Regulatory Storage of Medical Drugs

casestudyMedicines are sensitive products. Having them stored at temperatures too low or too high can affect their overall quality, potentially making them less effective and even causing adverse effects during use. This means that correct storage conditions are not only essential to ensure medicine quality, they are also required by law.

Why monitor environmental conditions?

Medicine control and EU GDP Guidelines suggest that suitable equipment and procedures should be in place to monitor the environment where medicinal products are stored. Environmental factors to be considered include temperature, light, humidity, and cleanliness. For example, many medicines should be stored between +15°C and +25°C to ensure their quality is maintained. Other temperature-sensitive drugs, such as insulin or some antibiotic liquids must be kept in refrigerators between +2°C and +8°C. If medicines are not stored at correct temperatures they muse be destroyed, resulting in large, unnecessary, financial losses.

How Rotronic can help?

Rotronic has over 50 years’ experience in environmental monitoring to GxP guidelines. With “RMS” Rotronic can provide a monitoring system that was developed based on GAMP5 recommendations, in collaboration with multiple experienced pharmaceutical users to comply with several industry regulations, including FDA CFR 21 Part 11 and EU Annex 11.

RMS is an advanced, modular monitoring system with all data available securely via any device, anywhere. It can provide users with exactly the data they need, in the format they require, with extensive reporting and configurable alarms.

One of the key features of RMS is that not only can it be used with Rotronic hardware, but it can also be used with existing hardware from other manufacturers, as well as interact with other software / hardware platforms. RMS can be provided as a hosted cloud service or using a traditional license whereby the client installs the system on their own servers (local or cloud).

In summary RMS provides….

  • Live and interactive charts for all monitored parameters
  • Full alarm and alerts, easily configured
  • All data available with automated scheduled report generation
  • Complete event logging and compliance with GxP requirements
  • Email, phone, SMS, relay and custom protocol alarm notifications
  • Automatic data back filling and retrospective alarms (ideal for transportation logging)
  • Interactive, user configurable on-screen layouts

Alarming / Reporting

The alarm function in RMS ensures users are alerted whenever conditions stray outside their set limits. For example, if a refrigerator is broken, causing its internal temperature to rise above limits, an alert is triggered, notifying users, via email, SMS, or phone call, to act before medicines are damaged. The warning function can also be used to warn users whenever environmental conditions get close their critical limits, giving time to react before the critical limit is reached. Depending on individual requirements, a detailed alarm report can be automatically generated and sent to selected users via email.

                                                            Rotronic products
RMS KITAutomated solution

The RMS Starter Kit for monitoring storage of medicines includes three wireless temperature loggers, a gateway (wireless receiver) and the corresponding software license. We have also included a service level agreement to help ensure a quick response to any questions that may arise.

Standalone solution

Data logger TL-1D or HL-1D Collage HL-1D.jpg
For a standalone solution, you can use our TL-1D temperature loggers or HL-1D humidity and temperature logger. These battery powered devices record environmental data which can be accessed by connecting the logger, via its USB port, to a PC running the free HW4-LITE software. These devices are not compatible with the RMS meaning data must be accessed manually. Once data has been downloaded, HW4 can be used to generate a detailed PDF report, which includes a graphical representation of the data, along with various statistics, and details of any period during which conditions where outside their alarm limits.

To find out more about our range of monitoring solutions, please contact us on 01293 571000 email: instruments@rotronic.co.uk or visit http://www.rotronic.com/rms

 

 

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