Part of the key to Silversons’ success – and that of our clients – is the accuracy with which we can predict the performance of our production scale mixers based on laboratory trials. There’s no point using a laboratory mixer capable of speeds of 25,000 rpm or more if the results cannot be replicated in production. That’s why our laboratory mixers are designed and built to the same tolerances as our production units; comparable rotor tip speed and shear rates across our entire product range means scalable results, time after time.
Recently, a multinational pharmaceutical company purchased two Ultra-Hygienic autoclavable design In-Line mixers, successfully scaling up a process they first tested on a lab mixer. The company was developing a modified virus to be used in treatment to destroy cancerous tumours. To do this they needed equipment that could finely disintegrate and disperse cells in water, using these cells to develop the virus. The milling of the cells is the step which releases the virus, after which it can be extracted and then genetically modified to target and destroy cancerous tumours.
The company contacted Silverson to test a lab mixer at the first stage of process development and the results they achieved were very good. In order to make the process safer, the company wanted to try a Sealed Unit lab mixer. They purchased a Sealed Unit lab mixer with assemblies that they could sterilise by autoclaving.
After using the sealed units for further trials, they wanted to be able to control the amount of shear imparted to the product during operation to get the precise results they were looking for. They decided to buy a laboratory scale In-Line assembly as this provides intense yet targeted high shear to the small amount of material in the mixing chamber; In-Line mixers can also be used for discreet passes between two vessels, giving the ultimate in control as they product can be processed by a defined amount.
They purchased several L5Ms with In-Line assemblies for use on 2-5 litre batches. After each use the In-Line assemblies were sterilised in an autoclave as they had done with their previous Sealed units.
As the development process advanced successfully, the company needed to be able to work on a larger scale, but wanted to keep their procedure the same as it had been during the initial development stage using the lab mixers. Silverson recommended a 200 UHS In-Line with autoclavable design. At 5,000 rpm the 200 UHS produces the same shear rate as that of the In-Line assembly at 8,000 rpm. This ensured the mixer produced the same results as the lab mixers and as a result, the process is now in industrial scale production, using two 200 UHS In-Lines with the autoclavable design. The mixers are used on 20 litre single use process bags. This highlights the advantages both of scalability within Silverson’s product range and our ability to design and manufacture custom built, highly specialised equipment. As a result, the company was able to scale up successfully from lab trials without intermediate testing, a considerable saving in development costs.
From laboratory to production-scale, Silverson Machines offers an unparalleled range of high shear mixers and the largest capacity range from a single manufacturer, and continually add new mixers to this already substantial range.
The recently launches 150 UHS In-Line mixer is designed for Ultra-Hygienic applications typically encountered in the pharmaceutical, nutraceutical and biotech industries. This mixer is especially useful where the smallest production scale mixers may be too large, but laboratory equipment may not offer sufficient capacity. This model is built to the same high specification as production scale UHS In-Line mixers and can be supplied with Silverson-designed hygienic single mechanical shaft seals, which can be converted to hygienic double mechanical shaft seals suitable for pressurised flush. They have a crevice-free construction and are designed for Clean-In-Place (CIP) and Sterilise-In-Place (SIP) operations. Ideal for batches of up to 50 litres, the mixer features a range of interchangeable workheads and screens, offering intense yet targeted high shear capability; a conversion kit allowing it to be used as a Multistage 088/150 is available. The mixer can be supplied with data dossier documentation packages conforming to all regulatory standards, for example, cGMP and FDA and EC1935/2004.
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