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.
The Single Particle Explorer (SPE) is an automated system that is able to find and identify particles within minutes by determing morphological and chemical information of organic, inorganic, and metal particles.
Without any user interaction, the system initially gathers information on particle number, size and shape. It applies in a second step 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 2ɥm. Intelligent chemometric algorithms match each individual particle’s spectroscopic fingerprint with a reference spectra in a database, thereby identifying the particle and ultimately determining the source.
rap.ID is the inventor of image directed micro spectroscopy. This technology pinpoints micro-particles on a filter and identifies them via fully automated spectroscopy methods, including Raman [chemical Structure] and LIBS [chemical Elements].
SPE - life and science (SPE-ls)
The Single Particle Explorer instrument is able to gather morphological information and determine the chemical composition of organic, inorganic, and metal particles.
SPE - microbio (SPE-microbio)
Delivers fast and reliable identification of bacteria, germs, and micro-particles. It is able to prove and identify the viability of a single microorganism. It helps to ensure sterile environment in pharmaceutical and in aerospace industries' production process.
The Layer Explorer instrument measures the thickness and homogeneity of the silicone oil layer on the inside walls of spray-on pre-filled syringes, as well as on baked-on cartridges and vials.
The robust and compliant Layer Explorer device determines the silicone oil layer quality parameters with ultra-high accuracy and reproducibility. It delivers data on the critical quality aspect: siliconization.
rap.ID offers FDA and GMP compliant contract testing services including: quick root cause investigation of foreign particulate matter, chemically specific particle sizing and the measurement of silicone in pre-filled syringes.
Particle counting methods such as: USP<788> (M1 and M2) or EP 2.9.19 are our service portfolios.
For biopharmaceutical quality control and formulation development we offer FlowCam; and sub-visible particle ID on protein aggregates in situ and subvisible particles.
The novel wet-dispersion.AID enables in combination with the SPE raman.ID 532 the identification and chemical characterization of particles in protein based formulations. Only a year after its introduction, it is widely used in formulation development and stability improvement in the leading biopharmaceutical companies.
Combination drug product testing including siliconization testing, particle evaluation and gliding-force functional testing are added to the company’s contract testing capabilities. This makes rap.ID a one stop agency on functionality, stability and compatibility testing of pre-filled syringes and cartridges used in modern auto-injection systems.
rap.ID provide the worlds fastest chemically specific sizing solution for topicals such as cremes and ointments. It has a great track record of method development and validation important for NDA and ANDA submitted to the US-FDA.
rap.ID Particle Systems GmbH
Koepenicker Str. 325
Phone: +49 30 65763440
Fax: +49 30 65763441
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