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Central monitoring of audit-relevant environmental parameters.

6 Degrees of Separation: Conclusion (Part 8)

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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 requirements from the FDA.  Other industry standards like USP (United States Pharmacopeia) and ISPE (International Society of Pharmaceutical Engineers) can also help guide to the best practices within the life science industry.

Remember, there are initial steps involved in choosing the best equipment or right space for your storage conditions.  You need to do research on certain equipment and technology as it can affect the effectiveness or potency of your product in storage.  You need to decide what equipment best meets your needs in recording temperature and crucial data with written user requirements.  Validation of your equipment needs to be performed initially and periodically afterwards.  Once the unit has been validated, it is time to install and validate your continuous monitoring system.  After all that upfront work, you can finally sit back and watch your temperature data continuously be captured within your monitoring system.  All the factors mentioned above work to keep your temperature requirements for raw materials, finished products, and testing standards stable and free from degradation over time.

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Another huge temperature process is sterilization in life sciences.  If you would like to improve your manufacturing, quality control, and validation processes temperature once again needs to be validated and continuously monitored.  Autoclaves are a different type of animal as they combine steam, heat, and pressure into a vacuum.  Autoclave cycles need to be validated and monitored in order to prove sterility or lethality.  In order to validate autoclave cycles regularly, robust data loggers that can withstand extreme conditions are crucial for durability and quality assurance. The loggers should be combined with a 21 CFR Part 11 certified software solution that is user friendly and tracks every action with an audit trail. All these factors can improve your entire facility’s sterilization process for raw materials while improving your validation and quality control processes.

If you would like to learn more about life science processes, validation, and other interesting topics check back to the blog regularly for the latest updates and subscribe here.

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