Particle ID in Parenterals

Thanks to our cooperation with more than 40 manufacturers of liquid pharmaceuticals, rap.ID has comprehensive experience in the counting and analysis of foreign particles in parenterals. With rap.ID technology, the source of particles can rapidly be found in the manufacturing and filling process, accomplishing a professional root cause analysis.

We are experienced in:

	Primary particle controls for foreign particles
	Source of subvisible particles (10 - 50 µm)
	OOS analysis of "visible rejects"
	Clarification of specific foreign particle issues
	Automated size distribution measurement of subvisual particles in suspensions
	Routine particle counting using the optical particle counter method in compliance with USP <788>
	Particle emission behavior of stoppers according to DIN EN ISO 8317
	Sources of defects in product containers after blow-fill-seal processes
	Training courses for particle isolation, counting and identification

Our Methods:

	Raman-Spectroscopy
	LIBS (metal.ID)
	FT-IR Mikrospectroscopy
	REM/EDX-Analysis
	Membrane Particle Counting Optical Particle Counting

Examples of Investigations:

	Troubleshooting in clean production processes
	Identification of Particulate Matter - Reject Small Volume Patenteral

Results:

Substance	Number	Size
		>=50	>=100
Cellulose	4	4	0
Polyethylene	4	2	2
Total	8	6	2