Most pharmaceutical products like vaccines and medicines are extremely sensitive to temperature changes. Handling, storage, and transportation of these products should be done at a controlled temperature to ensure that the drugs remain in perfect condition for human and animal use.
Below are some of the benchmarks that will go a long way in creating the perfect pharmaceutical temperature monitoring system.
01 GMP Pharmacy: Temperature Monitoring in the Pharmaceutical Environment
There are several ways of monitoring and recording temperature in a pharmaceutical environment with some being more efficient than others.
Monitoring ranges from handwritten logs to networked data logging systems, which we shall look into further.
GMP Pharmacy Guide for Pharmaceutical Temperature Monitoring
When data loggers have reached a temperature excursion, the data logger base activates an alarm. Some independent monitoring systems were designed explicitly for pharmaceutical temperature monitoring.
02 Pharmacopeia Europe and Helvetica
The main reason why this reference on pharmaceutical products was created was to ensure that all drugs making their way into the consumer market are of high quality, are safe, and are still useful. This can only be done through proper temperature monitoring and control.
Information for a compliant calibration certificate for a pharmacy temperature monitoring system should show the following;
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An accreditation logo together with an accreditation number, and they both should be visible.
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The environmental conditions that were present at the calibration time should be indicated.
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The calibration method used should also be indicated in case there is a need to recreate the calibration.
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The calibration system, a minimum of a two-point calibration, should be indicated on the certificate.
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Traceability proof to the calibration standard where the calibration was done should also be included on the certificate.
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Information such as the day the calibration was performed, the person who did it, and the certificate's date of approval.
Pharmacopeia Europe and Helvetica: This is the Status Quo
As highlighted in the Pharmacopoeia Europe and Helvetica, these rules were initially put into place to liberalize earlier regulations regarding thermometer calibration. Find out more today.
03 Pharmaceutical Quality Control: 24/7 Real-Time Refrigerator Monitoring
ELPRO, through the invention of LIBERO, had set a new standard in terms of security and real-time visibility of pharmaceutical products, which helps one react before any damage has happened.
In real-time, LIBERO G monitors the humidity and temperature levels of pharmaceutical products when they are in a room, air, road, container, or in the ocean.
This is done by utilizing the public 4G LTE mobile network and the all-new NB-IoT technology. LIBERO G facilitates connectivity that is deeper than its rivals and has a longer battery life for use in pharmaceutical temperature monitoring.
LIBERO G is easy to use for pharmaceutical temperature solutions and is easily configurable for refrigerator monitoring for an end-to-end journey offering total visibility.
Additionally, LIBERO G offers an informative device display that is easy to read and provides a secure process without training.
LIBERO G delivers a safe and uninterrupted solution that is fit for one trip use, and usually lasts 110 days or up to 1 year of monitoring--long after pharmaceutical products have reached their final destination.
Finally, this form of 24/7 real-time monitoring system offers immediate real-time alerts for pharmaceutical shipments and pharmaceutical refrigerators. It also provides multi-level alarm criteria.
Pharmaceutical Quality Control: 24/7 Real-Time Refrigerator Monitoring in 5 Steps
In a pharmaceutical lab, cold temperatures are crucial for production and storage of pharmaceutical products. Without the right temperature margins, it will be impossible to achieve the required product quality. Get more details today.
04 Refrigerator Temperature Log in a Pharmaceutical Environment
Stand-alone data loggers, manual paper reports, and chart recorders only provide local alarms, which is only useful when someone is nearby. What happens if your facility is not staffed 24/7/365? An effective alarming system sends alarms and alerts via text, email or phone to the appropriate responders.
One good example of this is when a massive storm knocked out power in a cancer center, which caused over $147,000 in terms of drug losses. Central monitoring systems (CMS) with remote alarming capabilities offer a practical solution because they provide a reliable temperature logging solution and send notifications in the event of an alert or alarm in a pharmaceutical environment.
Several benefits are gained by using CMS for temperature monitoring.
A central monitoring system (CMS) with remote alarming capability offers a practical solution to help ensure expensive vaccines and medicines are safe when staff are away or the facility is closed. In many ways, it's like investing in an insurance policy.
First, it offers a central database for archiving and auditing by the relevant authorities.
Secondly, it provides a sensor-based system that is useful to allow access to the assets to specific people or groups of people.
Thirdly, CMS comes with reporting capabilities for refrigerator temperature logging solutions by sending automated reports whenever staff need them.
Finally, CMS offers real-time remote alerts and alarms of temperature data excursions from any location and at any time.
[Best Practice] Refrigerator Temperature Log in a Pharmaceutical Environment
Technology, via electronic temperature logging systems, offers more efficient options for maintaining an accurate temperature log. Explore your options today.
05 Sensor Network: Setting Up the Right Radio Connection for a Pharmacy
Most pharmaceutical products like medicines and vaccines are generally sensitive and require storage in optimum temperature and humidity conditions. Having a properly functioning pharmaceutical temperature monitoring system has a lot to do with the radio connection that has been installed.
GxP compliant wireless temperature sensors are currently being used because of the fantastic results that come with installing them.
Finding the perfect radio connection for a pharmaceutical room is not that simple. This is primarily attributed to the various interference factors like walls, pallets, forklifts, and other communication systems that might get in the way if the set-up is not done correctly.
Radio Interference Factors and How to Mitigate Them
1. Racks and Walls
Most pharmaceutical walls are made of metal and concrete, reflecting or absorbing radio signals transmitted between the transmitters and the loggers. This can be easily overcome by ensuring direct intervisibility between the two components.
2. Products within the Room and Pallets
Anything that stands between data loggers and the transmitters negatively impacts radio signal strength. One way of dealing with this is waiting until the room is fully occupied then positioning the sensors.
3. Forklifts, Humans, and Loaders
As components move around the room, there will inevitably be a temporary radio signal loss. To deal with this, it is vital to install an alarm delay that will wait till the signal is back up to transmit the information.
Sensor Network: What is the best radio connection for pharmaceutical rooms?
Setting up the best radio connection is not particularly easy. Factors such as infrastructure type, interference, wireless performance, and frequencies tall play a role. Explore the details today.
06 IoT Loggers Vs. Data logger Cloud: Cost Comparison
Depending on the application, IoT enabled loggers may be more efficient than traditional data loggers. Below are several fronts in which IoT loggers are more efficient than their counterparts.
IoT Loggers Vs. Data logger Cloud: Cost Comparison for Pharmacy Monitoring
The big question is: which approach is the proper one? Cloud hosting and cloud computing popularity has grown mainly because of various advantages. Learn more today.
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