Temperature Requirements Within Your Facility
The Importance of Calibration
In the Pharmaceutical and Life Science industry calibration is an important topic that is almost always coupled with purchase of analog and digital probes, software, and hardware. The most common questions are how does calibration and re-calibration work? What is the recommended calibration interval? What is the difference between analog and digital probes? All these questions are very important in deciding what...  Read More
What is URS (User Requirement Specification) (Part 2)
Welcome back to the second discussion and example document generation of a User Requirement Specification! I had promised to go over an example system and help craft a draft URS but first there needs to be a standard for documenting what types of systems need which documentation.  Read More
What is a URS? (User Requirement Specification) (Part 1)
Welcome back temperature sleuths and life science experts to a new week and a new thrilling topic! This week I am going in depth into a crucial piece of quality compliance and validation documentation called a User Requirement Specification or URS for short. Now why is this topic so important in today's pharmaceutical and life science industries?   Read More
6 Degrees of Separation: Conclusion (Part 8)
Now that we have approached the final post of our series about temperature, let’s go through how temperature is connected within your facility. The image below depicts the equipment and temperature requirements that when combined with robust and durable data loggers and FDA complaint 21 CFR Part 11 software can help you achieve quality products for your customers and patients. But first, in order to achieve quality products, temperature must be validated and continuously monitored and recorded consistently with regulatory...  Read More
6 Degrees of Separation: -20°C to -40°C (Part 7)
Do you want a pizza, fifty frozen burgers, how about some test standards? I knew you would go for the test standards! Once again, we are back discussing temperature within the life science industry, and this time we are chatting about -20°C and -40°C freezer temperatures...   Read More
6 Degrees of Separation: 121°C of Separation (Part 6)
Are you ready to talk about extremely hot temperatures and high pressures? Well you have come to the right place as we talk about the +121°C sterilization temperature. This temperature is not only crucial to sterilization and cleaning of integral products in manufacturing, but also in...   Read More
6 Degrees of Separation: 32°C of Separation (Part 5)
I knew that you’d come back to learn about more temperature applications within the life science industry! Today we are discussing a slightly warm, maybe uncomfortably warm, temperature, 32°C! This temperature is important in quality control testing and manufacturing of biological drug products.
One example is in biologic facilities, where the manufacture of drug products could start...   Read more...
6 Degrees of Separation: -80°C of Separation (Part 4)
Welcome back temperature sleuths! Today we are discussing another important storage temperature within the life sciences industry. The Ultracold or -80°C temperature is another crucial temperature for long term storage of materials that require stable, controlled, deeply frozen environments. The ultracold temperature is essential in storage of biological materials to  Read More
6 Degrees of Separation: 2 - 8°C (Part Three)
When we think of 2-8°C, we automatically think of our household refrigerators which keep our groceries fresh and our beer cold. However, in the life sciences industry, fridges keep the ideal, stable temperature for everything from integral and important testing standards to products and raw materials. In order to keep these integral products, raw materials and test standards safely stored, companies need to  Read More
6 Degrees of Separation: 25°C (Part 2)
In the life sciences industry, 25°C is considered one of the most important temperatures as it is an ambient or immediate surrounding temperature condition. All life science facilities develop, manufacture, research, or store raw materials and finished product under ambient conditions. The 25°C temperature condition needs to be mapped, validated, monitored, and controlled by many different integral systems.  Read More
6 Degrees of Separation: Introduction (Part 1)
This is post 1 of an 8-part series that we are calling “What can Temperature Do for You?” In this 8-part series, we will be looking at the various areas and applications where temperature is the guiding factor to a successful product or process. Every week we will focus in on certain temperatures and discuss life science industry applications with equipment and software solutions to help you understand each temperature requirement within your facility. Stay tuned!   Read More
CDC Guidance Document H3>
Review our CDC Guidance Document highlighting best practices and solutions for temperature and humidity monitoring.
Monitoring Systems H3>
Mapping Services H3>
Custom mapping and validation solutions in accordance with cGxP storage and distribution practices
21 CFR Part 11 White Paper H3>
Fulfilling the Food and Drug Administration’s (FDA) 21 CFR Part 11 regulatory requirements using testo Saveris
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