multi N/C pharma Series 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
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.
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.
Brochures
| Title | Language | Info |
|---|---|---|
| Brochure multi N/C pharma (EN) | en | PDF, 595 KB |
| Produktkatalog Chemische Analyse (DE) | de | PDF, 909 KB |
| Product Guide Chemical Analysis (EN) | en | PDF, 886 KB |
| Flyer Calibration Standard Offering (EN) | en | PDF, 265 KB |
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.
Products
multi N/C 2100S pharma - TN analyzer for aqueous protein solutions
Total protein analysis by catalytic high-temperature combustion and CLD detection. Septum-free direct injection method without carry-over. High degree of automation and unattended 24/7 operation.
Order number: 450-200.103-2
multi N/C 3100 pharma - TOC/TN analyzer for pharmaceutical applications
High throughput TOC/TN analysis in a wide concentration range with catalytic high-temperature combustion. Highest automation level by parallel purge and analysis, automatic sample acidification and effective reverse rinse function.
Order number: 450-200.503-2
multi N/C pharma HT - TOC/TN analyzer for pharmaceutical applications
Highly sensitive TOC/TN trace analysis with catalytic high-temperature combustion. Highest precision in the ultratrace area due to high injection volumes. Upgrade for direct swab combustion for TOC cleaning validation.
Order number: 450-200.600-2
multi N/C pharma UV - TOC analyzer for pharmaceutical applications
Highly sensitive TOC trace analysis by wet chemical UV digestion. Lowest operating costs - no catalyst or combustion tube, 3 years UV lamp warranty, no additional reagents needed for most applications.
Order number: 450-200.800-2
Applications
Applications
-
Total Protein Determination in Pharmaceutical Products (Vaccines) by TNb Analysis (EN)
-
TOC System Suitability Test – Redefined According to New USP Regulations (EN)
-
Cleaning Validation Procedures in the Pharmaceutical Industry by TOC Analysis (EN)
-
Establishing Extractables Testing from Plastic Packaging Materials and Systems for Pharmaceutical Use by TOC Analysis According to USP <661> (EN)
-
TOC Performance Test as per Japanese Pharmcopoeia (EN)
Technical Data
Measuring Time | Digestion Mode | Precision | Injection Volume | Detector | Sample Supply | Gas supply | Measurement Range | Limit of Detection | Parameters | Dimension (width x depth x height) | Optional Parameters | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| multi N/C 2100S pharma - TN analyzer for aqueous protein solutions | 3 - 5 min | High temperature combustion up to 950°C | 1 - 2 % | 50 - 500 µL | Chemiluminescence Detector (CLD) | Direct injection | Oxygen 4.5 or synthetic air (CO2 <1 ppm, hydrocarbons <0.5 ppm) | 0 - 200 mg/L | 5 µg/L | TN | 813 mm x 500 mm x 970 mm | |
| multi N/C 3100 pharma - TOC/TN analyzer for pharmaceutical applications | 3 - 5 min | High temperature combustion up to 950°C | 1 - 2 % | 100 - 1000 µL | Focus Radiation NDIR | Flow injection | Oxygen 4.5 or synthetic air (CO2 <1 ppm, hydrocarbons <0.5 ppm) | 0 - 30000 mg/L | 4 µg/L | TC, TIC, TOC, DOC, NPOC, NPOCplus | 513 mm x 464 mm x 550 mm | TNb (CLD), POC (direct measurement) |
| multi N/C pharma HT - TOC/TN analyzer for pharmaceutical applications | 3 - 5 min | High temperature combustion up to 950°C | 1 - 2 % | 50 - 3000 µL | Focus Radiation NDIR | Flow injection | Oxygen 4.5 or synthetic air (CO2 <1 ppm, hydrocarbons <0.5 ppm) | 0 - 30000 mg/L | 4 µg/L | TC, TIC, TOC, DOC, NPOC, NPOCplus | 513 mm x 464 mm x 550 mm | TN (CLD) |
| multi N/C pharma UV - TOC analyzer for pharmaceutical applications | 3 - 5 min | UV wet chemical digestion | 1 - 2 % | 50 - 20000 µL | Focus Radiation NDIR | Flow injection | Nitrogen 5.0 or Argon 4.6 | 0 - 10000 mg/L | 1 µg/L | TC, TIC, TOC, DOC, NPOC, NPOCplus | 513 mm x 464 mm x 550 mm |
Order Information
Order number | Description |
|---|---|
| 450-200.103-2 | multi N/C 2100S pharma - TN analyzer for aqueous protein solutions |
| 450-200.503-2 | multi N/C 3100 pharma - TOC/TN analyzer for pharmaceutical applications |
| 450-200.600-2 | multi N/C pharma HT - TOC/TN analyzer for pharmaceutical applications |
| 450-200.800-2 | multi N/C pharma UV - TOC analyzer for pharmaceutical applications |
Smart solutions for convenient TOC/TN analysis
Reliable detection – Focus Radiation NDIR detector
The heart of every multi N/C device is the Focus Radiation NDIR detector for CO2 detection. High-energy IR radiation is focused on the micro detector by means of integrated optics. The obtained radiation density exceeds classical detectors and guarantees higher sensitivity and precision over a measuring range from 0 to 30,000 mg/L TOC without sample dilution. You save on operating costs thanks to corrosion- and maintenance-free operation and a long-term warranty of ten years.
