Contained Active Freeze Drying could revolutionise pharmaceutical materials drying
A new method of lyophilisation or freeze drying
that uses a single, sterilisable, closed vessel to deliver lump free, fine
powder product has the capability to revolutionise the production of bulk
pharmaceutical powders. With the benefits of improved operator safety, reduced
equipment requirements and high quality, contaminant free end product results, the
proven, Active Freeze Drying technology, from Hosokawa Micron B.V., is making
pharmaceutical manufacturers worldwide reconsider their existing tray type
freeze drying methods.
Hosokawa
Micron’s active freeze drying technology incorporates the use of a jacketed and
stirred dryer and collection filter. Material is frozen quickly inside the
vessel. Energy needed for sublimation is applied through the jacket and
distributed efficiently throughout the product by the stirrer which moves the
finished dried material, in the form of a fine loose powder to the filter.
Hosokawa
Micron’s Active Freeze Drying system is capable of drying solutions,
dispersions, pastes and wet solids with successful applications including
antibiotics, APIs, proteins, collagens and electrolytes.
A
Contained Freeze Drying System
Gerard
Geurtsen, Senior Application Engineer at Hosokawa Micron B.V., explains why
this unique closed lyophilisation process is creating such intense interest
from pharmaceutical manufacturers.
“Every production step is completed within a
single, sterile closed chamber. There is no dust to compromise operator safety.
Nothing can enter the sealed system to contaminate the product within. Wet
product is transferred from a reactor vessel, so no contamination risks
associated with manual handling are introduced and aseptic operation enabled.
When the vacuum is broken, on cycle completion, the finished dry powder is
discharged directly into a container that was sterilised along with the full
system internals before product entered the system. There is no requirement for
additional containment equipment to protect operators or product for this
pack-off stage.”
Lump Free Finished Product
Unlike
the hard baked/crusty material resulting from tray drying the final product
from the Hosokawa system is loose, free flowing and requiring no additional
crushing stage. A classification stage may not be required as particle size of
the final product is often extremely fine and uniform. The product is very often porous and the easy
dissolution facilitates for use in injections etc. Without the need to
introduce a milling stage the product is not damaged – we achieve ‘drying
without harming’ of even the most sensitive, delicately structured products and
living organisms.
Aseptic Processing
The
fully contained system allows for aseptic processing. Cleaning of the system is
easy and effective. There is no need for operatives in suits to be involved.
Spray nozzles in the drying chamber start the cleaning and sterilisation
process on batch completion. SIP is achieved by pressurised steam or vaporised
Hydrogen Peroxide. Quick drying times due to the high rate of heat transfer, simple
filling and discharge plus the speed of system cleaning ensures volume
throughputs are achievable with this ‘single operator’, system.
Cost Efficient
The
Active Freeze Drying process is often faster and always less labour intensive
than the traditional tray freeze drying process; producing lump free, free
flowing powders in one step. Consequently handling times are shorter and
simpler thereby saving time and money. The system is compact to leave floor
space free for other operations and the benefit of a simplified system means
there is less equipment to purchase.
Try Before You Buy
Hosokawa Micron B.V. offer a ‘try before you buy’ opportunity supported by extensive test and toll processing facilities for, initial product tests, product development and customer trials.
Explains Gerard Geurtsen, “Our test centre includes 1, 5, 60 and 800 litre units available for customer tests and to demonstrate scale up potential. We are pleased to work closely with you to assess the specific benefits of Active Free Drying of your products.”
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