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Manesty Coating Presentation - 2009
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Transcript of Manesty Coating Presentation - 2009
BASF Film Coating Workshop 16th – 17th September 2009 [email protected] 1
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Tablet film coating usingside vented pan technology
Brian A. Helsdon.
Customer Training Manager.
OYSTAR Manesty
Film Coating WorkshopLudwigshafen, 16th -17th September 2009.
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Side Vented Coating Pan Technology
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Coating System
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Coating System
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Coating System
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Key Benefits• 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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Oystar Manesty Coating Systems
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Oystar Manesty Coater Range
All fitted with
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Oystar Manesty XLTMLab Coater Range(XLTMLab01 - XLTMLab02)
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Oystar XLCOTATM Range(150 – 350 – 750)
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Oystar PremierTM Range(200 – 500 – 900)
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M-tecTM Control System
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M-tec Control System
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Recipe PC / Supervisor PC(Option)
HMI / PC
PLC
COATERINLET AIRHANDLER
EXHAUSTSYSTEM
SPRAYSYSTEM
CIP FILTER
M-tec Control System
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M-tec Control System
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M-tec Parameters Screen
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Inlet and Exhaust Units - HVAC
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Inlet Air Handler
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Exhaust Filter / Fan Unit
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Aqueous Spray / Pump System
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Aqueous Film Coating System
Stand alone pump unit.
• Utilises air atomised sprayguns for theapplication of the coating solution.
• All pneumatic supplies contained within thecoater and are controlled via the PLC
• Atomising air pressure
• Fan width air pressure
• Pilot air
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Aqueous Film Coating System
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Magnetic Solution Flowmeter
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Solution Vessel
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Aqueous Film Coating System
• Coating solution is delivered tosprayguns via a multi headed peristalticpump.
• Eliminates preferential sprayingbetween sprayguns
• Common inlet solution manifold
• Overpressure monitoring of the solutiondelivery to the sprayguns
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Aqueous Film Coating System
• Solution pumpheads are driven via acombined motor and gearbox
• Motor and gearbox are controlled via anVFD / inverter
• A Magnetic Solution Flowmeter isutilised to determine the total solutiondelivery to the sprayguns
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Film coating process
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Side Vented Coating Pan
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Side Vented Coating Pan
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Process variables
• Drum mixing
• Airflow
• Inlet, outlet and bed temperature
• Tablet size and shape
• Batch size
• Gun design
• Spray position
• Spray rate
• Droplet size
• Atomising air pressure
• Fan air pressure
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Drum Mixing
Factors Influencing mixing efficiency:
• Batch size
• Drum speed
• Baffle design
• Process time
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Drum Mixing
• Increased batch size improves mixing due to formation of steeperbed angle and hence increased tablet velocity
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Drum Mixing
• Smaller tablets pack together more tightly and rise higher up thedrum, increasing bed angle and hence tablet velocity
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Drum speed
Directly influences:
• Mixing
• Tablet abrasion
• Spray rate
• Coating distribution
• Process time
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Mixing Baffles Types
Rabbit EarBaffles
Fitted to older machines
PloughshareBaffles
Available on current machinesLow batch version also available
TubularBaffles
Available on current machines
Ploughshare and Tubular are Interchangeable on most machine
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Accelacota 10 with rabbit ear baffles
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Oystar Manesty ploughshare baffles
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Oystar Manesty tubular baffle
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Mixing Baffles - Summary
Mixingefficiency
Type ofmixing
Best suited
Rabbit EarBaffles
Low GentleLong processes
Highly friable tablets
PloughshareBaffles
Intermediate ModerateSugar coating and
low batch sizes
TubularBaffles
Very high AggressiveFilm coating of Low
friability tablet
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Airflow
• Volume passing through drum
• Balance between inlet and outlet air volumes which control the‘pressure’ in the drum
• Drying efficiency is high in side vented pan
• Airflow can be influenced by tablet size and shape
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Temperature
• Adhesion on cohesion aided by applying warm solutions to a warmtablet bed
• High evaporation rate can adversely effect droplet mobility upontablet impingement
• Excessive heating can cause thermal degradation of active
• Consider thermal expansion of cores
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Temperature
• 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 totablet bed temperature
• In general high temperature = high film stress
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Core size and weight
• The pattern of movement of cores in a coater will be influenced bytheir size / weight.
• This in turn may affect film formation due to changes in:
• the time exposed to the atomised droplets when the core passesthrough the spray
• the length of time between each pass through the spray (circulationtime)
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Core size and weight
• Core size will influence the amount of coating material needed togive a particular coat thickness.
• For example, decreasing core size will:
• increase the specific surface area (m2/g) to be covered
• increase the amount of polymer needed to reach the required coatlevel (i.e. thickness)
• increase the time for the coating process
• If the droplet size is not tightly controlled, batch variation in releasecharacteristics may result.
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Core shape
• During coating the cores will be “tacky” while the applied coatingformulation is drying
• To minimise agglomeration cores must be in constant motion andhave a shape to minimise the contact area.
• Easiest shapes to coat without agglomeration are thereforespheres and most difficult are cubes.
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Core shape
• Flat-faced tablets tend to form “stacks” unless great care is takenduring coating to minimise drying times.
• Most tablets for coating should have rounded surfaces - the moreconvex, the less likely is agglomeration.
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Core shape
• “Sharp” edges are more vulnerable to physical damage duringcoating.
• Shape of the intagliation may be important in governing ifintagliation bridging occurs.
• Larger and/or deeper intagliations are less susceptible to bridging
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Batch size
• Influences mixing efficiency
• Influences air flow
• Can influence process efficiency
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Spray rate
• Apply at as fast a rate as possible but avoid overwetting
• Low spray rates can lead to small droplet size which spread poorlyand 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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Spray Position
• Sprays should be positioned radially so that the spray hits the bedat the undisturbed area between where baffles enter and leave
• Use maximum number of sprays which cover the largest area ofthe bed but which do not overlap
• Gun to bed distance controls droplet size and hence spreading andcoalescence of droplets at tablet bed
• Avoid overwetting or spray drying
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Gun Position
• Guns are spaced at equally distanceposition around the centre line of thedrum mesh
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Gun Position
1/3
2/3
900 Angle
Drying area
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Gun Position
Gun to Bed Distance
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Atomising air pressure
• Increasing atomising air pressure decreases mean droplet size
• Increasing atomising air pressure decreases the range in dropletdiameter
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Fan air pressure
• Increase fan air pressure changes spray shape from a solid to a flatellipse
• At high fan air pressures droplet size distribution widens
• Different gun designs are influenced differently by changes inatomising or fan air pressure
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Increasing fan air pressure
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Opti Coat™ spray gun
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Opti Coat™ spray gun
• Optimum performance & ‘anti-bearding’ cap
• The Opti Coat™ spray gun is the ultimate choicefor Pharmaceutical tablet film coating.
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Opti Coat™ spray gun - Key benefits
• ‘Anti-bearding’ system with superior spray pattern
• Enhanced droplet performance
• Low profile shape with integral connections forreduced airflow turbulence
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Opti Coat™ spray gun - Key benefits
• Tool free, GMP compliant design
• Retro-fit capability to upgrade existing coating equipment (Manestyand non-Manesty equipment)
• Recirculation option
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Opti Coat™ spray gun
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Opti Coat™ spray gun
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OYSTAR ManestyKitling Road Knowsley
Merseyside England L34 9JST +44 (0)151 547 8000 F +44 (0) 151 547 8001
[email protected] www.oystar.manesty.com