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The disc stack centrifuge online cleaning CIP and online sterilization SIP operation process is designed to improve the cleaning and sterilization efficiency of the equipment, and is generally applicable to the fields of biopharmaceuticals and bioengineering.
The following is a general online cleaning (CIP) and online sterilization (SIP) operation process:
Online cleaning (CIP) operation process:
1. Preparation phase
Make sure the centrifuge is in a stopped state and check the operating manual.
Check the connection of the cleaning system and equipment to ensure that there is no leakage.
2. Set up the cleaning program
Set up the cleaning program according to the cleaning requirements of the equipment, including the type, concentration, flow rate and temperature of the cleaning agent.
Usually, it is necessary to use cleaning agents suitable for biopharmaceuticals, such as alkaline cleaning agents or acidic cleaning agents.
3. Preliminary rinse
Start the cleaning program, perform a preliminary rinse, and use warm or cold water to remove surface residues.
Usually lasts for 5-10 minutes, ensuring that the flow rate and pressure meet the requirements.
4. Cleaning agent circulation
Start the cleaning agent circulation, inject the cleaning agent, and maintain a certain flow rate and temperature.
The cycle time is generally 15-30 minutes, depending on the equipment and dirt type.
5. Neutralization and final rinse
Run the neutralization program (if necessary) to remove the cleaning agent residue.
Perform a final rinse with clean water to ensure that there is no cleaning agent residue.
6. Drying (if necessary)
If necessary, a drying step can be performed to dry the cleaned parts using hot air or air flow.
7. Record and verify
Record the cleaning operation, including parameters such as the cleaning agent used, time, temperature and pressure.
Check the cleaning effect to ensure that the expected cleaning standard is achieved.
Sterilization in Place (SIP) operation process:
1. Prepare sterilization equipment
Ensure that the centrifuge and its related equipment are in normal working condition.
Check the temperature, pressure and time settings of the sterilizer.
2. Set the sterilization program
Configure the online sterilization program according to the specific sterilization requirements, including sterilization temperature, pressure and time.
Common sterilization parameters are 121°C, 15-30 minutes.
3. Start the sterilization cycle
Start the sterilization cycle, gradually increase the temperature and pressure to ensure that the set sterilization conditions are achieved.
Maintain for a certain time to ensure the sterilization effect.
4. Cooling stage
After the sterilization is completed, gradually reduce the pressure and temperature to avoid damage to the equipment caused by sudden cooling.
Wait until the pressure returns to normal pressure before opening the equipment.
5. Remove and inspect
Carefully remove the sterilized parts to avoid contamination.
Check whether the equipment is normal and ensure that there is no damage.
6. Record and verify
Record the sterilization operation, including information such as time, temperature, pressure and operator.
Perform sterilization effect verification to ensure that the expected sterilization standards are met.
Notes:
Operation records: Ensure that each cleaning and sterilization process is recorded in detail for traceability and auditing.
Personal protection: Operators should wear appropriate personal protective equipment (PPE) when performing online cleaning and sterilization operations.
Regular maintenance: Regularly check and maintain cleaning and sterilization equipment to ensure its normal operation and extend the service life of the equipment.
Summary:
Online cleaning and sterilization are important steps to ensure the hygiene and safety of biopharmaceutical equipment. Follow relevant standards and operating specifications to ensure the effectiveness and reliability of the cleaning and sterilization process.
