Continuously Improving Process Manufacturing FreDrive-Lab is Frewitt’s modular milling system...
Transcript of Continuously Improving Process Manufacturing FreDrive-Lab is Frewitt’s modular milling system...
s3process.co.uk
Continuously Improving Process Manufacturing
R&D Equipment for Oral Solid Dosage Forms
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MILLING & SIEVING 2
POWDER BLENDING 3
DRY GRANULATION 4
WET GRANULATION & DRYING 6
TABLET COMPRESSION 8
TABLET COATING 10
OUR CLIENTS 12
Any investment in innovative and advanced
manufacturing techniques requires the best clinical
development equipment to optimise processes
and to minimise - or even eliminate - scale up and
technical transfer risks.
We offer the most advanced technologies to achieve
these aims, working closely with our clients to
specify and help you to select the most appropriate
equipment and configuration.
s3process.co.uk Continuously Improving Process Manufacturing 1
S3 Process supplies leading process equipment
for research and development and for clinical
scale manufacturing.
The FreDrive-Lab is Frewitt’s modular milling system
offering R&D departments true flexibility between
different milling processes. With a single, easy to use
tri-clamp connection, the 5-in-1 milling system
incorporates five interchangeable milling heads; a
conical sieve mill, cylindrical sieve mill, oscillating mill,
hammer mill and a pin mill.
2 MILLING & SIEVING
MILLING & SIEVINGFrewitt
From 50g to 30kg/hour throughput
Particle reduction to <20 microns
5 milling processes in a single machine
Simple, flexible and upgradeable thanks to the modular concept
ATEX zone 1/21 available
5” Touchscreen with intuitive, user friendly software
FreDrive-Lab, R&D Scale Milling System
The SP15 Laboratory Blender from GEA is designed
for small scale low shear tumble blending for
powders and granular material. The SP15 allows
containers from 3L up to 15L to be tumble blended
at variable speeds for variable times or a specified
number of revolutions.
The SP15NIR model fully integrates Near-Infrared
to allow powder mixing to be measured in real time.
This reduces the amount of sampling and analysis
required in order to fast-track development and
reduce development costs.
s3process.co.uk POWDER BLENDING 3
POWDER BLENDINGGEA
SP15 Blender, Lab Scale IBC Blending
3L, 5L, 10L and 15L blending vessels
Optional Near-Infrared PAT system available
Portable design
PLC and HMI allowing flexibility over blend parameters
Optional Blending Prism available to enhance the blending process
DRY GRANULATION4
DRY GRANULATIONGerteis
The MINI-POLYGRAN® PLUS R&D roller compactor
combines Gerteis’ advanced roller compaction
technology with a fully integrated granulation mill,
within a compact unit.
With many of the unique Gerteis roller compactor
technologies included, the MINI-POLYGRAN® PLUS
offers an outstanding opportunity to successfully
develop dry granulation formulas with excellent dry
granulation results assured.
From 10g to 40kg/hour
Compact design for laboratory environment
Unique feeding system guarantees a constant powder feed to the rollers
Integrated two-step granulation system
Validated force and gap measurement
150mm Ø rollers deliver longer dwell times compared with other R&D roller compactors
A range of different roller surfaces are available to optimise your process
Virtually no heat gain with the Gerteis® patented angled roller design
Mini-Polygran Plus, Roller Compactor
s3process.co.uk DRY GRANULATION 5
Mini-Pactor, Roller Compactor
The MINI-PACTOR® roller compactor is designed
for both laboratory development and for small to
medium scale production runs, and is the most
capable roller-compactor available on the market.
By having the same diameter rollers as the larger
Macro-Pactor, scaling up from development scale to
commercial scale is simple and quick, reducing time
to market and delivering significant cost reductions in
time and material.
Superior feed system to the rollers with torque control of the augers ensuring precise dosing of powder
Angled compaction rollers to allow feed consistency, constant ribbon density and to minimise temperature gain
Free floating gap design and in-process force control producing a constant density ribbon
Large diameter rollers to produce the longest possible dwell time in the nip area
Three stage milling process with the granulating oscillating mill with adjustable screen clearance, to produce a
consistent and controllable particle size distribution
Full instrumentation with critical quality process parameter data-acquisition
Standard containment performance of 3 µg/m3 Time Weighted Average
WET GRANULATION & DRYING s3process.co.uk6
WET GRANULATION & DRYINGGEA
ConsiGma™ is a complete manufacturing line for
producing tablets in development, pilot, clinical
and production volumes in a single compact unit.
The system can perform dosing and mixing of raw
materials, wet granulation, drying, tabletting and
quality control, all in one line.
The ConsiGma™ 1 is the laboratory scale continuous
twin screw wet granulation and drying system, and is
capable of running batches of a couple of hundred
grams up to 5 kg (or more if necessary), with less than
10 g of product held up in the process. Because of the
fast processing times, minimal retention times and
flexibility of the system, it is ideal for developing the
formula and process parameters with minimal API
and in a short period of time. The process parameters
developed with ConsiGma™ 1 can be directly
transferred to the full ConsiGma™ system.
