Highly efficient validation qualification of freeze-drying proceses with the testo 190 CFR Data Logger System.

PublishTime：2022-06-08

●In order to ensure compliance and security throughout the manufacture of active pharmaceutical ingredients (API’s) by freeze-drying processes, cGxP requirements and CFR Part 11 / Annex 11 regulatory requirements have to be met. More often than not, manufacturers are using cabled systems to provide proof of adherence to these requirements. When using the cabled systems, Excel spreadsheets with complex calculations are frequently used as standard-compliant documentation.
●In order to alleviate validation representatives from compiling large swaths of data and making labor-intensive calculations, Testo developed the testo 190 CFR data logger system.
●The testo 190 CFR data logger system is the intelligent solution for the cGxP monitoring, documenting, and mapping of the temperature profiles throughout the entire freeze-drying process.The smart all-in-one solution contains robust hardware and intuitive software, which enables you to monitor your freeze drying processes more efficiently while optimizing each process. Testo also offers exceptional service to each client just in case you need help or guidance in maximizing your processes. This means you reliably adhere to government regulatory and site quality standards, while saving time and money.
●Overview of Advantages
■Large measurement data memory
■Fast and reliable overview of the measurement results
■Less effort and lower error potential
■No data export to other systems needed
■Compliant with GxP and 21 CFR Part 11
■1-click report
■Integration of up to 254 measurement points per validation process into the software possible

Brand of Product：	TESTO
Part#：	testo 190 、 21 CFR Part 11 More Part#
Product Category：	CFR Data Logger System More
Application：	[ freeze-drying proceses ] More
Data Type：	Application note & Design Guide More
Safety & Environment Standards：	More
Operating Temperature：	Please see the document for details
Qualification Grade：	More
Qualification Approval：	More
Package：
Language：	English Chinese Chinese and English Japanese
Date of Creation：	2020/5/5
Version Number：
Data Encoding：
Data Size：	3 MB

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