Reliable digestion − high power long life UV reactor
The high-power, long-life UV reactor uses two UV wavelengths simultaneously for oxidation (254/185 nm). This high-energy radiation ensures fast and complete digestion even of very stable carbon compounds. Therefore, additional reagents are not required for many applications or can be prepared by the user. Together with the three-year warranty for the UV reactor, this leads to minimum running costs.
Reliable performance – VITA and Easy Cal
The VITA Flow Management System allows for the rapid injection of large sample volumes into high temperature TOC analyzers and significantly improves result accuracy and sensitivity in the trace range. In addition, Easy Cal makes it possible for multi-point calibrations to be performed from a single stock solution using different injection volumes. The generated calibration curves are independent of the injection volume and extremely long-term stable. The automatic and correct calibration range selection for each sample measurement allows for easier operations at the highest level.
Accessories
AS 60 Autosampler for multi N/C 2100S, 2100S duo and 2100S pharma
Autosampler for all multi N/C 2100S direct injection TOC/TN analyzers with 60 or 112 sample positions. Automatic sample acidification and homogenization as well as effective syringe rinse included.
Order number: 450-126.682
AS vario Autosampler for multi N/C 3100, 3100 pharma, UV HS, pharma UV / HT
Variable high capacity autosampler with up to 6 freely selectable sample racks for up to 146 samples. Automatic sample homogenization, sample acidification and parallel purge (NPOC) included.
Order number: 450-900.140
EPA Sampler with Piercing function for multi N/C 3100, UV HS and multi N/C pharma
Automation for up to 64 septum-capped EPA vials (40 mL). Automatic sample acidification, homogenization and parallel purge and analyze (NPOC) included.
Order number: 450-126.693
AS 21hp Autosampler for multi N/C UV HS, multi N/C pharma and multi N/C 3100
High performance autosampler for up to 21 samples, including automatic sample homogenization and parallel purge in NPOC mode. Protective cover available.
Order number: 450-900.106
AS 10e Autosampler for multi N/C UV HS, multi N/C pharma and multi N/C 3100
Economic automation for particle-free samples or calibration runs. 10 sample positions for 40/50 mL vials with automatic NPOC purge and protective cover available.
Order number: 450-900.111
AS vario ER Autosampler with ext. needle cleaning for multi N/C 3100 and UV HS
Variable high capacity autosampler with external needle rinse function. Choose from 4 different sample racks for up to 146 samples. Automatic sample homogenization, sample acidification and parallel purge (NPOC) included.
Order number: 450-900.148
CLD upgrade for simultaneous nitrogen determination
Upgrade module for combustion-based multi N/C analyzers for simultaneous TNb determination from aqueous samples by chemiluminescence detection.
Order number: 450-200.650
Swab Test Module for multi N/C pharma HT
Horizontal sample introduction by quartz boats for determination of total organic carbon on quartz fiber swabs by direct catalytic combustion at up to 950°C. Suitable for TOC cleaning validation.
Order number: 450-900.121
POC module "basic" for multi N/C 3100, 3100 duo und 3100 pharma
Manually operated module for the direct determination of purgeable organic carbon (POC) in water samples.
Order number: 450-126.621
POC module "automatic" for multi N/C 3100, 3100 duo or 3100 pharma
Module for fully automated direct determination of purgeable organic carbon (POC) in water samples in combination with the EPA sampler.
Order number: 450-900.130
Software
multiWin
The intuitive multiWin software monitors and controls all important system parameters and provides a clear display of the measurement results. Available in many languages, e.g. English, French, Spanish, Chinese, Korean, Russian.
