Pilot SIP Bioreactors

Pilot SIP Bioreactors

GMP-Ready Stainless Steel Fermenters (20 L – 500 L)

KBiotech Pilot SIP Bioreactors enable a seamless transition from lab-scale development to clinical and industrial manufacturing.

Built from electropolished 316L stainless steel and powered by BIOFLEX™ SCADA automation, these systems deliver fully automated SIP/CIP, GMP compliance, and geometry-matched scalability from 20 L to 500 L.

Why Choose Pilot SIP Bioreactors?

From development to production — scale with precision and compliance.

350L+All in one+35L_Front

Seamless Scale-Up

Geometry-matched vessels (3:1, 2:1, 1.5:1 H/D ratios) ensure consistent kLa and mixing performance from R&D through production.

Automated SIP & CIP

Integrated sterilization and cleaning cycles reduce downtime by up to 60%, maximizing batch throughput.

GMP-Ready Design

Certified to ISO 9001, ASME BPE, PED, and CE standards for compliant clinical and industrial operation.

Technical Specifications

Working Volumes

20 L – 500 L (pilot to clinical scale)

Material & Finish

316L stainless steel, Ra ≤ 0.2 μm (electropolished)

Sterilization & Cleaning

Fully automated SIP/CIP (121–130 °C)

Agitation System

Rushton, Marine, Anchor (top or bottom drive)

Temperature & Pressure

4 – 150 °C (± 0.1 °C) / -1 – 15 barg (± 0.1 °P)

350L_System

Skid-Mounted SIP vs. Cleanroom SIP Installation

Both configurations ensure identical software logic, recipes, and automation across all scales.

ALLIONE™
Unified SIP & CIP Technology

KBiotech’s exclusive ALLIONE™ system integrates steam-in-place and clean-in-place into a single automated cycle — the only platform of its kind at pilot scale.

Single-pass sterilization + cleaning in one run

Up to 60 % faster turnaround and reduced contamination risk

Plug-and-play with Pilot SIP vessels via BIOFLEX™ SCADA

Validated GMP cycles with full audit trails

SmartBioFlex™ Control

Elevate your BioBook Compact bioreactor with BioFlex™ Software — a powerful, intuitive platform that simplifies process control, ensures regulatory compliance, and delivers real-time insights for smarter bioprocessing.

Seamless Integration

SmartBioFlex™ combines an industrial distributed control core with an intuitive web interface.

From Recipe to Data Export

Users build multiphase recipes via draganddrop cascades, monitor critical parameters remotely and export encrypted data directly to LIMS.

Audit Trails and Onboarding

A complete audit trail supports regulatory inspections, while onboarding guidance assists less experienced operators.

Inline Analytics & PAT Modules

  • KG-FERM — real-time off-gas (O₂, CO₂, CH₄, H₂, CO) analysis
  • KBIO-TBD — optical & capacitance biomass monitoring
  • LIVE-CELL™ — inline cell viability and density measurement
  • Inline Raman Spectroscopy — molecular fingerprinting for metabolite and product profiling
  • Automated Sampling Ports — sterile inline collection for offline QC

Continuous Processing & Downstream Integration

Upstream–downstream continuity, on your benchtop.

  • ATF: Ultra-high cell densities with low-shear circulation.
  • TFF: Stable medium exchange for extended continuous runs.
  • Smart Harvest: Weight-based, automated fluid management for consistent yields.

Request a Quote

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Application Type
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Working Volume Range
Volumes range: 500L - 50.000L
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Sterilization in Place (SIP)
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Cleaning in Place (CIP)
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Automation Level
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Steam Generator Required
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Technical Specifications
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Got questions?
Well, we’ve got answers

Yes. All vessels follow consistent geometries and software logic—no revalidation required.

Fully compliant with GMP, ISO 9001, ASME BPE, PED, and CFR 21 Part 11 standards.

Typically 1–4 weeks, including SCADA configuration and validation.

Absolutely. Our modular systems support fast changeovers and multi-product use.

Yes. Recipes, alarms, dashboards, and interfaces are fully configurable to your batch needs.