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Home SPE Model RangeSPE raman.ID + metal.ID 5Application
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High throughput particle characterization enables any operator to quickly determine the chemical composition of particles from high-purity liquids such as parenteral drugs and process media. This capability opens the door to a broad range of applications. In a case where a product may fall outside specification limits, showing an excessive concentration of particles, the contamination source can be identified and eliminated during operation within minutes.
Particle samples are collected for metal.ID on standard Cellulose Nitrate, similar filter papers, or filtr.AID patches.
Improved process knowledge based on statistically relevant particle identification has made it possible to improve the quality and production yield of particle-sensitive products.
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Application Notes |
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Particle contamination on implants |
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Quality control of implants |
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Verify the quality of the water produced from water purification systems |
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Product quality control for particle contamination |
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Continous and routine testing of particle sensitive products and production environment |
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Micronanalysis |
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Paint and glass delamination investigations |
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Control of liquid crystals, cleansing solutions process media and baths |
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Cross sectional Identification analysis |
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Reverse engineering |
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Parenterals |
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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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Identification of foreign particles, residues and particulate contamination for root cause investigations |
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Cleaning process validation |
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Quality Assurance routine counting 4 min/sample with possibility to immediate response to out of spec situations (OOS) or out of trend (OOT) through integrated particle ID |
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References |
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VALET, O., LANKERS, M., (2008), Higher Yield and Quality through Particle Identification, Journal of the IEST, October 2008 |
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VALET, O., HESS, U., (2007), Method for Foreign Particles Counting and Identification in a Cellulose Containing Suspension of a Nasal Spray Formulation, RDD Europe 2007, Vol 1, pp 325-328 |
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LANKERS, M., (2004), Differentiation between Foreign and Protein Particles in Biopharmaceutical Preparations , RISBM 2004 "Raman and IR Spectroscopy in Biology and Medicine" |
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VALET, O., (2002), Made to Measure, Cleanroom Technology, Polygon Media |
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LANKERS, M., (2002), Determining particle composition: Consider the path to the source, Cleanrooms, PennWell |
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