xltmcota established coating technology
TRANSCRIPT
XLTMCotaEstablished coating technology
www.oystar.manesty.com
• XLTMCota 150• XLTMCota 350• XLTMCota 750
EsTabLishEd CoaTing TEChnoLogy – XL™Cota 150, 350 and 750
The XL™Cota is used as a model against which all other manufacturers units are compared* and is the Pharmaceutical Industry‘s tablet coating standard. Benefiting from a proven global installed base of XL™Cota 150 and XL™Cota 350 and now joined by the new XL™Cota 750.
This high quality coating equipment, designed to cover a wide range of production batches from medium scale to large scale, has an unbeatable combination of a very efficient coating process coupled with a high rate of return on investment.Innovative science based developments in the four key areas of; tablet mixing, spraying, drying efficiency and control system technology, guarantee that the XL™Cota provides a very effective solution to obtaining a highly controlled process, ensuring the delivery of high quality end product.
Key benefits• Low capital investment• Reduced cost of ownership• Unique mixing baffle designs• Anti-bearding spray system• m-tec™ integrated control system• Globally installed, proven technology
The coater can also be provided with an optional validated Clean in Place (CIP) system with strategically located cleaning nozzles, controlled by m-tec™ control system technology.
Effective dryingThe fully perforated side-vented coater drum and cabinet design allows highly effective drying capacity in the process without the need to use high drying temperatures eliminating lower process efficiencies (spray drying) and detrimental thermal stresses on the product.
XL™Cota 150• Suitable for medium scale production• Standard drum capacity 170 litres• Alternative drum capacity of 230 litres is
available • Segmented drums available for pellet coating
XL™Cota 350• Suitable for large scale production• Standard drum capacity 500 litres• Alternative drum capacities of 310 or 450 litres
are available • Segmented drums available for pellet coating
XL™Cota 750• Suitable for large scale production• Standard drum capacity 800 litres• Alternative drum capacity of 750 litres is
available • Segmented drums available for pellet coating
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drum capacities
XLTMCota 750
XLTMCota 350
XLTMCota 150
Nominal batch size (litres)
* Pharmaceutical Coating Technology, Coley, hogan and aulton
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EsTabLishEd TEChnoLogy – why you shouLd ChoosE ThE oysTaR ManEsTy XL™Cota wiTh m-tec™
The XL™Cota range offers a high ROI. m-tec™ is a fully modular control system. You determine the level of automation.
Ploughshare stealth TubularMixing efficiency high high highestApplications high friable products friable products products with friability <1%
reduced batch sizes products with difficult flowhigh weight gain characteristicssugar coating
Key benefits• Baffle designs to cover all product forms• Increased productivity, reduced product
variability• Reduction in material costs• Controlled product movement
Ploughshare baffle stealth baffle Tubular baffle
Mixing efficiencyOYSTAR Manesty determine the product movement in the coating pan to be a key attribute in the coating process. Effective mixing will give the benefits of low product losses, low coating weight variability eliminate product damage and therefore increase productivity.
unique designsDue to the unique designs of mixing baffles offered on the XL™Cota range, controlled product movement and even distribution of the coating solution is achieved.
Mixing timesBaffle designs have shown mixing times of 40 to 50 minutes. These times have been determined using a Colourimeter to measure the colour build up on tablets during a coating process.
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nEw siMuLaTion TEChnoLogiEs opti Coat sPRay sCiEnCE
Computational Fluid Dynamics (CFD) simulation software has been utilised to gain an understanding of the complex nature of the atomization process and has allowed engineers to optimise the airflow characteristics of the microclimate, which occurs in the vicinity of the spray gun nozzle and the form of internal liquid and air flow passageways.
OYSTAR Manesty has also considered how the coater cabinet drying airflow is affected in the region of the spray guns and its manifold assembly. This has led to a reduced spray gun profile design, which also optimises the drying air passage to the tablet bed surface, thereby achieving ideal conditions for coating film formation. By utilising new simulation technologies OYSTAR Manesty has adopted a science based design approach, which has led
The opti Coat spray gun is the ultimate choice for Pharmaceutical film coating.
