Manesty Coating Presentation - 2009 [PDF]

Zitiervorschau

Tablet film coating using side vented pan technology Brian A. Helsdon. Customer Training Manager. OYSTAR Manesty

Film Coating Workshop Ludwigshafen, 16th -17th September 2009. 1

Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Side Vented Coating Pan Technology

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

BASF Film Coating Workshop 16th – 17th September 2009

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Coating System

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

[email protected]

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Coating System

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Coating System

Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

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Key Benefits

Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Oystar Manesty Coating Systems • High process efficiency • high air flow • mixing ability • Flexibility • all forms of suspensions • sugar • aqueous • organic solvent • tablets and pellets

• Reproducibility

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

BASF Film Coating Workshop 16th – 17th September 2009

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

[email protected]

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Oystar Manesty Coater Range

Oystar Manesty XLTMLab Coater Range (XLTMLab01 - XLTMLab02)

All fitted with

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Oystar XLCOTATM Range (150 – 350 – 750)

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

BASF Film Coating Workshop 16th – 17th September 2009

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Oystar PremierTM Range (200 – 500 – 900)

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

[email protected]

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M-tec Control System

M-tecTM Control System

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

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M-tec Control System

Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

M-tec Control System

Recipe PC / Supervisor PC (Option)

HMI / PC

PLC

COATER

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INLET AIR HANDLER

EXHAUST SYSTEM

SPRAY SYSTEM

CIP

FILTER

Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

BASF Film Coating Workshop 16th – 17th September 2009

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

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M-tec Parameters Screen

Inlet and Exhaust Units - HVAC

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Inlet Air Handler

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

BASF Film Coating Workshop 16th – 17th September 2009

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Exhaust Filter / Fan Unit

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

[email protected]

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Aqueous Film Coating System

Stand alone pump unit.

Aqueous Spray / Pump System

• Utilises air atomised sprayguns for the application of the coating solution.

• All pneumatic supplies contained within the coater and are controlled via the PLC • Atomising air pressure • Fan width air pressure • Pilot air

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Aqueous Film Coating System

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

BASF Film Coating Workshop 16th – 17th September 2009

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Magnetic Solution Flowmeter

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

[email protected]

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Solution Vessel

Aqueous Film Coating System

• Coating solution is delivered to sprayguns via a multi headed peristaltic pump.

• Eliminates preferential spraying between sprayguns

• Common inlet solution manifold • Overpressure monitoring of the solution delivery to the sprayguns

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Aqueous Film Coating System

• Solution pumpheads are driven via a combined motor and gearbox

Film coating process

• Motor and gearbox are controlled via an VFD / inverter

• A Magnetic Solution Flowmeter is utilised to determine the total solution delivery to the sprayguns

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

BASF Film Coating Workshop 16th – 17th September 2009

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

[email protected]

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Side Vented Coating Pan

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Side Vented Coating Pan

Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

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Process variables

Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Drum Mixing

• Drum mixing

• Gun design

• Airflow

• Spray position

• Inlet, outlet and bed temperature

• Spray rate

• Tablet size and shape

• Droplet size

• Batch size

• Atomising air pressure

Factors Influencing mixing efficiency:

• Batch size • Drum speed

• Fan air pressure

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

BASF Film Coating Workshop 16th – 17th September 2009

• Baffle design • Process time

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

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Drum Mixing

Drum Mixing

• Increased batch size improves mixing due to formation of steeper

• Smaller tablets pack together more tightly and rise higher up the

bed angle and hence increased tablet velocity

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Drum speed

drum, increasing bed angle and hence tablet velocity

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Mixing Baffles Types

Directly influences:

• Mixing • Tablet abrasion • Spray rate

Rabbit Ear Baffles

Fitted to older machines

Ploughshare Baffles

Available on current machines Low batch version also available

Tubular Baffles

Available on current machines

• Coating distribution • Process time Ploughshare and Tubular are Interchangeable on most machine 35

Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

BASF Film Coating Workshop 16th – 17th September 2009

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

[email protected]

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Accelacota 10 with rabbit ear baffles

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Oystar Manesty tubular baffle

Oystar Manesty ploughshare baffles

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Mixing Baffles - Summary

Rabbit E ar B affles

M ixing efficiency

T ype of m ixing

B est suited

Low

G entle

Long processes Highly friable tablets

M oderate

S ugar coating and low batch sizes

Aggressive

Film coating of Low friability tablet

Ploughshare Interm ediate B affles Tubular B affles

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

BASF Film Coating Workshop 16th – 17th September 2009

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V ery high

Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

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Airflow

Temperature

• Volume passing through drum

• Adhesion on cohesion aided by applying warm solutions to a warm tablet bed

• Balance between inlet and outlet air volumes which control the ‘pressure’ in the drum

• High evaporation rate can adversely effect droplet mobility upon tablet impingement

• Drying efficiency is high in side vented pan • Airflow can be influenced by tablet size and shape

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

• Excessive heating can cause thermal degradation of active • Consider thermal expansion of cores

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Temperature

Core size and weight

• Excessive heat can cause spray drying or pinhole formation

• The pattern of movement of cores in a coater will be influenced by their size / weight.

