The new definition of tablet coating Pharmaceutical Tablet Coater

Pharmaceutical Tablet Coater
with Exchangeable Drums
The new definition of tablet coating
Manufacturing solution...
The new Accela-Cota® FLEX 500 is a manufacturing solution to increase tablet coating productivity while maintaining
product quality, consistency, and process reliability.
The FLEX 500 has a unique combination of features to help reduce down time for batch-to-batch change over, giving
the coater more process time to coat tablets – enhanced utilization, higher throughput, better profit!
With almost limitless possibilities, the FLEX 500 is the preferred choice for processing tablets using film, sugar,
functional, and drug layer coatings. Built for today’s needs – adaptable for tomorrow’s. The ultimate in versatility.
INNOVATION
Production Scale Coater with Exchangeable Drums
• Enhanced coater utilization
• Removable drum for inspection and cleaning
• Exchangeable drums for unmatched flexibility
• Interchangeable mixing baffles
• Patented Thomas Spray Bar
• Adjustable gun-to-bed angle/distance for all
load sizes
VERSATILITY
Superior Performance for a Range of Processes
• Aqueous film coatings
• Functional and modified release coatings
• Coating with one or more drug layers
• Sugar coating
FLEXIBILITY
Easily Configured to Best Suit a Process
• Five exchangeable drum configurations available
• Process batch loads from 25% to 100% of
drum capacity
• Dedicate drums to product classes or to contract
manufacturing clients
• Interchangeable spray bar and gun manifolds
• Easy to use graphic HMI with multiple languages
• Adapt easily to future needs
CLEANABILITY
Choose the original…choose success!
“Total Access” Design
• Optimized chamber design
for enhanced cleanability
• Faster and more effective cleaning
• Reduced cleaning validation expense
• Supports automated or assisted wash options
• Range of affordable WIP options
Patent Pending
Innovative Drum Exchange
Thomas Engineering is the originator of the fully perforated side-vented drum. Today, Thomas continues our legacy of
imaginative and practical coater design with the introduction of the FLEX 500. The FLEX 500 is the only production class tablet
coater with exchangeable drums. The compelling simplicity of the design makes routine drum exchange fast and easy.
Imagine the possibilities…
• Choose a drum configuration and
mixing baffles to best suit requirements
of the process
• Dedicate drums to specific drug
compounds or to individual clients
• Reduce risk of cross-contamination
• Achieve faster cleanings and
product changeovers for
enhanced utilization
• Reduce facility improvement
costs and operating expenses
– build and staff one coating
suite for the FLEX 500 instead of
two or more suites for ordinary
tablet coaters
All illustrations and specifications are
subject to change without notice
Drum Exchange
Pre-WIP
Patent Pending
Disengage
Drum Extraction
Coater WIP
Drum Exchange
Imagine the Possibilities
The FLEX 500
...is the most versatile and flexible tablet
Flexibility
• Routine exchange of drums within the
coating suite
• Wide turndown volume of 50 to 700 liters
in same machine – 5 drum sizes available
• Process batch loads from 25% to 100% of
drum capacity
• Externally position spray bar for optimal
angle and distance to bed
• Exchangeable mixing baffles
• Install Through-the-Wall, Rear Flush,
or Free Standing
• Adapt easily to future manufacturing needs
coater on the market today. It is the first
production class coater to offer drum
exchange, versatility and flexibility
for enhanced utilization and cleanability.
