SPE CSS - Particle Control

The SPE CSS is capable of analyzing GxP environments with varied norms and regulations. The SPE delivers validated documentation results for both pharmaceuticals and component cleanliness applications.
Solid contamination is the main factor that causes failures, misfunction, and decay in hydraulic systems.

The SPE CSS measures contamination levels by determining the particle count per unit of volume in a liquid (ISO 4407:2002.)

This number can then be classified in Contamination Classes according to international standards. The most popular standards for determining Contamination Classes for hydraulic systems are ISO 4406:1999; and NAS 1638 (under revision.)

Application Notes:

ISO 4407:2002 Fluid Contamination Determination

Troubleshooting in clean production processes

Particle release behaviour of stoppers according to DIN EN ISO 8871-3

Foreign Particles in Parenterals

	Pharmaceutical Water For Injection (WFI) monitoring
	Control of cleanliness levels in pre-filled-syringes
	Visible and sub-visible particle contamination testing
	Cleaning process validation
	Qualification of production facilities after installation, reconstruction, standstill etc.
	Testing surfaces, consumables and primary packaging
	Development and control of foreign particulates level on parenterals primary packaging materials

Pharmaceuticals

	Particle counting in creams
	Particle shape and size distribution of solid state drug substances, drug products and excipients
	Foreign particles, resitdues and contamination analyses
	Particle shape and size distribution of solid state drug substances, drug products and excipients
	Powders - Particles morphology and size distribution characterization

OINDP

	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

Implants

	Quality control of implants foreign particle status
	Verify the quality of the water produced from water purification systems
	Continous and routine testing of cleanroom production environment

Hydraulics Fluid testing

	Gear boxes and other engine components cleanliness testing
	Control hydraulics and airspace liquids and fluids
	Subsea drilling hydraulics fluid control

Components and parts cleanliness

	Evaluation of tool, machine and component cleanliness
	Fuel and injection systems cleanliness control, testing and development
	Oil debris and wear particles identification for diagnosis and oil change descisions

Microanalysis

	Paint and glass delamination investigations
	Control of liquid crystals, cleansing solutions process media and baths
	Micro Spot Analysis of contamination and material inclusions

References

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), Higher Yield and Quality through Particle Identification, Journal of the IEST, October 2008

VALET, O., (2006), Application: Safe and Simple Component Cleanliness, rap.ID Particle Systems GmbH

LANKERS, M., et. al., (2004) Protecting the Patient, Cleanroom Technology, July 2004

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