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.

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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

Pharma & Life Sciences

Show applications

Applications

  • Total Protein Determination in Pharmaceutical Products (Vaccines) by TNb Analysis (EN)

    Open application

  • TOC System Suitability Test – Redefined According to New USP Regulations (EN)

    Open application

  • Cleaning Validation Procedures in the Pharmaceutical Industry by TOC Analysis (EN)

    Open application

  • Establishing Extractables Testing from Plastic Packaging Materials and Systems for Pharmaceutical Use by TOC Analysis According to USP <661> (EN)

    Open application

  • TOC Performance Test as per Japanese Pharmcopoeia (EN)

    Open application

Technical Data

Parameters

Limit of Detection

Measurement Range

Gas supply

Digestion Mode

Measuring Time

Detector

Injection Volume

Sample Supply

Precision

Dimension (width x depth x height)

Optional Parameters

multi N/C 2100S pharma - TN analyzer for aqueous protein solutions
450-200.103-2

TN 5 µg/L 0 - 200 mg/L Oxygen 4.5 or synthetic air (CO2 <1 ppm, hydrocarbons <0.5 ppm) High temperature combustion up to 950°C 3 - 5 min Chemiluminescence Detector (CLD) 50 - 500 µL Direct injection 1 - 2 % 813 mm x 500 mm x 970 mm

multi N/C 3100 pharma - TOC/TN analyzer for pharmaceutical applications
450-200.503-2

TC, TIC, TOC, DOC, NPOC, NPOCplus 4 µg/L 0 - 30000 mg/L Oxygen 4.5 or synthetic air (CO2 <1 ppm, hydrocarbons <0.5 ppm) High temperature combustion up to 950°C 3 - 5 min Focus Radiation NDIR 100 - 1000 µL Flow injection 1 - 2 % 513 mm x 464 mm x 550 mm TNb (CLD), POC (direct measurement)

multi N/C pharma HT - TOC/TN analyzer for pharmaceutical applications
450-200.600-2

TC, TIC, TOC, DOC, NPOC, NPOCplus 4 µg/L 0 - 30000 mg/L Oxygen 4.5 or synthetic air (CO2 <1 ppm, hydrocarbons <0.5 ppm) High temperature combustion up to 950°C 3 - 5 min Focus Radiation NDIR 50 - 3000 µL Flow injection 1 - 2 % 513 mm x 464 mm x 550 mm TN (CLD)

multi N/C pharma UV - TOC analyzer for pharmaceutical applications
450-200.800-2

TC, TIC, TOC, DOC, NPOC, NPOCplus 1 µg/L 0 - 10000 mg/L Nitrogen 5.0 or Argon 4.6 UV wet chemical digestion 3 - 5 min Focus Radiation NDIR 50 - 20000 µL Flow injection 1 - 2 % 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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