Amanta Healthcare Production Manager Interview Questions, Process, and Tips for Experienced

The Knapp test kit is used to evaluate the visual inspection process through a machine.

• The Knapp test kit helps in assessing the accuracy and efficiency of visual inspection processes performed by machines.

• It can be used to identify any potential issues or defects in the inspection process.

• The kit typically includes various tools and materials to simulate different inspection scenarios.

• Results from the Knapp test kit c...read more

A clean room can be made by controlling air flow, using proper filtration systems, maintaining cleanliness, and implementing strict protocols.

• Control air flow to prevent contaminants from entering the room

• Use HEPA filters to remove particles from the air

• Regularly clean surfaces and equipment to prevent buildup of dust and debris

• Implement strict protocols for entering and exiting the clean room

Viable and non-viable monitoring involves assessing the presence of living and non-living organisms in a production environment.

• Viable monitoring involves counting living organisms such as bacteria or fungi using culture-based methods.

• Non-viable monitoring involves measuring total microbial counts, including both living and dead organisms, using methods like ATP bioluminescence.

• Regular monitoring helps ensure product q...read more

Cleaning validation is performed to ensure that the cleaning process effectively removes residues from equipment.

• Identify critical cleaning steps and equipment to be validated

• Establish acceptance criteria for residue limits

• Select appropriate analytical methods for detection

• Perform cleaning verification tests before validation

• Document all procedures and results for regulatory compliance

The number of tests available for tunnel and filling machine validation varies depending on the specific requirements of the production process.

• The number of tests for tunnel and filling machine validation can range from a few basic tests to a comprehensive validation protocol.

• Common tests include functionality testing, performance testing, and validation of critical process parameters.

• The number of tests may also depe...read more