Enhancing Visibility along Medical Supply Chains

In 2013, the EU overhauled medical regulations, requiring pharma firms to verify the temperature of medicines throughout supply chains. Even for medications which do not require refrigeration, extreme temperatures can damage their viability. As a result, controlled room temperature (CRT) compliance has become a major consideration for pharma firms. Medical authorities now require that pharma manufacturers guarantee the stability and shelf life of their medications by proving shipments remained at optimal temperatures throughout the distribution process. What is an optimal temperature?

The EU set the optimal temperature range for most medications between 68 and 77 degrees. And with good reason – storing or transporting medications in ambient temperatures above 86 degrees can have a stark effect on potency.  Even brief temperature fluctuations can affect product stability. Many medicines which contain hormones like birth control are protein based. Moderately high temperatures can cook proteins like an egg.

 

Fluctuations in temperature affect the potency of most medications.

  • When stored at 98 degrees or more, diazepam and lorazepam decrease in potency by 25 and 75 percent respectively.
  • Insulin and Thyroid hormones lose 50% potency in high temperatures.
  • Repetitive heating and cooling causes epinephrine to lose potency by 64 percent.
  • Heated and decayed antibiotics cause stomach and kidney damage.
  • Freezing temperatures compromise the efficacy of insulin as well as any suspended medication.

 

Proof of Compliance 

The vast majority of medical supply chains already ensure stable temperatures throughout supply chains. Regulating temperatures in storage and in transit is not as challenging as providing proof that regulations were followed. Over the past five years, pharma firms have committed vast resources to controlling temperatures and tracking climates during shipment. However, systems remain inefficient because of traditional sensor technology and geographical variations in regulatory guidelines.

 

 

European Pharmacopoeia

WHO Guidance

U.S. Pharmacopeia

Japanese Pharmacopoeia (JP)

Room Temperature

15°-25°C

15°-25°C

Temperature in work area

1°C-30°C

Controlled Room Temperature (CRT)

–           

–           

20°C-25°C with allowable excursions down to 15°C and up to 30°C

Ambient temperature

–           

15°-25°C/30°C

 


Accountability doesn’t have to be expensive 

Pharma requires solutions which eliminate the possiblity for human error. Traditionally, RFID and WSN have been used to take readings of assets during fixed points throughout the distribution process. Radio frequency identification (RFID) is a well-known and widely adopted identification technology used within traceability systems to track and monitor the location and ambient temperature of assets. RFID has provided a decision support system for perishable products such as medicine. In conjunction with wireless sensor networks (WSNs) which monitor temperature and humidity, RFID systems can detect failures in temperature regulatory systems, saving products in the critical minutes following failure or informing decisions about product disposal – protecting customers from impotent medications. Despite the success of RFID and WSN, simpler solutions exist which provide real-time monitoring.

 

Bluetooth Beacons: Cost Effective Asset Tracking and Monitoring

Bluetooth is taking over as the tech of choice for the medical and healthcare industries. While most of us use Bluetooth in minor day to day capacities, the technology has a promising future in the medical industry. Bluetooth beacons and gateways are cost-effective and portable, capable of interacting with any smart device with Bluetooth capabilities. Beacons measure environment data when mounted on flat surfaces, and also track the location of assets and critical equipment. Their batteries can last years depending on the strength and frequency of their signal (Tx factor). Beacons do much more than monitor temperature compliance tracking in real time the location of assets while in manufacturing facilities, warehouses, in transit, and on shelves.

Bluetooth enables communication between beacons and smart phones – allowing real-time alerts to be sent out if temperatures dip or spike. A beacon’s temperature sensors are connected to smartphones via cloud networking. Software takes the raw data from beacons and creates visualizations for users to view in monitoring facilities or on smartphones. These platforms which incorporate smart phones, beacons, and gateways spread responsibility for temperature regulation to every point of contact. Corrective actions can be taken immediately based on real-time information.

Beacons are inexpensive compared to RFID because they interact directly with tablets and smart devices, saving thousands to hundreds of thousands depending on the scale of deployment. For medical manufacturers, cost-effective scaled solutions are critical to keeping costs low. Governments are constantly pushing for lowered costs of generic medication. Pharma firms must meet the demand by keeping EU compliance affordable. Bluetooth-powered beacons eliminate the need for WSNs and sensor technology because of their versatility and the myriad of sensors that come built-in to their hardware.

 

bluetooth tag

Bluetooth beacons come equipped with environmental sensors.

When ten minutes of an open vehicle door can make a world of difference in the potency of critical medications, industries need modern technology to prevent product spoilage and ensure regulatory compliance. As part of the future of cold chain solutions, beacons and bluetooth will draw on big data and analytics to create efficient supply chains.

 

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