Foreign particle control in Parenterals & Medical Devices

With the Single Particle Explorer SPE-ls raman.ID + metal.ID system anybody can determine the size, shape and chemical composition of hundreds of metallic, organic and inorganic particles ranging from 5 µm and larger. The unique combination of imaging analysis and spectroscopy allows the chemical characterization of hundreds of particles per hour. Imaging analysis delivers size and morphology data of the particles. Individual particles are selected for their identification by their morphology for their spectroscopy and identification.
Simply insert the sample, select the relevant particle shape and size parameters, and then allow the fully automated system to identify the exact chemical structure and chemical elements distribution.

Produce results in a timely manner

Reliable imaging + spectroscopy combination - integrated imaging directed spectroscopy ensures the measurement of just the particles you are interested in.
High reproducability – no user interaction is required to run samples. All measurement parameters are set in receipt files.
Total traceability – produce valid results with built-in traceable standards and CFR 21 Part 11 raw data compatibilty.
Fast results – enumeration of a sample in just 5 minutes. Identification of 50-3000 individual Foreign Particles, FP, per hour.
High sample throughput - load up to 4 samples into the system and run them fully automated.
Minimal user training - after 1-3 days of on site user training, anybody is able to work with the system.
Robust - integrated system with worldwide support.

Applications

You are able to detect the foreign particulate sources in medical devices and sterile pharmaceutical products such as parenterals with unprecedented speed and accuracy.

Medical device - Easily control the cleanliness on your medical device such as spine, brain, hip, teeth and etc. Reports the origin of contamination or particle release behaviour of cardiovascular stents.

Parenterals - Perform root-cause analysis and CAPA of visible contamination rejects within minutes. Investigate stability issues in cytostatics or protein based drugs.

Pharmaceuticals - Document and ID the origin of: spots on tabletts, agglomerates in powders or discolorations in blister packaging and many other solid applications.

Designed for routine applications

Insert up to 4 filter patches at once, select the relevant particle shape and size parameters, and then allow the automated system to write a report on the particle size distribution as well as the chemical composition of the particles. Select pre-defined methods and run routine jobs such as identify the largest 200 foreign particulates on a filter patch in just 40 minutes:

1. scan entire filter patch -> size and shape of each particle > 5 µm
2. locate to the largest 200 particles and perform auto exposure Raman spectroscopy on each ( parameters: 5 mW, 532 nm, 9 µm laser focus, 1 measurement point)
3. identify the particles -> compare the Raman signals with the library
4. write a user defined standard report file -> particle size distribution of the individual particles and matches of the Raman library search of the particles + individual images + fingerprint spectra of the largest 10 particles
5. work under cGMP -> store particle size and chemical distribution as well as all raw data, audit-trail in compliance with 21 CFR Part11

Image analysis -> particle number, size and shape

The system gathers morphological particles information without any user interaction. From each particle the system reports:

Number, size:
Feret's diameter (longest dimension)

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.

Imaging led spectroscopy:
The coordinates for each particle are potential spectroscopy target locations. Select particles morphology for the identification.

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

raman.ID -> chemical structure

raman.ID gives fingerprint spectra of the vibrations of all molecules. With the integrated unique spectra interpretation you can quickly and reliably identify organic and inorganic particle materials by their spectra without specialized knowledge. The fingerprint spectra is extremely sensitive to the chemical structures to identify inorganic and organic materials.

Raman spectroscopy delivers within 5-60 s reliable spectra of the particles larger than 2 µm. It is non-destructive and virtually free of sample preparation. Depending on your particle material and your specific application you can choose between 532 nm, 785 nm or 1064 nm laser excitation wavelength.

Particle size and chemical distribution

Analysis time: 20 min
Let the SPE raman.ID deliver results on hundreds of inorganic or organic particles in just a couple of minutes for you. Save years of laboratory time with imaging-led spectroscopy.

metal -> chemical elements

metal.ID gives spectra of the chemical elements. You can quickly and reliably identify inorganic and metallic materials by their spectroscopic fingerprints without specialized knowledge.

Particle size and chemical distribution

Analysis time: 15 min
metal.ID is Laser Induced Breakdown Spectroscopy, LIBS. It is sensitive, ultra fast (1 s / Particle) and virtually free of sample preparation. It gives spectra of the several elements e.g.: Al, Au, Ag, Ba, Ca, Cr, Cu, Co, Fe, Li, Mn, Mg, Ni, Pb, Sn, Sr, Si, Sb, Ti, V, Zr, Zn as well as of hundreds of mixtures and alloys.