High Shear Mixer for Sterile manufacturing

PCC wet milling

Integrating Wahal high shear mixers into sterile manufacturing skids requires careful consideration to maintain sterility and ensure efficient processing. Here’s how it’s typically done:

1. Sanitary Design and Materials:

  • Materials:
    • Wahal High shear mixers used in sterile applications are constructed from materials that meet stringent sanitary requirements, primarily SS 316L stainless steel.
    • Elastomers and seals are chosen for compatibility with sterilization processes (e.g., SIP) and the products being manufactured.
  • Surface Finish:
    • The Wahal mixer’s internal surfaces undergo high-level polishing (e.g., electropolishing) to minimize crevices and facilitate cleaning.
    • This smooth surface finish reduces the risk of microbial buildup.
  • Clean-in-Place (CIP):
    • Wahal High shear mixers are designed for CIP, allowing for automated cleaning without disassembly.
    • This involves incorporating spray balls, optimized flow paths, and drainable designs.
  • Sterilization-in-Place (SIP):
    • For critical sterile processes, the mixers must be compatible with SIP, typically using steam sterilization.
    • This requires materials and designs that can withstand high temperatures and pressures.

2. Aseptic Connections and Integration:

  • Aseptic Connections:
    • The Wahal mixer’s connections to the skid’s piping and vessels utilize aseptic connectors (e.g., tri-clamp fittings) to maintain sterility.
  • Integration:
    • The mixer is integrated into the skid’s process flow to ensure seamless material transfer and processing.
    • This involves careful design of piping, valves, and instrumentation to minimize dead legs and maintain sterility.
  • Seals:
    • Mechanical seals that are used must be sanitary, and able to withstand the sterilization processes.

3. Process Control and Monitoring:

  • Instrumentation:
    • Sensors and instrumentation are integrated into the skid to monitor critical process parameters, such as speed, temperature, and pressure.
    • This data is used to control the mixing process and ensure consistency.
  • Automation:
    • The Wahal mixer’s operation is often automated as part of the skid’s control system.
    • This allows for precise control of mixing parameters and reduces the risk of human error.
  • Validation:
    • The complete integrated system will need to be validated, to prove that the sterile process is reliable.

4. Considerations:

  • Containment:
    • In some applications, particularly those involving potent compounds, the mixer may be integrated with containment systems to protect operators and the environment.
  • Scale-up:
    • When scaling up production, it’s essential to select a high shear mixer that can maintain consistent performance at the desired production volume.

In essence, the integration of high shear mixers into sterile manufacturing skids involves a holistic approach that prioritizes sterility, cleanability, and precise process control.