Continuously Improving Process Manufacturing

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1 s3process.co.uk Continuously Improving Process Manufacturing R&D Equipment for Oral Solid Dosage Forms

2 MILLING & SIEVING 2 POWDER BLENDING 3 DRY GRANULATION 4 WET GRANULATION & DRYING 6 TABLET COMPRESSION 8 TABLET COATING 10 OUR CLIENTS

3 S3 Process supplies leading process equipment for research and development and for clinical scale manufacturing. 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

MILLING & SIEVING Frewitt FreDrive-Lab, R&D Scale Milling System The FreDrive-Lab is Frewitt s modular milling system offering R&D departments true flexibility between different milling processes.

4 MILLING & SIEVING Frewitt FreDrive-Lab, R&D Scale Milling System 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. 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 2 MILLING & SIEVING

POWDER BLENDING GEA SP15 Blender, Lab Scale IBC Blending The SP15 Laboratory Blender from GEA is designed for small scale low shear tumble blending for powders and granular material.

5 POWDER BLENDING GEA SP15 Blender, Lab Scale IBC Blending 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. 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 s3process.co.uk POWDER BLENDING 3

DRY GRANULATION Gerteis Mini-Polygran Plus, Roller Compactor The MINI-POLYGRAN PLUS R&D roller compactor combines Gerteis advanced roller compaction technology with a fully integrated granulation

6 DRY GRANULATION Gerteis Mini-Polygran Plus, Roller Compactor 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 4 DRY GRANULATION

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

7 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/m 3 Time Weighted Average s3process.co.uk DRY GRANULATION 5

WET GRANULATION & DRYING GEA ConsiGma 1, Continuous Twin-Screw Granulator & Dryer ConsiGma is a complete manufacturing line for producing tablets in development, pilot, clinical and production

8 WET GRANULATION & DRYING GEA ConsiGma 1, Continuous Twin-Screw Granulator & Dryer 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. 6 WET GRANULATION & DRYING s3process.co.uk

9 UltimaPro 10/25, Single Pot Processor 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. 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 WET GRANULATION & DRYING 7

10 TABLET COMPRESSION kg-pharma RoTab T 2.0, R&D Tablet Press 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. A Bi-Layer upgrade is also available, making the RoTab the perfect tablet press for the R&D department. 8 TABLET COMPRESSION

GEA Modul P, Development Scale Tablet Press 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

11 GEA Modul P, Development Scale Tablet Press 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. 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. s3process.co.uk TABLET COMPRESSION 9

TABLET COATING O Hara LabCoat, Development & Pilot Scale Tablet Coaters O Hara s range of laboratory tablet coaters - the LabCoat range offers a compact sized coater with interchangeable pans.

12 TABLET COATING O Hara LabCoat, Development & Pilot Scale Tablet Coaters 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 10 TABLET COATING s3process.co.uk

Continuous Coating Development Work 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

13 Continuous Coating Development Work 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 sprayrates, 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. TABLET COATING 11

OUR CLIENTS Delivering 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

14 OUR CLIENTS Delivering 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. 12 OUR CLIENTS

15 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

16 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. T E + 44 (0) info@s3process.co.uk S3 Process Limited, East Cartshed Barn, Borough Hill Farm, Catton Road, Walton-on-Trent, Derbyshire, DE12 8LL, UK s3process.co.uk S3 Process Limited Registered in England & Wales:

LÖDIGE ALWAYS THE RIGHT MIX

System Solutions for the Pharmaceutical Industry www.loedige.de LÖDIGE ALWAYS THE RIGHT MIX 1 Pharmaceutical Industry High-Tech Made by People for People 2 www.loedige.de Product-specific process design