Applications · Food & Pharma

STATIC MIXER FOR VACCINE ADJUVANT EMULSIFICATION

Emulsification of oil-based adjuvants (squalene, MF59) with aqueous antigen solutions. Precise droplet size and distribution are critical for immune response consistency.

Sanitary | Ultra-Low Shear | Aseptic
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Coefficient of Variation (CoV) ≤0.01
Key Parameter 1
Ra ≤0.5 µm ASME BPE
Key Parameter 2
DN10–DN50
Key Parameter 3
Aseptic Design
Key Parameter 4
Process Scheme
Antigen Solution
Adjuvant / Oil Phase
SX Sanitary Mixer
Sterile Filter
Fill Station
Vials

Mixing Criteria

Coefficient of Variation (CoV) ≤0.01 for emulsion uniformity. Gentle laminar SX mixing preferred over turbulent KE to avoid adjuvant droplet over-shearing. Ultra-low flowrates (ml/min at pilot scale) — DN10–DN25 typical. Complete steam sterilisability in-place.

Typical Viscosity
1–100 cP (centipoise) (aqueous antigen) and 10–500 cP (centipoise) (adjuvant oil phase)
Reynolds Number (Re)
Reynolds Number (Re) <2,000 (laminar for gentle emulsification)

Material & Special Requirements

Preferred MOC: 316L SS electropolished Ra ≤0.5 µm. ASME Bio-Processing Equipment (BPE) all wetted surfaces. Tri-clamp. Steam-sterilisable all joints. PTFE diaphragm valves upstream and downstream.

Steam-sterilisable in-place (SIP) design. ASME Bio-Processing Equipment (BPE) Ra ≤0.5 µm. No dead legs anywhere in the system. Validation: FAT, IQ, OQ, PQ, microbiological validation. Material certificates 3.1 for all wetted components.

Recommended Mixer
SX Series — Cross-Bar
Sulzer SMX-equivalent. ±45° corrugated bar lattice. 2^N striation growth per element. Deep laminar only (Re<500). Essential for viscosity ratios >1000:1.
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