Home Life & SciencesSPE raman.ID biopharma
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Imaging led raman spectroscopy on micro particles |
The SPE raman.ID biopharma is designed to quickly enumerate and identify silicone particles and agglomerates recovered from protein based drug formulations. The standard particle size ranges from 1 µm (collection on filtr.AID patches).
The system is suited to perform both enumeration and particle size distribution of filtr.AID in 2-3 minutes and Raman identification of single 1 µm particles in just 1 - 3 seconds each. The integrated sampling and image analysis guided spectroscopy is saving you man years of operator time compared to manual Raman microscopes.
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The speed of this process enables the equiment to conduct silicone protein interaction studies or other formulation stability related investigations. Measuring and identifying nano particles is now as easy as a touch of a button. All raw data including raw images, analyzed images, particle morphology, particle stitch merging, and spectra are stored in a “results” file in compliance with 21 CFR Part 11.
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Free registration for Premium-access:
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Log in for Downloads: |
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SPE raman.ID biopharma - Application |
You can use the system to develop biopharmaceutical drug formulation in combination with micro flow imaging to identify what you see with the MFI. Also you can use the system to perform fast and reliable root cause searches of particles in your parenteral drug products.
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Streamlined development of protein based drugs |
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Corrective and Preventive action fast, realiable and with minimal manpower |
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Streamlined stability studies - fast and reliable identification of particles and agglomerates recovered from biopharmaceutical intrinsic particles |
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Development and quality control of biopharmaceuticals |
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Pharmaceutical Water For Injection (WFI) monitoring |
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Control of cleanliness levels in pre-filled-syringes |
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Visible and sub-visible particle contamination testing |
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Qualification of production facilities after installation, reconstruction, standstill etc. |
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Testing surfaces, consumables and primary packaging |
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Testing the effectiveness of cleaning and disinfection measures during operation and at the end of production |
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Development and control of foreign particulates level on parenterals primary packaging materials |
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Streamlined process and product understanding (QbD) leading to process and product improvement studies |
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Preventive quality assurance (CAPA) in the production of parenterals |
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Continuous monitoring of the chemical composition of foreign particles for process optimization (clean intelligence) |
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Image analysis -> number, size and shape |
The Single Particle Explorer provides fast and reliable identification of particles and agglomerates for particles of 1 µm and larger:
Number, Size:
Longest expansion in accordance with Feret
Shape:
Elongation; angularity, circular equivalency, diameter, area
Particle chemical ID:
Raman-vibrational-spectroscopy with database allocation
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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.
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raman.ID:
Cellulose
Database Match: excellent
Lenght: 1005.0 µm
Width: 12.6 µm
Elongation: 104
Rectangularity: 0.07
Fibrosity: 8.1 |
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Particle size and chemical destribution |
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0,5 - 2 µm |
2 - 5 µm |
5 - 10 µm |
10 - 25 µm |
25 - 50 µm |
>50 µm |
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1 |
0 |
2 |
0 |
0 |
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5 |
10 |
1 |
0 |
1 |
2 |
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186 |
7 |
2 |
3 |
1 |
0 |
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1487 |
2 |
0 |
0 |
1 |
1 |
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1680 |
20 |
3 |
5 |
3 |
3 |
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2675 |
825 |
23 |
31 |
15 |
12 |
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