Excellence in Pharmaceutical TOC Testing and Vaccine Quality Control
- Standard-compliant analysis according to international pharmacopoeias
- Data integrity guaranteed
- Extraordinary detection sensitivity and long-term stability
As a parameter for the quality and purity of water, the TOC content must be determined in international pharmacopoeias for various applications. It allows quick and reliable conclusions to be drawn about organic impurities and is, therefore, an integral part of the standards for ultrapure water control, cleaning validation, and testing of extractable components from packaging materials for pharmaceuticals.
The multi N/C pharma series offers tailor-made solutions for this pharma-specific TOC analysis. A special device for total protein analysis in aqueous pharmaceutical solutions also offers a simple method for the quality control of vaccines.
TOC ultrapure water testing and TOC/TN cleaning validation
The TOC ultrapure water test for water for injection (WFI) and Aqua purificata (purified water – AP) can be carried out per pharmacopoeias, e.g. USP <643> or EP 2.2.44, using high-temperature combustion or wet chemical UV digestion. In TOC cleaning validation, the same approach is used as a substance-independent method for the detection of organic residues, e.g. active pharmaceutical ingredients (API), additives and cleaning agents, on production equipment. multi N/C pharma offers solutions for both processes, whereby the devices for high-temperature combustion also allow the simultaneous determination of total nitrogen (TN) for cleaning validation.
Testing of extractable components from packaging materials
To ensure the suitability of polymer packaging systems for use in the pharmaceutical industry, USP <661.1> and <661.2> require the analysis of extractable components from the material or the packaging systems. For this purpose, ultrapure water eluates from the packaging materials or systems are tested for their TOC content according to USP <643>.
Quality control of vaccines
The total protein analysis in the production of vaccines by determination of the total nitrogen content according to e.g. USP <1057>, Method 7.2, enables the quantification of attenuated or devitalized viruses or bacteria as well as antigens. In the production of allergenic vaccines, this method can also be used to analyze raw materials such as pollen lyophilisates as well as different dosage forms such as desensitization vaccines, prick test solutions or sublingual drugs with the same TN test method.
Our models for the pharmaceutical industry
| multi N/C pharma UV | multi N/C pharma HT | multi N/C 3100 pharma | multi N/C 2100S pharma | |
| Sample digestion | UV/Persulfate | HTC | HTC | HTC |
| Sample injection principle | Flow injection technique | Flow injection technique | Flow injection technique | Direct injection technique |
| Measuring range [mg/l] TC/TOC/NPOC/TIC |
0 – 10,000 | 0 – 30,000 | 0 – 30,000 | – |
| Measuring range TNb mg/l (CLD) | – | 0 – 200 | 0 – 200 | 0 – 200 |
| Maximum injection volume | 20,000 µl | 3,000 µl | 1,000 µl | 500 µl |
| Highest precision in the TOC trace range | x | x | (x)1 | – |
| Highest automation comfort for NPOC (automatic acidification) | x | – | X | – |
| Additional flushing function | x | – | X | x |
| Self Check System/ VITA/ Easy Cal | x | x | X | x |
1) suitable as secondary application
If you are still not sure which model fits best to your requirements – use our finder.
multi N/C pharma UV – highly sensitive TOC trace analysis
The efficient TOC analyzer based on wet-chemical UV digestion for highly sensitive TOC trace analysis in ultrapure water analysis and cleaning validation allows injection volumes of up to 20.0 ml.
Characteristics of the multi N/C pharma UV:
- TOC determination in direct NPOC mode without blank value influences for highest sensitivity and precision
- TOC measurement <1 ppm without oxidation reagent
- Lowest operating costs – no catalyst or combustion tube, no additional reagents required
- Extension of the working range to up to 10,000 ppm using oxidation reagent that can be easily produced by the user
multi N/C pharma HT – the flexible TOC/TN analyzer
The versatile TOC/TN ultra-trace analyzer for ultrapure water and cleaning validation testing using high-temperature combustion. The optional direct swab combustion allows the determination of water-insoluble or sparingly soluble impurities in the TOC cleaning validation.
Characteristics of the multi N/C pharma HT:
- TOC determination in direct NPOC mode for highest precision in the ultra-trace range
- Injection volume up to 3.0 ml
- Optional TN cleaning validation
multi N/C 3100 pharma – High throughput TOC/TN analysis
The system based on catalytic high-temperature combustion offers a large working range with effective rinsing function, a high degree of automation and parallel purge and analyzing for a high sample throughput.
Characteristics of the multi N/C 3100 pharma:
- TOC determination in direct NPOC mode for high precision in the ultra-trace range
- Injection volume up to 1.0 ml
- Covering a TOC concentration range of 0 – 30,000 ppm
- Automatic sample acidification and effective reverse rinse function to prevent sample carry-over in case of concentration changes
multi N/C 2100S pharma – the specialist for total protein analysis
The TN analyzer with catalytic high-temperature combustion and CLD detection for efficient protein analysis in vaccine production or TN cleaning validation with minimal sample consumption and a high degree of automation.
Characteristics of the multi N/C 2100S pharma:
- No sample carry-over due to septum-free direct injection by means of microliter syringe and effective rinsing routines
- Minimum sample consumption with a typical injection volume of 50 – 200 μl (max. 1.8 ml) Savings on costs for expensive products e.g. in vaccine quality control
- Large working range from 0 – 200 ppm TN
- High degree of automation for large sample sequences (up to 112 sample positions for HPLC vials)
- Unattended 24/7 operation thanks to self-check system
Downloads
Brochure Pharmaceutical TOC Water Testing and Vaccine Quality control
multi N/C Series – Find the Right TOC Analyzer for Your Needs (English)
