First successful inspection by the US Food and Drug Administration (FDA) at rap.ID
(PresseBox) - Late January, three days under audit of the US American Food and Drug Administration (FDA) at the rap.ID Particle Systems GmbH in Berlin. In addition to a product-specific inspection for one of our customers, a general Good Manufacturing Practice (cGMP) audit of the entire company was obligatory.
Successfully, no observations were identified during the inspection, permitting rap.ID to pass the audit.
Main inspection points included Method Development and Validation of Foreign Particulate Matter testing, as well as release testing of one product. In addition, the identification of Foreign Particulate Matter by Raman spectroscopy and LIBS was also appraised. Greater attention was paid to the documentation standards (installation and performance qualification, IQ / OQ / PQ), the traceable standards, and the software development of rap. ID's own creation, the particle analysis system titled 'The Single Particle Explorer'.
"The successful US FDA inspection shows us that we have implemented high GMP quality standards in the development, manufacturing, and installation of our equipment and contract testing services. I am especially happy about the exceptional performance and preparation of the rap.ID employees both before and throughout the duration of the audit". Emphasizes rap.IDs Managing Director Dr. Oliver Valet.
rap.ID is the inventor of image directed micro spectroscopy for Raman and LIBS. Apart from the manufacturing of unique particle analysis systems, the company provides micro particle contract testing services on site within its laboratories in Berlin, Germany, and Princeton, New Jersey, USA.
Over the last two decades rap.ID has been involved in the development and amelioration of a new class of industrialized micro-particle identification systems. We have developed an automated system that is able to find and identify particles within minutes. The Single Particle Explorer (SPE) is able to gather morphological information and determine the chemical composition of organic, inorganic, and metal particles. Without any user interaction, the system initially gathers information on particle number, size and shape, then later uniquely applies micro Raman and/or Laser Induced Breakdown Spectroscopy (LIBS) on the individual particles to reveal their composition. It is the only automated system available that combines both spectroscopic techniques with advanced image analysis to identify particles as small as 2?m. Intelligent chemo-metric algorithms match each individual particle's spectroscopic fingerprint with a control spectra in a reference library, thereby identifying the particle and ultimately determining the source.
Over the last two decades rap.ID has been involved in the development and amelioration of a new class of industrialized micro-particle identification systems. We have developed an automated system that is able to find and identify particles within minutes. The Single Particle Explorer (SPE) is able to gather morphological information and determine the chemical composition of organic, inorganic, and metal particles. Without any user interaction, the system initially gathers information on particle number, size and shape, then later uniquely applies micro Raman and/or Laser Induced Breakdown Spectroscopy (LIBS) on the individual particles to reveal their composition. It is the only automated system available that combines both spectroscopic techniques with advanced image analysis to identify particles as small as 2?m. Intelligent chemo-metric algorithms match each individual particle's spectroscopic fingerprint with a control spectra in a reference library, thereby identifying the particle and ultimately determining the source.
Datum: 09.02.2015 - 14:04 Uhr
Sprache: Deutsch
News-ID 370061
Anzahl Zeichen: 2780
contact information:
Town:
Berlin
Kategorie:
Consulting
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"First successful inspection by the US Food and Drug Administration (FDA) at rap.ID"
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