TOCnology made for pharma New: FDA 21 CFR Part 11 Compliance Module
TOCnology: Inspired by you, developed for you
The new multi N/C x300 analyzers make your lab work noticeably easier and more efficient! With sophisticated TOCnologies, an intuitive new software and a variety of automation functions, multi N/C x300 enable simple operation, reduce your workload and eliminate time-consuming tasks. Your analysis results stand up to every interlaboratory test and with the FDA CFR 21 Part 11 compliance software module, you will comply with international regulations and standards.
FDA 21 CFR Part 11 Compliance Module: Register now for our web seminar
Get to know the new FDA CFR 21 Part 11 Compliance module of multiWin pro. Learn how the new software module saves you time and effort in pharma-compliant TOC/TN analysis with and reduces the risk of errors. Our experts will introduce the features and benefits of the new software to you and shows you which of the analyzers of the multi N/C x300 series is most suitable for your application.
Highlights:
- More time for what matters with minimum sample preparation, long term stable calibration and customized automation
- As versatile as your challenges with excellent particle handling, a wide measurement range, high sensitivity, a salt kit and many other accessories
- A sustainable investment through low costs and time per sample, long-term warranties and low wear and tear even in demanding matrices
- Everything at a glance with the new software enabling intuitive operation, uninterrupted workflows, self-monitoring functions and much more
- A partnership that takes you further with a long-term supplier offering robust analyzers and a comprehensive service package
Customer Voices
Everpharma works with multi N/C 4300 UV with FDA 21 CFR Part 11 Software Module
“I have been working with Analytik Jena TOC analyzers in pharma quality control for many years and very much appreciated the opportunity to participate in the beta test of the new multiWin pro TOC software. The compliance module meets the industry-specific requirements of FDA 21 CFR Part 11 and covers all data integrity requirements. I was particularly impressed by the user management and the easy-to-filter audit trail functions. I would like to thank Analytik-Jena for the trustful cooperation.”
Thomas Beinicke, Head of Quality Control at EVER Pharma Jena GmbH
Meet the Family: The New multi N/C x300 Series
The Specialist: multi N/C 2300
A combustion device specializing in the analysis of particle-rich samples and samples that are only present in small volumes.
The Allrounder: multi N/C 3300
Particle-rich, salt-containing, or very pure samples? A combustion analyzer optimized for high throughput that offers the perfect balance between samples of all kinds.
The Trace Detector: multi N/C 4300 UV
An extremely sensitive and precise UV digestion device, which is ideally suited for ultra-pure water analysis - in the trace range even without persulfate.
Applications
Particle-rich Water
No sample dilution necessary
No sample carryover
No blocking of sample path
Septum-free direct injection
Surface Water
Wide measurement range
High sample throughput
Best particle handling
Loop injection
Solid samples
Direct analysis of up to 3g
No wrapping
No elaborate conversion
Horizontal boat drive
Cleaning validation
High sensitivity
No persulfate needed
Swab test module for HTCO-devices
FDA 21 CFR part 11 software module
Water for injection
Ultra-sensitive TOC determination in lower ppb range
No persulfate needed with UV digestion system
FDA 21 CFR Part 11 compliant software module
Total protein determination
Precise dosage of small volumes
High automation degree
Short measurement times
Automatic result conversion from TN to total protein content
Highly saline samples
Salt kit prevents deposits after evaporation
Extended service intervals
Low wear and tear
No blockage of ceramic tube
Rare and valuable samples
Low injection volumes from 10 µL-500 µL
Precise direct dosage from microlitre syringe
Best particle handling
Broad measurement range
multiWin pro: Everything at a Glance with Our New Software
Discover the brand new multiWin pro software that takes your TOC/TNb analysis to the next level. The intuitive user interface makes operation easy and many new and sophisticated functions result in greater efficiency. And the new FDA 21 CFR part 11 compliant software module enables data integrity in regulated environments.
