About Bruker Optics
OPUS 6.5 Software Package
MPA and MATRIX- F FT-NIR Spectrometers
Optics, part of the Bruker Corporation (NASDAQ:BRKR) is the leading
manufacturer and worldwide supplier of Fourier Transform Infrared, Near Infrared
and Raman spectrometers for various industries and applications.
Bruker entered the field of FT-IR spectroscopy in 1974. The early instruments
set new standards in research FT-IR with evacuable optics, high resolution and
automatic range change. Since then, the product line has been continuously
expanding with instruments suitable for both analytical and research
applications with exceptional performance characteristics.
Today, Bruker Optics offers FT-IR, NIR, Raman, TD-NMR,
TeraHertz spectrometers and imaging spectrographs for various markets and
applications. Bruker Optics has R&D and manufacturing centers in
Ettlingen, Germany and The Woodlands, USA, technical support centers and sales
offices throughout Europe, North and South America and Asia.
Pharmaceutical and Biotech companies are starting to implement faster, more
reliable analysis methods both throughout their research and development centers
and within the manufacturing process. Today, Bruker
Optics fulfills many of the needs of the Pharmaceutical and Biotech
industries, ranging from quality control to process monitoring, by implementing
spectroscopic solutions such as:
Developing and marketing new pharmaceutical products has forced the
regulation of research and development programs. All pharmaceutical companies
marketing, or intending to market, their products to the US must comply with the
21 CFR Part 11 regulations as defined by The Food and Drug Administration (FDA).
These regulations control the integrity of electronic data records and
electronic signatures and any other information represented in a digital form.
The importance of authentication and software security is increasing due to the
expansion in the use of computer-based instrumentation and the requirement to
regulate and record access to computer resources as well as manage electronic
records residing on these computer systems. It is therefore now one of the main
factors to consider when implementing environments that will manage electronic
records as set forth in FDA regulations.
The latest Bruker Optics OPUS 6.5 software package has been developed,
tested and validated in compliance with the requirements of 21 CFR Part 11. Data
integrity compliance is provided by a secure log-in, multi-level user access
groups for users with different permission levels, and audit trails, recording
all logins, illegal logins and password changes as required by the Food and Drug
One of the first steps in the manufacturing of any pharmaceutical product is
the identification and validation of various incoming raw materials. NIR
spectroscopy via fiber optic probes is rapidly becoming a standard method of
accomplishing this crucial material validation, providing unprecedented speed
and flexibility for identification of both solid materials and liquids. Bruker
Optics offers a complete turn key system for quick and accurate
identification of raw materials. Both MPA and MATRIX- F
FT-NIR spectrometers can be equipped with fiber optic probes for direct analysis
of raw materials in their containers. Complete identification software guides
the user through the library creation process and provides single click
identification even at the loading dock. The MATRIX- F
system comes with a NEMA rated enclosure enabling it to withstand the
toughest plant environments.
Source Bruker Optics
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