Contents
PROCESS OVERVIEW
The Wet Granulation Process Steps
Wet Granulation is selected as the manufacturing process when the Oral Solid Dosage (OSD) pharmaceutical powders possess poor compressibility. It is the most commonly used production method for Pharmaceutical OSD products as it suits most types of powders (whether they have high or low flowability properties) and has been proven over time to be highly successful.
When the original powdered ingredients for the pharmaceutical batch arrive at the manufacturing facility, many of them may have agglomerated and created pellets or lumps in the powder.
As a pre-step, these powders are conditioned to become more free-flowing, removing the lumps and creating the target particle size distribution (PSD) required by the formulation.
This can be achieved in a number of ways depending on the state of the powder:
- Delumping can be done with a Quadro® FlexSift for powders that have easily breakable lumps. Concurrently, the FlexSift provides added security screening to catch any trapped materials in the incoming batch of ingredients.
- For harder lumps in powders, the Quadro® Comil® with a large holed screen and slow impeller speed can be used for deagglomeration.
- To achieve target PSDs, the Quadro® Comil® is often used for Milling of APIs and excipients which will also improve the blend homogeneity and powder flow. If required due to stringent OEB requirements, this can be done in an Isolator to ensure operator safety and/or to retain product integrity.
After the high-shear granulation (HSG) mixing process, where typically water or solvents are added to wet the powders, a wet mass is produced. This material is often lumpy and sticky and needs to be fed into the Fluid Bed Dryer (FBD) for the drying phase.
If the granules in the wet mass material introduced into the FBD are not of a similar size they will dry at different rates – the small particles will dry quickly, whilst the bigger lumps could remain wet at the core, which will cause problems down the line at the dry milling stage (after the FBD), where they will smear on the screen resulting in product waste and milling stoppages.
Following the Fluid Bed Dryer (FBD) stage, the now dry material is passed through a mill once more, fine-tuning its particle size to meet the specific requirements of the manufacturing protocol. At this stage, the material is milled to ‘calibrate’ the final target particle size (PSD) – which is also known as the dry milling step.
Having achieved the correct powder condition, the pharmaceutical material is now efficiently fed to the tablet press or sachet/capsule fillers.
Equipment
Milling, Screening and Deagglomeration for Manufacturing Pharmaceuticals
View our range of sanitary, high performance size reduction, milling, and screening machines for dry and wet processes. From the lab to full production, you can rely on Quadro Engineering.
The Quadro® Comil® Underdriven Series
Compact, inline underdriven cone mill for easy integration.
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Equipment Testing
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Our knowledgeable product and application specialists will be on hand to offer:
- Feasibility tests to support new product developments.
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- Proof of concept for process scaling.
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