Hosokawa Micron partnered with one of the largest pharmaceutical companies globally to develop a novel Contained Particle Size Reduction Facility to realize flexible milling down to superfine particles of active pharmaceutical ingredients at R&D, pilot scale and small scale production volumes.
Features of the New Facility
The Contained API Particle Size Reduction Facility consists of three mills including a lump breaker. The facility has three material feed options and operator exposure levels less than 1μg/m3. Designed with cGMP specifications and combined with full SCADA control makes this facility one of its kind to provide high levels of complex but user- friendly operational flexibility to suit the competitive economy today.
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The system is installed with two separate but interconnected isolator chambers, the product collection chamber and the milling chamber. Placement of the product feed and the mill is towards the rear of the unit while the production operations are carried out at the front of the unit.
- The milling chamber – is designed to handle multi-powder size reduction using three separate mills that can be used within the system.
- The interchangeable mills are equipped on wheeled skids to be wheeled into a position to ensure docking.
- The seals used for interlocking make sure that the mills are fully engaged and connected so that they are ready for operation. The seals maintain the less than 1μg/m3 OELs to be realized.
Additional Components to the Original System Design
The system equipped with an impact mill for fine grinding and a spiral jet mill for finer grinding is also provided with a third fluidized opposed jet mill for finest micronising. The Microniser is another component that has been added to this system from another system to achieve the skid mounted needs of the new size reduction plant. An in-line lump breaker is housed in the grinding chamber for coarse grinding and preconditioning the powder before fine size reduction.
Multi-Feed Options
Three feed options have been provided to ease the problems relating to different handling characteristics of materials to be processed with the choice of switching between options as required. The three options are a rotary valve, a screw feeder and manual feed through a small hopper that may be the most suitable solution when small batches have to be processed.
Product Collection Chamber of the Facility
While the facilty’s first isolator is solely used for production of small and gramme batches, the second isolator is utilized for large batch production, sub-division and dispensary operations. The product is collected with a reverse jet filter.
The chamber is equipped with in-line laser diffraction particle size analysis or manual sampling options so as to realize precise product specification.
Additional Facility Features
The Contained API Particle Size Reduction Facility features half suit technology for an improved ergonomic and less restricted work environment which has lift platforms to provide the operator with easy accessibility for all procedures. Easy clean construction of the facility helps in eliminating collection of dust and dead spots, thus enabling the handheld lance WIP operations to meet the stringent standards.
An advantage of this system is that it can be further upgraded to a closed loop intelligent system control when the need arises in the future.
The Pharma Team Leader of Hosokawa Micron, Mike Coffey observed that the engineers from Hosokawa have partnered well with the customer’s production and engineering teams to deliver this futuristic flexible API processing facility. He added that using existing equipment and related performance information they were able to find customized solutions.
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This information has been sourced, reviewed and adapted from materials provided by Hosokawa Micron.
For more information on this source, please visit Hosokawa Micron.