GMP REACTOR
Borosilicate 3.3 Glass according EN1595 with or without jacket
Monobloc inner vessel, ≤ Ra 0.02 μm
Customized design (Optimization of the KLa)
AGITATION
Minimization of agitation restrictions (CFD)
Mechanical or magnetic
COVER & ACCESSORIES
Stainless steel 316 L or Alloy
Ferrite content < 5%
Electro polished finish Ra < 0.5 μm
EPDM gaskets with FDA, USP certificates
SERVICES
QA / QC plan
FAT, SAT
Qualification : DQ, IQ, OQ
Aftersales and spare parts
DOCUMENTATION
According to GMP requirement
CONTROL / SUPERVISION
Entry level with variable speed control
21 CFR part11 Control interface (on request) pH, RedOx, T°, aeration (KLa), stirring speed, ...