“Top 7 Granulation Interview Questions in Pharma and How to Answer Them”

What factors influence particle size distribution in the granulation process?

The particle size distribution during granulation can be controlled by adjusting several parameters, including the concentration of the binder, impeller speed, and the duration of granulation. Additionally, optimizing drying conditions plays a crucial role in ensuring uniformity in the granule size, which is vital for downstream processes like tableting.

How do you monitor and control moisture content in granules, and why is this important?

Moisture content affects both the physical properties and the stability of granules. Common methods for monitoring include using techniques like loss on drying (LOD) or near-infrared (NIR) spectroscopy. Proper moisture control helps prevent over-wetting or under-wetting, ensuring product consistency and reducing batch rejection rates.

How do you improve the compressibility of granules?

Granule compressibility is crucial for tablet formation. You can improve it by adjusting the formulation, utilizing tests such as the Hausner ratio and Carr’s index, and fine-tuning process parameters like the binder concentration and granulation time to achieve the desired mechanical strength.

What is friability, and how can it be controlled in tablet granulation?

Friability refers to the tendency of granules or tablets to chip or break during handling. Controlling friability involves selecting the appropriate binder and optimizing the granulation process to ensure that the tablets or granules remain intact during production and transportation.

How do you ensure content uniformity in granulation?

Content uniformity is critical for ensuring dosage accuracy. It can be maintained through proper mixing, using effective granulating agents, and implementing robust sampling techniques during production.

How would you troubleshoot common granulation issues like over-wetting or poor flow properties?

Common granulation issues such as over-wetting can be resolved by adjusting the rate at which the binder is added or modifying drying parameters. Poor flow properties can be addressed by incorporating flow enhancers or altering the granulation time and moisture content to improve process efficiency.

What safety measures are essential when handling potent active pharmaceutical ingredients (APIs) during granulation?

Handling potent APIs requires strict safety measures, such as using personal protective equipment (PPE), proper containment systems, and adhering to occupational safety protocols to prevent exposure and ensure worker safety.