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Foreign Particle Studies and Routine Analysis:

Foreign Particle detection 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.

IPAC-RS proposes a best-practice approach for the control and enumeration of foreign particulate matter. Identification of any foreign particulate matter (FPM) is to occur during development. This all follows the quality by design, QbD approach of the FDA.


IPAC-RS proposes a best-practice approach for the control and enumeration of foreign particulate matter. Identification of any foreign particulate matter (FPM) is to occur during development. This all follows the quality by design, QbD approach of the FDA.

How we control FPM in OINDP:

Collect the delivered dose in a collection tube designed for low blank values

Dissolve active and excipient particles

Enumerate the particles isolated on a filtr.AID patch with the Single Particle Explorer

Identify automatically hundreds of the FPM with the Single Particle Explorer

Document the status of FPM numbers and composition in an OINDP



Your Advantages:

We provide FPM identification method development and validation within an extremely short timeline. Contact us today to streamline your new drug application, NDA regarding FPM assessment. By using our services you have access to over 7 years experience in the field of foreign particulate matter enumeration and identification in OINDP, based on more than 10 successfully performed FPM studies. Our experience ranges from method development and validation for the enumeration to the identification of foreign particulate matter.
Simply contact us and we will get back to you with a proposal following the ICH guidelines.



The rap.ID way to control FPM in your OIND Product

Whilst maintaining a close discussion with the client we develop a method to control the level of FPM in your product. With this method we then create a preliminary validation, thus ensuring that we have all the parameters determined for the following ICH validation attributes: linearity, accuracy, precision, repeatability and intermediate precision.

Typical Applications

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

Foreign Particles in Dry Powder Inhaler

Troubleshooting in Clean Production Processes

Fast chemical mapping of a Dry Powder Inhaler Formulation





Example

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.



Publications

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