Key benefits• Anti-bearding system with superior spray
pattern• Enhanced droplet performance• Tool free, GMP compliant design• Low profile shape with integral connec-
tions for reduced airflow turbulence• Retro-fit capability to upgrade existing
coating equipment
to the successful development of the Opti Coat spray gun. Many factors influence the quality of the final film coated product, some key study areas are:
spray pattern analysisThe difference in spray gun designs becomes more apparent when observing the spray patterns produced. At corresponding air pressures, a spray gun with large air outlet orifices produces
an air pattern that is less favourable in terms of distribution of the solution onto the tablet bed. With competitor air cap designs spray pattern air pressures have to be higher so as to generate a desired elliptical spray pattern. The Opti Coat spray gun air cap design balances the need for anti-bearding characteristics with the requirement to generate effective spray patterns.
droplet measurementFrom a process perspective the overall droplet size and distribution (span) will influence the occurrence of process related problems such as spray drying and over wetting. The greater the control on droplet size the easier it will be to have a repeatable high efficiency coating process. By employing state-of-the-art Laser Diffraction Measurement technology, OYSTAR Manesty has produced the Opti Coat spray gun to produce the narrowest droplet size distribution.
Predictive capabilitiesOYSTAR Manesty Process Scientists have developed a computer-generated matrix model providing the ability to predict the influence of critical process parameters on droplet size and span, as well as process scale up.
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m-tec™ ConTRoL sysTEM TEChnoLogy
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architecture and designm-tec™ control system design takes advantage of years of coating experience and through in-house software development, provides the most intuitive operator interface. Primary design focus on process functionality provides excellent alignment with user requirements.
• Robust machine control: PLC based machine control to handle control
devices and safety systems.• Operator HMI: PC-based operator interface with touch screen
and stainless steel keyboard. Hazardous area option also available.
• Flexible automation: Automated sequences tailored to suit
customers’ process requirements.
Key benefits• Common, scaleable platform for R&D,
pilot plant and production• Standard operation, reporting and
automation• Improved maintenance and process
support• Modular software to enable easy
upgrade path
• Data exchange: Integration to company networks and batch
management systems available using industry standards. m-tec™ utilises Microsoft Technology and OPC communications. User Access Control Management. Designed to enable regulatory compliance with cGAMP and FDA 21 CFR Part 11.
automation managerPowerful configuration tools provided for users to develop recipe driven automation for both coating and Clean in Place (CIP) operations consistent with industry standards.
• Recipe management: Product recipes can be created from pre-built
recipe method templates prior to release to production.
• Recipe method editor: For development of custom recipe method
templates.
Reporting toolsRange of Reporting and Trending packages to support manual operation and flexible automation. Accurate data acquisition and comprehensive production records, suitable for use in 21 CFR Part 11 compliant systems, ensures high level of traceability.
OYSTAR Manesty coater systems are equipped with the latest m-tec™ control system technology. This provides complete control of the coating process including air handling and solution delivery, as well as subsequent Clean in Place (CIP) requirements. The control system is common across the entire range of coating machines available from OYSTAR Manesty, including the laboratory XL™Lab, the Premier™ and of course the XL™Cota. m-tec™ systems are tailored, specific to customers requirements by building from a library of generic modules. These packages can be upgraded later as user needs change or develop.
As you would expect from a worldwide supplier of coating systems, a range of optional equipment and services are available to suit budget, process, regulatory and climatic requirements. As a major innovator in side vented pan technology for over 30 years, use our proven design and process support personnel to optimise the design and implementa-tion of your coating requirements.
FLEXibLE CoaTing CaPabiLiTy FRoM oysTaR ManEsTy
ProvenA large global installed base of equipment, successfully coating tablets for many years.
oysTaR ManestyOur unrivalled process knowledge, equipment quality and services support ensures our customers are choosing the number one supplier of coating equipment packages in the world.
design expertiseFrom your basic specifications we can provide design drawings that will optimise available space to ensure the best ergonomic positioning of the XL™Cota and its ancillary equipment. Take advantage of our knowledge to ensure ductwork specifications and routings meet process requirements and exhaust air is safely taken away. We can save you time by calculating all the important HVAC requirements to allow the coating process to be the most efficient possible.
Turnkey installationIncreasingly, customers are looking for a complete solution not only for their equipment needs but also for its safe and rapid installation and its associated services and utilities. This ensures that a single main contractor takes responsibility for the complete line, guaranteeing smooth transition to full operational status. From design, health and safety, ductwork supply and installa-
tion, positioning of equipment, utility connections, commissioning, validation and training – take advantage of OYSTAR Manesty’s One Stop Solution.
inlet air handlingAs we supply our XL™Cota coaters worldwide, different climatic conditions require a custom made solution for the delivery of process air at the correct volume, temperature and humidity. Our modular and flexible air-handling units condition the incoming air to meet the required process conditions. Options include preheating, humidity control and filtration. The units can also be flexibly installed as a single horizontal line or in a ‘dual deck’ format to optimise the use of available space.
