ParticleScope™ - Particle
Measurement System
Phoenix Imaging, Ltd. has released a new website dedicated
to Bio-Pharma, Healthcare and Pharmaceutical
related products and services at
www.mib-lights.com. Please visit this site for the latest information
regarding
RLPS™, MIB and ParticleScope™ products.
Patented Non-Destructive Particle Detection and
Measurement System used for Parential (SVI) Products.
Phoenix Imaging releases a new product for the detection
and measurement of small contamination particles in small vial for injection (SVI).
The ParticleScope™
instrument is unique in its approach for the isolation of suspect contamination
particles in the solution. Unlike many of the automated inspection systems
that were previously sold, the ParticleScope™ instrument utilizes multiple high
resolution images that are acquired from simultaneous sensors. The typical
inspection will acquire as many as 50 images from each of the sensors. Two
sensor resolutions are available for the system, 2 mega-pixel or 5 mega-pixel.
The 2 mega-pixel system can resolve 50µm diameter particles while the 5
mega-pixel sensor can resolve <25µm particles. The system is the only
Particle Detection and Measurement system that provides NIST traceable measurements of the contaminating particle size. The inspection system is
designed as as small bench top unit that is totally self-contained (except for
wireless keyboard and mouse).
The ParticleScope™ instrument is designed to perform
non-destructive testing on one sample at a time. The sample can be either
a small vial (1ml to 20 ml), a Cartridge or a Syringe. The system options
include precise measurement of a single particle or measurement of multiple
particles to determine the size distribution for each image frame. This
system will detect a contaminating particle 100% of the time. The
determination of actual particle size requires that minimum number of frames
with the same aspect ratio particle be isolated. If the particle is
isolated and measured in the minimum number of frames the "particle size" is
reported.
The ParticleScope™ instrument has already been issued
several patents with others patents pending. This technology has been
under development for over 10 years before the first release of the instrument.
The instrument is available now in Version 1.2 running under the Windows® 7
environment. The system is self contained and only requires 120VAC power
for operation.
The unique cube lighting system implements over 1,000
LED's that provide directional illumination on demand. The wavelength of
the LED's are optimized for the CCD sensor's. The inspection system
Patented angle of image acquisition insures that even the heaviest particles
that settle on the floor of the container will be detected and measured.
The second sensor inspects the fill fluid all the way to the meniscus.
Both of these areas are often ignored by other inspection technologies.
All of the inspection parameters are available for
modification by the user, provided that they have the proper security level and
permission to alter inspection parameters. The software is part 11
compliant and permanently records all changes is a edit log. Once a test
has been run the results and test parameters can not be altered. The
inspection of a specific product will be defined by the "Velocity Motion
Profile" or VMF. The VMF defines the acceleration, maximum velocity,
duration and deceleration rate of the container to properly agitate the fluid in
the container. The VMF depends on the container size, shape, fill volume,
fluid viscosity and temperature of the fluid. Each can have a unique VMF
associated with the testing procedure. In addition each test may have more
than one VMF. In most cases at least two VMF's are used for the
inspection, one for low density particle detection and one for high density
particle detection. This system allows you to discover the best testing
properties.
The inspection results are available for review in both .csv
and Microsoft® Access database formats. There are two files associated
with each inspection result, a "Summary" file and "Detail" file. The
summary provides a single line of results for each container inspected in a Lot.
The detail files provide the results of each individual inspection frame.
Information contained in "Summary" result files include:
|
Product / Test Description |
sample # |
max blobs |
Avg of max blobs |
min Blob
size µm |
min Blob aspect Ratio |
min Blob occup Ratio |
max Blob size µm |
max Blob aspect Ratio |
max Blob occup Ratio |
Frames with 5+ particles |
Frames with 4 particles |
Frames with 3 particles |
Frames with 2 particles |
1 p's |
0 p's |
n frames |
in frame #(s)[phase] |
This system provides a wealth of information about the
samples being tested. In addition the system provides the most consistent
detection and measurement results of any non-destructive inspection technology
SVI containers.
The image at the right illustrates a typical image that is
acquired with the 2 mega-pixel sensor. The 100µm diameter particle is
clearly visible as is the reflection of the particle just below it. The
ParticleScope™ system is intelligent enough to ignore multiple particles that
have the same trajectory or path in the solution and only count the real
particle. The system can detect much smaller particles that the minimum
measurement size. However, measurement is limited to particles that are
larger than a minimum pixel area. The instrument measures particles using
two different measurement techniques, each of which have their own calibration
curves associated with them. The most common technique is the binary
representation of the particle is good for detection if a sufficient number
inspection frames are acquired (typically 10 or more). The more precise
method of measurement implements our patented "Grayscale Summation" technique
that integrates all of the gray values in the particle after image
normalization. The error bars are approximately one-third the width of the
binary measurement. The results can only be achieved using a minimum 2
mega-pixel sensor but are much better with the larger 5 mega-pixel sensor.
The ParticleScope™
instrument has many uses but high on the application list are non-subjective
inspection of Lot samples, testing of formulations by particle size
distribution, determining the efficiency and aiding with the validation of high
speed automated inspection equipment. Give us a call and we can discuss
your application to see if the ParticleScope™ is the correct instrument for your
project.
A typical 100µm particle as shown in the image to the
right will be approximately 100 pixels in size.
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