All Information at a glance
- Sample input and live result display in one place
- Status display of leak-tightness, temperatures, and detectors
- Detailed display of replicates including measurement curves
Long-term stable calibration
- Stable up to one year
- Multi-point calibration from one stock solution
- Blank value correction included
Automated workflows
- Calibration as part of the measurement sequence
- Automated evaluation and application of the calibration to subsequent samples
- Import sample IDs and methods
Simple parameter conversion
- Convert TOC results to COD /BOD5
- Convert TIC results to CO2
- Convert TN to total protein content
FDA 21 CFR Part 11-compliant pharma module
- Data integrity
- User administration
- Audit trail
- Electronic signatures
- Software validation
Self check system
- Continuous monitoring of leak-tightness
- Temperature monitoring of furnace and Peltier element
- Montoring of detector status
- Tracking of maintenance intervals
FDA 21 CFR Part 11 Software Module
- User management: Tailor access and editing rights and assign user roles to your team members.
- Central data management: Store the data from multiple instruments centrally and access them from any computer with multiWin pro installed.
- Audit trail and versioning: Track the time, author and details of each action (including changed values) easily review changes on data and methods based on previous record versions.
- Electronic signatures: Formally document the three step process „created - and checked - approved“ following the dual control principle. Ensure only released methods and calibrations are used.
- Carry out SST measurements with predefined sample sets and automatic result evaluation according to USP <643> bulk water and sterile water, EP 2.2.44, JP 2.59, and KP
- Qualification and validation services: Get started sooner with equipment qualification (DQ, IQ, OQ, PQ) and on-site software validation.
Take the strain out of your pharmaceutical applications! With devices supporting your workflows, FDA 21 CFR Part 11 compliant handling and an all-round service package, you achieve reproducible results, data integrity and worry-free operation.
Work in compliance with the following standards and guidelines
- ICH Q7
- FDA 21 CFR part 11
- TOC: USP <643> bulk water, USP <643> sterile water, EP 2.2.44, JP 2.59, KP
- TN: USP <1057>, EP 2.5.33, JP XVIII <G3-12-172>
e-book
Compliant TOC/TN Analysis in Pharma
In the present e-book, we highlight some of the most common pharmaceutical TOC and TN applications that have been carried out with our new multi N/C x300 analyzers: Ultrapure water testing, TOC cleaning validation, analysis of extractable organic components from packaging materials and quality control of vaccines. We also provide details on how the FDA 21 CFR Part 11 Compliance module of the multiWin pro software supports you to ensure audit-safe and compliant data handling with a server-based central data management.
Particle handling: Sophisticated injection technologies
Our high-temperature combustion devices multi N/C 2300 and multi N/C 3300 are unbeatable when it comes to analyzing particle-rich samples. Their unique injection and rinsing techniques prevent sample carryover and increase the service life of your device.
The multi N/C 2300 injects the sample directly into the furnace from the microliter syringe. The sample, including all particles is transferred as the syringe is emptied from top to bottom. The syringe is effectively rinsed and thermally cleaned from the outside, eliminating any chance of sample carry-over.
With the multi N/C 3300, the sample is drawn up into a large-diameter sample loop instead of a syringe. From this, it is completely injected into the furnace, including all particles. The injection system is then effectively rinsed - also by backwashing into the waste container of the autosampler.
COD / BOD5 - TOC Parameter Conversion
Do you use the parameters chemical (COD) and biological oxygen demand (BOD5) to monitor the organic pollution of water? Did you know that measuring the parameter TOC and then converting it into COD and BOD5 is more precise, considerably faster and can be done without hazardous reagents or costly test kits? Discover how easily it can be measured and converted using a multi N/C x300 analyzer, and how quickly your investment is amortized.
Download Case Study: Switching from COD/BOD5 to TOC
Read our case study to find out how measuring TOC and converting it into COD/BOD5 increases your throughput, reduces the workload of your team, and saves running costs, thereby generating a higher return on investment.
Salt Kit
With the multi N/C 3300, we offer a salt kit for analyzing TOC in highly saline samples, for example in brine, seawater, or cathode materials for lithium-ion batteries. With the salt kit, you can extend the service life of consumables and thus significantly reduce maintenance work and running costs.
The salt trap collects salt that remains after sample evaporation, thus preventing these deposits from causing rapid wear of the catalyst and the combustion tube as well as preventing blockages in the carrier gas flow. The salt kit thereby ensures the accuracy and precision of the measurement results for a significantly higher number of samples. Thus, maintenance intervals are extended.
For more insights on how the salt kit performs in practice, make sure to download the application notes below.
