Biocon Biologics Quality Assurance/Quality Control Manager Interview Questions and Answers

Factors affecting lyophilization

• Temperature: The temperature during the lyophilization process affects the rate of sublimation and drying.

• Pressure: The pressure inside the lyophilizer chamber affects the rate of sublimation and drying.

• Product formulation: The composition and concentration of the product being lyophilized can impact the process.

• Freezing method: The method used to freeze the product prior to lyophilizati...read more

The triple point is the temperature and pressure at which all three phases of a substance (solid, liquid, and gas) coexist in equilibrium.

• The triple point is a unique combination of temperature and pressure for a substance.

• At the triple point, the solid, liquid, and gas phases of the substance can coexist in equilibrium.

• It is the point on a phase diagram where all three phases meet.

• The triple point is a fixed point use...read more

Validation of lyophilizer involves testing and documentation to ensure its performance and reliability.

• Validation of lyophilizer is necessary to ensure that it consistently produces high-quality freeze-dried products.

• The process involves testing various parameters such as temperature, pressure, and drying time to ensure they meet predetermined specifications.

• Documentation of the validation process is crucial for regula...read more

Maintaining HSO in lyophilized product involves proper storage conditions and packaging.

• Store the lyophilized product in a cool and dry environment to prevent moisture absorption.

• Use appropriate packaging materials that provide a barrier against moisture and oxygen.

• Ensure the lyophilized product is sealed tightly to prevent any exposure to air.

• Consider using desiccants or moisture-absorbing packets in the packaging.

• Per...read more