Total Organic Carbon and Total Bound Nitrogen Analysis for Pharmaceutical Industry (TOC/TN pharma)
The multi N/C pharma series offers tailored solutions for TOC cleaning validation, extractables testing from packaging materials, ultrapure water control, and total protein analysis in aqueous pharmaceutical solutions e.g., vaccines.
Description
Tailored Solutions for TOC and TN Analyses in the Pharmaceutical Industry
The multi N/C pharma series offers tailor-made solutions for all pharma-specific TOC applications with full compliance to FDA 21 CFR part 11 and pharmacopoeia regulations. A dedicated total protein analyser provides a fast and reliable method for product quality control in aqueous pharmaceutical solutions, e.g., vaccines.
- Focus Radiation NDIR detector – Highest radiation density for highest sensitivity and precision
- VITA Flow Management System – Continues to work where classical TOC analyzers reach their limits
- Easy Cal – Calibration has never been so easy
- High Power Long Life UV Reactor – Convincing performance in wet chemical oxidation
- Ten-year warranty on the NDIR detector and on the furnace technology of combustion-based multi N/C models
- Three-year warranty on the UV reactor for UV-based multi N/C models.
Sophisticated Technologies for Your TOC/TN Analysis
As a quality parameter for the purity of water, the total organic carbon content (TOC) must be determined according to international pharmacopoeia methods for various applications. TOC allows quick and reliable conclusions to be drawn about organic impurities and is therefore an integral part of the standards for the monitoring of purified water (PW) and water for injection (WFI), like USP <643>, EP 2.2.44, or JP 17, section 2.59. TOC is also increasingly used as the most important cleaning validation parameter and for testing of extractable organic compounts from packaging materials and packaging systems for pharmaceutical products according to USP < 661.1> and < 661.2>. Enhanced software features make sure for full data integrity and FDA 21 CFR part 11 compliance. A complete service package including system qualification and software validation provides you with maximum comfort in operating your analyzer.
With a wide product range of four different multi N/C pharma models Analytik Jena offers tailored solutions for all pharma specific TOC/TN applications. The multi N/C pharma UV as a wet chemical digestion based TOC analyzer provides with the highest sample injection volumes also the best sensitivity and is best suited for WFI and AP analysis as well as for TOC cleaning validation from swab extracts or last rinse samples and is also suitable for the extractables testing from packaging materials. The two combustion-based TOC analyzers multi N/C pharma HT and multi N/C 3100 pharma are also best suited for the above described applications, however extend the application range to total nitrogen (TN) analysis in cleaning validation as well as a direct swab combustion option for ceramic fiber swabs in cleaning validation. Last but not least the dedicated vaccine analyzer multi N/C 2100S pharma provides fast and fully automated total protein analysis for the quantification of attenuated or devitalized viruses or bacteria as well as antigens in pharmaceutical product QC according to e.g., EP 2.5.33, Method 7B or USP <1057>, Method 7.2.
