Cold chain storage is an important segment of the pharmaceutical industry. It’s expected to grow to be worth $21 billion by 2024.
Medications are sensitive to even the slightest temperature changes. Many become useless when exposed to heat. This causes major losses for consumers and pharmaceutical manufacturers.
Medications need to be monitored from the moment they arrive at a storage facility to when they arrive at a pharmacy. Read our guide to learn the process and importance of pharmaceutical temperature mapping.
What Is Pharmaceutical Temperature Mapping?
A pharmaceutical industry survey found that 41% of temperature changes are over 4°. 21% are over 8° and don’t meet FDA compliance standards.
This rapid change of temperatures can wreak havoc on a medication supply. Regular temperature checks are the only way to prevent this.
Thermal mapping tests the temperature of equipment, vehicles, and storage areas.
Pharmaceutical temperature mapping is a specific type that focuses on medications. It ensures that they maintain a stable temperature while being used or transported.
How to Perform Pharamecutic Temperature Mapping
Medications and their environment need constant attention. Leaving them alone for even a moment can be catastrophic.
The process starts with choosing and installing the best equipment. It also involves several tests and consistent monitoring and maintenance.
Start by determining which areas need to be monitored. Determine where you’ll need to place your sensors.
You’ll need several types of sensors. Some are pre-calibrated for specific temperatures. Others record both temperature and humidity. Finding ones that log data will save you time.
Pharmaceutical temperature mapping equipment varies in accuracy and response time. Look for equipment that’s accurate within 0.3° C to get the best results.
Load and Failure Testing
Perform a load test on your facility. It determines the impact of your cooling systems on the pharmaceuticals. It also helps you decide whether they’ll need to be cooled when they arrive.
Perform simulated failure tests on your equipment as well.
Put a few sensors in areas where temperatures change. Place the rest in stable areas. Make sure they’re near the pharmaceutical products. Use different heights and follow local layout guidelines.
Organize your sensors into zones. Each one should be based on what influences temperature in a specific area. You could designate one for each corner and others for areas with frequent temperature fluctuation.
Place your sensors in containers of thermal fluid known as thermal lags. It dampens their reaction to temperature changes. This mimicks the effect of product packaging.
Remember to install a backup system in case of failure.
Performing Temperature Mapping
Get uniform results from each of your sensors. Factor in the current climate, where they are in the room, whether they’re close to HVAC systems, doors, or windows. All of these factors can affect temperature.
Conducting tests at different times of the year will give you a more complete picture of the facility. Test your transport vehicles as well.
Temperature recovery time is another crucial measure. Open and close a door to let the air out. Check how long it takes for your storage unit or vehicle to return to its normal temperature.
According to USP guidelines, all pharmaceutical thermal mapping tests must be performed for at least 24 hours.
Maintenance and Recalibration
You’ll need to regularly maintain your system and recalibrate it at least once a year. Monitor these procedures the same way you monitor temperatures.
Your equipment should meet NIST, ISO17025, and/or international calibration standards. It should also come with a certificate of calibration.
Warehouses experience wide variations in temperatures. This is why they require complex temperature monitoring.
Take care if your storage area is inside a warehouse. Test it during extreme periods of temperature change. You’ll get a more complete picture of its temperature fluctuations.
Cold rooms and refrigerators have more consistent temperatures. They may only need one instance of temperature mapping.
Why Do You Need Pharmaceutical Temperature Mapping?
Temperature monitoring is important for the entire health industry because it prevents essential pieces of equipment from breaking down. It’s even more necessary for pharmaceuticals.
Your medication supply must always stay at the right temperature. This keeps it deteriorating and becoming ineffective.
A controlled room temperature of 77°F is best for storing most medications. Liquid medications can withstand temperatures as low as 52°F.
There are no pharmaceuticals that last above 86°F unless they’re only exposed for short periods known as controlled excursions.
Failure to check medication temperatures costs the biopharma industry over $35 billion per year. Replacing lost products and replicating trials is expensive and time-consuming.
Maintaining medication temperatures helps manufacturers save money. It also keeps their products safe, protects their reputation, increases sales, and helps them meet regulatory standards.
What Are the Pharmaceutical Temperature Mapping Regulations?
The latest USP or United States Pharmacopeia guidelines regulate how medications are stored and shipped.
Freezer storage must be between -25 and 10° C. Refrigerated storage must be between 2-8° C. Cool storage must be between 8-15° C.
Room temperature is 20-25° C with outer limits of 15-30° C. The optimal controlled room temperature is 20-25° C.
All medications that are sensitive to light and humidity must include labels. They should tell consumers to store their medicine in a cool dry place or protect it from light.
The cGMP or Current Good Manufacturing Practice is a compliance regulation set in place by the FDA. It regulates drug manufacturing.
Drug companies need to use the most up-to-date systems and technologies. Each monitoring stage is highly regulated and strict testing is required. These regulations are meant to ensure that all drugs are safe and effective.
Where Can I Get Temperature Mapping Products?
Pharmaceutical temperature mapping protects medications and keeps them from becoming ineffective. It involves setting up a system of sensors in the right areas to monitor the environment.
Regular temperature monitoring protects medication, but only if it provides accurate measurements. This makes choosing the right equipment one of the most important parts of the process.
SensoScientific has products that can help you monitor everything from temperature to CO2. Contact us today to see how our products can help your business.