SUMMER2006

EXHIBITIONSInterphex

AsiaJune 2006

EasyfairNovember 2006

Interphex China

November 2006

With workforce safety of paramountimportance, a leading API manufacturer hasinstalled containment equipment to provideoperator exposure levels of <30ng/m3 at theirstate of the art Mexican plant. The containmentequipment covers manual operations includingpacking from dryers in intermediate and finalstep production, consolidation/sub-division ofmaterial and milling/micronising of finishedpowder together with associated packing andfinishing.

The installation was undertaken byHosokawa Containment (a Division ofHosokawa Micron Ltd.) in conjunction withHosokawa Micron Powder Systems of theUSA and Hosokawa Alpine AG of Germanyand incorporated five identical and staticdryer pack-off isolators sited below each offive dryers and one mobile isolator whichcan be moved while the dryer is rotatedduring processing.

The dryer pack-off isolators were designed tosuit the customer’s preferred method ofhandling and allowed easy transfer of RTPcanisters for further processing. Materialfrom the dryer is dosed vertically into eachisolator with single inlet and double outletextract HEPA filter positioned for optimumflow across the packing head.

From initial 3D modelling, wooden mockups were built and ergonomic assessmentscarried out to ensure tasks could be fullycompleted without compromise, ancillary

equipment could be designed and protocolsestablished for various operations.

From these test results final designs werecompleted with equipment enhancements toextract fans, process instrumentation andpneumatic controls for the drum lifter andsimplified piping and wiring systemsresulting in a neater and more compactcontrol unit. The pneumatic drum liftingsystem with automatic positioning for drumdocking ensures safe drum handling with theequipment taking the weight of the drum andnot the operator.

Control of the entire packing procedure is byPLC via an operator interface with start upand shutdown sequences fully controlled byPLC to operate in a controlled and definedmanner.

A second phase of equipment whichincorporates the consolidation/sub-divisionisolator, milling/micronising system andisolator, product collection filter and mobilepack-off isolator is currently in manufacture.

HOSOKAWA MICRON LTD

C O N T E N T S2 New Freeze Drying

Technology

2 Hosokawa Waste No Time

3 Containment Levels to<10ng/m3

3 Particle Engineering forDrug Delivery Systems

3 Mixing Sensor

4 Fast Clean MeasuringMachine

4 Shaggy Dog Story

CONTACTSFCM Team -

Stewart Bryan

Pharmaceutical Team -Mike Coffey

Containment Division -Jim McEwan

After Sales Team -David Lyon

Toll Processing -Simon Gillingham

High Containment Levels<30ng/m3

Full details of the installation are available at www.hosokawa.co.uk

Newsletter Spring 2006 14/7/06 12:24 Page 1

Hosokawa Waste no Time

New Freeze Drying TechnologySensitive and precious products can now be dried quickly and without changesin their structure with Hosokawa’s new stirred freeze drying technology.

Ideal for drying of pro-biotics, pharmaceuticals and nano-materials wheredemand for pristine, undamaged final products is essential, stirred freezedrying offers final products with good shelf stability and which remainunchanged after reconstitution.

Stirred Freeze Drying Vs Conventional Freeze Drying (tray dryer)

Stirred freeze drying is quicker, less manually intensive with no trays to befilled and emptied and as no crushing of dry, hard baked product is requiredthere is less risk of product damage.

Stirred Freeze DryingUtilising a jacketed and stirred, Vrieco-Nauta, conical vacuum dryer operatedat low temperature and pressure, a lump free, free flowing, freeze dried productis produced. As the material is constantly in motion stirred freeze drying offersincreased heat transfer rates which shortens the drying time. The final freezingstage is simplified because it can be done in the same vessel instead of havingto transfer the product to a separate freezing unit.

Stirred freeze drying can be operated continuously with dry particles releasedfrom the frozen material during the drying process collected in a filteralongside the actual dryer.

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A multinational biotech production companyand Hosokawa Containment have jointlydeveloped a bespoke liquid waste handlingsystem to protect personnel from exposureto airborne contamination.

Designed to minimise the release of airbornecontaminants during the waste collectionprocess the system was fast tracked to meetthe biotech company’s vaccine productiondeadlines.

