Medicines are sensitive products. Excessively high or low storage temperatures can impair their quality. Incorrectly stored medicines lose their efficacy and can be harmful to health. Correct storage is therefore vital, offering as it does the guarantee that medicines remain safe and efficacious and retain their high quality right up to their expiry date. The Rosengarten Apotheke AG Bassersdorf relies on the Rotronic Monitoring System (RMS).
Meeting GDP/GMP requirements in pharmacies
The storage of medicines is legally regulated by GDP Standard 9.2, and is inspected by the responsible authorities (therapeutic product control). Temperature-sensitive pharmaceuticals such as insulins, liquid antibiotics or certain eye drops, for instance, must be stored in medicine refrigerators at a temperature between 2 °C and 8 °C. A temperature range of 15 °C to 25 °C applies to the vast majority of other medicines. It is compulsory to document the storage conditions of all medicines.
Previously, the Rosengarten Apotheke pharmacy read out its temperature values manually every day. The Rotronic Monitoring System RMS now eliminates this work. The new RMS loggers transmit their measured values to the ISO27001-certified RMS Data Center via a gateway in real time. It stores the data centrally and securely. The responsible pharmacists can access the measured values from anywhere and at any time via a secure internet address. Monthly reports required by the therapeutic product control can be generated quickly and easily.
“WE SAVE PRECIOUS TIME EVERY DAY, WHICH WE URGENTLY NEED FOR OUR TALKS WITH CUSTOMERS.”
Ivan Mihajlovic, Rosengarten Apotheke AG
Mr. Mihajlovic opted for an RMS leasing contract which includes the use of hardware – a total of 9 loggers (some with cable probes) and 2 receivers – and use of cloud software. With this (SaaS) solution, Rosengarten Apotheke did not have to purchase any equipment or set up its own IT infrastructure and benefits from the full service package. This includes annual calibration, battery replacement and personal support as needed.
The Rotronic team picked up the needs of the Rosengarten Apotheke and, in consultation with the customer, defined and proposed the monitoring system required to meet the legal requirements. After approval, the required hardware was calibrated, installed and configured by Rotronic on site (naming of loggers, setting of alarm limits, reports with pharmacy logo, mail connection, etc.). The customer is satisfied: “The Rotronic Monitoring System is easy to operate, monitors all critical measured values reliably and alerts and documents according to the QMS requirements. The carefree package for temperature monitoring, documentation and calibration was tailored to my needs by Rotronic. We save precious time every day, which we urgently need for our talks with customers.”
As soon as a measured value falls below or exceeds the defined limit, the system triggers an alarm. An e-mail is sent to the proprietor and the responsible pharmacists. Four alarm levels can be selected in the RMS, depending on the risk. “Reminders” for non-urgent events, “Warnings” or “Alarms” for measured values outside set limits and “Errors” for possible hardware errors. Alerted events must be acknowledged; causes and measures can also be entered and stored in a text field.