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rap.ID Particle Systems GmbH

Köpenicker Str. 325 Haus 11/12, 12555 Berlin

Germany

+49 30 6576 3440

www.rap-id.com

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.

Products and Service

• Particle Explorer

Single Particle Explorer life and science (SPE-Is)
Single Particle Explorer microbio (SPE-microbio)

• Layer Explorer
• Contract Testing

Particle Explorer

Single Particle Explorer 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.
Designed for the fast and reliable identification of particles and agglomerates or contamination source detection and production process issues for the Pharmaceutical and Biopharmaceutical Industries.
This unique particle identification instrument is equipped with fully automated microscope functions and integrated spectroscopy. It allows you to work, with minimum time, on just one visible particulate matter or on thousands of micro particles. Depending on your user level, you have maximum flexibility for your scientific research, or a great tool to streamline your best practice GMP routine quality control.

 Single Particle Explorer microbio (SPE-microbio)

Delivers fast and reliable identification of single bacteria, germs, and micro-particles. It is able to prove and identify the viability of a single microorganism. It ensures sterility in pharmaceuticals during sterile production and in aerospace technologies during assembly.

Layer Explorer

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.

Contract Testing

rap.ID offers FDA inspected 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.
USP, EP and JP Compendial particle counting methods such as: USP<788> (M1 and M2) or EP 2.9.19 complete the services.
For biopharmaceutical quality control and formulation development we offer FlowCam; and sub-visible particle ID on protein aggregates in situ and subvisible particles.

News and Innovations
Enhanced biopharmaceutical development: 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.


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