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Foreign Particle Studies and Routine Analysis:

Particle size plays a particularly significant role in inhalable drug production because particles from 2-15 µm do not disappear after inhalation, but rather settle in the alveolus. Therefore, regulatory agencies and manufacturers alike follow strict regulations regarding proper detection of foreign particles in inhalable drugs. rap.ID technology implements FDA initiatives including: Process Analytic Technology (PAT) and Quality by Design (QbD) in production and validation analyses to ensure quality.

Particle Source in Respiratory Drugs

Our Experience:

Studies show that more than 95% of all foreign particles in this substance class are organic by origin and, therefore cannot be attributed to any substance found through REM/EDX analysis. The Single Particle Explorer detects, enumerates and identifies particles in this substance class. rap.ID technology utilizes unique methods to provide rapid and relevant information about inhalables from 2-10 µm.

Foreign particle status of formulations, agents and excipients; foreign particle load in administered doses

Method development and validation of foreign particle studies

Routine foreign particle monitoring in nasal spray suspensions

Testing for particulate matter release on capsules and inhaler parts

Quality assurance and foreign particle analytics in inhalable drugs

Cleanliness analyses for incoming inspection of inhaler component parts



Typical Applications:

Foreign Particles in Dry Powder Inhaler

Troubleshooting in Clean Production Processes

Fast chemical mapping of a Dry Powder Inhaler Formulation



Dry Powder Inhaler Study:

This particular study, conducted in cooperation with a leading dry powder inhaler manufacturer, provides evidence that a specific foreign particle profile can be attained after successful method development analysis.



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Publications:

VALET, O., (2011), MDI Foreign Particulate Matter Raman Determination Method Validation According to ICH Parameters, RDD 2011, Vol 2, pp 419-424

VALET, O., et al., (2010),The Use of High Throughput Raman Microscopy for the Concurrent Size Determination and Chemical Characterization of Inhalation Particles, RDD 2010, Vol 3, pp 763-768

VALET, O., LANKERS, M., (2008), Automated Imaging Analysis coupled with Raman Identification of 0.5-5000 µm Particles – Particle Explorer, PSA 2008

Valet, O., Lankers, M., (2008), Measurement and Identification of Foreign Particles in a QbD Environment – Streamlining with Efficient Analytical Methods, RDD 2008, Vol 3, pp 723-726

VALET, O., LANKERS, M., (2008), Higher Yield and Quality through Particle Identification, Journal of the IEST, October 2008

CHAMARTHY, S., et al., (2007) Why Powders Don't Behave the Way We Want? Understanding How Surfaces of Pharmaceutical Powders Influence Functionality, RDD Europe 2007, Vol 1, pp 321-324

BLANCHARD, J., et al., (2007), Best Practices for Managing Quality and Safety of Foreign Particles in Orally Inhaled and Nasal Drug Products, and an Evaluation of Clinical Relevance, Pharmaceutical Research, Vol. 24, No. 3

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

Valet, O., Niemann, M., (2006), Qualification of the Particle Explorer System for Foreign Particles Counting and Identification in a Dry Powder Inhaler Product Based on IPAC-RS Recommendations, RDD 2006, Vol 3, pp 761-764

VALET, O., (2006), Automatische Partikelidentifikation - Aufklärung von Mikrometer Kontaminationen ab 500nm, rap.ID Particle Systems GmbH

Niemann, M., Valet, O., (2005), Development of an Integrated Measurement System for Foreign Particles Testing in OINDP Based on IPAC-RS Recommendations, RDD Europe 2005, Vol 1, pp 181-184

RÖSCH, P., et. al., (2005) Chemotaxonomic Identification of Single Bacteria by Micro-Raman Spectroscopy: Application to Clean-Room-Relevant Biological Contaminations, Applied and Environmental Microbiology, March 2005

VALET, O., LANKERS, M., (2005) Automated Raman Spectroscopy of ambient Aerosols with Airborne Particle Explorer, AAAR 2005

KREHER, C., et al., (2004), Foreign Particle Characterization in Inhalation Drug Products: A Critical Comparison of Methods and Techniques, Respiratory Drug Delivery, IX p x-y

VALET, O., (2002), Made to Measure, Cleanroom Technology, Polygon Media

LANKERS, M., (2002), Determining particle composition: Consider the path to the source, Cleanrooms, PennWell

LEWANS, M., (2001), Fingerprinting particles "automatically” , CleanRooms Magazine, 9

VALET, O., (2001), Woher stammen Partikel, Reinraumtechnik, GIT-Verlag

VALET, O., (2001), Schnelle Materialbestimmung von Mikropartikeln, Laborzeitschrift, GIT-Verlag