ConsiGma™ 1, Continuous Twin-Screw Granulator & Dryer
WET GRANULATION & DRYING 7
The UltimaPro™ allows high shear mixing, wet
granulation and drying within one process vessel.
With highly efficient high-shear wet granulation utilising
GEA’s advanced impeller and chopper blades taking
place within the bowl, the application of vacuum and
optional microwaves allow temperature sensitive
products to be dried in a very gentle way. With no
material transfers between separate mixing and drying
equipment, the technology is perfect for contained
processing of potent compounds.
At R&D scale, the UltimaPro™ is available in 10L and 25L
sizes, allowing for development batches from 1kg – 10kg.
UltimaPro™ 10/25, Single Pot Processor
Deep vacuum drying technology with optional Microwave technology
Optional Swinging Bowl for even gentler drying
Easy CIP design, fast product changeover
Ideal for contained processing of potent products
Efficient solvent recovery
TABLET COMPRESSION8
TABLET COMPRESSIONkg-pharma
The RoTab™ T 2.0 R&D tablet press is specifically
designed for R&D tabletting and tablet runs
for clinical trials, with compression of batch sizes as
small as 50g and with tablet outputs of up to
42,000 tablets per hour.
The RoTab™ R&D tablet press needs very little room
and is easily moveable. Intuitively operated via a
15” touchscreen display, an extensive amount of
compression data can be displayed to allow quick
and easy development of the optimum tablet
compression settings.
RoTab™ T 2.0, R&D Tablet Press
A Bi-Layer upgrade is also available,
making the RoTab™ the perfect tablet
press for the R&D department.
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GEA
The Modul P tablet press from GEA allows the development of tablets with as
little as 50g of material, but with the capability of running commercial batches
at 187,000 tabs / hour on B tooling.
Special R&D turrets are available with reduced punch positions, and with ‘B’
and ‘D’ mixed punch sizes allowing a fully flexible tablet development press.
Modul P, Development Scale Tablet Press
s3process.co.uk TABLET COMPRESSION
By developing on a large turret and with a larger paddle feeder, scale
up times from development scale to commercial scale are reduced,
saving on expensive material and valuable development time.
TABLET COATING s3process.co.uk10
TABLET COATINGO’Hara
O’Hara’s range of laboratory tablet coaters - the LabCoat range –
offers a compact sized coater with interchangeable pans.
The LabCoat laboratory tablet coater provides the flexibility needed
at development level by utilising a wide range of interchangeable
pans allowing development from 1kg to 10kg. The LabCoat is
equipped with anti-bearding spray nozzles, built-in peristaltic pump,
supply and exhaust fans, and user-friendly operator panel all within
one mobile machine.
Portable and self-contained, simple installation
Inter-changeable pans from 8” up to 19”
From 1kg to 10kg with interchangeable coating pans and anti-bearding spray nozzles
Easy installation and validation
Aqueos and solvent design
LabCoat, Development & Pilot Scale Tablet Coaters
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O’Hara is at the forefront of continuous tablet coating, having
developed and patented Zero Waste start-up and shut-down in
order to make continuous coating in the pharmaceutical industry
an acceptable technology.
The shallower tablet bed and increased number of spray guns
delivers a huge reduction in coating times whilst at the same time
improving coating uniformity. This provides huge reductions in
coating costs and coating times for tablet manufacturers.
The critical process parameters of the continuous coaters – spray-
rates, air flow and temperature, and gun to tablet bed distance
– for a given diameter coating drum are almost identical to those
parameters seen on the same diameter coating pan for the lab
scale batch coater. This means that development work undertaken
with 1kg of tablets on a 10.5” pan using the LabCoat can be easily
transferred to the LC C75. Likewise, development work using a
19” pan using the LabCoat is easily transferred to the FC C500
continuous coater which can coat up 500kg tablets / hour in its 19”
pan configuration.
Continuous Coating Development Work
OUR CLIENTS12
OUR CLIENTSDelivering R&D Equipment
Working with many of the leading pharmaceutical
companies, our R&D and clinical scale has been used
to develop some of the most innovative solid dosage
form medicines.
Recent work includes continuous granulation
equipment that has significantly reduced development
cost and shortened time to market for those medicines.
Modul P tablet press for both development and pilot scale batch sizes, within the Contained Manufacturing Facility (CMF) at PCI Pharma Services.
CLIENTS INCLUDE
ABBVIE
ACTAVIS
AESICA
ALKERMES
ALMAC
ASTRAZENECA
CUSTOM
DECHRA
ELI LILLY
GILEAD
GSK
JUNIPER
KELLOGGS
MACFARLAN SMITH
MSD
MUNDIPHARMA
NAPP
PATHEON
PCI
PFIZER
PIRAMAL
RECKITT BENCKISER
TEVA
UNILEVER
s3process.co.uk OUR CLIENTS 13
CONTACT US
Talk with us today to see how the combination of our
expertise and the world’s leading process technologies
can help drive efficiencies and improve your process.
+ 44 (0) 845 5053530T
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Catton Road, Walton-on-Trent, Derbyshire, DE12 8LL, UK
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S3 Process Limited, East Cartshed Barn, Borough Hill Farm,
[email protected] s3process.co.uk