System solutions for the Pharmaceutical

LODIGE - ALWAYS THE RIGHT MIX

Product-orientated process design guarantees the specified quality of fragile, sensitive

Developed in compliance with the complex regulations for laboratory and production units, the Lodige systems are used for the production of solid materials in a wide variety of applications.

Pharmaceutical production is subjected worldwide to stringent regulations with regard to safety, cleanliness and reproduceability. The quality of our machines and units complies with these international standards.

In context with these criteria, our specific process know-how for mixing, coating and drying systems is the basis of innovative systems for the pharmaceutical industry,

During decades of close cooperation with leading pharmaceutical producers, our competence has been developed and implemented in the supply of more than 1000 tailormade systems,

Drying• Active agents• Moist product(e.g. for tablet masses)

Coating• Tablets• Capsules• Pellets• Granules• Shapes using

nanoparticle coating solutions

• Other shapes

Mixing / Granulating• Basic pharmaceutical

materials• Excipients• Active agents

Mixing and Granulating in a horizontal system

The invention of the Plough-share® Mixer has had a lasting effect on mixing and processing technology. Large numbers of patented innovations are based on this system, and quality of Lodige processing systems has been practice-proven in the pharmaceutical industry for many years.

Ploughshare® Shovels rotate in special arrangement along the horizontal shaft inside a horizontal, cylindrical mixing drum.

The size, number, positioning, geometric shape and peripheral speed of the mixing elements are coordinated for three-dimensional movement of the components inside the mixing drum.

The resultant turbulence - the so- called mechanically generated fluid bed - prevents the formation of dead or static zones and results in gentle, precision mixing within the shortest possible time.

This process is highly suitable for mixing processes whereby the components have widely differing bulk densities, particle sizes, rheological features and highly different mass fractions.

In the case of special applications and particularly when liquid is added or during granulation processes, separately driven, high-speed choppers can be used to back up the mixing effect.

The mixing process can be also be carried out continuously in

Lodige Mixer GMP® 1600 prepared for black/white zones

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Mixing and Granulating in a vertical systemMixing Granulators / High Shear Mixers are standardized systems complying with all requirements of the GMP / WIP design.These systems are particularly easy to clean. Low-mainte- nance is a further feature of the Lodige Mixing Granulators.

A three-arm mixing element rotates close to the wall and with minimum clearance from the bottom of a vertical mixing container.

The special shape of this element and its peripheral speed are coordinated in such a way that the mixing product is circulated as a vortex and thereby accelerated horizontally and vertically,

This product movement assures rapid, intensive mixing, even in the case of components with widely varied particle shapes and sizes, bulk densities and surface condition, High mixing precision is obtained within minimum time,

If necessary, a separately driven chopper disperses lumps, distributes liquid uniformly and promotes wet

granulation, The point of granulation can be controlled as required,

Our Single Pot Mixing Granulator of type MGT-S is equipped with a heating jacket and designed for vacuum for the process steps mixing, granulating and drying,

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Mixing and Processing in a continuous ring layer systemThe Lodige High SpeedContinuous Mixer oftype CoriMix® CM isdesigned for a widerange of applicationslike mixing, granu-lating and compacting.CoriMix® Systemsprovide optimal

The system is based on the high peripheral speed of the mixing elements of up to 40 m/s, the resultant centrifugal force forming a concentric product ring,

The product ring achieves a high mixing intensity generated by the high differential speed between the rotating

specially shaped mixingelements and the mixerwall,

The product is movedthrough the mixingchamber in a drop-like flow,The filling degree, the speed,the geometry and theadjustment of the mixingelements combined with

feed rate influence the residence time,

The mixing chamber is divided into zones of different shear intensity, ensuring system optimization for varying product properties,

Liquid components are directly introduced into the product ring providing homogeneous distribution within the mixture, The mixer wall and the mixing shaft remain unwetted,

High Speed Continuous Mixer of type CoriMix® in pharma design for primary moistening and granulating processes. The upper part can be opened over the entire length of the drum.

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cleaning. Compact units are suitable for high feed rates of 20 - 200 kg/h.These systems achieve a constant product quality ensuring the specified granulate material.

A version with pull-out mixing elements is also available.

Drying, Granulating and Coating in a Fluid Bed Processor

The Lodige Fluid Bed Processor LFP is available in different sizes suitable for batches from 0,1 to 1800 kg. A wide range of options ensures customizing to your requirements and conditions.

LFP 70Production unit for batches up to 70 kg

The Fluid Bed Technology of the Lodige LFP achieves constant and reproducible product quality while ensuring gentle process in short process times,

Processes ranging from powdery materials to free-flowing materials can be carried out as well as the drying of moist products (e.g. moist granulates), Powders, granulates and other- shapes can be coated in this system too, During the process, heated air - in defined quantity and speed -continuously flows through the special designed Conidur® bottom into the product vessel, The product starts to fluidize and can be moistened by means of a spray nozzle and granulated, depending on the application,

Tangential spray nozzles in the area of the Conidur® bottom (underfeed) or a Wurster system are used for coating pellets,

Integrated filters - selected according to the process and product - hold back the powder particles in the processor, The

Manual product handling

Pneumaticproducthandling

LFP 8 for developing new recipes and for production of small batchsizes

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Drying in a Vacuum Shovel DryerLodige and Drais horizontal Drying Systems guarantee precisely reproducible, constant and reliable processes. All Shovel Dryers variations can be manufactured in containment design.

