 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
 |
|
|
 |
|
|
| |
The
single Particle Explorer is a technology platform for particle characterisation.
Depending upon user preferences and target application, you have the choice
of 3 versions: |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
 |
Single
Particle Explorer basic ® |
|
|
|
| |
|
|
The
particle monitor is able to comfortably analyze filters and obtains particle
size distributions starting from 500 nm: Particle size, count, and shape. |
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
Single
Particle Explorer economy ® |
|
|
|
| |
|
|
Combines
the characteristics of the basic SPE but incorporates Raman spectroscopy.
Individual particles are selected comfortably for automated spectroscopy
and interpretation. |
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
Single
Particle Explorer professional ® |
|
|
|
| |
|
|
For
use in high throughput particle analysis. Through the automation of all
procedures, hundreds of particles an hour can be identified with ease. |
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
Features |
|
|
|
Applications |
|
Options |
|
|
|
| |
|
|
Advantages |
|
|
|
Specifications |
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
 |
|
The
Single Particle Explorer® (SPE) is designed for routine particle characterization.
With optimized particle filtration and illumination, fully automated image
evaluation and Raman spectroscopy, the SPE is ideal for particles from
5 µm.
|
|
|
|
| |
Number
& Size: |
| |
|
longest
dimension according to Feret |
| |
Shape:
|
| |
|
length/width;
angularity,circular-equivalent diameter, area |
|
Datenblatt
Download  |
|
Chemical
Composition: |
| |
|
|
material
ID with database level of conformability |
| |
|
|
|
|
| |
 |
|
 |
|
| |
|
|
|
|
|
|
| |
Results: |
|
|
|
|
| |
| Substance |
10-25 µm |
25-50 µm |
50-100 µm |
| Rubber |
13 |
27 |
0 |
| Paper |
101 |
58 |
54 |
| Polyethylene |
246 |
121 |
103 |
| Glass |
18 |
11 |
7 |
| Sand |
17 |
5 |
0 |
| Image recognition (all particles) |
395 |
222 |
164 |
|
|
|
| |
|
|
|
|
|
| |
Features: |
-
Patented filtr.AID System filters
particles from all liquids and gases within minutes
-
Integrated system includes sample
preparation and mounting; illumination, image capture and analysis;
and optionally Raman spectroscopy
-
Automated image analysis and shape
recognition of particles; Raman spectroscopy, issue of report as per
21 CFR Part 11
-
Database for material ID easy to
expand
-
Range of measurement and light intensity
of Raman spectra optimized for automated database comparison
-
Programmed according to GAMP 4
standards, manufactured as per ISO 9001:2000
-
Device qualification optional:
IQ, OQ and PQ documentation
-
Expandable for standard filter evaluations
according to USP <788>, ISO 4407 or ISO 16232
-
Global service and support, from
methods development to qualification
-
Measuring methods validation as
well as IQ, OQ and PQ documentation qualification services
|
|
|
|
| |
|
|
|
|
|
| |
Advantages: |
-
Sample production and measurement
in just minutes with filtr.AID
-
Reliably reproducible particle count,
size and shape starting at 500 nm
-
Automated chemical material ID from
5 µm up
-
Objective results through automation
with automatic issued report
-
Calibration verifiable at any time
with qualified particle standard
|
|
|
|
| |
|
|
|
|
|
| |
Applications: |
|
|
Identification
of Particulate Matter - Reject Small Volume Patentral |
|
|
|
| |
|
|
| |
|
|
|
Development
and Quality Control of Biopharmaceuticals |
|
|
|
| |
|
|
|
Foreign
Particles in Dry Powder Inhaler DPI |
|
|
|
| |
|
|
|
Troubleshooting
in Clean Production Processes |
|
|
|
| |
|
|
|
|
Fast
Chemical Mapping of a Dry Powder Inhaler Formulation |
|
|
|
| |
|
|
|
|
|
| |
|
-
Foreign particle and contamination
investigations
-
Cleanliness inspection of components
and systems
-
Particle characterization for paint,
powder and cosmetics manufacturers
-
Quality control of implants
-
Corrective and Preventive Action
(CAPA) in manufacturing of parenterals
-
Foreign particle analyses for approval
studies or quality control of oral or nasal medications
-
Development and inspection of primary
packaging and parenterals
-
Continued monitoring of material
composition of foreign particles for process optimization/Clean Intelligence
|
|
|
|
| |
|
|
|
|
|
| |
Specification: |
|
Basic: |
|
|
|
| |
|
-
Motorized X,Y,Z stage with focus
- 1 minute measuring time for count over a 5x5 mm area
with a nominal resolution of 1 µm
-
Integrated digital camera, also
available in color (only useful with bright-field illumination)
-
Measuring interval for morphological
analysis dependent on magnification from 0,5µm-30 mm
- Software and results compliant with 21 CFR Part 11
and GAMP IV
|
|
|
|
| |
|
|
|
|
|
|
| |
|
|
Spectroscopy: |
|
|
|
| |
|
- Laser 532 nm, 10 mW, adjustable for 5%, 10%, 25%, 50%,
100%, 785 or 830 nm optionally
- Identification with Raman: depending on material and
size, ca. 5-100 s/particle
- Spectral resolution: 8 cm-1
- Spectral range: 400-2000 cm-1
- Integrated database: 700 entries expandable with client-specific
database
|
|
|
|
| |
|
|
|
|
|
|
| |
|
|
Automation: |
|
|
|
| |
|
-
Bright-field illumination for evaluations
outlined in USP <788>
-
4-position sample changer
-
Extra laser / detector wavelength,
e.g. 670 nm
-
Automatic lens changer
-
Automatic laser power control
|
|
|
|
| |
|
|
|
|
|
| |
Contact: |
|
|
|
Request
Information |
|
|
|
|
|
|
www.rap-ID.com |
|
|
back
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
 |
|
