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Monitoring Medicines: Why correct storage is vital

17 June 2019

Blog by Emma Batchelor

Medicines are sensitive products. High or low storage temperatures can impair their quality. Incorrectly stored medicines lose their efficiency and can be harmful to health. Therefore correct storage is vital to ensure that medicines remain safe, efficacious and retain their high quality right up to their stated expiry dates. The Rosengarten Apotheke Pharmacy in Bassersdorf, Switzerland relies on the Rotronic Monitoring System to record temperature conditions during medicine and chemical storage, with full alarms.

GDP/GMP requirements in pharmacies

The storage of medicines is legally regulated by GDP Standard 9.2. Temperature sensitive pharmaceuticals such as insulin, liquid antibiotics and certain eye drops, must be stored in medicine refrigerators 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 actual storage conditions of all medicines. The Rosengarten Apotheke Pharmacy previously recorded temperature values by hand. The Rotronic Monitoring System (RMS) now eliminates this work. The RMS loggers transmit their measured values to the ISO 27001-certified RMS Data Centre via a gateway in real time; it stores the data centrally and securely. Access to all the data is available anywhere, on any device via a secure internet address. Measurement devices also log several weeks of data providing a secure backup in the event of any communication or power interruption to the facility.

RMS-overzichtCarefree package

The Rosengarten Apotheke Pharmacy opted for an RMS leasing contract which includes the use of hardware and cloud-based software and support all under one fixed price Service Agreement. With this convenient solution Rosengarten Apotheke Pharmacy did not have to purchase any equipment or set up its own IT infrastructure and benefits from the full service package. This includes annual sensor calibration, battery replacement and direct support as needed. During the consultation meetings with the customer, we defined and proposed the monitoring system as required to meet the legal requirements. After approval, the required hardware was calibrated, installed and configured by Rotronic personnel on site.

Alarms

As soon as a measured temperature value falls below or exceeds the defined limits, the system triggers an alarm; an email is then sent to the designated person. Four alarm levels can be selected in 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. Notified alarms must be acknowledged; causes and corrective measures can be entered and stored for audit and route cause analysis purposes.

The Rosengarten Apotheke Pharmacy has been deeply rooted in the community of Bassersdorf Switzerland, since 1960.

Monitored areas:
• Sales and storage rooms
• Picking machines
• Refrigerators for medicines and chemicals

For more information, please contact:

Chris Fox
Rotronic Instruments (UK)
Crompton Fields
Crompton Way
Crawley
West Sussex
RH10 9EE
Tel:  +44 (0)1293 571000
Email: instruments@rotronic.co.uk
Web:  www.rotronic.co.uk
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