TOC monitor.

A new generation of TOC monitors for regulatory compliance in pure, ultrapure and WFI water applications has been announced by Swan Analytical. With simple, intuitive controls and rugged components, the new AMI-II LineTOC analysers enhance reliability in the continuous measurement of total organic carbon (TOC).

“The AMI-II LineTOC instruments have been developed to meet a number of important customer needs,” explained Swan’s Russell Culver (Pharma Business Development Manager*). “First and foremost, the monitor enables Pharmacopoeia compliance whilst supporting FDA 21 CFR Part 11, providing a compliant audit trail. However, the instrument is simple to operate, requiring minimal training, even for validation and calibration. Combine this with long-term reliability, durability and the AMI-II LineTOC lowers not just the cost of purchase, but also the cost of ownership.”

TOC derived from organics is one of the most common sources of contamination in ultra-pure water systems, so monitoring is mandatory in the pharmaceutical industry, where UPW is used as a process medium, as a solvent, as an ingredient, as medical water for injection, and within APIs, intermediates and reagents. Continuous monitoring and a fast reliable response time are therefore essential – to detect any contamination, to monitor trends and raise alarms of excursions.

The new AMI-II LineTOC provides reagent-free TOC measurement by conductivity differential before and after UV-oxidation. With a new enhanced display/transmitter the analyser offers a wide measurement range from 0 to 1000 ppb with a resolution of 0.01 ppb in its lowest range. A compact version of the AMI-II LineTOC is also available to facilitate greater flexibility where space is of a premium, making it suitable for integration in water purification systems or distribution skids.

Both versions of the AMI-II LineTOC are supplied as a complete working system, which means that it is not necessary to purchase secondary equipment, such as a calibration module for example. Standard equipment includes three sample bottles that can be utilised during functionality and system suitability tests, or as the repository for grab samples – thereby avoiding the need for laboratory analysis.

Looking forward, Russell says: “We are tremendously excited about the opportunities that exist for this new generation of monitors in a variety of sectors where the continuous monitoring of pure and ultrapure water is either essential or mandatory, or both. For example, with IQ/OQ/PQ validation and full compliance to Global Pharmacopoeias and FDA 21 CFR Part 11, the new AMI-II LineTOC will bring peace of mind to pharmaceutical manufacturers and system providers alike.”

---

* Pharma business development Manager. (21/1/2025)

@_Enviro_News @swan_usa #PAuto #Water