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The Challenge of Staying Compliant and Keeping Drugs Safe

Even the smallest of deviations can have detrimental effects on the integrity of drugs kept within medicine storages. Deviations that, without the use of independent monitoring processes and equipment, could easily go unnoticed.

Medicine storage conditions are required by the FDA to be monitored for the safety and stability of medicines, and are typically kept around 2-8 °C. The performance of storage units, however, may vary and degrade over time, which could have devastating effects if not caught in time.

In addition to that, the ‘Misuse of Drugs Safe Custody Regulations’ requires that companies store all schedule 2 drugs within a cabinet or safe that is locked with a key. The storage area should be made of metal and fixed to the wall or floor.

As medicine storage units are difficult and expensive to replace, an accurate and wireless solution could be the key to maintaining the integrity and quality of stock.

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Narrowing Down the Options to Locate the Ideal Choice

The Hanwell radio telemetry was put to the test when the Director of Clinical Service, Keith DeDonder, at the VBRC required a wireless data logger to record ambient temperature and humidity within a steel medicine storage vault and transmit data to their local PC within their Kansas site.

With the initial intention of using a cable between the door seal, it quickly became apparent that the solution could be made much simpler thanks to the power of the wireless Hanwell radio telemetry.

DeDonder had been set to the task of finding ambient temperature and humidity monitoring systems that VBRC could use for various applications on site, with the added challenge of monitoring temperature and humidity within their ½ feet thick (15.24 cm) steel and concrete vault door.

Finding a solution to this and other unique challenges within their facility was not going to be easy, and after contacting several other companies, it quickly became clear that Hanwell was the ideal choice, passing all the initial tests and seeming to be the perfect fit for their monitoring needs.

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The Ultimate Monitoring Solution for Ensuring Drug Integrity

The Hanwell Pro monitoring system is well established as being the most reliable radio system on the market with the ability to reach over 10,000 ft. (3.5 km) over open ground, so we were keen to show how the strength of the Hanwell radio range could meet the unique wireless requirements set out for us by VBRC.

Following DeDonder’s initial review of the technology he explains: “Overall I was very surprised with the capabilities of this unit in this situation as well as all other facets of the service and products of Hanwell/Ellab.”

The Hanwell system collects data from each of these critical points to a centralized system that enables users access to data in and out of working hours via a PC, tablet or browser. Emails and Hanwell smart app alerts are also set up for alarm notifications out of normal working hours.

The system is used to schedule regular reports to designated staff members and ensure historical data is accurate and available for regulatory purposes.

“We were also able to use the monitoring system within our specialist rooms that are encased on all sides with 8” steel reinforced concrete walls. The units have not missed a beat and continue to outperform expectations,” says DeDonder.

Outperforming Expectations

As expected, the Hanwell Pro radio range didn’t let us or VBRC down. The radio strength effortlessly powered through the thick steel and concrete obstructions, sending data to a base station. This and other sensor data now flows to their local PC/Network, providing them with constant real-time environmental data for their entire site with immediate access to alerts 24/7.

 

Industry: Pharmaceutical
Company Size: Small to medium
Location: Kansas, USA

In this Case we Used…

We installed a variety of products. For the steel and concrete safe, we used 1 x RL4114 with 1 x J140 which transmits to an SR2 base station. The SR2 is networked to a local PC and network for access to the comprehensive monitoring software.

 

An additional 15 sensors were placed around the site for various other applications such as, ultra-low freezers, ambient storage vault, -20 °C freezers, a fridge, an incubator and ambient room conditions.

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