Product category:
Liquid Analysis: Spectroscopy, Colour
News Release from: Thermo Fisher Scientific | Subject: Nicolet Antaris
Edited by the Processingtalk Editorial
Team on 31 May 2004
Near-infrared spectrometer for process
analysis
Thermo Electron Nicolet Antaris near-infrared spectrometer provides a single instrument platform for process analytical technology
Thermo Electron Nicolet Antaris near-infrared spectrometer provides a single instrument platform for process analytical technology With the Nicolet Antaris FT-near infrared (FT-NIR) analyser, Thermo Electron Corporation, a charter member of the IFPATma association, offers a ready-made solution for process engineers and application scientists in the pharmaceutical industry wishing to implement Process Analytical Technologies (PAT)
This article was originally published on Processingtalk on 4 May 2004 at 8.00am (UK)
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Benefiting from a single analyser platform connecting drug development and pharmaceutical manufacturing, the instrument eliminates the need for laboratory testing results, and the uncertainty of inexact, recipe-based manufacturing processes.
Widely used for incoming materials inspection and final product testing in over 60 pharmaceutical companies, the Nicolet Antaris FT-NIR platform now enables pharmaceutical manufacturers to replace laboratory testing queues with real-time monitoring of critical manufacturing parameters.
Now a top priority for both the US Food and Drug Administration (FDA) and the pharmaceutical industry, PAT programs are being created to move the pharmaceutical industry from finished product-based testing to in-process analysis that allow more efficient drug manufacturing and higher quality, consistently manufactured drug products.
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The Nicolet Antaris FT-NIR platform facilitates implementation using the FDA-recommended approach in which PAT systems are developed in parallel with drug development and formulation so that analytical methodology is fully understood at manufacturing scale-up.
All Nicolet Antaris analysers are built upon a common platform with methods that can easily be transferred from system to system without recalibration, thereby greatly reducing implementation costs and validation efforts.
Comprising a quality system making cGMP compliant use inherent, the platform has been designed to operate in severe conditions, with minimal operator training or unmanned operation.
The Nicolet Antaris FT-NIR platform includes several innovative features enabling PAT programs: a method development sampling (MDS) system equipped with all near-infrared sampling techniques on a single system.
Connectivity between the lab and the plant reduces cost of operation and reduces the risks of redevelopment and re-validation on derivative analysers.
Sampling methods can be developed at one facility and seamlessly transferred to other parts of the production environment or even to plants in other parts of the world.
A Multiplexer system extends analyser capabilities to continuous process monitoring of multiple or sequential sampling points by supporting up to 12 fibre optic probes.
The Multiplexer features revolutionary fitness-for-purpose design specifications well-suited to PAT, including an internal reference channel that allows USP-based qualification while probes are online, and exclusive algorithms that can account for fibre optic variability (developed in conjunction with Sandia National Laboratories).
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