Exhaust air handlingOnce again a range of options are available to remove the air from the XL™Cota. From a simple Mechanical Shake System to Full Safe Change capability to handle potent compounds, OYSTAR Manesty can provide the appropriate solution for you. To ensure there is no water damage to the filters during the Clean in Place (CIP) process a bypass system is fitted as standard.
Clean in Place (CiP)In conjunction with our m-tec™ control system we can provide a fully validatable Clean in Place (CIP)
option to remove all contaminates. This avoids the need to undertake further manual work which is often the case at the end of a WIP system. From the initial rinse through to compressed air cleaning of solution tubes, the XL™Cota was designed for Clean in Place (CIP) at its conception. Our package will ensure you will be coating your next batch of tablets in the minimum possible time.
solution delivery systemsThe new Opti Coat spray gun is supported by an efficient peristaltic pump delivery system. This ensures excellent control of solution delivery as the pump speed is controlled by the m-tec™ control system. By simply switching tubing, a range of aqueous and organic solvents can be successfully used. Individual monitoring of the performance of each solution line is also available. Other delivery systems are available to enable the coating of tablets with sugar suspensions or more difficult organic solvents if required.
Loading and unloading systemsTypically, tablets are delivered into the drum via a loading chute or material handling system via the door of the coater. 100% of the tablets will be discharged through the front of the coater by using reverse unload package. This valuable option quickly and safely removes tablets from the drum and delivers them into your container.
Post delivery supportFollowing delivery to your site our commissioning personnel will ensure performance to Site Accep-tance Testing (SAT) requirements. Fully comprehensive validation documentation will ensure that your new XL™Cota Coating System fully supports the appropriate regulatory requirements that you need to comply with. The installation Qualification (IQ) and Operational Qualification (OQ) elements of this documentation can also be implemented by OYSTAR Manesty personnel (in support of your own staff) to allow the start of Process Qualification (PQ) testing in the shortest time possible.
Key Exhaust Filter unit Exhaust air duct inlet air duct air handling unit supervisor station operator interface Coater
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Control functionality depends on optional package purchased.
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sPECiFiCaTions
XLC 150Weight 1590 kgCoater Dimensions H 2065 × W 1665 × D 1309Spray Guns 3 to 4Working Volume 170 LCompressed Air Consumption(@5bar from Coater)
7.9
Air Volume Range (m3/hr)
1500 – 2500
Main Heater Tempera-ture Range (degC)
10 – 85
Main Heater Steam Consumption (kg/hr)
117
XL™Cota 150
XLC 350Weight 2600 kgCoater Dimensions H 2400 × W 2050 × D 1630Spray Guns 5 to 6Working Volume 450 LCompressed Air Consumption(@5bar from Coater)
13
Air Volume Range (m3/hr)
2500 – 6500
Main Heater Tempera-ture Range (degC)
10 – 85
Main Heater Steam Consumption (kg/hr)
343
XL™Cota 750
XLC 750Weight 3438 kgCoater Dimensions H 2400 × W 2050 × D 2414Spray Guns 8Working Volume 800 LCompressed Air Consumption(@5bar from Coater)
21
Air Volume Range (m3/hr)
5000 – 12000
Main Heater Tempera-ture Range (degC)
10 – 85
Main Heater Steam Consumption (kg/hr)
550
3100 1900
2595
2295 27
00
2050
2400
2414
2050
16301795
2400
2295
2581 1275
2621
2065
2327
1962
1665
14751309
12002196
XL™Cota 350
6 7
3100 1900
2595
2295 27
00
2050
2400
2414
2050
16301795
2400
2295
2581 1275
2621
2065
2327
1962
1665
14751309
12002196
3100 1900
2595
2295 27
00
2050
2400
2414
2050
16301795
2400
2295
2581 1275
2621
2065
2327
1962
1665
14751309
12002196
3100 1900
2595
2295 27
00
2050
2400
2414
2050
16301795
2400
2295
2581 1275
2621
2065
2327
1962
1665
14751309
12002196
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