SPE raman.ID 5 - Applications

High throughput characterization enables any operator to quickly determine the chemical composition of particles in 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 the specification limits, showing an excessive concentration of particles, the contamination source can be identified and eliminated during operation within minutes.

Thanks to improved process knowledge, based on statistically relevant particle identification, it is possible to improve the quality and production yield of particle-sensitive products.

Application Notes

	Troubleshooting in Clean Production Processes
	Identification of Particulate Matter - Reject Small Volume Parenteral

The SPE raman.ID 5 is dedicated for the following applications:

Particle Contamination on Implants

	Quality control of implants
	Verify the quality of the water produced from water purification systems
	Product quality control for particle contamination
	Continous and routine testing of particle sensitive products and production environment

Microanalysis

	Paint and glass delamination investigations.
	Control of liquid crystals, cleansing solutions, process media and baths.
	Cross-Sectional Identification Analysis
	Reverse engineering

Parenterals

	Pharmaceutical Water For Injection (WFI) monitoring
	Control of cleanliness levels in pre-filled-syringes
	Visible and sub-visible particle contamination testing
	Qualification of production facilities after installation, reconstruction, standstill etc.
	Testing surfaces, consumables and primary packaging
	Testing the effectiveness of cleaning and disinfection measures during operation and at the end of production
	Development and control of foreign particulates level on parenterals primary packaging materials
	Streamlined process and product understanding (QbD) leading to process and product improvement studies
	Preventive quality assurance (CAPA) in the production of parenterals
	Continuous monitoring of the chemical composition of foreign particles for process optimization (clean intelligence)
	Identification of foreign particles, residues and particulate contamination for root cause investigations
	Cleaning process validation
	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

Pharmaceuticals

	Foreign particles, residues and contamination analysis
	Particle shape and size distribution of solide state drug substances, drug products and excipients
	Powders - Particles morphology and size distribution characterization

References

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

Identification in a Cellulose Containing Suspension of a Nasal Spray Formulation, RDD Eurpe 2007, Vol 1 pp 325-328

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