Senior Validation Associate Interview Questions and Answers

The positive growth in isolator is handled by following the established procedures and notifying the appropriate personnel.

• Follow the established procedures for handling positive growth in isolator

• Notify the appropriate personnel such as the supervisor or quality control department

• Isolate the affected area and perform additional testing to determine the extent of contamination

• Implement corrective actions to prevent future occurrences

Parameters to validate filling machine

• Accuracy of fill volume

• Consistency of fill volume

• Linearity of fill volume

• Cleanliness of the machine

• Proper functioning of sensors and alarms

Tests to qualify steam quality testing

• Chemical analysis of steam condensate

• Measurement of steam pressure and temperature

• Testing for impurities such as dissolved solids and gases

• Verification of steam flow rate

• Testing for microbiological contamination

The make of the lyophilizer is not specified in the question.

• The make of the lyophilizer may vary depending on the manufacturer.

• It is important to know the make of the lyophilizer for validation purposes.

• Some common makes of lyophilizers include Labconco, Virtis, and Millrock.

• The make of the lyophilizer may affect the validation process and requirements.