We have all bought something that didn’t quite work the way we wanted. We get home, we set it up, and in the end, we get a dose of disappointment. Hopefully it can be returned and all we have wasted is time. However, in the world of compliance, a piece of equipment that does not work the way it needs to, can call the quality of a product into question. For example, equipment that controls temperature is especially prone to change in function. This can range anywhere from refrigerators, freezers, stability chambers, incubators, and autoclaves, to environmentally controlled rooms. A GMP freezer may work properly when new, but ice build-up can alter the function of the freezer. Other common issues are defrost cycles, hot-spots, cold-spots, and improper control logic. Knowing an equipment’s failure modes and confronting these issues proactively will improve quality.
Knowing the limitations of your GMP equipment can potentially save money and product in the long run. At Kymanox, we find that data logging and temperature mapping is the best way to identify these types of issues, and has a variety of applications beyond initial equipment qualification. Equipment Validation utilizes data logging at strategic locations within a piece of equipment. These points are chosen based on Kymanox’s experience and knowledge of temperature controlling equipment. Kymanox owns specialized validation equipment for data logging which allows us to have versatile options on how we use the data to improve product quality. The software for these data loggers can group probes and data, and these groups can reveal trends for different areas in equipment. For instance, a shelf near a condenser fan may be the coldest shelf, and the data groupings can show just how much the difference is. Graphical trends can show the cycling of the freezer, and using those trends over time can proactively evaluate if the cycle is beginning to drift away from the intended functionality. This is an early indication of a problem with the equipment which could impact the product. This trending application of data used by Kymanox that is outside of the normal qualification and re-qualification for minimum compliance is a commitment to proactive engagement of technology to improve product quality.
Making sure equipment works properly and knowing the limitations of your equipment are a great way to circumvent future problems with quality and the FDA. This applies to all areas of pharmaceutical and medical manufacturing, not just for environmentally controlled chambers. Use data logging and mapping as one of your tools to understand your equipment. Kymanox has the team and equipment available to assist you.
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