New Instrument Helps Pharma Labs Comply with Global Quality Requirements

Beckman Coulter Life Sciences has launched the QbD1200 Total Organic Carbon (TOC) Analyzer.  Designed to be faster for higher TOC sample analysis throughput for the busy QC laboratory, the new instrument also carries out direct TOC analysis for greater quality and regulatory compliance.

“The QbD1200 is designed to assist the pharmaceutical industry to meet the increasingly strict requirements of the major global regulatory* guidelines,” said Howie Carpenter, Beckman Coulter Life Sciences Business Unit Manager for TOC.  “The QbD1200 represents a new standard for analytical performance, simplicity, and cost of ownership for laboratory TOC analyzers.” 

The QbD1200 is ideally suited for measuring Water For Injection (WFI), Purified Water (PW), bulk sterile water, and cleaning validation samples. “We have also designed fully automated, fast and convenient validation and qualification procedures for the QbD1200,” added Mr. Carpenter.

A full 18-point, automated calibration (6 concentrations, 3 replicates each) takes only 90 minutes. The technology underpinning the new system virtually eliminates sample-to-sample carryover to <0.2% so that labs will no longer need to throw away their first sample.

Unlike many TOC analyzers, the QBD1200 does a direct TOC measurement.  Mr. Carpenter explained: “The measurement obtained from extracting Total Inorganic Carbon (TIC) from the Total Carbon (TC) is error-prone and not suitable for the new quality requirements.  It often leads to negative TOC values being reported due to measurement uncertainties between the two sensors.

 “Instead, the QbD1200 first removes all TIC from the sample, using dynamic end point detection to ensure everything is removed.  It then takes a direct measurement of the remaining TOC in the sample.”

The QbD1200 features a unique implementation of the UV / persulphate oxidation method which combines acid and oxidizer into a single reagent (patent pending).  To help provide an attractive total cost of ownership, this single reagent can be purchased as a concentrated stock solution, or prepared by the user following the simple recipe provided.  

To help pharmaceutical manufacturers reduce paper records and tightly eliminate the use of USB memory sticks in their laboratory environments, the QbD1200 is designed to export all reports and qualification results, such as Calibration and System Suitability, over Ethernet using a secure FTP protocol to a central server.  The lab can then keep all records required for audit in a single location, simplifying record keeping. 

The QbD1200 is designed to be used in a 21 CFR part 11 environment, with all data stored in an encrypted database with a complete audit log.  As the QbD1200 is a self-contained system and not controlled by an external computer, no Computer System Validation (CSV) is required, simplifying the qualification and validation of the analyzer in the regulated pharmaceutical environment.

Beckman Coulter Life Sciences is dedicated to empowering discovery and scientific breakthroughs. The company’s global leadership and world-class service and support delivers sophisticated instrument systems, reagents and services to life science researchers in academic and commercial laboratories, enabling new discoveries in biology-based research and development. A leader in centrifugation and flow cytometry, Beckman Coulter has long been an innovator in particle characterization and laboratory automation, and its products are used at the forefront of important areas of investigation, including genomics and proteomics.

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