Sanzyme Senior Executive Interview Questions and Answers

CSV stands for Comma Separated Values and is a file format used to store data in a tabular form.

• CSV files can be created using spreadsheet software like Microsoft Excel or Google Sheets.

• Validation deliverables for CSV files include verifying the accuracy of data, ensuring proper formatting, and checking for any errors or inconsistencies.

• Validation can be done manually or through automated tools like scripts or software...read more

Method development parameters as per ICH

• ICH guidelines provide recommendations for method development in the pharmaceutical industry

• Parameters include specificity, linearity, range, accuracy, precision, robustness, and system suitability

• Specificity ensures that the method measures only the analyte of interest

• Linearity determines the relationship between analyte concentration and response

• Range defines the concentration ...read more

The fill volume formula calculates the volume of liquid or gas that can be held in a container.

• The fill volume formula is typically calculated by multiplying the area of the base of the container by its height.

• For example, the fill volume of a cylindrical tank can be calculated using the formula V = πr^2h, where r is the radius of the base and h is the height of the tank.

• Different shapes of containers will have differe...read more

Dynamic pass box allows for continuous transfer of materials while static pass box requires manual transfer.

• Dynamic pass box has a conveyor belt for continuous transfer of materials.

• Static pass box requires manual transfer of materials.

• Dynamic pass box is more efficient for high volume transfer.

• Static pass box is suitable for low volume transfer or when contamination risk is high.

• Examples: Pharmaceutical industry uses ...read more

Clean room areas are classified based on the level of cleanliness required for the specific activities performed within them.

• Clean room areas are classified using ISO standards, with Class 1 being the cleanest and Class 9 being the least clean.

• The classification is based on the maximum allowable concentration of particles per cubic meter of air.

• Examples of clean room areas include semiconductor manufacturing facilities...read more

Provision for expenses refers to setting aside funds to cover anticipated future expenses.

• Provision for expenses is a common practice in financial planning to ensure that there are enough funds available to cover future expenses.

• It involves estimating the amount of expenses that may arise in the future and allocating funds accordingly.

• Examples of expenses that may require provision include taxes, insurance premiums, an...read more

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