Nasal spray pumps cleanliness and particle release testing

Foreign particle analyses in the context of approval studies or in the quality control of orally and nasally administered drugs

DPI Inhaler device cleanliness testing

Dry Powder Inhaler formulation particle design with morphological analysis and particle size distribution

MDI valve and canister cleanliness and particle release testing

Dry Powder Inhaler formulation particle design with chemical ID analysis and to monitor content blend uniformity and particle size distribution of active pharmaceutical ingrediance

FP profiling for New Drug Application or delivery device design changes through high throughput FP identification

Streamlined process and product understanding (QbD) leading to process and product improvement studies

Troubleshooting in Clean Production Processes

Identification of Particulate Matter - Reject Small Volume Parenteral

Foreign Particles in Dry Powder Inhalers

Fast chemical mapping of a Dry Powder Inhaler Formulation

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

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

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

LANKERS, M., (2004), Differentiation between Foreign and Protein Particles in Biopharmaceutical Preparations , RISBM 2004 "Raman and IR Spectroscopy in Biology and Medicine"

LANKERS, M., (2003), Higher Productivity through Particle Identification - Manufacturing of Parenterals, Annual Meeting der PDA 2003

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

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