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