Simply stated, the temperature and environmental conditions affects everything. Unacceptable levels of change can breakdown or change a material through chemical reactions, biological growth and interference, or desiccation.
01 Industries Dependent on Temperature Control
A material’s performance is often dependent on environmental factors. For example, certain temperature and humidity conditions can preserve or degrade a substance. To ensure a product’s ability to perform at its prime or intended purpose, these conditions have to be monitored and controlled.
So, what industries consider environmental conditions to be a significant risk? This article discusses the businesses and organizations with the highest risks. The highest risk is the health and safety of consumers. Therefore, the industries that top our list are the ones that sell products for human and animal consumption. The pharmaceutical and food industries are among the largest and arguably the most important. Though, other industries like fine arts and antiquities must preserve their contents to preserve knowledge — that of religion, culture, history, and prehistory.
Industry Risks from Temperature Change
What are industry risks? In the absence of temperature monitoring, a plethora of changes occur, which are not always visible to the eye.
02 Temperature Monitoring Regulations for Pharmaceuticals
You may have a great idea. You may even have the cure. But, before you get too excited, you are going to have to prove to the authorities that you are distributing a product that is safe. The proof is a regulated paper trail of every detail involved in production and distribution. We’re talking about details regarding the housing facility, equipment, personnel, packaging, shipping, data and research, and environmental conditions.
The idea is to show that every element of the project is performed as intended. There should be evidence that data is secure and accurate, there has been no security breach, and no one has tampered with the product. Additionally, there should be evidence that the product was kept within conditions that are favorable to the product’s efficacy and safety. This is the only way to realistically anticipate the impact the product will have on the consumer.
03 GxP Compliance for a Temperature Monitoring System
Before you start monitoring, you have to document that your temperature monitoring system works. Good manufacturing practices (GMP) and good distribution practices (GDP) both require your monitoring system to be qualified. Calibration justifies qualification.
What is temperature calibration?
Temperature calibration meaning: A calibration demonstrates that a sensor is accurate by comparing its output to a verified standard. The calibration temperature is defined in the standard. Calibration verifies the precision and reproducibility of the sensor’s measurements. Just like temperature sensor calibration, humidity sensors need to be calibrated as well.
You also need to prove that your sensors are placed strategically in your container or facility to ensure a quality read. Temperature mapping validation is when data loggers are placed throughout a room or container in order to identify the most hot and cold areas. Either the areas are altered to fix the temperature extremes, products are moved from the areas at risk, or sensors are permanently positioned in the areas. Mapping justifies qualification.
GxP Temperature Calibration and Mapping
To qualify a temperature monitoring system, calibration and mapping are both required.
04 The Audit Trail
“If you didn’t document it, it didn’t happen.”
I think you may have heard that one before. In the eyes of an auditor or governing authority, that quote very well may be true. That being said, it would be wise to annotate too much rather than too little. An audit trail is the collection of documents that detail every part of your project, from start to finish. You probably may have already identified documents that should be saved and updated regularly. For example, the user requirement specifications (URS), standard operation procedures (SOP), certificates, training programs, contractual agreements, raw data, etc. The list goes on. . . But when discussing the requirements of temperature monitoring alone, there are specific elements to annotate.
What is in the audit trail?
Find out the "who, what, where, when, and why" of temperature reporting.
05 All About Temperature Monitoring
A monitoring system typically consists of a sensor conducting measurements of temperature or other environmental data in a defined interval. The sensor transmits the values wired or wireless to a data logger, which acts as a communication bridge. The Software collects the values in real-time in order to perform the following functions:
- assessing the data
- triggering warnings and alarms
- facilitating evaluation and acknowledgement
- archiving the data
Temperature monitoring systems can be connected to your internal network. Alternatively, online temperature monitoring systems allow authorized users to access data anywhere there is internet access. Also known as a web based temperature monitoring system or a cloud based temperature monitoring system, cloud temperature monitoring can connect to wired devices or a cloud temperature logger or sensor that is wireless.
Each system needs its appropriate measuring technology. There are a few options when it comes to digital temperature and humidity monitoring. Thermocouples, negative and positive temperature coefficient, and digital sensors are among the technologies used for digital temperature monitoring. Conductivity and capacitive humidity monitoring. They all have their advantages and disadvantages. This blog assesses which method is most fitting for your application.
All About Temperature Monitoring
Explore the history and technology behind temperature monitoring cold chains.
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Industries Most Dependent on Temperature Control
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