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Pharmaceutical

Avian Influenza Vaccine Project Achieving Complete Sealing Without Process Modification

Project Overview

Animal vaccine company C produces egg protein-based avian influenza vaccines.

Maintaining an airtight process is essential to prevent virus leakage, but the leakage risk of the existing mechanical seal agitator had always been a concern.

Company C was looking for a mixing solution that could achieve complete hermetic sealing while maintaining the existing tank validation conditions and piping layout.

Challenges

1. Limits of Virus Containment and Sealing

Due to the nature of the process handling avian influenza virus, maintaining airtight containment to prevent external leakage was the top priority. However, the existing mechanical seal system had a risk of micro-leakage, requiring a more complete containment technology.

2. Maintaining Validation and Limited Top Space

To maintain the already validated process, a conventional bottom-mounted magnetic mixer requiring tank bottom modification could not be applied. A seal-free agitator was required while keeping the existing top-entry drive configuration.

3. Cleaning Difficulty of Sticky Egg Protein

Egg protein, the main raw material, has high viscosity and easily adheres to equipment surfaces. Therefore, even with a complex top-entry agitator structure, the system had to support complete CIP and SIP without dead zones.

SEDNA Solution

1. SRFT Series (Patented Top-Mounted Magnetic Mixer)

SEDNA ENG proposed the SRFT top-mounted magnetic mixer, patented in Korea, the U.S., and China. Although installed from the top of the tank, the SRFT uses magnetic coupling and an isolation barrier to completely separate the inside and outside of the tank without mechanical seals.

2. Seamless Retrofit (Fully Compatible with Existing Equipment)

The SRFT model is designed to fit a similar headspace as conventional mechanical seal agitators. This allowed Company C to replace only the agitator without modifying the tank or making major piping changes, while maintaining existing validation data and upgrading containment performance.

3. CIP/SIP Optimized Body Design

To address the customer’s cleaning concerns, the shaft and drive connection areas were specially designed to allow cleaning fluid to reach every internal surface. Actual CIP/SIP testing confirmed complete cleaning and sterilization with no protein residue.

PROBLEM

SOLUTION

01 Zero Leakage

By applying magnetic coupling technology, SEDNA ENG fundamentally blocked the risk of virus leakage and maximized process safety.

02 Validation Continuity

Through a 1:1 retrofit without tank modification, validation cost and time were significantly reduced.

03 Perfect Hygiene

Complete CIP/SIP performance with no residue was proven even in a challenging egg protein process, turning on-site concerns into confidence.