New Laboratory TOC analyzer
The new QbD1200 TOC analyzer is designed to make testing easier, reproducible and accurate. The new TOC analyzer promises highest performance while dramatically reducing cost of ownership by using one reagent for the test and requiring only one annual service call rather than frequent maintenance. The new TOC analyzer eliminates the dependency on lengthy overnight routines that may fail.
The design of the analyzer is based on the concept of ‘Quality by Design’, which is defined as a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.” The QbD1200 was designed with ease of maintenance in mind and regulatory compliance to all major pharmacopoeias.
Regulatory Compliance:
Fully complies with all global pharmacopoeia regulations
Simple IQ/OQ/PQ qualification routine compliant with ICH guidelines
Convenient automated routines for USP Bulk- and Sterile Water, JP SBDS validation
Secure and Easy Data Management:
Designed for 21 CFR part 11 compliance
Simply paperless feature allows export of data via FTP over secure ethernet
Send data and reports to a single location for centralized record keeping
Integrated hard drive encrypts all data with ample storage for lifetime of measurements
Create reports with the touch of a button
Measurement performance:
QbD1200 has virtually eliminated sample-to-sample carryover
No more inconsistent results, QbD1200 has outstanding reproducibility
Faster sampling through best accuracy and reproducibility (only three replicates)
Simplicity: Very easy to operate and maintain
Simple user interface on large (10.4 inch) color touch screen
User interface guides operator through steps, no need to refer to a complex manual
Auto-ranging– no need to know sample concentration ahead of time
Only one reagent (make your own, or purchase stock solution)
Simple paperless report transfer via secure Ethernet connection
Low total cost of ownership:
Low reagent cost
Say goodbye to frequent maintenance; annual service vs. monthly
No requirement for external PC
Qbd1200 Laboratory TOC Analyzer:
Regulatory Compliance to USP <643>, EP <2.2.44>, JP 16 <2.59>, IP, KP, ICH
Simple IQ/OQ/PQ qualification routine compliant with ICH Guidelines
Secure and Easy Data Management
Low total cost of ownership
Saves time with only 90 minute calibration routine
21 CFR part 11 Compliance
Intuitive user interface
Embedded software, no external software validation required
Only one reagent, make your own or puchase stock solution
Quality By Design reliability (QbD):
Diagnostics ensure reliable measurement
7 different types of sensors continuously monitoring instrument health status
Startup self-check and on-demand diagnostic reporting
Saves time:
Only 90 minute calibration routine!
12-month calibration stability
Overload recovery:
Requires no special service, maintenance, or cleaning after an overload event
Sample cell and lines are flushed between each sample
Pharmaceutical Applications:
Water for injection
Bulk water
Sterile water
Cleaning validation