- Data integrity requirements in accordance with FDA 21 CFR part 11
- IQ, OQ and PQ documents optimized for the pharmaceutical industry, software validation certificate, SST report function
- User management with personalized administrator and service login
- Release of calibration reports, methods and analysis results with electronic signatures
- Audit trail with extensive filter and search functions
- Freely configurable password rules
- Multipoint calibration with a single standard (Easy Cal), blank value correction, result recalculation, and other functions
- Automatic monitoring of maintenance intervals, gas flows and pressures, temperatures and detector status (Self-Check-System)
- Convenient management and storage of measurement data and parameters
- Automatic or manual data export in different formats (LIMS, CSV, PDF)
| Product | Required | Included |
|---|---|---|
| multi N/C 2100S pharma - TN analyzer for aqueous protein solutions (450-200.103-2) | ||
| multi N/C 3100 pharma - TOC/TN analyzer for pharmaceutical applications (450-200.503-2) | ||
| multi N/C pharma HT - TOC/TN analyzer for pharmaceutical applications (450-200.600-2) | ||
| multi N/C pharma UV - TOC analyzer for pharmaceutical applications (450-200.800-2) |
Consumables
| Order number | Name |
|---|---|
| 402-820.075 | Bottle Insert for Screw Cap GL 45 (Schott bottle) |
| 899-BSASET1 | BSA calibration kit standard solutions 1 - 15 mg/L N incl. blank solution |
| 899-BSASS2 | BSA stock solution 200 mg/L N, Protein standard for total nitrogen calibration |
| 402-890.217 | Certified TOC reactor, 16 mm for multi N/C pharma HT and 3100 pharma |
| 402-890.211 | Certified TOC reactor, 26 mm for multi N/C pharma HT and pharma HS |
| 402-825.110 | Collection tray multi N/C - diameter 100 mm, height 50 mm |
| 402-885.010P | Combustion tube pharma - O.D. 26 mm, for multi N/C pharma HT & pharma HS |
| 402-890.136 | Combustion tube, O.D. 16 mm, quartz combustion tube TOC/TNb with holder |
| 402-890.134 | Combustion tube, O.D. 16 mm, quartz combustion tube TOC/TNb |
| 402-890.219 | Combustion tube, O.D. 16 mm, quartz combustion tube TOC/TNb, set of 5 pieces |
| 402-885.010 | Combustion tube, O.D. 26 mm, quartz combustion tube TOC/TNb |
| 402-950.009 | Condensation coil for multi N/C 3100 |
| 402-950.011 | Condensation coil for multi N/C pharma HT |
| 402-950.002 | Condensation coil multi N/C 2100/S for S/N 500 and higher |
| 402-950.017 | Connector IC vessel - TC prefilter |
| 450-900.226 | Consumables kit multi N/C pharma HT, 16 mm CT (S/N 500 and higher) |
| 450-900.224 | Consumables kit multi N/C UV HS / pharma UV |
| 450-900.220 | Consumables kit multi N/C 2100S, 16 mm CT (S/N 500 and higher) |
| 450-900.222 | Consumables kit multi N/C 3100 16 mm CT (S/N 500 and higher) |
| 402-007.513 | FAST connector , angled |
| 402-007.884 | FAST connector , straight |
| 402-007.508 | FAST connector , straight |
| 402-007.988 | FAST connector straight |
| 402-890.202 | Filling for reactor (26 mm CT) for multi N/C pharma HT and pharma HS |
| 402-881.027 | Finger-Tight-Set 1/16" for tube set, PEEK |
| 402-881.026 | Finger-Tight-Set 1/8" for tube set, PEEK |
| 402-825.041 | Fork clamp KS 13/2 with locking screw |
| 402-810.050 | Halogen absorber filling, 11mm 1 refill of the halogen absorber U-tube, I.D. 11 mm |
| 402-810.083 | Halogen absorber filling, 11mm 5 refills of the halogen absorber U-tube, I.D. 11 mm |
| 402-885.045 | High-temperature mat rectangular, for 16 mm combustion tube |
| 402-885.017 | High-temperature mat, round, for 26 mm combustion tube |
| 402-950.004 | IC condensing vessel for multi N/C 2100 S (S/N 500 and higher) |
| 402-950.012 | IC/Condensation vessel for multi N/C UV HS and pharma UV (S/N 500 and higher) |
