High speed, high shear mixers for the pharmaceutical industry

Published: 3-May-2024

From laboratory scale mixers capable of handling as little as 1 mL to production-scale models, including hygienic and ultra-hygienic mixing equipment specifically designed for pharmaceutical applications, Silverson Machines has a vast product range

Scale-up is a relatively simple process as all Silverson mixers are manufactured to the same precision engineered tolerances. As such, anything you produce in the laboratory can be replicated at production scale without the need to reformulate.

Having supplied pharmaceutical companies from global leaders to small, highly specialised companies for more than 75 years, Silverson has an unrivalled knowledge of the requirements of pharmaceutical applications and regulatory bodies (US FDA, 3-A, cGMP, etc.).

This year, Silverson Machines will be exhibiting at CHEMUK on stand J56. Here is an overview of the products that will be available to visitors to view at the show.

Laboratory mixers

From small start-ups to larger international brands, Silverson laboratory mixers have been sold to companies all over the world.

The popularity of Silverson laboratory mixers can be attributed to their versatility; they can be used to mix, emulsify, homogenise, disintegrate and dissolve with an efficiency and flexibility unmatched by other machines.

On the CHEMUK stand, visitors will be able to see the “standard” L5M-A model, which is now available with the body finished in white engineered polymer for increased durability and ease of maintenance.

The updated radiused edges allow for easier cleaning. With its integral tachometer, ammeter and programmable timer, the L5M-A offers a level of instrumentation that’s invaluable in applications when process validation and repeatability are required.

The advantage of a Silverson compared with simple agitators and stirrers stems from the specially designed rotor/stator workhead; the high-speed rotation of the rotor blades draws materials into the workhead where they are intensively mixed.

High speed, high shear mixers for the pharmaceutical industry

The blend is then subjected to intense mechanical and hydraulic shear as it’s projected back into the body of the mix at high velocity. With this method, ingredients are fully incorporated and any agglomerates are eliminated.

There are more than 40 workheads, screens and assemblies available for Silverson laboratory mixers.

These easily interchangeable workheads enable any machine to accommodate a wide range of mixing operations and allow one mixer to perform duties that, in the past, may have required several different pieces of processing equipment.

These mixers are ideal for small batches (1 mL up to 12 L) and can mix inline with flow rates up to 20 L/min using an inline mixing assembly, further increasing versatility.

Benchtop inline mixer/homogenisers

When higher throughputs or a designated inline laboratory unit are required, Silverson has designed the Verso. Visitors to the stand at CHEMUK will be able to see the Verso, a benchtop inline mixer that can be supplied with a vessel package to replicate a recirculation process at pilot scale.

The Verso offers an easy and accurate way to forecast the performance of larger inline mixers under full-scale working conditions. Silverson’s line of high shear inline mixers offers a great many advantages to the operator, including speed, versatility, aeration-free mixing and guaranteed efficiency.

These mixers are ideal for continuous mixing. Silverson inline mixers can produce a uniform droplet size in the range of 2–5 microns. The Verso is now also available in an ultra-hygienic specification as the Verso-UHS and, for high-viscosity mixing, as the Verso-UHS-HV.

A conversion kit is available that enables the Verso-UHS-HV to be configured as an FMX5 laboratory scale powder/liquid mixer, further increasing the unit’s versatility.

New small-scale inline mixers

Silverson Machines is launching new mixer variants at this year’s CHEMUK show. The new mixers have been developed in response to demand for small-scale inline and powder/liquid equipment that bridges the gap between the laboratory scale versions detailed above and the production-scale units currently available in the Silverson product range.

For use in a variety of industries, these new options will be particularly useful for pharmaceutical applications.

One of these new mixers is the 150 UHS In-Line, which has been specifically designed for the ultra-hygienic applications typically encountered in the pharmaceutical and biotech industries; here, the smallest production-scale mixers may be too large, but laboratory equipment doesn’t offer sufficient capacity.

These mixers are built to the same high specifications as production-scale UHS mixers and can be supplied with Silverson-designed hygienic single mechanical shaft seals, which can be converted to hygienic double mechanical shaft seals if a pressurised flush is required.

They have a crevice-free construction and are designed for clean-in-place (CIP) and sterilise-in-place (SIP) operation. Ideal for batches of up to 50 L, they can also be supplied with multistage rotor/stator workheads to provide intense yet targeted high-shear capability.

As with all Silverson UHS models, they can be supplied with data dossiers/documentation packages conforming to all regulatory standards (such as cGMP and FDA).

In-tank batch mixers

Some mixer manufacturers specialise in production models but have no laboratory scale options; conversely, some offer high-speed laboratory mixers that have no production equivalent.

This can make it difficult — if not impossible — to scale-up successfully from the lab to full production. One of the main advantages when choosing a Silverson laboratory mixer for R&D or pilot-scale production is the ability to scale-up from the laboratory to full-scale production models with ease.

For in-tank mixing of volumes up to 30,000 L, Silverson supplies a comprehensive range of batch models.

Capable of performing all the same mixing process as Silverson laboratory mixers, it’s possible to reduce mixing times by up to 90% when using high-shear batch mixers (compared with traditional mixing methods such as stirrers or agitators).

Small-to-medium-range batch mixers can be used on mobile floor stands, further increasing their versatility.

High speed, high shear mixers for the pharmaceutical industry

New small-scale powder/liquid mixer

Another new mixer launching at CHEMUK is the FMX10. This mixer bridges the gap between the laboratory scale FMX5 and the larger Flashmix product range.

It provides a simple, effective and hygienic means of powder/liquid mixing on a small scale, with a batch size of up to 50 L depending on viscosity.

Featuring the same pumping rotor design as the HV model, the FMX10 can process higher viscosity mixes; the option of a high-speed motor, capable of 9000 rpm, and Flameproof ATEX specification makes this model even more versatile.

In operation, the mixer recirculates liquid from the vessel and powder is loaded into the stainless-steel hopper. Once the powder feed valve is opened, the powder is drawn into the high velocity liquid stream; the ingredients come into contact with each other just prior to the mixer’s high shear rotor/stator workhead.

A brief period of recirculation results in an agglomerate-free, homogenous dispersion in a matter of minutes. The standard powder feed hopper has a 5 L capacity. Different designs are available to assist with the flow of more cohesive powders.

To mix large quantities of powder, Silverson developed the Flashmix powder/liquid mixer, which will also be on the stand at CHEMUK. These are just a few of the mixer options available in the Silverson product range.

You can discover more about additional models, such as the ultra-hygienic range, on the Silverson website.

Visit Silverson Machines on stand J56 at CHEMUK 2024

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