life & science

Single Particle Explorer  (SPE-ls)

Increase your particle characterization efficiency in your cGMP environment with rap.ID´s one-of-a-kind SPE-ls raman.ID+LIBS.ID. 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.

Intelligent spectroscopy target acquisition Ultra-fast reproducible particle recognition

 

  • Integrated sample preparation – disperse your particles - dry or wet - or isolate them on standard filter patches. The patented coated filter membrane, filtr.AID, isolates particles easily from liquids and provides an excellent substrate for raman.ID.
  • Flexible microscopy ensure perfect contrast of any particle on any substrate - flexible illumination includes: fluorescence option, polarized illumination, dark field and bright field illumination.
  • Ultra-fast reproducible particle recognition –  allows you to scan with  your chosen resolution, in order to detect the particles. Image directed spectroscopy enables the identification of up to 3000 individual particles per hour.
  •  Intelligent spectroscopy target acquisition – use computerized or manual binarization, and unlimited morphological parameters, to select particulate matter for spectroscopic identification.

  • Robust Raman and LIBS spectroscopy – the world´s first combined elemental and structural analysis setup for particulate matter ID, streamlines foreign particulate matter identification in industrial and forensics work. Compare and combine the material fingerprints from two independent spectroscopy methods for maximum discrimination power.
  • Highly intuitive software –  truly easy to use software adaptable from beginner to expert levels. Create and optimize your measurement parameters and put them into unique traceable report files for maximum GMP compliance and measurement reproducibility. 
  •  Total traceability and Superior training and global support – constant innovation for pharmaceutical quality control, and over 15 years experience with the 21 CFR Part 11 regulations, ensures this instrument fits extremely  well in your GMP environment. rap.ID service teams in Germany and USA guarantee a 12 hour response time to your calls.

Streamlined particulate matter analysis

sample preparation Filtration with wet cell or filtr.AID membrane

Sample Preparation

Disperse particles by an external computer-controlled dry dispersion unit, in the flexible wet cell, or simply filter the particles on to the filtr.AID membrane, or on simple paper filters.

automated microscopy reproducibly sharp images

Automated microscopy

Based on the measurement method, the sample is illuminated to optimize contrast between the substrate and the particles. The autofocus operation ensures reproducibly sharp images.

particle analysis particles are recognized using based on their morphological parameters

Particle analysis

Individual particles are recognized using the most suitable threshold algorithms, or your pre-set parameters and measured individually based on their morphological parameters.

target-selection Particles touching multiple fields of view are merged into one particle object

Target selection

Each particle image is stored together with the particle’s location data. Particles touching multiple fields of view are merged into one particle object.

The most interesting particles are recorded and photographed by higher power magnification and even 3D stacks, with maximum focus depth to obtain optimum (X, Y and Z) spectroscopy locations. The height of a particle is also measured.

Chemical identification

raman spectroscopy particles are measured by means of Raman and/or LIBS spectroscopy

raman.ID 532

The physically characterized particles are then measured by means of Raman and/or LIBS spectroscopy. The spectra are immediately compared with pre-recorded spectra in a library to produce reliable matches.

Second spectroscopy  

You can automatically apply Raman spectroscopy using a 785 nm laser or Laser-Induced Breakdown Spectroscopy (LIBS), if you are interested in the elements of the particulate matter.

The results from the particle's morphology, chemical structure, and elemental abundance are combined to deliver powerful information, especially helpful in transferring previously unknown particles into known ones.

The compliant report is written and the raw data is stored, so that it could be reproduced, if necessary.

Compile great standard reports and combine morphology, color, size, chemical structure and elements into compelling information

Perfect sample preparation

Filtration

The gold-coated filters (filtr.AID membranes with 0.8, 3, 5, and 10 µm pore sizes) are perfect substrates for ensuring both robust counting and Raman signals, without substrate interference.

Wet dispersion

Specifically designed to obtain perfect powerful low-noise Raman signals from aggregates and particulates in bio therapeutics.

Dry dispersion

Standardized and computercon-trolled powder dispersion pushes powders into a vacuum. The particles fall slowly and are perfectly distributed on any kind of substrate.

Flexible imaging (microscopy)

After you set the illumination and magnification needed, the software automatically takes images of the particles in bright field, dark field, and fluorescence modes.

The illumination required depends on the particles and the substrate. For morphological-directed Raman spectroscopy of foreign particulate matter, the gold coated filtr.AID filters are optimal. The best illumination for this sample is the dark field option.

With pre-defined methods illumination, auto-thresh-olding, and auto-focus, a complete method is established. This ensures easy compliance, high repeatability, and reproducibility of the counting results.

Fastest particle detection

The system uses different objectives for scanning (particle recognition) and spectroscopy for the fastest particle detection. The SPE automatically applies the right lens for optimum signal and aligns the analysis laser with the particle. This transfer of the particle coordinates over different powers of magnification and ensures ultra-fast image analysis-directed spectroscopy.