• Under steady conditions of inlet temperature, inlet air volume, spray rate and batch size, exhaust temperature is a good guide to tablet bed temperature

• This in turn may affect film formation due to changes in: • the time exposed to the atomised droplets when the core passes

• In general high temperature = high film stress

through the spray

• the length of time between each pass through the spray (circulation time)

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

BASF Film Coating Workshop 16th – 17th September 2009

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

[email protected]

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Core size and weight

Core shape

• Core size will influence the amount of coating material needed to

• During coating the cores will be “tacky” while the applied coating

give a particular coat thickness.

formulation is drying

• For example, decreasing core size will: • To minimise agglomeration cores must be in constant motion and • increase the specific surface area (m2/g) to be covered • increase the amount of polymer needed to reach the required coat

have a shape to minimise the contact area.

level (i.e. thickness)

• increase the time for the coating process

• If the droplet size is not tightly controlled, batch variation in release

• Easiest shapes to coat without agglomeration are therefore spheres and most difficult are cubes.

characteristics may result. 45

Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Core shape

Core shape

• Flat-faced tablets tend to form “stacks” unless great care is taken

• “Sharp” edges are more vulnerable to physical damage during

during coating to minimise drying times.

• Most tablets for coating should have rounded surfaces - the more convex, the less likely is agglomeration.

coating.

• Shape of the intagliation may be important in governing if intagliation bridging occurs.

• Larger and/or deeper intagliations are less susceptible to bridging

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

BASF Film Coating Workshop 16th – 17th September 2009

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

[email protected]

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Batch size

Spray rate

• Influences mixing efficiency

• Apply at as fast a rate as possible but avoid overwetting

• Influences air flow

• Low spray rates can lead to small droplet size which spread poorly and can lead to orange peel effect

• Can influence process efficiency • High spray rates can lead to picking or twinning • Spray rate can influence process efficiency

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Spray Position

Gun Position

• Sprays should be positioned radially so that the spray hits the bed

• Guns are spaced at equally distance

at the undisturbed area between where baffles enter and leave

position around the centre line of the drum mesh

• Use maximum number of sprays which cover the largest area of the bed but which do not overlap

• Gun to bed distance controls droplet size and hence spreading and coalescence of droplets at tablet bed

• Avoid overwetting or spray drying

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

BASF Film Coating Workshop 16th – 17th September 2009

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

[email protected]

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Gun Position

Gun Position

1/3 Gun to Bed Distance

900 Angle

2/3 Drying area

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Atomising air pressure

Fan air pressure

• Increasing atomising air pressure decreases mean droplet size

• Increase fan air pressure changes spray shape from a solid to a flat ellipse

• Increasing atomising air pressure decreases the range in droplet diameter

• At high fan air pressures droplet size distribution widens • Different gun designs are influenced differently by changes in atomising or fan air pressure

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

BASF Film Coating Workshop 16th – 17th September 2009

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

[email protected]

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Increasing fan air pressure

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Opti Coat™ spray gun

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Opti Coat™ spray gun

Opti Coat™ spray gun - Key benefits

• Optimum performance & ‘anti-bearding’ cap

• ‘Anti-bearding’ system with superior spray pattern

• Enhanced droplet performance • The Opti Coat™ spray gun is the ultimate choice for Pharmaceutical tablet film coating.

• Low profile shape with integral connections for reduced airflow turbulence

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

BASF Film Coating Workshop 16th – 17th September 2009

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

[email protected]

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Opti Coat™ spray gun - Key benefits

Opti Coat™ spray gun

• Tool free, GMP compliant design

• Retro-fit capability to upgrade existing coating equipment (Manesty and non-Manesty equipment)

• Recirculation option 61

Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Opti Coat™ spray gun

OYSTAR Manesty Kitling Road Knowsley Merseyside England L34 9JS T +44 (0)151 547 8000 F +44 (0) 151 547 8001 [email protected] www.oystar.manesty.com 63

Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

BASF Film Coating Workshop 16th – 17th September 2009

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

[email protected]

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