Wholesalers and pharmacies are required to transport and store medicinal products in accordance with the manufacturer’s instructions.
The pharmacy, after receiving medicines and vaccines that have been transported in accordance with the “cold supply chain”, is required to monitor every room where the medicines are stored. The key parameters to be controlled are temperature and humidity, and pharmacists are required to keep records.
Pharmacy premises should therefore have an appropriate microclimate ensuring safe storage of pharmaceutical products, including medicines.
The requirement to monitor temperature and humidity in the pharmacy is regulated by the Regulation of the Minister of Health of 13 March 2015 (Journal of Laws of 19 March 2015 item 381), which clearly indicates that every room in the pharmacy where products are stored or manufactured medicinal and medical devices must be mandatorily equipped with a hygrometer and thermometer.
“The entrepreneur will provide equipment for 24-hour control of the temperature of the rooms in which medicinal products are stored, and introduce appropriate procedures, taking into account environmental factors: temperature, light, humidity and cleanliness of the rooms.”
The same regulation imposes an obligation on pharmacy managers and drug suppliers to have the necessary measuring infrastructure and to provide 24-hour monitoring of microclimate parameters in rooms where medicinal products are stored. A dedicated alarm system should be alerted to any deviations from established events and storage limits, the levels of which must be set so as to ensure the highest quality of stored medicinal products.
The measurement of air temperature and humidity must be: recorded regularly and recorded at least twice a day. Measurements should be provided each time a pharmaceutical supervision inspector checks. Pharmacy air temperature ranges have been set between 15 and 25 ° C, and humidity may not exceed 70%.
Efento Inspector is a solution dedicated for clinics, health centers and pharmacies to monitor the temperature in medical refrigerators. The system allows, among others, sending SMS / email alerts, generating automatic reports, sound alarming on exceeding thresholds and signaling power failure in the facility.
The loggers are accurate and reliable, durable and easy to maintain.
Secure software with encrypted connections – proven in over 300 large installations with up to 1000 sensors.
The solution complies with the legal requirements of the GxP, HACCP guidelines, FDA 21 CFR Part 11, GMP, the manufacturer provides materials for validation.
Easy and self-installation, the sensor is ready to use right out of the box. System configuration will take less than 15 minutes.
Manufacturer’s warranty for 2 years.
A pharmacy with medicinal products and medical devices requires constant monitoring and registration of the temperature in refrigerators, as well as temperature and humidity in rooms where medicinal products and medical devices are stored.
Maintaining optimal storage conditions for drugs, vaccines, etc. affects their safety and effectiveness.
Enclosed spaces that only authorized persons have access to may be secured by means of opening/closing sensors that detect the unauthorized opening of doors or windows.
In pharmacy, energy costs are a significant item in the statement of expenditure. It is not surprising, therefore, that measures to reduce them are treated more and more seriously, as reducing these costs may increase the company’s profitability.
The Efento system allows you to monitor not only electricity but also water or gas consumption. The use of pulse counters allows constant monitoring of costs, generating alarms when exceeded, as well as full visualization of data on the cloud platform.
Regulations require that refrigerated vaccines also be subject to temperature monitoring on saturdays and sundays. The system alerts you of deviations from the storage conditions. and archiving of measurement data.