System OverviewThe liquid waste is pumped to a doubleoutlet inside a laminar air flow booth, eachoutlet is connected through a series ofsafety interlocks to an empty IBC manuallyplaced on a weigh scale and connected byan airtight seal. A preset volume of wasteis pumped into the IBC. The weigh scalesact as a safety back up, switching off theflow to prevent overfill. Safety sensorsprevent the flow of waste without thepresence and connection of an unfilledIBC. Air displaced from the IBC is drawnoff by an extraction system and passedthrough a HEPA filter to prevent airbornecontamination.

Once the IBC is filled and the flow ofwaste stopped, spray balls wash the chute

and outlet valve with water to ensure thatno waste product contaminates the top ofthe IBC on seal removal. The operator isthen able to break the seal on the outlet ofthe IBC to fit the sealing cap. A localisedextraction system removes the air withinthe area of operation, providing a furthersafeguard for operators against contaminationby any airborne substances.

For safety reasons the system allows onlyone IBC to be filled at once.

“Your commitment to the project was trulyprofessional, borne out by the delivering ofa quality product on time and to budget. Itis reassuring to know that companies suchas Hosokawa Containment exist, focusedon customer needs and in your case,offering bespoke solutions. Thank you foryour attention to detail, which is alwayscritical to the success of any fast track job”.Commented a spokesperson for thecustomer.

Newsletter Spring 2006 14/7/06 12:24 Page 2

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Innovative particle engineering technologies from HosokawaMicron Ltd now offer a solution to the problems associated withthe handling of the ultra-fine nano-particles demanded in newpulmonary drug delivery systems.

Pulmonary drug delivery offers unique patient benefits, ease ofadministration through aerosol inhaler or pump action spray and anincrease in efficiency through pulmonary absorption. This type ofdrug delivery has become more and more popular for the treatmentof both respiratory and non-respiratory diseases eliminating theneed for drug delivery by injection or ingestion.

The advancements in nano-particle production have beeninstrumental in the development of this type of drug deliverysystem with particle size reduction increasing pulmonary drugabsorption rates. However the finer the particles the more acute thepowder handling problems become. Whilst nano-particle handlingcan be improved by the creation of composite particles, it isimportant that these agglomerates can continue to fulfil theirfunction by disintegrating back into isolated particles on contactwith the moisture in the respiratory tract.

To facilitate nano-particle handling Hosokawa Micron Ltd. offer twodifferent technologies for creating composite nano-particles which

fulfil the drug delivery system disintegration and absorption criteria.Both methods follow simple spherical crystalization of individualnanospheres into nano-particle agglomerates.

Secondary GranulationPranlukast hydrate, a high molecular binder is atomised via theHosokawa Agglomaster, fluidised bed granulator’s spray nozzlesinto the fluidised bed of nano-particles. Particle to particleagglomeration takes place with composite particles created tospecific parameters.

Dry BondingThe Mechano-Chemical bonding method combines nano-particleagglomerates over the surface of a carrier material. The carriermaterial dissolves in water allowing the composite particle todisintegrate.

Hosokawa Micron Ltd. are able to offer a range of equipmentvariants to suit individual material characteristics and productionparameters as well as ancillary equipment to facilitate fullyautomated production lines.

Particle Engineering for Drug Delivery Systems

Containment levels to<10ng m3

Independent airborne containment testing, of the new plug and play, “off the shelf” FlexibleCompact Isolator and Glove Box System from Hosokawa Containment, verifies ultra highcontainment levels to <10ng m3.

This cost effective FCI is ideal for scientific research, bio-technology or pharmaceuticaldevelopment of even the finest nano-particles. Lightweight and portable with either adisposable/flexible plastic canopy or a rigid acrylic canopy fitted to the standard 1m x0.6m stainless steel base unit, the FCI is a contained workstation. The ergonomic andflexible design means that the Stott FCI can be easily upgraded as requirements change.

Suitable for small-scale processing applications eg. laboratory analysis, micronising,drying, packing, product transfer and sampling of high potency compounds, the StottFlexible Compact Isolator enables manual and automatic procedures to be carried outwith minimal operator exposure.

The basic bench-mounted FCI unit can be upgraded with various additional features such asa free-standing base frame, on-board air handling system, CIP system, HEPA filtration andrapid transfer ports, to allow it to be tailored to individual customer requirements.

