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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 2 Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Side Vented Coating Pan Technology

Coating System

Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

BASF Film Coating Workshop 16th 17th September 2009

brian.helsdon@oystar.manesty.com

Coating System

Coating System

Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Key Benefits
High process efficiency high air flow mixing ability Flexibility all forms of suspensions
sugar aqueous organic solvent tablets and pellets

Oystar Manesty Coating Systems

Reproducibility

Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

BASF Film Coating Workshop 16th 17th September 2009

brian.helsdon@oystar.manesty.com

Oystar Manesty Coater Range

Oystar Manesty XLTMLab Coater Range (XLTMLab01 - XLTMLab02)

All fitted with

Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Oystar XLCOTATM Range (150 350 750)

Oystar PremierTM Range (200 500 900)

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

BASF Film Coating Workshop 16th 17th September 2009

brian.helsdon@oystar.manesty.com

M-tec Control System

M-tecTM Control System

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

M-tec Control System

M-tec Control System

HMI / PC

Recipe PC / Supervisor PC (Option)

PLC

COATER

INLET AIR HANDLER

EXHAUST SYSTEM

SPRAY SYSTEM

CIP

FILTER

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

BASF Film Coating Workshop 16th 17th September 2009

brian.helsdon@oystar.manesty.com

M-tec Parameters Screen

Inlet and Exhaust Units - HVAC

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Inlet Air Handler

Exhaust Filter / Fan Unit

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

BASF Film Coating Workshop 16th 17th September 2009

brian.helsdon@oystar.manesty.com

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

Magnetic Solution Flowmeter

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

BASF Film Coating Workshop 16th 17th September 2009

brian.helsdon@oystar.manesty.com

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

Motor and gearbox are controlled via an


VFD / inverter

Film coating process

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

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

BASF Film Coating Workshop 16th 17th September 2009

brian.helsdon@oystar.manesty.com

Side Vented Coating Pan

Side Vented Coating Pan

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Process variables

Drum Mixing

Drum mixing Airflow Inlet, outlet and bed temperature Tablet size and shape Batch size

Gun design Spray position Spray rate

Factors Influencing mixing efficiency:

Batch size Drum speed

Droplet size Atomising air pressure Fan air pressure

Baffle design Process time

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

BASF Film Coating Workshop 16th 17th September 2009

brian.helsdon@oystar.manesty.com

Drum Mixing

Drum Mixing

Increased batch size improves mixing due to formation of steeper


bed angle and hence increased tablet velocity

Smaller tablets pack together more tightly and rise higher up the
drum, increasing bed angle and hence tablet velocity

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Drum speed

Mixing Baffles Types

Directly influences:

Mixing Tablet abrasion Spray rate Coating distribution Process time

Rabbit Ear Baffles Ploughshare Baffles Tubular Baffles

Fitted to older machines Available on current machines Low batch version also available Available on current machines

Ploughshare and Tubular are Interchangeable on most machine


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BASF Film Coating Workshop 16th 17th September 2009

brian.helsdon@oystar.manesty.com

Accelacota 10 with rabbit ear baffles

Oystar Manesty ploughshare baffles

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

Oystar Manesty tubular baffle

Mixing Baffles - Summary

M ixing efficiency Rabbit E ar B affles Low

T ype of m ixing G entle

B est suited Long processes Highly friable tablets S ugar coating and low batch sizes Film coating of Low friability tablet

Ploughshare Interm ediate B affles Tubular B affles V ery high

M oderate

Aggressive

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

BASF Film Coating Workshop 16th 17th September 2009

brian.helsdon@oystar.manesty.com

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Airflow

Temperature

Volume passing through drum Balance between inlet and outlet air volumes which control the
pressure in the drum

Adhesion on cohesion aided by applying warm solutions to a warm


tablet bed

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

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

The pattern of movement of cores in a coater will be influenced by


their size / weight.

This in turn may affect film formation due to changes in:


the time exposed to the atomised droplets when the core passes
through the spray

In general high temperature = high film stress

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

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

BASF Film Coating Workshop 16th 17th September 2009

brian.helsdon@oystar.manesty.com

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Core size and weight

Core shape

Core size will influence the amount of coating material needed to


give a particular coat thickness.

During coating the cores will be tacky while the applied coating
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
level (i.e. thickness)

have a shape to minimise the contact area.

increase the time for the coating process

Easiest shapes to coat without agglomeration are therefore


spheres and most difficult are cubes.

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


characteristics may result.
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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


during coating to minimise drying times.

Sharp edges are more vulnerable to physical damage during


coating.

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

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

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

BASF Film Coating Workshop 16th 17th September 2009

brian.helsdon@oystar.manesty.com

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Batch size

Spray rate

Influences mixing efficiency Influences air flow Can influence process efficiency

Apply at as fast a rate as possible but avoid overwetting Low spray rates can lead to small droplet size which spread poorly
and can lead to orange peel effect

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
at the undisturbed area between where baffles enter and leave

Guns are spaced at equally distance


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

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

BASF Film Coating Workshop 16th 17th September 2009

brian.helsdon@oystar.manesty.com

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Gun Position

Gun Position

1/3
900 Angle

Gun to Bed Distance

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 Increasing atomising air pressure decreases the range in droplet
diameter

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

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

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Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

BASF Film Coating Workshop 16th 17th September 2009

brian.helsdon@oystar.manesty.com

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Increasing fan air pressure

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

brian.helsdon@oystar.manesty.com

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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
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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 Info@oystar.manesty.com www.oystar.manesty.com
63 Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809 64 Manesty Coating Presentation - 2009 | Brian A Helsdon | 260809

BASF Film Coating Workshop 16th 17th September 2009

brian.helsdon@oystar.manesty.com

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