Operational Process Requirements Assessment Answer

Bioreactor P&ID

Antifoam Tank P&ID

Clean-in-place (CIP) P&ID

Media Sterilizing P&ID

The protocol

Performance Test 1: Temperature Range Verification Test

Set the bioreactor temperature to 20°C and wait for 30 minutes to stabilize.

Verify that the bioreactor can maintain the temperature range of 20-40°C for a duration of 6 hours.

Set the bioreactor temperature to 40°C and wait for 30 minutes to stabilize.

Verify that the bioreactor can maintain the temperature range of 20-40°C for a duration of 6 hours.

Solution:

To perform the Temperature Range Verification Test, follow the below steps:

Start the bioreactor system and set the temperature to 20°C. Wait for 30 minutes to stabilize the temperature.

Check and verify that the bioreactor can maintain the temperature range between 20°C to 40°C for a duration of 6 hours.

After 6 hours, set the temperature to 40°C and wait for 30 minutes to stabilize the temperature.

Check and verify that the bioreactor can maintain the temperature range between 20°C to 40°C for a duration of 6 hours.

Performance Test 2: Antifoam Level Verification Test

Start the bioreactor system and run it for 8 hours.

Verify that the antifoam tank can maintain a constant level of antifoam agent during operation.

Introduce a sudden increase in foam production and verify that the antifoam tank can respond quickly to maintain the desired antifoam level.

Solution:

To perform the Antifoam Level Verification Test, follow the below steps:

Start the bioreactor system and run it for 8 hours.

Check and verify that the antifoam tank can maintain a constant level of antifoam agent during operation.

Introduce a sudden increase in foam production by adding extra foam agents to the bioreactor system and verify that the antifoam tank can respond quickly to maintain the desired antifoam level.

Performance Test 3: CIP System Cleaning Verification Test

Run the CIP system and clean all process equipment.

Conduct a visual inspection of all process equipment to verify that they are cleaned to the desired level.

Conduct a microbial test on the cleaned equipment to verify that they are free of any microbial contamination.

Solution:

To perform the CIP System Cleaning Verification Test, follow the below steps:

Start the CIP system and clean all process equipment to the desired level.

Conduct a visual inspection of all process equipment to verify that they are cleaned to the desired level. Check for any residue or discoloration and ensure that all equipment is thoroughly cleaned.

Conduct a microbial test on the cleaned equipment to verify that they are free of any microbial contamination. This test should confirm that the cleaning process has effectively removed all microbes from the process equipment.

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