Malvern analyzers for the pharmaceutical industry

Automatic process control and on-line QC place high demands on the uptime performance of a particle size analyzer, and all Malvern systems are designed from the outset for process use. Key to their success is the ability to be installed almost anywhere, thanks to strong interfacing capabilities, both to the process and to the control system.

• Highly robust high speed instruments
• Hygienic fittings to ensure ease of cleaning between production campaigns of entire sample path
• Designed for pharmaceutical use in a GAMP4 environment
• Pharmaceutical kit option includes validation documentation, 21 CFR part 11 compliance, materials traceability, and pharmaceutical grade stainless steel surface finish

Below is a table outlining the different analysis solutions available:

Dry powders

Environment		Analyzer		Accessories		Process Interface		Useful for.
GAMP4 Production facility		0.1-1000µm, Static integrated analyzer: Non-IS: Insitec T IS: Insitec X		Various automated options Pharmaceutical kit option		Dilute streams: In-line dry flow cells		Mill or spray drier exit
						Medium-high concentration: Jet-stream eductor		Classifier (final grade) exit
						At-line: manual sampling accessory		General near-process QC
Pilot studies		0.1-1000µm, Mobile analyzer: Insitec Voyager		"plus" pack, (automation option) Non-IS: Insitec T IS: Insitec X Pharmaceutical kit option		On-line: Jet-stream eductor At-line: manual sampling accessory		Spray drier optimization Mill optimization
		50-2500µm, Static integrated analyzer Non-IS: Parsum IPP70S IS: Parsum IPP70SE		Analogue 4-20mA outputs		In-line probe with variety of custom measurement zones		Mill feed (processability)

Wet particulate suspensions

Environment		Analyzer		Accessories		Process Interface		Useful for.
GAMP4 Production facility		0.1-1000µm, Static integrated analyzer: Insitec L		Pharmaceutical kit option Various automated options		Dilute streams: In-line wet flow cells Medium-high concentration: cascade diluter eductor		Exit to wet mill or classifier
Pilot studies		0.1-1000µm, Mobile analyzer: Insitec Voyager		"plus" pack, (automation option) Insitec L		Dilute streams: In-line wet flow cells Medium-high concentration: cascade diluter eductor		Mill optimization
Sprays		0.1-1000µm analyzer: Insitec S		Various optical bridges		Open unit Flow cell		Delivery system optimization