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Optimal particles and agglomerates with the Super Clean Mill and Nebulasizer
Good results included

Reliable standard operations are essential in the pharmaceutical and food industries. They guarantee safety during production as well as delivery of a high-quality product. In order to reach this target, it is necessary to master every single process step and make every activity easy to handle as well as – above all – safe. Nara’s Super Clean Mill (SCM) and Nebulasizer are two products that fulfil these requirements.

Wilfried Pieper

The Nara SCM pharmaceutical mill was specifically designed for the pharmaceutical and food industries. Its working method is based on the principle of a conventional pin mill, in conformance with the requirements of good manufacturing practice (GMP). The minimal heating-up during milling, the easy adjustment of the particle size by means of screen inserts and the simple layout to facilitate quick and easy cleaning and maintenance are just some of the advantages of this machine.
The mill is equipped with several design features to prevent contamination, for example an air-purged shaft seal, a direct drive and physical separation from the milling area and drive unit.
Two other important aspects linked to the good manufacturing practice of the Super Clean Mill are that all product-contacted parts are made of stainless steel with a polished or highly machined surface quality of Ra# 0.8 µm; moreover, all lubricants and seals are certified by the FDA or another appropriate authority. In order to comply with safety requirements, the mill is fitted with safety switches, so that rotating parts cannot be touched. Nara offers its novel and patented double gas shaft seal for this machine as an option, to ensure even better protection against contamination. CIP and SIP are likewise available.
Particle standardisation
Another machine that allows processing under GMP conditions is the Nebulasizer, which is designed to optimise the size distribution of granules. It is equally suitable for both wet and dry products. In each case, the oversized particles are ground to a standard size. In wet agglomerates, the fine particles are increased in size, too. It is thus possible to eliminate the coarse particles and agglomerate the fine particles in a single step. Additional process steps such as sieving can be dispensed with. This process leads to considerable cost-savings, especially with expensive products that cannot be recycled due either to their properties or to the fact that no recycling method exists for them.
Assembly and disassembly of the Nebulasizer are quick and flexible, allowing grain size distributions between 100 and 4000 µm. Extruded, granulated and centrifuged products are particularly well standardised in this machine. Models with capacities between 20 and 4000 kg/h are currently available.
The Nebulasizer’s type of construction ensures that material fed between its cone-shaped rotor and the stator is cracked and standardised by the shear force generated between these two components without over-milling the particles. The gap between the rotor and the stator can be easily adjusted for perfect control of the particle size.
A key advantage of this technology is the ability to standardise wet products. The Nebulasizer can be retrofitted to a process like mixing & granulating, the extrusion of pharmaceutical products or following ablution. A standardised particle size distribution is prepared in this way for the downstream drying process. As the oversized particles have already been eliminated and sieving is no longer necessary, there are no oversized agglomerates to be dried, in other words the residence time in the dryer is much shorter.
The Nebulasizer’s operating principle is ideal for wet products, which are more malleable than dry ones. Hence, the coarse grained particles can be crushed and the share of fines minimised in a single step.
Another unique feature of the Nebulasizer is its mechanical design and concept. All forms of sieve were deliberately omitted. Contamination of the product due to dam-aged screens or screen clogging – often a problem with other processing methods and techniques – is ruled out completely. Finally, easy cleaning of the machine is a further major advantage.
Hall 6.0, Booth F13
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