Temperature Monitoring Comparisons For The Pharmaceutical Supply Chain
By Jeff Clark, 7P™ Solutions
Over the last several months I have written a couple of articles focused on the pharmaceutical time and temperature supply chain. While some may have found the opinions to be a bit strong as they related to the lack of proper training within the industry, I believe I received more “behind the scenes” agreement than not. The fact of the matter is, any of us involved in this important supply chain must understand not only the regulations that touch our individual businesses, but we must also understand the product which we have been given responsibility to manage and ensure patient safety!
Based on my day-to-day experience and where the rubber meets the road training remains the biggest challenge in today’s time and temperature supply chain. Dry ice and wet ice are not the same for example! Nevertheless, within the pharma climate controlled supply chain there are tools of the trade which also must be understood, vetted, validated, and used properly to perform the tasks that they were designed for. The important tools that seem to be getting a lot of coverage lately are the various types of temperature monitoring or data logging devices which are on the market.
Today, there are many choices and types of monitoring solutions, and companies should be familiar with each technology to ensure that they are utilizing the right device for the task. It may or may not be a one-size-fits-all application. To be responsible to the climate controlled supply chain, I believe that we as an industry must educate and guide in order for informed decisions to be made. And companies must take the time internally to go through that process, especially today as regulations around the world become tighter.
There are many types of temperature monitoring devices such as chemical and electronic indicators, chart recorders, data loggers, USB and PDF loggers, RFID, and GPS-GSM devices. I wanted to address some of the more popular solutions that we see on the market today.
Data Loggers: These devices perform well, and the only drawback is that the destination requires software to download the data, and the shipper must program it to how they want to use it. Many pharmaceutical companies will not allow use of the reusable device due to worries of the device not properly erasing (or human error) the prior trip.
In a relative quick period of time the USB and PDF loggers have become very popular because they are small and easy to use. I like these loggers because they do not require a lot of training and they remove most human intervention. Upon arrival at the destination, stick the USB into a computer and you have a nice easy-to-read PDF of the temperature history. However, you must know who requires a copy of this information by email, and then must remember to properly file it electronically in the proper file on a server. This is all fairly simple and easy to do, but can be labor intensive if you are receiving multiple shipments. One limiting factor on some of these devices is they must be preprogrammed by the manufacture for a specific temperature range and alarming conditions.
RFID and GPS-GSM: These are the newest devices and maybe the most unknown on the market. RFID has been around for many years and is utilized in many industries to perform different tasks. However it is relatively new to the temperature monitoring industry and today still continues to challenge me and my thought process. As long as you have the ability to wand the packages, pallets — or there are readers at the entrance and exits of each facility — then there is the ability to easily collect the data. My question for that process is what happens when those readers and wands are absent at a particular location in the supply chain?
GPS-GSM might need the most explanation based on what I have heard and read. There are a few very good technologies on the market today, and they do have a role within the time and temperature supply chain. Using the proper technologies these devices can remove most of the human involvement, provide real-time decision making, improve productivity and enhance shipment visibility. However there is a myth that the cost of these devices is almost prohibitively expensive. Compared to what? I believe if you compare its cost to a single- use USB or PDF device, you will find the total cost very comparable.
When comparing a GPS-GSM solution to the other popular solutions on the market today, the technology can provide some distinctive benefits. First, the environmental data received is real-time, regardless of where in the world the shipment may be located. This allows the team responsible for the product to make immediate decisions should any of the data points being monitored go out of range versus after the fact. It does not require staff sitting in front of a computer screen watching a shipment track across the globe when using event based applications.
If the design of the application is done properly, most of the human intervention is removed from the entire process and everything becomes completely automated. Essentially staff is trained to perform a few tasks:
- Selecting a device for the shipment
- Placing it in the package
- Destination removing the device and placing it in the return pouch –
- Repeat the process for the next shipment.
Event based applications reduce labor, expedite decisions and save dollars spent on product waste. For example, companies now have the ability to make a decision to move $30 million worth of product into an FTZ after arrival, or return it without importing it into U.S. Commerce and paying duties if the product arrives out of scope – all due to an alarm received on a mobile phone or email as the shipment is being offloaded from the flight.
When looking at these technologies, companies must again educate themselves. As with anything there are enhancements that will be gained and challenges that may be encountered. However, it is important to note that the challenges are few and far between and the enhancements can have a positive effect on the flow of information, decision making, improvement in the supply chain visibility, enhanced security, and much more.
We suggest companies ask these questions before deciding on a temperature monitoring solution:
- How are the devices and operating software platform validated and to what standards
- In addition to environmental monitoring, are there applications for security applications?
- Can multiple probes be tied to the same GPS device?
- Is the device and probe diverse? Can it be used not only for cargo embedment, but also transportation vehicles, facilities, refrigerators-freezers – alarming and data logging.
- How is the data backed up if communications with GPS, GSP is lost?
- How long is data stored on the servers, or does the client have to maintain the data?
- Is there a call center available that can monitor for environmental and security protocols 24/7/365 and what are the protocols?
- Does the system require that the service provider have staff onsite at the shipping facilities?
- Does the system require that software be downloaded?
- How sensitive is the GPS chip being used, and what is the frequency of pings?
Understanding and learning about all of the technologies available to monitor and manage the temperature, humidity, and other important points of your product during transport and in-transit storage is becoming more important than ever. As GMP-GDP regulations around the world guide us to understand and document how that product was handled as it travels throughout the supply chain, visibility and proof will become paramount.
Climate Control | Security | Quality Management
About The Author:
Jeff Clark is the Founder and President of 7PSolutions, LLC, a company focused on implementing quality management systems across the pharmaceutical climate-controlled supply chain, as well as providing the latest in GPS-GSM environmental and security monitoring and management technologies to the pharma and logistics industry. With an IATA/FIATA Cargo Agent certification in 1982, Jeff has a very unique background that combines global transportation with the pharmaceutical and biotech industries.