Aseptic preparation filling primarily uses two types of filling pumps: ceramic plunger pumps and peristaltic pumps. Each has specific advantages and drawbacks:

• Ceramic Plunger Pump:
  • Advantage: High precision.
  • Disadvantages: High shear force and limited filling range.
• Peristaltic Pump:
  • Advantage: Commonly used for high-end aseptic preparation filling, as it better meets the unique requirements of certain high-value products.

In the filling process of aseptic preparations, ensuring sterility and filling accuracy are fundamental requirements. Therefore, peristaltic pumps in this application need to meet specific standards:

1. All Stainless Steel Material

• The aseptic preparation filling process occurs in a Class A environment, requiring the peristaltic pump to:
  • Be made entirely of stainless steel.
  • Have an embedded design compatible with isolators to optimize installation space.

 

2. High Precision

• Aseptic preparations, especially high-value-added products (e.g., vaccines, monoclonal antibodies), demand high yield rates (98% or higher).
• High-precision dispensing peristaltic pumps meet this requirement with:
  • A multi-roller cross design that reduces pulsation, delivering liquid smoothly.
  • Improved filling accuracy, contributing to increased drug yield.
• The peristaltic pump filling system can also be equipped to collect tail fluid, minimizing waste of expensive medications.

3. Multi-Channel Solution

• In sterile formulation manufacturing, maintaining sterility is critical. Therefore:
  • Filling lines must ensure sterility throughout.
  • The biopharmaceutical industry typically employs disposable pipeline components, which are pre-sterilized by irradiation.
  • During filling, liquid medicines are transported through sterile pipelines, thereby eliminating the risk of contamination.

 

Conclusion:

peristaltic pumps are ideal for aseptic preparation filling due to their stainless steel design, high precision, and compatibility with sterile, multi-channel setups. Unlike ceramic plunger pumps, they ensure low shear, broad filling ranges, and enhanced yield accuracy—making them especially suited for high-value products like vaccines and monoclonal antibodies.