A new sensor that “watches” the mixing process, from inside the mixer, can optimisebatch mixing, saving valuable time and costs associated with under or over mixing,whilst improving product consistency.

The light-emitting sensor is located in the mixer vessel wall and by measuring thelight reflected on the material continuously passing the sensor, particle size, density,roughness etc. can be measured. Information is continuously obtained about the mixcomposition and shown on a graphical display in the form of a Mixing Index.

The sensor enables operators to monitor the mixing system and check product actually during the production process rather than afterthe event which can eliminate out of specification batches. Laboratory analysis time can also be reduced.

Mixing Sensor

Newsletter Spring 2006 14/7/06 12:24 Page 3

HOSOKAWA MICRON LTDRivington Road, Whitehouse Industrial Estate, Runcorn, Cheshire, England. WA7 3DS.

Tel: +44 (0) 1928 755100 Fax: +44 (0) 1928 714325 E.mail: powder@hmluk.hosokawa.com www.hosokawa.co.uk

For further information on anything within this newsletter please visit w w w. h o s o k a w a . c o . u k

powder@hmluk.hosokawa.com +44 (0) 1928 755100

containment@hmluk.hosokawa.com +44 (0) 1422 314151

or email:or telephone

Hosokawa Micron’sShaggy Dog Story

Fast, Clean,MeasuringMachine

The upgraded Hosokawa PowderCharacteristics Tester PT-S now offersquicker, more accurate, automaticmeasuring of powder characteristics:

Angle of Repose, Compressibility,Angle of Spatula, Cohesion, Angle ofFall, Dispersibility, Angle of Difference.PLUS Aerated Bulk Density, PackedBulked Density and Uniformity.

It is essential in design, planning andquality control of powder processing andbulk handling operations in the chemical,mineral, food and pharmaceuticalindustries.

� Easier to use, � Easier to clean

� Less potential for operator error.

A CCD (Charge CoupledDevice) camera and image processingautomatically measures the Angle ofRepose and Angle of Spatula withimproved accuracy.

Radar type chart of themeasured results giving a clear visualimage which can quickly be evaluatedby the operator using a standard PC.

JIS Ceramics Standard (JISR 1628, JIS R 1639-2): Kawakita’sCompressibility Evaluation Method:USP Tapping Density specificgravity measurements now available.

NEW

NEW

NEW

Pampered pooches and pussies need worryno more about where their next good mealis coming from after a Naturediet PetFoods, a UK based pet food companyinvested in a new state of the art productionfacility in Norfolk. The family runcompany, established over 30 years ago, isa pioneer in providing food for dogs andcats which is without artificial additives,preservatives and colourings and which isproduced using a balanced recipe of naturalingredients.

The factory is DEFRA registered andapproved by the British Holistic Society, -with pet food manufactured to humanconsumption standards, using the highestquality ingredients, on the speciallydesigned and equipped site.

As part of the new production facility,Hosokawa Micron has supplied aHosokawa Rietz Extructor, for the frontend reduction of the frozen minced meatblocks prior to blending and cooking.

The RE15 Extructor operates with hookedhammers rotating between fixed anvils,shearing and cutting the material prior todischarge. The low rotational speed andhigh torque enables materials to be reducedin size easily and quickly and with minimalbruising. Able to withstand shock loads, thefrozen blocks can be fed directly into theExtructor without band sawing whichmeans little or no fluid is lost. As there isvirtually no rise in temperature of materialduring size reduction there is nodegradation of the meat prior to furtherprocessing.

Manufactured to a sanitary standard tomeet the customers exacting productiondemands the machine was supplied pre-assembled, cabled and tested for easyinstallation into the meat processing line.

The low power consumption to highthroughput ratio means the HosokawaRietz Extructor is cost effective to operatewhilst the low maintenance requirement ofthe machine proves an excellent investmentwith rapid pay-back potential. There are noknives to sharpen thus contributing tominimal down time and allowingcontinuous production should this beneeded.

This robust machine demonstrates it’stough but gentle processing capability inthe manufacture of pet food, where productconsistency is of paramount importanceand where the integrity of ingredients isnecessary to prevent damage to importantnutrients.

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Newsletter Spring 2006 14/7/06 12:24 Page 4