s3process.co.uk

Continuously Improving Process Manufacturing

R&D Equipment for Oral Solid Dosage Forms

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.

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MILLING & SIEVING 2POWDER BLENDING 3DRY GRANULATION 4WET GRANULATION & DRYING 6TABLET COMPRESSION 8

TABLET COATING 10OUR CLIENTS 12

MATERIALS HANDLING

MILLING & SIEVING

TABLET COATING

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.

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

MATERIALS HANDLINGPuroVaso®

Lightweight plastic pharma containers

The PuroVaso® system provides an effective solution for the handling of powders, granules and tablets during R&D.

PuroVaso® containers are moulded from FDA compliant Polyethylene (PE) plastic materials, and offer the benefits of disposable single use technology whilst also being suitable for multi-use applications.

The manual handling of pharmaceutical products can often be difficult due to the weight of the container. PuroVaso® have changed the product to container weight ratio to ensure operators handling limits are driven by product weight and not by the weight of the container. The result is a unique combination of value and performance.

� Comes in 1L, 2.5L, 5L, 10L, 15L, 30L and 50L � Choice of 100mm or 150mm neck sizes and can fit any valve type with a tri-clamp connection � Available in 3 material choices to allow visualisation of fill levels, UV protection or when handling static sensitive materials � FDA CFR 177.1520 (c), 178.3297, 178.2010 EC-directive 10/2011 � BSE/TSE Free, Melamine and Phthalate Free � All PuroVaso® containers are suitable for Zone 20, 21 and 22 rated areas � ‘Conductive Black’ containers are suitable for Zone 0/20, 1/21 and 2/22 rated areas � Range of accessories to optimise handling including PuroValve™, PuroGrab™ and PuroLid™

2 MATERIALS HANDLING

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

Five milling processes in a single machine

MILLING & SIEVING 3s3process.co.uk

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.

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 powderAngled compaction rollers to allow feed consistency, constant ribbon density and to minimise temperature gainFree floating gap design and in-process force control producing a constant density ribbonLarge diameter rollers to produce the longest possible dwell time in the nip areaThree stage milling process with the granulating oscillating mill with adjustable screen clearance, to produce a consistent and controllable particle size distributionFull instrumentation with critical quality process parameter data-acquisitionStandard containment performance of 3 µg/m3 Time Weighted Average

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 powderAngled compaction rollers to allow feed consistency, constant ribbon density and to minimise temperature gainFree floating gap design and in-process force control producing a constant density ribbonLarge diameter rollers to produce the longest possible dwell time in the nip areaThree stage milling process with the granulating oscillating mill with adjustable screen clearance, to produce a consistent and controllable particle size distributionFull instrumentation with critical quality process parameter data-acquisitionStandard containment performance of 3 µg/m3 Time Weighted Average

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

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

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.

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

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.

Deep vacuum drying technology with optional microwave technology

Optional swinging bowl for even gentler drying

9

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 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.

TABLET COMPRESSION kg-pharma

Futorque® X-1 R&D Tablet Press

The Futorque® X-1 is a compact tablet press that offers impressive R&D and clinical development scale capacities of up to 130,000 tablets/h. Featuring intuitive operator control via a brilliant 18.5”, multitouch display screen with control software that makes the Futorque® user friendly and includes remote operation via smart phone devices.

� Compact design with plug and play installation � High torque servo drive as standard � Optional FlexAdapt turret system "one-fits-all punch formats" without turret exchange � Modular design with sealed process chamber � Options for WIP and high containment up to OEB 5 � Compatible with PuroVaso loading and unloading � Upgrade packages for up to OEB 3 (SmartClean) and up to OEB 5 (WIP)

9

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

TABLET COATING 11

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

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, plus user-friendly operator panel all within one mobile machine.

Aqueous and solvent design

TABLET COATING 11

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

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 a19” 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.

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 ABBVIEACTAVISAESICAALKERMESALMACASTRAZENECA

CUSTOMDECHRAELI LILLYGILEADGSKJUNIPER

KELLOGGSMACFARLAN SMITHMSDMUNDIPHARMANAPPPATHEON

PCIPFIZERPIRAMALRECKITT BENCKISERTEVAUNILEVER

s3process.co.uk OUR CLIENTS 13

CLIENTS INCLUDE ABBVIEACTAVISAESICAALKERMESALMACASTRAZENECA

CUSTOMDECHRAELI LILLYGILEADGSKJUNIPER

KELLOGGSMACFARLAN SMITHMSDMUNDIPHARMANAPPPATHEON

PCIPFIZERPIRAMALRECKITT BENCKISERTEVAUNILEVER

s3process.co.uk OUR CLIENTS 13

CATALENTDECHRAELI LILLYGILEADGSKCUSTOM

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

E

© S3 Process Limited Registered in England & Wales: 06864748

info@s3process.co.uk

S3 Process Limited, 6-8 Stable Offices, Catton Estate,

Catton Road, Swadlincote, Derbyshire, DE12 8LN, UK

s3process.co.uk

v2 MAY20