The system gathers the particle's morphology and location without any user interaction. You choose the best of 6 integrated manual or auto-thresholding algorithms for your sample.

  • Number, size:

    Particle Ferret's diameter (longest dimension), particle circular equivalent diameter, or stretched fiber length

  • Shape:

    Aspect ratio; angularity, rectangularity, elongation, area, perimeter, circularity, solidity, fibrosity, convexity, and height

  • Particle color image:

    Automatically collect and document high resolution sharp (auto-focus) color images of the particles

 

With pre-defined methods illumination, auto-thresholding, and auto-focus, a complete test method is established. This ensures high repeatability and reproducibility of the counting results.

Ultra fast image spectroscopy target acquisition

The instrument scans the surface of your sample automatically for particles. You choose the right magnification, depending on the particle size e.g. 5x for particles >25 µm. Counting all the particles in your sample takes less than a minute. The lower the magnification, the larger the field

of view, and the faster the scanning. For spectroscopy a high Numerical Aperture, N.A. value is essential to collect a maximum of light, unfortunately by the laws of physics, the focus depth and field of view are minimized in this case.

Robust raman.ID

The SPE device combines optical microscopy with a reliable spectroscopic diagnosis and therefore delivers composition identification for 150 million chemical substances. raman.ID delivers fingerprint spectra of molecules. In less than 60 seconds, you gather detailed information about the chemical structure of your sample, enabling the initially unknown organic and inorganic micro particles to become well-known. It even works in water so you can collect valuable information about particulates in situ by using a wet cell for your investigation.

ID chemical structure with multiple raman.ID colors

Raman spectroscopy works with a laser. The laser color is variable. Depending on your sample, you choose the right wavelength or test a combination. A green 532 nm laser works well with low noise and ultra-fast exposure time, this is perfect for white powders and protein aggregates. Particles coming from the environment, so called extrinsic particles, demand the red 785 nm laser that minimizes fluorescence. If you don`t know which you have, let the instrument use both lasers and choose the higher quality spectrum.

Fully integrated identification and interpretation

The system comes with a library to match particle spectra to spectra of typical extrinsic contaminants. In addition, within a few minutes, you can record your own substances and update your product-related library. Integrated algorithms optimize spectra by removing weak fluorescence backgrounds, and match the particle spectra with the pre-recorded library spectra using Pearson´s algorithm, combined with a supervised search strategy. With every spectrum, the software tells you the quality of the match with the library spectra and spectral quality. You can set your required level of minimal quality for the spectra, as well as the matching index. This makes anybody working with your method able to reliably produce ID of particles down to the 1 µm size level.

Micro LIBS.ID

The SPE device also combines optical microscopy with a highly reliable automated element analysis system. Within one second, it delivers identities of chemical elements of your sample. This is excellent information to make unknown inorganic and metal material samples known.

 

ID chemical elements from   to

Laser-induced breakdown spectroscopy (LIBS) works well for identifying the lighter elements down to hydrogen. Alloy quantitative composition, e.g. copper in aluminum, is detectable down to 0.1 mass percent.

µ-drill and surface cleaner

The ablation from the LIBS process removes the top layers (~1 µm) of your sample within microseconds. This helps to measure through surface coatings or contaminations. You can also gain access to material beneath deeper layers of your sample.

One click identification and interpretation

Easy-to-use measurement methods provide the tools of modern data analysis and automated particle classification (e.g. inclusions and impurities) into different material bins.

Highly intuitive software

From easy parameter setup, you transform your method development into solid GMP proof measurement receipts for your analysis. Individual spectra included in the report, or on the entire data set, from a whole measurement run

 

on thousands of particles, can be pre- or post-processed with appropriate tools. This makes the software perfect for R&D, as well as for your routine quality operations.

  
 

Sophisticated spectra processing

 

For each particle, a 21 CFR Part 11 compliant report shows the following:

 

 – The spectrum as it was obtained by the system

 

 – The raw spectrum after the integration of the background and fluorescence removal

 

 – The best database match according to your preferred matching algorithm, e.g. Pearson´s

Total traceability

Mitigate user bias completely and produce valid, traceable results with certified size, count, and material standards and save the entire raw data in the encrypted CFR 21 Part 11 compliant files. Standards for numbers and size from the

National Physics Laboratory come with every system. To ensure reliable spectroscopy, you use traceable material standards to show that the system is in calibration.

Superior training and global support

From your User Requirement Specification, (URS) to Factory to Site Acceptance Test (FAT to SAT) protocol, we compliantly install the system at your site. We have the highest quality parts combined with second-to-none software, developed during 15 years of experience. You receive maximum quality and sustainability in this product.

Our installation, training, and application support teams make you an expert after just a few training days. We guarantee to support you personally from our ISO 9001:2008 certified German and US service locations, with on-site, remote support and training every where on this beautiful planet.