Particle Origins in Parenterals

Modern biopharmaceuticals contain a manageable number of foreign particles and even less intrinsic contamination sources as a result of parenteral production processes. The SPE raman.ID biopharma is a device that is used to determine the formation of protein aggregates in new formulations.

SPE-ls enables the user to identify and eliminate contamination sources using a streamlined database with over 700 standard entries of potentially contaminating materials such as cleaning agents, clean room clothing, primary packaging, etc.

Biopharmaceutical Formulations:

Today's modern biopharmaceuticals pose a significant challenge to manufacturers and developers due to their complex nature. The SPE makes small variations in formulations, and thereby reliably identifies protein particles. Highly sensitive analytical results are particularly important in silicone compatibility studies in biopharmaceutical formulations.

Foreign Particulate Matter:

Identify find and Eliminate Sources of Foreign Particulate Matter

Over 90% of all foreign particulate matter can be reliably identified using combined LIBS (metal.ID)/raman.ID technologies. metal.ID can also distinguish different types of glass and rubber stoppers. Furthermore, hundreds of individual inorganic (metal.ID) and organic (raman.ID) particles can be easily searched, identified and tracked back to their originating sources using the automated database.

Packaging is one of the primary sources of particulate contamination in parenterals. Controlling the cleanliness levels of syringes, stoppers and their containers is a very useful method to detect and minimize rejects.Single Particle Explorer CSS (SPE CSS) performs standard container cleanliness control and closure systems analysis prior to filling. The fully automated system is also easily validated to work according to the membrane counting method described in the USP <788>.

Publications:

LANKERS, M., VALET, O., (2010), Quantification of Protein Agglomeration in Differently Siliconized Syringes, PDA Annual Meeting Orlando 2010

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

LANKERS, M., VALET O., (2008), Differentiation between foreign particulate matter and silicone oil induced protein aggregation in drug solutions by automated Ramanspectroscopy, Microscopy and Microanalysis, 14 (Suppl. 2), Conference 2008

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

LANKERS, M., VALET, O., (2007), Improved Quality through Particle Identification . PDA Journal of GMP and Validation in Japan, 9: 82-89, 2007

DAS, T., (2007), Early Stage Protein Formulation Development and Use of High Throughput Screening Methods, AAPS NBC , San Diego 2007

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

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

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

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

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

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