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Key fact Detail
- Compliance
- cGMP and 21 CFR Part 11
- Models
- Lab, pilot and commercial production
- Coating
- Wet or organic
- Pans
- Interchangeable pan sizes
- Construction
- SS 316 or SS 316L
The auto coater
It features a perforated coating solution container and a peristaltic pump with pressure controls for differential pressure filter control.
The unique design offers an effective cascading flow of tablets and ensures coating uniformity. The GMP design is an in-wall concept with four user levels, JOG function for heating and cooling cores and an automatic washing system.
An automatic tablet coating machine is called automatic because it runs to a recipe. The word does not refer to how the tablets are loaded.
Coating needs a balance between spraying and drying. The coating solution must reach the tablet surface a little faster than the air dries it.
If it does not, the film does not form. It must also arrive a little slower than the tablet surface can absorb it.
If it does not, the tablets in the pan get too wet.
When an operator holds this balance by hand over a long run, defects appear. The type of defect depends on which way the balance moved.
An automatic coating system holds the balance by following a recipe.
The pharmaceutical coating page explains the defects that appear when the balance is lost. It also explains the four coating types this machine applies.
Auto coater specifications
- Interchangeable pan sizes with dedicated height-adjustable spray nozzles.
- Spray pressure and rate, with the air temperature and quantity, provide the equilibrium needed for smooth coating operations.
- The gentle movement of the pan is designed to coat tablets of varying shapes, contours and sizes.
- Recipe-based operations.
Roto Granulator
FabLife's Roto Granulator is one of our latest innovations in process technology equipment.
It can be safely called the 3G version of the Fluid Bed Processor, for its ability to convert a skill-based pan-coating art into a programmable technology. The high and denser yielding of granules and drug loading make it a superior, fast-paced and highly reproducible technology.
The Roto Granulator is not a separate type of machine. It is the tangential-spray version of the fluid bed processor.
Fabtech describes fluid bed technology in three generations. The first is top spray.
The second is the bottom-spray Wurster. The third is tangential spray, also called Roto Granulation.
This third generation is what "3G version" means above. All three make pellets, which are small round granules.
The tangential version makes them faster and yields denser granules.
Roto Granulator specifications
- Ideally used for pellet generation from sugar crystals or non-pareil seeds, to load drugs even up to 500% by weight or more in less than 2 hours under most conditions.
- Centrifugal motion leads to rapid drying and hence faster process times.
- Easy accessibility of nozzle during the process.
- Recipe-based batches can be set, and critical process parameters can be validated.
- Process times are typically less than one hour regardless of coating weight gains.
Scale, materials and compliance
Our Auto coaters are cGMP and 21 CFR Part 11 compliant and available in lab, pilot and commercial production models constructed with SS 316/SS316L.
The product contact parts are mirror-finished, and the non-contact parts are matt-finished.
Lab, pilot and production models are in one range, so a coating recipe can move from one size to the next. A film proved on a laboratory pan is proved again at production scale.
It does not have to be developed again from the start. This is the difference between a scale-up and a second development project.
How it is specified, built and qualified
We supply the machine to a User Requirement Specification and hand it over with a qualification file.
The User Requirement Specification (URS) is the document that lists what the machine must do.
The work starts with the URS and the design qualification. Next comes a factory acceptance test before the machine is shipped.
Then come site acceptance and the installation, operation and performance qualification at your plant. The full sequence is on the qualification page.
Buyers who search for an auto coater machine manufacturer are looking for one company that takes responsibility for the machine. Fabtech supplies the auto coater and stays responsible for it.
We specify the pan, the nozzles and the air handling to suit your tablet, instead of offering one fixed configuration. The rest of the range is in the process equipment catalogue.
The step before coating is on granulation techniques. If the coating suite is part of a facility, a turnkey pharmaceutical project covers the process, water, air and rooms together.
We reply within 24 hours.
FAQ
What is an auto coater?
It is an automatic coating machine for tablets. The tablets turn in a perforated pan and pass through the spray. The operator sets a recipe. The machine keeps the spray rate, air temperature, air volume and pan speed at the recipe settings for the whole run.
What makes a coating machine automatic?
The recipe makes it automatic. Coating needs a balance between how fast the solution reaches the tablet surface and how fast the air dries it. Holding this balance by hand over a long run causes defects. An automatic coating system holds it at set parameters and records what it did.
What pan sizes are available?
The pans are interchangeable. Each pan has its own dedicated height-adjustable spray nozzles. The machine is available in lab, pilot and commercial production models.
Can it coat tablets of different shapes?
Yes. The gentle movement of the pan is designed to coat tablets of varying shapes, contours and sizes. The tablets roll over each other in a cascading flow, and this flow gives a uniform coating on all of them.
Is the machine cGMP and 21 CFR Part 11 compliant?
Yes. It is built to cGMP, with an in-wall design and four user levels. It is also built to 21 CFR Part 11 for the electronic records its control system creates. It is made of SS 316 or SS 316L. Product contact parts are mirror-finished, and non-contact parts are matt-finished.
What is a Roto Granulator?
It is the tangential-spray version of a fluid bed processor. It makes pellets from sugar crystals or non-pareil seeds. It can load drugs up to 500% by weight or more in under two hours. The three generations of the technology are top spray, bottom-spray Wurster and tangential spray. All make pellets. The tangential version is faster and makes denser pellets.
Send us your tablet, batch size and coating type, and we will specify the machine