Continuously Improving Process Manufacturing FreDrive-Lab is Frewitt’s modular milling system...

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

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.

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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

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

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