The Super Clean Mill meets the requirements of good manufacturing practice (GMP) in the pharmaceutical and food industries. The special design of this pin mill allows broad use. For processing newly developed active substances, the GMP-compliant mill is housed in a containment.
Reliable standard operations are essential in the pharmaceutical industry. They guarantee safety during production as well as the delivery of high-quality products. In order to reach this target, it is necessary to cope with every single process step and make every activity easy to handle – and above all safe. The Super Clean Mill (SCM) pharmaceutical mill is designed and refined to meet the worldwide requirements of the GMP standard. Its working method is based on the principle of a conventional pin mill. The minimal heating-up during milling as well as the straightforward adjustment of the particle size by screen inserts and the simple structure for fast and easy cleaning and maintenance are just some of this machine’s many advantages.
Depending on the application, different rotors and a wide range of screens with diameters from 0.2 to 5 mm can be supplied for adjusting the particle size of the final prod-uct. However, the exact definition of the final particle size not only results from the grinding tool geometry but also from the chosen rotation speed. As the screen is a major grinding tool, its insertion into the mill has been optimised for one-hand exchange. Screen replacement is consequently fast, the effort for cleaning is low and maintenance due to cGMP presents no problems. The design of the casing has moreover been perfected to make it easily cleanable: it is split into several slices.
The mill is equipped with different design features to prevent contamination, e.g. the arrangement of the air-purged shaft seal and the direct drive or the spatial separa-tion between the milling area and the drive unit. Other important innovations of the Super Clean Mill linked to good manufacturing practice include:
- All product-contacted parts are made of stainless steel with a polished or highly machined surface quality of Ra #0.8 µm
- All lubricants and seals are certified by the FDA or an appropriate authority
In order to fulfil the safety requirements, the mill is equipped with switches and locks as needed, so that rotating parts cannot be touched. Nara additionally offers a specially developed double gas shaft seal for this machine as an option, to ensure even better protection against all kinds of exterior product contamination. CIP (cleaning in place) and SIP (sterilisation in place) are likewise available.
Grinding under containment
Processing newly developed active substances with increased efficiency requires changes to the equipment design and the operational sequences. Protecting the operator from these active substances and isolating the product from impurities in the environment are two particularly impor-tant aspects. The Millbox was developed collaboratively by PSL and Nara. It is a GMP-compliant pin mill, optimised for use in a containment. The inserted mills are of the Super Clean Mill type and available in different sizes.
It is not sufficient to use a dust-tight mill for highly potent drugs due to product change procedures. Changing the product would lead to increased exposure to the surrounding atmosphere and the operator. Working in a containment affords the very high protection that is mandatory here. An O.E.L. of less than 1 µg/m³ can be achieved with adequately shielded product feeding and discharge devices. The mill is dismantled and cleaned actually inside the Millbox using half-arm gloves, the position of which is ergonomically adapted to the operator.
Hall 7, Booth 359
Online-Info www.cpp-net.com/2110404
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