Content on PharmTech.com this week ranged from fundamentals on the use of digital pathology in drug development, discussions on the use of AI in pharma, and regulatory actions impacting the industry.
|Articles|June 13, 2023
Shimadzu TOC-1000e
Author(s)Shimadzu Europa GmbH
Take ultrapure water monitoring to new heights using Shimadzu’s TOC-1000e. Benefit from a 12-month maintenance interval, resulting in reduced plant downtime, cutting calibration and revalidation effort in half.
Ultrapure water is essential for pharmaceutical production, requiring complex treatment process to maintain its purity. Strict regulations prescribe parameters such as conductivity, Total Organic Carbon (TOC) and microbial levels to ensure its purity. By implementing Process Analytical Technology (PAT) and using Shimadzu’s TOC-1000e, pharmaceutical manufacturers can ensure consistent water quality, minimize contamination risks and comply with regulations.
Shimadzu’s TOC-1000e, a state-of-the-art process analyzer, specializes in this field. It employs fast oxidation technology and a mercury-free excimer lamp to accurately measure TOC content and electrical conductivity. Its advanced features include an extended 12-month maintenance cycle, which reduces plant downtime and enhances productivity. By doubling the maintenance cycle duration from the industry-typical 6 months to 12 months, TOC-1000e minimizes water plant downtime, which translates into increased productivity and efficiency in production facilities. Additionally, the longer maintenance cycle decreases calibration and validation efforts.
TOC-1000e meets pharmacopoeial regulations and incorporates user management, audit trail functionalities and can be seamlessly integrated with electronic signature platforms to facilitate compliance with data integrity requirements such as FDA 21 CFR Part 11.
With its precise analysis capabilities, the TOC-1000e empowers pharmaceutical manufacturers to uphold the highest standards of water quality, ensuring purity and integrity throughout the production process.
For more information on the TOC-1000e, click
Shimadzu Europa GmbH
Albert-Hahn-Straße 6–10
47269 Duisburg
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