GE Analytical Instruments offers Sievers Total
Organic Carbon (TOC) Analyzers and the CheckPoint Portable/On-Line TOC Sensor for a wide range of pharmaceutical
applications, including:
Whether your Total Organic Carbon (TOC) applications include monitoring
pharmaceutical
waters for USP, EP or JP compliance, sampling for cleaning
validation applications, or on-line TOC monitoring within a Process
Analytical Technology (PAT) framework, GE Analytical Instruments
provides the right instrument for your application. With integrated
or add-on 21
CFR Part 11 compliance support software, we've greatly simplified
the complexities of regulatory compliance. In addition, GE Analytical
Instruments' validation services include an instrument
validation performed by highly-trained personnel. These services
are used by hundreds of pharmaceutical customers worldwide.
Pharmaceutical
Waters
The United States Pharmacopoeia (USP) and European Pharmacopoeia
(EP) regulations require TOC to be monitored in pharmaceutical waters.
GE Analytical Instruments provides both laboratory TOC analysis, as
well as on-line TOC monitoring solutions for process waters (PW) and
water for injection (WFI), to meet your regulatory needs.
Cleaning
Validation
The FDA considers TOC analysis an acceptable cleaning validation
method, and many pharmaceutical companies have adopted TOC over other
traditional methods, due to the application versatility, accuracy
in measuring contaminant residues, faster analysis time, cost-effectiveness,
and real-time analysis feedback of rinse/cleaning status. TOC analysis
is suitable for quality assurance testing, equipment release, USP
release, swab sampling, rinse sampling, clean in place (CIP) applications,
and on-line process control to satisfy the FDA’s Process Analytical
Technology (PAT) initiative. GE Analytical Instruments offers application-specific
Sievers TOC Analyzers to meet your particular cleaning validation
needs and is leading the industry with on-line cleaning validation
using the new Sievers
500 RL On-Line TOC Analyzer. To see an animation of real-time
on-line cleaning validation using TOC, click here.
On-Line
TOC and Process Analytical Technology (PAT)
On-line TOC instruments provide real-time, continuous analysis and real-time
release of Process Water (PW) or Water for Injection (WFI) in pharmaceutical
manufacturing, meeting a key role in the FDA’s Process Analytical
Technology (PAT) initiative. The FDA encourages on-line TOC analyzer
use for cleaning validation processes such as controlling the end point
of equipment rinse down, and to help eliminate manual errors in the
manufacturing process. Sievers TOC Analyzers help pharmaceutical manufacturers
comply with the PAT initiative, and achieve more cost-effective and
higher quality pharmaceuticals.
Rapid Diagnostic Sampling and Troubleshooting
The CheckPoint Portable/On-Line TOC Sensor gives manufacturers maximum flexibility in process monitoring, process trending, screening potential trouble areas, and diagnosing problems in real time. It is the first battery-powered TOC measuring device, weighs just 3.6 kg (7.9 lb) with battery, and features 15-second measurements.
21
CFR Part 11 Compliance
GE Analytical Instruments has implemented multiple systems for Sievers
TOC Analyzers to support compliance with 21
CFR Part 11. In the lab, the DataPro
900 Autosampler software for 900 Series TOC Analyzers addresses
many of the requirements for controlling user and level authorities,
as well as the stability and security of data. On-line, the Sievers
500
RL, 900
and 400
ES employ an embedded version of DataGuard, specifically
designed for 21 CFR Part 11 compliance in on-line environments.
DataGuard, an optional module within the DataPro Software, offers
a user-level security system, electronic signature capabilities,
and automatic generation of audit trails to track all system
activity.
Sievers TOC Analyzers
Two of the Sievers 900 Series TOC Analyzers — the 900
Laboratory and the 900
Portable — can be used with the 900
Autosampler for high throughput laboratory analysis. For more information
on these analyzers, please select from the list below:
