due to the fact that the DataLogger source was not downloaded correctly”.

Hours later, and explaining what happened in the morning, Luis Rocha, operator of the vaccine depot in Tucumán, explained: “The temperature was constant and there was thermal equilibrium. We activate the data logger system before putting the vaccine in the conservatory”.

When each conservator arrived we took the record, at the moment in which we put our thermometer in each box at -40 degrees“, large. It should be noted that the conservation of these vaccines is at -18 degrees, which is a less complex temperature to handle than that of other doses, which must be moved to -60 degrees.

Operators unload, on December 24, 2020, from an Aerolineas Argentinas plane the first containers of the Russian Sputnik V vaccine against covid-19, at the Ezeiza Airport in Buenos Aires (Argentina).  EFE / Juan Ignacio Roncoroni
Operators unload, on December 24, 2020, from an Aerolineas Argentinas plane the first containers of the Russian Sputnik V vaccine against covid-19, at the Ezeiza Airport in Buenos Aires (Argentina). EFE / Juan Ignacio Roncoroni

From the Government of Tucumán issued a statement in which claim that vaccines “never lost the cold chain” and that the person in charge of the place where the vaccines are located explained that the variations within the sensors are due to technical issues that are within the expected.

From the Central Depot of the Provincial Health System (SIPROSA) where the Sputnik V vaccines are stored before starting the application, they detailed that there was no anomaly in the protection of the cold chain and that the data from the sensors, which unleashed the confusion, is part of a technical process.

According to the warehouse manager, Eduardo Carrillo, “All the processes that the sensors have have a moment of thermal inertia from the moment they are used. That is, they immediately acquire the temperature until they reach the reference values, that is the concrete explanation. At no time did the vaccines lose the cold chain. The temperature of -40º was kept constant throughout the treatment time ”.

The distribution of the initial 300 thousand doses of the Sputnik V vaccine is carried out simultaneously by the Andreani company (REUTERS / Agustin Marcarian)
The distribution of the initial 300 thousand doses of the Sputnik V vaccine is carried out simultaneously by the Andreani company (REUTERS / Agustin Marcarian)

In that sense, Carrillo added that “when preparing a box for medicines, a thermal base (in this case cold) must be prepared both on the floor and on the walls. When the vaccines are placed at the end, the sensor is put on and activated. The moment it is activated, the temperature begins to drop drastically until it reaches -40º; begins to look for the thermal balance ”.

“The confusion arose because one of the sensors used (Datalogger) to measure the temperature of the conservatives, it marked for a few minutes a temperature lower than that required by Sputnik V for its conservation ”, they warned from the Government of Tucumán. “He DataLogger measures when the conservator closes. From the moment it marks -40º the temperature remains constant. To explain it basically is what happens when you put something in the fridge. The dataloger would be a can that is kept in the refrigerator. When you hold it in hand, it has a temperature, but when you put it in the refrigerator and close the door, it begins to have the temperature of the refrigerator. In this case it works the same”They compared.

Carrillo also stated that “everything is registered with probe thermometers that the vaccines never lost the cold chain and were kept at -40º”.

The storage temperature of the Russian Sputnik V vaccine must be below -18 ° C (Europa Press)
The storage temperature of the Russian Sputnik V vaccine must be below -18 ° C (Europa Press)

From Andreani they also referred to the event that generated a failure: “With respect to different interpretations in relation to the data record that is downloaded from the”DataLoggers”With which the temperature of the preservatives is controlled, Andreani Logistics Group points out: At the beginning or end of the data recording process, the temperature graph can present temperatures higher than -18 degrees Celsius. This is due to the manual process that the temperature recorder requires to start with the start button during the preparation of the packaging, and on the other hand, due to the setting carried out by the operator who receives the conservator at destination and takes the recorder in his hands. temperature to stop and read your data. These readings do not represent the temperature of the vaccines since they are readings that are taken with the temperature recorder outside the conservator”.

“For his part, All the conservatives dispatched from the Andreani plant in Avellaneda, Province of Buenos Aires, were packed with materials to guarantee 60 hours of cold. In the specific case of Tucumán, the conservatives were delivered in 30 hours“, They add and specify:” From Andreani we confirm that all vaccines were delivered in a timely manner, respecting the cold chain”.

They also highlight that they have “capacity to distribute 400 million medicines per year, in all its temperature ranges and to its different channels. Its infrastructure has more than 2,000 m3 of storage in chamber for refrigerated products from 2 ° to 8 ° C, equipment and supplies for temperatures below zero (-20 ° / -50 ° / -196 ° C), in addition to Validated computer systems for end-to-end stock management and order traceability, and online temperature control in cold rooms with automatic alarm emission”.

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