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New Developments in "Ultra Hygienic" Process Equipment
The pharmaceutical industry presents many applications with unique process requirements, so to meet these challenges, a flexible
but positive approach to equipment design and manufacture is required. Working closely with their clients, Silverson has responded
to demands for increasing standards of hygienic construction, by developing a complete range of "Ultra Hygienic" equipment,
including In-Line mixers, top and bottom entry immersion/batch mixers and powder/liquid mixing systems.
Silverson High Shear Bottom Entry Mixers are increasingly being specified by the pharmaceutical sector for applications where
focused high shear in-tank mixing is required. Using their expertise in the design and manufacture of Ultra Hygienic In-Line and
top entry batch mixers, Silverson have advanced their range of Bottom Entry mixers incorporating specific features, for example
minimised number of product contact parts, "crevice-free" design, electro-polished finish, and special hygienic shaft seals.
Complete documentation packages and data manuals including IQ/OQ documentation to comply with FDA and cGMP requirements can also
be supplied.
These mixers can be used in conjunction with slow speed stirrer/scraper units, the action of the two being complementary to one
another, the Silverson rotor/stator workhead providing high shear which stirrer/scraper units cannot impart. The stirrer/scraper
unit complements this action by distributing the homogenised output of the bottom entry mixer uniformly throughout the vessel.
This combination is ideal for high viscosity products, those that increase in viscosity on cooling - for example, pharmaceutical
creams and ointments - and where heat sensitive materials such as active ingredients may only be added at low temperatures.
With lower viscosity products, Bottom Entry units can be used without any additional in-tank agitation. This eliminates the
problems associated with immersed shafts and difficult-to-clean scraper blades, offering improvements in process hygiene,
especially where large quantities of powder have to be dispersed into liquids using an in-tank mixer. Typical applications
include the manufacture of vaccines and pharmaceutical suspensions.
As with all Silverson mixers, a range of interchangeable workheads and screens is available for bottom entry units, offering
unrivalled versatility by allowing them to be adapted to perform a wide range of mixing tasks, including emulsifying, homogenising,
disintegrating, dissolving, dispersing, suspending, particle size reduction, reaction acceleration and de-agglomerating. This
makes them particularly suitable for R&D and pilot plant applications.
These recent advances in hygienic design and construction have largely been made as a result of Silverson working closely and
confidentially with their clients. This approach has led to the development of several new techniques to ensure that equipment
not only meets current standards but is also capable of defining those of the future.
Click here to view more information about the In-Line
ultra sanitary mixers.
To speak with a Silverson representative or arrange for a free trial, please contact us.
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