Particle Identification @ 5µm

Foreign Particles in Parenterals & Medical Devices

The fully automated SPE raman.ID 5 system determines the chemical composition of particles ranging from 5 µm and larger at a rate of hundreds per hour. The intuitive software control obtains statistically relevant information after a short introductory training period. Simply insert the sample, select the relevant particle shape and size parameters, and then allow the automated system to identify the elemental distribution at a throughput rate of 100 - 600 particles per hour. The fully automated and highly accurate system identifies the contamination source with unprecedented speed and accuracy.

The SPE raman.ID 5 implements all of the features of the SPE CSS and more. Particle information including: count, shape, and size is available for particles ranging from 0.5 µm and larger. A size distribution with 8 customizable size classes quickly counts the sample in just 1 - 15 minutes.

The equipment is designed to test parts cleanliness as well as identify foreign particles larger than 0.5 µm in medical devices and sterile pharmaceutical products such as parenterals with the use of integrated raman spectroscopy. Particle samples are collected on filtr.AID patches or other standard membranes for raman spectroscopy analyzation. Analysis reports as well as all raw data are stored in a “results” file in compliance with 21 CFR Part11.

Image analysis:

Number, size:
Feret's diameter (longest dimension)
Shape:
Length/width; Angularity, rectangularity, elongation, area
Particle source:
Raman vibration spectroscopy with database matching

The SPE raman.ID 5 is a reliable tool for routine particle status monitoring and, if required, the rapid detection of contamination sources through single particle analysis.

Once particle analysis (count, shape, and size) has been performed, you can move individual particles into the center of the crosshairs andinitiate features such as: fully automated spectrum scans, data interpretation and documentation with a single mouse click. You can quickly and reliably identify materials by their spectroscopic fingerprints without specialized knowledge. Internal standards control adjustments. New suspicious materials can be added to the database at the push of a button. This system enables you to analyze and document particles and detect contamination sources at an unbeatable price.


Individual image	Analyzed image	Result

Performance features of the SPE raman.ID 20:

	Includes all the features of the SPE CSS
	Raman spectrum measurement and interpretation are performed fully automatically. You do not need to be an expert because the system features self-optimizing spectrum acquistion and software-controlled database interpretation and querying.
	System calibration and system performance can be controlled with just a push of a button. System callibration/performance can be controlled to ensure identification accuracy.
	Auto-focus, auto-exposure, auto laser power control, and auto fluorescence minimization facilitate your work and guarantee reproducible results.
	We offer worldwide service – Data security solutions can be applied to avoid invaluable information losses in GxP environments.

Result:

Substance	10 - 25 µm	25 - 50 µm	50 - 100 µm
Rubber	3	3	0
Paper	5	3	2
Polyethylene	8	5	1
Metal	1	0	0
Identified	17	11	3
Image analysis (all particles)	395	105	26