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, ...