| 402-950.010 | IC/Condensation vessel for multi NC 3100 and pharma HT (S/N 500 and higher) |
| 402-884.019 | Injection tube for furnace head, pre-assembled |
| 899-JPPT1A | JP SST kit, HTC JP performance test kit stabilized with HCl |
| 899-JPPT2SA | JP SST kit, UV, JP performance test kit stabilized with H2SO4 |
| 402-812.513 | Knurled screw with slot M3 x 25 mm, for multi N/C series |
| 899-LIN1A | Linearity test kit, HTC, 0.5 mg/L C sucrose for combustion based TOC systems |
| 899-LIN1SA | Linearity test kit, UV, 0.25 mg/L C sucrose for UV digestion TOC systems |
| 899-LIN2SA | Linearity test kit, UV, 0.50 mg/L C sucrose for UV digestion TOC systems |
| 402-950.015 | Luer-tubing adaptor for water trap |
| 402-823.056 | Needles, I.D. 0.35 mm for syringes |
| 402-815.102 | O-rings for combustion tube, I.D. 16 mm |
| 402-810.048 | Platinum catalyst 15 mL for TOC/TNb determination |
| 402-810.059 | Platinum catalyst 80 mL for TOC/TNb determination |
| 402-886.333 | Platinum net |
| 450-900.225 | Preventive maintenance kit multi N/C UV HS / pharma UV (S/N 500 and higher) |
| 450-900.221 | Preventive maintenance kit multi N/C 2100S (S/N 500 and higher) |
| 450-900.223 | Preventive maintenance kit multi N/C 3100 (S/N 500 and higher) |
| 450-900.227 | Preventive maintenance kit multi N/C pharma HT (S/N 500 and higher) |
| 402-885.011 | Pump hose for H3PO4 pump (perestaltic pump) |
| 402-884.005 | Pump hose for waste pump (perestaltic pump) |
| 402-881.006 | Quartz glass cullet, coarse grain, 80 g |
| 402-825.044 | Quartz wool |
| 402-825.091 | Reagent bottle 250 mL for sodium peroxo disulfate |
| 402-825.097 | Reagent bottle, 250 ml for phosphoric acid |
| 402-883.005 | Sample aspiration tube |
| 402-885.016 | Sample aspiration tube with screw joint |
| 402-884.007 | Sample purge tube |
| 402-884.026 | Sample purge tube with screw joint |
| 402-825.095 | Schott bottle with screw cap, 100 mL |
| 402-825.086 | Screw cap bottle 2.5 L for ultra-pure rinse water supply |
| 402-881.238 | Septa O.D. 10 mm for pneumatic furnace head |
| 402-886.327 | Septum pre-cut (red/white) for TIC port, O.D. 17 mm, set á 5 pieces |
| 402-886.329 | Septum pre-cut for TIC port - O.D. 17 mm, set á 5 pieces |
| 402-950.005 | Set of FAST-Connectors, 8 pcs. |
| 402-881.245 | Set of TC prefilter and water trap |
| 402-810.058 | Special catalyst CeO2 for TOC/TNb determination approx. 200g |
| 402-810.047 | Special catalyst CeO2 for TOC/TNb determination approx. 40 g |
| 402-823.033 | Syringe 25 mL for syringe pump, 9 port |
| 402-886.311 | Syringe 500 µL, graduated, for manual injection |
| 402-823.110 | Syringe for dosing pump, 5 mL |
| 899-TOCC3A | TOC calibration kit 0.6 mg/L C - HTC, sucrose solution stabilized with HCl |
| 899-CLUVSA | TOC calibration kit 0.6 mg/L C - UV, sucrose solution stabilized with H2SO4 |
| 899-W500A | TOC preparation water, HTC stabilized with HCl for combustion based TOC systems |
| 899-W500SA | TOC preparation water, UV stabilized with H2SO4 for UV digestion TOC systems |
| 899-TOCBNS | TOC stock solution para-benzoquinone USP, 100 mg/L C |
| 899-TOCSNS | TOC stock solution sucrose USP, 100 mg/L C |
| 402-890.110 | Tube kit for multi N/C 2100 S |
| 402-890.193 | Tube kit for multi N/C 3100 |
| 402-890.204 | Tube kit for multi N/C pharma HT and pharma HS |
| 402-890.305 | Tube kit for multi N/C UV HS and pharma UV |
| 402-950.001 | U-tube halogen absorber O.D. 11 mm |
| 899-USPS2A | USP TOC SST kit, HTC, SST test kit stabilized with HCl for combustion based TOC systems |
| 899-USPS1SA | USP TOC SST kit, UV, SST test kit stabilized with H2SO4 |
| 402-815.076 | Waste container 5 L |
| 402-884.021 | Waste hose TOC with screw joint for basic unit (2 m) |
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