Temperature and humidity monitoring is carried out in order to have documentary evidence

that storage processes comply with temperature and humidity parameters, according to the
specifications and requirements established for medical devices. In order to guarantee these
conditions, permanent records of these variables must be kept, using thermometers and
thermohygrometers for this purpose.

Verify that the measuring instrument is correctly located, with batteries installed and displaying
all the data on the screen.

Take temperature readings of the environment and refrigerators, where applicable, every day
at noon and in the afternoon, in places that have a thermohygrometer or thermometer.

Once you have obtained the data, record the maximum and minimum temperature in the
corresponding box according to the degrees and locate a signaling point.

Please note that the allowable range for storage sites of supplies and reagents is between 15
and 25 degrees Celsius (or according to the manufacturer's specifications). The allowable
temperature range for refrigerator storage is 2° Celsius to 8° Celsius. If the temperature
deviates from the established range, you should inform the chemist leader. Repeat these steps
every day.

Verify that the measuring instrument is located correctly, with batteries installed and showing
all the data on the screen. Locate the date and time you are going to record, placing it in the
morning, afternoon or night box as applicable. Take ambient humidity measurements every day
in the morning and afternoon, in places that have a thermohydrometer.

Once you have the data, record the relative humidity of the environment in the corresponding
box according to the data obtained and locate a signaling point. Continue drawing a line
between the morning and afternoon points for all the measurements of the month. Keep in
mind that the allowable range for storage sites is between 40 and 60 HR.

If the humidity deviates from the established range, you should inform the chemist leader

Purpose

Scope

Responsibilities

Tools

Procedure

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