Executive Microbiologist Interview Questions and Answers

Enumeration procedure for biological indicators involves inoculating the indicator with a known number of spores and then counting the surviving spores after exposure to a sterilization process.

• Inoculate the biological indicator with a known number of spores

• Expose the indicator to a sterilization process

• Count the surviving spores to determine the effectiveness of the sterilization process

• Examples of biological indicators include Bacillus stearothermophilus and Geobacillus ste...read more

Autoclave validation is a process to ensure that an autoclave is functioning properly and effectively sterilizing equipment.

• Perform temperature mapping to ensure uniform heat distribution throughout the autoclave chamber.

• Use biological indicators to confirm that the autoclave is effectively killing microorganisms.

• Document all validation procedures and results for regulatory compliance.

• Regularly monitor and re-validate the autoclave to ensure continued effectiveness.

• Consider f...read more

BET and Sterility testing are essential microbiological tests to ensure the safety and quality of pharmaceutical products.

• Performing Bacterial Endotoxin Testing (BET) involves using the Limulus Amebocyte Lysate (LAL) assay to detect endotoxins in pharmaceutical products.

• Sterility testing is done to determine the absence of viable microorganisms in pharmaceutical products.

• Both tests require strict aseptic techniques and adherence to regulatory guidelines such as USP <71> for S...read more

OOS investigation involves identifying and resolving deviations in test results that fall outside of established specifications.

• Gather all relevant data and documentation related to the OOS result.

• Conduct a thorough investigation to determine the root cause of the OOS result.

• Implement corrective actions to prevent recurrence of similar OOS results.

• Document all findings and actions taken in a detailed report for review and approval.

• Review and close the OOS investigation once a...read more