Drum Exchange
• Choose a drum to best suit the process
• Reduce cross contamination; lower
costs for cleaning validation studies
• Dedicate drums to product families or
contract manufacturing clients
• Faster batch-to-batch changeover time
• More throughput with fewer coaters
• Enhanced utilization – higher
productivity
Thomas Spray Bar
• Streamlined sanitary design
• Eliminates air and solution lines over
spray zone
• Schlick ABC™ anti-bearding spray nozzles
as standard
• Independent control of pattern and
atomizing air
• Tool-less gun inserts and bar assemblies
for fast, easy service
• Light weight sections for easy handling
• Service cart for convenient maintenance
and optional spray pattern testing
Solution Delivery
• Peristaltic pump with single or dual
element head
• Recirculation to reduce settling of solids
in solution lines
• Choice of volumetric or mass flowmeter
• Solution pressure monitoring
• Automated solution switching
All illustrations and specifications are
subject to change without notice
Patent Pending
Tomorrow’s Coater—Today
Automation
• Large color touch-screen operator
interface (HMI)
• Multiple languages
• Switch between languages at the
touch of a button
• Receptacle for detachable keyboard
and mouse
• Comprehensive recipe and report
management
• Sub-batch and campaign management
• Enables compliance with 21 CFR Part 11
Cleanability
• “ Total Access” design for swabbing
and routine inspection
• Optimized chamber design for
enhanced cleanability
• Continuously welded interior with
rounded corners
• Smooth chamber surface finishes
throughout
• Water-tight inflatable seals on
access doors
Mixing Baffles
• Removable for easy off-line cleaning
and inspection
• Exchange and select baffles to best
suit a process
• Designed for tool-less removal and
assembly
• Choice of plough or TEI helical
• High and low profile designs
Integrated Peripherals
• Range of affordable manual, assisted
and automated WIP executions
• Optional devices for assisted loading
using IBCs or drums
• Convenient front utility panel for
scales and drum inverters
• Purpose-built dollies for drum
exchange and storage
• Solution preparation equipment
and delivery tanks
Process Versatility
The Accela-Cota® FLEX 500 is a versatile coating platform that accommodates a wide range of coating applications.
Some processes may use just a single spray solution. More complex matrices may require a series of cycles or stages often with widely varied fluid properties - to develop functional layers, or layers containing active drugs. While there
can be many processes all with their own unique variables, they all have one demand in common – they need to be
implemented on a tablet coater that is efficient, highly available, easy to clean and capable of delivering consistently
good product quality. That coater is the FLEX 500!
Aqueous Film
Sugar
Functional
Drug Layer
The most widely used coating
process, these coating films
are used to produce color and
clear finishes on tablet cores,
and for overcoating tablets
with previously applied sugar,
functional, and drug layer
materials. Solution viscosities
are moderate and most coating
processes are fairly simple to
optimize.
The sugar coating process
is characterized by its many
iterations of a dose-distribute-dry
sequence using a heavy sugar
syrup. This produces a very thick
layer of solid material around the
tablet core. Sugar coatings are
commonly applied in conjunction
with functional seal coatings,
sometimes a drug layer, and
concluding with a color or clear
finish coat. The process requires
a coater with broad process
capabilities, such as the FLEX 500.
Functional coatings contain
materials that modify the release
profile of tablet cores. In many
cases, the materials consist of
high molecular weight polymers
in a high viscosity suspension.
Solution delivery systems are
required to efficiently provide
solution and air supply for
droplet atomization to ensure
quality film formation; selection
of spray nozzles is essential to
prevent gun bearding.
Coating suspensions containing active
drugs are applied to the tablet core in
layers, sometimes with protective barrier
layers between them. These highly
specialized processes are often
characterized by viscous suspensions
containing very low drug concentrations.
Layer development typically requires long
processing times with low bed depth to
achieve high content uniformity. A FLEX
500 coating drum with appropriate
geometry for desired batch size and bed
depth may be selected for the process.
Capabilities
For more than 50 years, Thomas Engineering has been a partner in the solid dosage manufacturing industry, helping
customers develop solutions to boost productivity and reduce manufacturing costs.
With the Accela-Cota® FLEX 500, Thomas is now positioned to help even more by offering this innovative “coating
platform” to provide unprecedented manufacturing flexibility. An investment in flexible technology gives our customers
a competitive advantage, allowing them to react quickly to changing market demands and product mix priorities.
Our customers appreciate the value of a partnership with Thomas Engineering, the market leader dedicated to tablet
coating. These customers know that their investment extends beyond a system of machines and controls – they also
benefit from our expertise and competency resulting from decades of experience with tablet coating systems in the
field. The dividend is their assurance that their TEI coating system will deliver reliable performance and consistently good
finished products for many years.
Choose the original…choose success…choose Thomas Engineering.
Thomas Engineering Inc.
575 West Central Road
Hoffman Estates, IL 60192
847/358-5800 F. 847/358-5817
www.thomaseng.com
All illustrations and specifications are
subject to change without notice
Patent Pending