Applications · Food & Pharma

STATIC MIXER FOR BUFFER SOLUTION PREPARATION

Continuous inline dilution and preparation of buffer solutions (phosphate, citrate, acetate, Tris, HEPES) for biopharmaceutical cell culture, chromatography, and TFF processes.

GMP | Inline Dilution | pH Precision
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±0.05 pH Buffer Precision
Key Parameter 1
Coefficient of Variation (CoV) ≤0.02
Key Parameter 2
Ra ≤0.8 µm
Key Parameter 3
DN10–DN100
Key Parameter 4
Process Scheme
Water for Injection (WFI) / Purified Water
Buffer Concentrate (10×)
KE Bio-Processing Equipment (BPE) Mixer
Inline pH Monitor
Buffer Distribution

Mixing Criteria

Coefficient of Variation (CoV) ≤0.02 for ±0.05 pH precision (10% concentration non-uniformity = 0.1 pH error). Inline pH electrode 3–5D downstream after thermal equilibration. Temperature affects buffer pKa — mixing must be complete before pH measurement. Water for Injection (WFI): TOC <500 ppb, endotoxins <0.25 EU/ml.

Typical Viscosity
0.8–5 cP (centipoise) (aqueous buffer solutions)
Reynolds Number (Re)
Reynolds Number (Re) 5,000–100,000 (turbulent)

Material & Special Requirements

Preferred MOC: 316L SS Ra ≤0.8 µm, tri-clamp, ASME Bio-Processing Equipment (BPE) compliant. Water for Injection (WFI)-compatible materials only — no zinc, copper, or lead alloys.

ASME Bio-Processing Equipment (BPE) documentation for IQ/OQ/PQ qualification. Inline pH probe housing 3–5D downstream (allow thermal equilibration). Sanitisation cycle: Sodium Hydroxide (NaOH) 0.1 M or steam-sterilisation. Water for Injection (WFI)-quality dilution water essential.

Recommended Mixer
KE Series — Helical Element
Kenics-equivalent. 180° RH/LH helical elements joined at 90°. Halves striation thickness per element. Works laminar to turbulent. Best general-purpose choice.
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