Underdriven Cone Mill (Continued)
(continued)
GSK’s ongoing relationship with Kemutec as one of their preferred suppliers meant that Colin Chapman, Plant Engineering & Operations leader at GSK’s R&D facility in Co. Cork had no hesitation in approaching Kemutec Powder Technologies when he had a requirement for a new size reduction mill. The R&D facility has been in operation since 2000 and since then a vibrating sieve had been used to classify the product particle size but this proved to be unproductive. As Colin Chapman comments, “The vibrating sieve wasn’t meeting our customers requirements. We decided that what we needed was a size reduction mill and Kemutec was happy to discuss the process and together we came up with the right solution.”
The operating process itself is uncomplicated. As the pharmaceutical powder exits the dryer, it is milled to ensure the correct sizing prior to the next stage of the process, which may be tableting or on to a milling suite for further size reduction i.e. nanomilling or classification. It was the specific location of the mill regarding space restrictions and the complexity of different products that were to be processed that created the challenge for Kemutec Powder Technologies.
The basic premise was to design a mill capable of handling materials with Occupational Exposure Levels in the order of < 1 microgramme/m3, with the ability to withstand chemical corrosion by the milled products and cleaning agents as well as incorporating the flexibility to accommodate the varying characteristics of many different product types.
Containment was a major issue to consider. Since the mill would be installed and operated outside the glove-box environment, it would be necessary to ensure the integrity of the design would match the desired containment levels. As such, the mill was designed, tested and certified to 1 bar g, thus ensuring containment under the normal ambient operating conditions.
In order to future proof the installation for unknown products and their likely associated astringent cleaning agents, the material of manufacture was C22 Hastelloy providing higher resistance than stainless steel to hazardous materials.
Because the mill was to be installed in an R&D facility, the capabilities needed to be flexible enough to handle different drugs of different properties with unique handling requirements and throughput rates. The equipment was required to fulfil the needs of process flexibility in terms of speed rates and input and output sizes. Layout flexibility was also a consideration in terms of interchangeability and quick change access between gloveboxes and operational flexibility in terms of independent local control or full system control.
The mill itself is a low profile design with the motor mounted through 180 degrees due to space constraints and is installed on a bespoke trolley to allow manoeuvrability. The trolley design facilitates the movement of equipment to remote cleaning areas and also permits flexibility for use with different products.
The KEK 170 Underdriven Cone mill is one of several Kemutec installations at the GSK R&D facility at Cork. This year alone, the R&D site has sourced a KEK K300C Centrifugal Sifter with RB Feeder in C22 Hastelloy interfacing with a glovebox to allow flexible feeding and sieving operations. In addition, they purchased a KEK 220 Cone Mill also manufactured in C22 Hastelloy mounted into the base of a glovebox to allow direct loading from an R&D Dryer. The production site at Cork have also installed a special KEK 170 Underdriven Cone Mill with jacketed and cooled bearing housing for milling materials with low temperature sensitivity as well as five Feeder-Cone Mill-Sifter arrangements in a variety of Stainless Steel and Hastelloy materials.
Kemutec Powder Technologies is very proud of the relationship that has developed with GSK, as KPT’s Sales Manager, Martin Thomson states “GSK are an innovative company and provide us with challenges that encourage us to explore new boundaries in pharmaceutical processes. We are extremely proud that GSK consistently choose us to develop new processes and I hope that we’ll continue to work closely with them”.
KEK Cone Mills are part of a comprehensive range of size reduction mills manufactured by Kemutec Powder Technologies, which also includes KEK Universal Fine Grinding Mills and PPS Air Classifier Mills. In addition, Kemutec also manufacture KEK Centrifugal Sifters, GARDNER Mixers and the MUCON range of Valves, Discharge Aids and Level Indicators.
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Fig. 2:
Series 170 Hastelloy Underdriven Cone Mill mounted into the base of glove-box
Attachments
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Underdriven Cone Mill
New Kemutec Installation at
GSK’s Research & Development Facility
Kemutec Powder Technologies (KPT) like nothing more than a challenge! Over the years it has been the demands of the pharmaceutical industry in particular that have been a major driving force behind the development of KPT’s range of state of the art size reduction and size classification equipment. Pharmaceutical manufacturers are constantly striving to meet the increased demands of today's rapidly changing healthcare environment and to adhere to ever more stringent legislation. KPT’s intimate knowledge of the pharmaceutical industry enables them to produce bespoke equipment to meet the demands of the major pharmaceutical companies and their regulatory authorities and are prepared to work with each customer to offer a process solution to any application requirement.
An example of this is the recent installation of a custom Series 170 Hastelloy Underdriven Cone Mill at GlaxoSmithKline’s Research and Development facility at Cork.
GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical company with an estimated seven per cent of the world's pharmaceutical market. GSK's broad pharmaceutical product line and constant commitment to innovation and development means that its Research and Development Facilities are at the forefront of drug development.
Kemutec Powder Technologies have supplied various mills and sifting machines over the years to both research & development and production facilities at GSK sites worldwide. The high tech R&D facility is at the forefront of GSK’s drug development campaign and the new cone mill is designed for Research and Development purposes to accurately replicate production processes and to facilitate small batch production as part of the solid dose process.
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Fig. 1:
The low profile design Cone Mill with special top mount motor minimizes space.
Attachments
kemutec_gsk_1 (JPG)
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