Pilot Stirred-Tank Bioreactor

What is the Pilot Stirred-Tank Bioreactor?

A pilot stirred-tank bioreactor is a 50 to 500 litre vessel with agitation, sparging and full control that reproduces stirred bench conditions. It is the standard platform for scale-up verification and trial batches.

Overview

A pilot stirred-tank bioreactor scales the impeller-agitated design to tens or hundreds of litres. The vessel is usually 316L stainless steel with a jacket or internal coil, a top-entry agitator with one or more impellers, a ring sparger and a headplate carrying probes, feed lines, antifoam and a condenser with exhaust filter. Clean-in-place spray devices and sterilize-in-place steam lines allow repeated campaigns without dismantling. Control covers temperature, pH, dissolved oxygen, pressure and often foam, with cascade control adjusting agitation, gas flow and back pressure. Sampling uses a steam-sterilized valve and harvest goes through a bottom valve. Because scale changes mixing, oxygen transfer and heat removal, the team selects a scale-up criterion and confirms it during the run.

How does it work?

A pilot bioreactor applies the same biological principles as a smaller vessel but at a scale where mixing, oxygen transfer and heat removal behave differently. Larger impellers and higher gas flow increase oxygen transfer, described by the volumetric mass-transfer coefficient, while a jacket or coil removes the greater metabolic heat load. Sensors for temperature, pH, dissolved oxygen, pressure and often foam or level sit in hygienic fittings, and cascade control adjusts agitation, gas composition and back pressure to hold dissolved oxygen. Because mixing time, tip speed and mass-transfer coefficient cannot all be matched to bench scale, engineers choose the most critical criterion and verify performance during the run. Pilot vessels may be reusable stainless steel or single-use, and they include defined sampling, feed and harvest points.

What are the key features?

• 316L stainless vessel with jacket or coil
• Top-entry agitator with one or more impellers
• Ring sparger with oxygen and back-pressure control
• Clean-in-place and sterilize-in-place capability
• Full process control with batch recording

What are the technical specifications?

A typical pilot stirred-tank bioreactor configuration offers working volume of 50–500 L, vessel material of 316L stainless steel, temperature range of 10–60 °C, ±0.2 °C, pH control of 2–12, ±0.05, dissolved oxygen control of 0–100% with air or O2 enrichment and agitation of 50–500 rpm, impeller dependent. Values are indicative of the product class; the exact figures for each configuration are confirmed on the quotation and the calibration documents supplied with the instrument.

Which applications is it used for?

The Pilot Stirred-Tank Bioreactor is used in scale-up verification, clinical and trial batch production, monoclonal antibody production and process transfer to production. Across the wider Pilot Bioreactors class, laboratories also deploy it for scale-up verification, clinical and trial batch production and monoclonal antibody and protein production.

Which standards and certifications apply?

Relevant standards and methods include EU GMP Annex 1, EU GMP Annex 11, 21 CFR Part 11, 21 CFR Part 211, GB/T 150, ISO 13485, USP <87>, USP <88>, ICH Q11 and IEC 61010-1. Certification candidates for this model are CE, ISO 9001 manufacturing and Pressure vessel compliance; each is to be confirmed for the specific configuration before shipment, and certificates are supplied only where they have been issued.

Qualify the vessel and its utilities with documented pressure, temperature, cleaning and sterilization tests. Calibrate pH and dissolved oxygen probes before each run and verify sensor placement so readings reflect bulk conditions. Establish the scale-up criterion and document why it was chosen, then record the supporting data. Monitor foam, heat removal and dissolved oxygen closely, since these are the usual scale-dependent problems. Keep batch records that capture setpoints, deviations and offline measurements such as cell count and metabolite levels. For reusable vessels, control cleaning cycles and gaskets; for single-use, manage bag lots, integrity and extractables data. Confirm electrical safety to IEC 61010-1.

How do I select the right Pilot Stirred-Tank Bioreactor?

Choose a pilot stirred tank to verify scale-up under well-understood mixing. In an RFQ specify working volume, design pressure and temperature, agitation power, aeration and oxygen enrichment, cleaning and sterilization design, and control and data recording features.

How does it compare with other Pilot Bioreactors variants?

Size the vessel to reproduce the most important bench parameter and to produce enough material for the next step, whether that is a clinical batch, a trial quantity or data for production design. Decide between stainless steel, which suits repeated campaigns and higher pressure, and single-use, which shortens changeover and reduces cleaning validation. Match the geometry, impeller type and gas handling to the scale-up criterion you intend to hold constant. List control loops and ranges, the number of feed, sampling and harvest ports, and whether redox, off-gas analysis or back pressure control are needed. Evaluate clean-in-place and sterilize-in-place for reusable designs, single-use bag performance for disposable designs, and the records and qualification package available for regulated work.