The fluid bed mechanically genera-ted by the Lodige mixing processensures efficient and gentle dryingprocesses.Intensive and homogeneous mixingprevents the development oftemperature and moisture gradients inthe product and increases at the sametime the heat exchange betweenproduct particles and heating jacket.

When drying is carried out undervacuum, theprocess can be runat low temperatu-res if fragile andheat sensitivecomponents areincluded in the mix.A high tempera-ture gradient isobtained betweenthe product andthe heating jacketresulting in theeffective intro-duction of heat.

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The moisture removed from the product during the drying process is recycled for further use (solvent recovery).

Shovel Dryers up to 1200 l total volume are constructed with only one drive-end bearing. Larger dryers are rather built with pull-out mixing shaft.

Vacuum Dryer with Special Mixing Elements

Mixing Dryer as Containment System

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Coating in a Lodige LHC CoaterLodige Coaters offer high degree of flexibility for gentle film and sugar coating due to various perforation formats of the drum.30 - 100% of the working capacity of the Coaters can be used without modification of the system.As well as the Coater itself, the LHC Coating System includes the inlet air treatment, the exhaust air system, the controls, liquid dosing, feeding and discharging and the CIP system.

Lodige LHC Coaters are used for different shapes of tablets, capsules and pellets and operate on the cocurrent, underpressure principle,

Dry air flows through an air inlet inserted through the front of the drum and flows in the same direction as the spray mist of coating solution onto the material bed,

Dry air flowing through the material bed is extracted by an exhaust fan through the perforations running beneath the bed and adapted exhaust channels,

A wearproof, rotary disc valve controls channeling of exhaust air ensuring forced circulation of drying air through only the material bed

The co-current, underpressure principle in Lodige Coaters ensures minimum loss of coating solution and optimum use of drying air energy,

With appropriately designed liquid dosing systems, LHC units can be used for both film and sugar coating processes,

Lodige Coaters can now be optionally equipped with a completely perforated drum.

Production Coater LHC 80

Production CoaterLHC 130

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Machines forresearch, productdevelopment andsample productionLodige Laboratory Systemsprovide reliable scale-up toproduction size.Laboratory mixers with thesame mixing principle as thatof production machines canalso be used for the productionof small quantities with thesame quality criteria.

Lodige Pharma Pilot Plant

The new Lodige Pharma Pilot Plant is equipped with the most modern machines for:• Mixing• Wet Granulating• Sieving• Drying• Tabletting• Coatingin compliance with GMP and at production conditions.

Laboratory and Pilot PlantThe Lodige Pilot Plant of more than 400 m2 provides trial capacity for more than 30 machines including a laboratory for physical analyses.

A separate area is specifically dedicated to pharma trials which are run in strictly compliance with GMP requirements.

The pilot machines are also designed for the production of small batch sizes at production conditions. All machines are suitable for WIP / CIP,

Mixing Granulator MGT 125• Mixing• Granulating• Wet granulating• Drying Total volume 125 l Working volume 90 lControl of the point of granulationDust-free feedingRasp / sieve downstream

Fluid Bed Processor LFP 70• Drying• Granulating• CoatingWorking volume up to 140 l Batch size from 6 - 70 kg Flame-proof construction 10 bar pressure burst resistance Various spray systems

Coating Unit LHC 80• Film coating• Sugar coatingPartially and completely perforated drumsWorking volume 55 lBatch sizes up to 40 kgDrums of10 / 20 / 40 / 55 lNew designed air supplyNew spraying arm concept

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The unit controls consist of the control part as well as the electric and pneumatic power parts (control cabinets). The control part will be installed in the production area close to the machine. The power part will be placed in the technical zone,

PLC or PC-based controls are both possible and are designed and made in accordance with the GAMP 4 regulations. 21 CFR Part 11 compliant requirements like Audit Trail and user administration are state of the art

Control partThe control part consists of a monitor integrated in a stainless steel housing, Either a PLC with Operator Panel is used or a PC-based system (Windows with visualization Win CC),

The PC controls offers the following modes:

• Service mode for the individual control of all functions

• Manual mode mainly for preparatory tasks

• Learn mode for creation of a recipe

• Recipe modeFully automatic execution of a recipe created or stored in learn mode

Cleaning processes are freely programmable like production processes,

The controls are designed for the administration of up to 200 processes, Recipes and protocols (curves, events and errors) are stored in data base and can be

Electrical power part and pneumatic partAll pneumatic and electric control elements like frequency converter, motor contractors, PLC and PC and modems for remote servicing,

Measurement technologyMeasuring instruments and all elements for preparing measured values. Relevant process parameters like e.g. temperature, speed rotation, moisture, pressure, product and air quantity, are usually recorded,

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The System ControlsThe systems and components as well as the whole unit technology are operated by a PLC or by PC-based controls.21 CFR Part 11 compliant operation is available with the PC-based controls.

Gebruder LodigeMaschinenbau GmbH

Postfach/P.O.Box 205033050 Paderborn

Elsener StraBe 7- 933102 PaderbornGermany

Phone: +49.52 51.309 0Fax: +49.5251.309129E-Mail: info@loedige.de

ServiceSales:

Phone: +49.52 51.309

147 After Sales:

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LODIGE - always the right mix

BP 03.GB.A 1000/03.2005/db/db - © Copyright by Gebr. Lodige Maschinenbau GmbH, D-33102 Paderborn. All rights reserved