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.
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.
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.