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Product category: Pharmaceutical Processing News
News Release from: Hosokawa Micron | Subject: Grinding/micronising suite
Edited by the Processingtalk Editorial Team on 03 February 2004

Multi purpose micronising plant for
pharma use

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Modern pharmaceutical plants are no longer single product facilities, the ideal is a highly flexible multi purpose plant, which can process several high value products in the one fully validated unit

Modern pharmaceutical manufacturing systems are moving away from dedicated single product facilities, now often regarded as a luxury, and the ideal is a highly flexible multi purpose plant, which can process several high value products in the one fully validated production unit It is with this design criteria in mind that Hosokawa Micron and a world-leader in pharmaceutical manufacturing have collaborated to produce a highly flexible ultra fine grinding/micronising suite with high containment isolation capable of meeting current and future micronising needs

The brief was to design a fine grinding system to mill pharmaceutical products while maintaining a philosophy of no reliance upon PPE (personal protective equipment) within the processing area so that no special protective clothing is required during processing with full CIP (clean in place) systems to ensure cleanliness between batches as well as operator safety during any dismantling operation.

The ultra fine grinding system consists of an enclosed drum tipping section for the unloading of the primary coarse product, a state of the art classifier milling unit and a final fill/weigh packing system for the end milled product.

Each of the drum handling operations is carried out in special, purpose designed negative pressure isolators where the requirements of the process equipment and operator activities were carefully considered.

Each isolator unit was designed for optimum ergonomic accessibility for processing, cleaning and maintenance and each has its own internal CIP capability.

Drum Tipping System.

Designed for maximum product manipulation whilst maintaining product isolation the drum tip unit is totally enclosed in a Stott isolator achieving barrier containment levels down to 5 microgrammes per m3.

Interlocked door access ensures each compartment is secure during processing and material from the drums is discharged into the next stage, the milling system.

Fine Grinding/Micronising System.

The customer requirement for a product having a steep particle size distribution free from oversize particles was best met using the Alpine 100ZPS Air Classifier Mill.

The internal air classifier of this mill ensures a sharp cut off at the top size and a narrow particle size distribution.

There is no oversize or coarse material tail, which would require further grinding.

The low energy, air swept design of the 100 ZPS unit is also ideal for milling temperature sensitive pharmaceutical materials.

Full flexibility is achieved as this 100ZPS mechanical mill can be simply converted to a 200AFG fluid bed jet micronising unit using compressed air or gas by simple exchange of the bottom section of the mill without the need to change any other component.

This allows the processing of all present products and gives the flexibility to introduce all future products with the ability to meet the product size specifications.

Working closely with the client engineers, Hosokawa Micron designed an integrated milling system with high containment Stott isolator units situated in a multi storey process area.

System controls were integrated into existing control systems at their site enabling monitoring of all critical process parameters for historic trend analysis.

The containment philosophy allows operation in dual mode with laminar flow achieving operator exposure levels of 10 microgrammes/m3 and full isolation achieving containment levels below 5 microgrammes/m3.

Through close partnership with the end user, Hosokawa Micron have engineered a flexible solution to meet the business demands and this relationship continues as new products are brought into the manufacturing plant.

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