Our stirred tank fermenters are fully designed, fabricated and inspected in strict accordance with ASME BPE bioprocessing equipment standards, tailored for microbial fermentation, plasmid amplification, adherent/suspension cell culture and perfusion biomanufacturing in cGMP-regulated biopharma facilities.
Product-contact surfaces adopt ultra-high electropolished 316L / 316Ti stainless steel, with precisely controlled surface roughness Ra ≤ 0.38 μm. All orbital welds undergo full visual inspection, penetrant testing and surface finish verification per ASME BPE piping & vessel requirements, eliminating dead legs, crevices and stagnant zones that trap residues or microbes. The vessel structure, impeller assembly, inlet/outlet nozzles, sampling ports and valve manifolds follow standardized hygienic design rules, supporting repeatable automated CIP/SIP cycles with complete drainability, no residual liquid retention.
Optimized agitation and sparging system delivers stable kLa oxygen transfer performance, adaptable to high-density E. coli fermentation, yeast culture and mammalian cell low-shear cultivation alike. Integrated calibrated online sensors for DO, pH, temperature, pressure and exhaust gas connect to ISA-88 compliant batch control platform, enabling closed-loop feeding strategy execution, unattended operation and full audit trails, meeting FDA, EMA and NMPA data integrity demands.
Every unit undergoes full FAT dimensional check, pressure testing, surface roughness documentation and weld record archiving prior to shipment. Complete ASME BPE compliance certification package, material test certificates (MTCs) and DQ/IQ/OQ supporting documents are supplied together. Seamless scale-up geometry ensures consistent process transfer from pilot to commercial scale. Widely applied for pDNA production, mRNA vaccine raw material lines, recombinant protein and therapeutic antibody upstream workshops.
