316L stainless steel bioreactors
and ancillary equipment
In-situ sterilizable 316L stainless steel systems, from 30 L to over 1,000 L total volume: the BioSIP series for R&D, the BioFerm series for pilot and production, and custom plants for large scale.
BioSIP series
Stainless steel bioreactor for research and development.
BioFerm series
Pilot & production in-situ sterilizable bioreactors & fermenters.
Custom bioreactor
Large-scale in-situ sterilizable bioreactors & fermenters.
Biogas
316L stainless steel bioreactors and fermenters for biogas research and scale-up, with BIOBOX and GASBOX modules, ATEX certification and PED compliance.
Media preparation
316L stainless steel tanks for aseptic media and buffer preparation, with magnetic mixer, jacketed thermal control and CIP/SIP.
SIP/CIP systems
K4812 pure steam generator with 4, 8 and 12 kW and the K1860 all-in-one CIP/SIP system from 18 to 60 kW.
Built around your process
The strength of this line is not a model list: the system is born from your specifications. Vessel geometry, agitation, sparging, sensor arrays and automation logic are all defined from your URS and from the process you need to take into production.
Let's talk about your process →- It starts from your URS. User requirement specifications drive the design — no configuration imposed by a catalogue.
- From concept to acceptance test. Design, fabrication, automation coding and FAT — 4–6 months for a standard project.
- 316L construction. Automated orbital welding, verified Ra ≤ 0.4 µm internal finish, full SIP/CIP compatibility.
- Documentation supplied. DQ/IQ/OQ/PQ packages and GMP documentation available on request.
What our supplier qualification rests on
We explicitly separate what is certified by a third party, what the system is designed and built compliant with, and what we can supply on request. That distinction matters during supplier qualification and audits.
Certifications held
- UL 508AIndustrial control panels built to the UL 508A standard — UL file E554925, Industrial Control Panels category. The automation systems we supply with our bioreactors fall within this scope.
Design & build compliance
- CE markingMachinery Directive 2006/42/EC.
- PED 2014/68/EUPressure Equipment Directive, for pressure-rated vessels.
- ASME VIII Div. 1Pressure vessel construction code: sizing, materials, welding and testing.
- ASME BPEBioprocessing equipment standard: surface finish, welds, drainability.
- FDA 21 CFR Part 11Bioflex™ SCADA software: audit trail, e-signatures, data integrity.
Available on request
- DQ / IQ / OQ / PQComplete qualification documentation packages.
- GMP / GLPDocumentation supporting regulated environments.
- ATEX 2014/34/EUDesign of systems for potentially explosive atmospheres.
The UL certification is held by Vinci Life Science Applied Italia Srl and can be verified in the public UL Product iQ database using the file number. Notified bodies, validity dates and the full scope of application are provided within the project documentation.
Documentation (PDF)
Technical documents in PDF · they download without a registration.
BioSIP, BioFerm and custom compared
Three in-situ sterilizable stainless steel lines, from research and development to large scale.
| Parameter | BioSIP | BioFerm | Custom |
|---|---|---|---|
| Use | R&D | Pilot & production | Large scale |
| Total volume | 30 – 150 L | 200 – 1,000 L | > 1,000 L |
| Configurations | S and PLUS | S and PLUS | To specification |
| Sterilization | In situ (SIP) | In situ (SIP) | In situ (SIP) |
| CIP with spray-ball | Optional (S) · included (PLUS) | Optional (S) · included (PLUS) | To specification |
| Software | Bioflex™ + 15.6″ touch screen | Bioflex™ + 15.6″ touch screen | Bioflex™ |
Frequently asked questions
BioSIP is the series for research and development, with total volumes from 30 to 150 L; BioFerm is the series for pilot scale and production, from 200 to 1,000 L. Both come in the S (base) and PLUS (full) configurations. Above 1,000 L, plants are custom-designed from the customer’s URS.
Yes. All three lines are in-situ sterilizable (SIP). The CIP system with spray-ball is included in the PLUS configuration and available as an option on the S; on custom plants it is defined in the specification.
Total volumes range from 30 to 150 L for BioSIP and from 200 to 1,000 L for BioFerm; above 1,000 L plants are custom-built. Custom volumes and multi-vessel skid configurations are defined case by case.
Systems are designed and built in compliance with the CE Machinery Directive 2006/42/EC, the PED 2014/68/EU pressure equipment directive, the ASME VIII Div. 1 code and ASME BPE standards. The Bioflex™ software is compliant with FDA 21 CFR Part 11. Industrial control panels are built to the UL 508A standard. DQ/IQ/OQ/PQ and GMP documentation is available on request.
Innovative solutions
for your bioprocesses
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