Applications · Food & Pharma

STATIC MIXER FOR API & EXCIPIENT BLENDING

GMP-compliant inline blending of active pharmaceutical ingredients, co-solvents, buffers, and excipients. Replaces batch mixing vessels and provides full Process Analytical Technology (PAT) (Process Analytical Technology) integration.

GMP | Sanitary | 3A / BPE
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Coefficient of Variation (CoV) ≤0.02 API Uniformity
Key Parameter 1
Ra ≤0.5 µm
Key Parameter 2
ASME BPE
Key Parameter 3
DN10–DN100
Key Parameter 4
Process Scheme
Purified Water / Solvent
API Solution / Excipients
KE Bio-Processing Equipment (BPE) Mixer
Process Analytical Technology (PAT) Analyser (UV/Raman)
Filled Vials / QC Release

Mixing Criteria

Coefficient of Variation (CoV) ≤0.02 at Process Analytical Technology (PAT) analyser. Electropolished Ra ≤0.5 µm for aseptic designs (steam-sterilisable). Fully drainable with no dead legs. Validated cleaning limits (TOC <500 ppb residual). GMP documentation required: FAT, IQ, OQ, PQ.

Typical Viscosity
0.5–100 cP (centipoise) (aqueous pharmaceutical streams)
Reynolds Number (Re)
Reynolds Number (Re) 2,000–100,000 (turbulent)

Material & Special Requirements

Preferred MOC: 316L SS electropolished Ra ≤0.5 µm. Tri-clamp connections. ASME Bio-Processing Equipment (BPE) compliant. No internal welds in product contact zone.

ASME Bio-Processing Equipment (BPE) compliance: Ra ≤0.5 µm, full material traceability, 3.1 material certificates. Steam sterilisation in-place (SIP) design. Process Analytical Technology (PAT) analyser (UV absorption or Raman spectroscopy) 3–5D downstream. FAT, IQ, OQ, PQ validation documentation package.

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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