Stirred-Tank Stainless Steel Bioreactor

What is the Stirred-Tank Stainless Steel Bioreactor?

A stirred-tank stainless steel bioreactor uses one or more impellers to mix and aerate the culture, giving flexible power input. It is the workhorse design for pilot and production cell culture and fermentation.

Overview

A stirred-tank stainless steel bioreactor mixes the broth with a top-entry agitator carrying one or more impellers, usually on a single shaft, with baffles on the vessel wall to prevent vortexing. Agitation power can be raised by speed or impeller number to meet oxygen demand, and gas is supplied through a ring or drilled-hole sparger. A jacket or internal coil controls temperature, and probes for temperature, pH, dissolved oxygen, pressure and level are fitted hygienically. The vessel is steam sterilized in place and cleaned in place with spray devices, so it supports repeated campaigns with documented cycles. Design pressure allows positive headspace pressure to improve oxygen transfer, and scale-up uses criteria such as constant tip speed or mass-transfer coefficient.

How does it work?

A stainless steel bioreactor provides a durable, pressure-rated and cleanable environment for cell culture or fermentation. The vessel is built from 316L or comparable stainless steel with hygienic welds and a smooth interior, and heat is supplied or removed through a jacket or internal coil. Mixing is by impeller, gas-driven circulation or a packed bed, and a sparger introduces air, oxygen, nitrogen and carbon dioxide. Because the vessel is reusable, it must be cleaned and sterilized between batches: spray devices and validated cleaning cycles remove soil, and steam sterilization raises all product-contact surfaces above the required temperature. Sensors for temperature, pH, dissolved oxygen, pressure and level are mounted in hygienic fittings, and the control system holds setpoints and records the batch.

What are the key features?

• Top-entry agitator with one or more impellers
• Baffles prevent vortexing and improve mixing
• Ring or drilled-hole sparger for gas supply
• Clean-in-place and sterilize-in-place design
• Hygienic sensor fittings and pressure-rated vessel

What are the technical specifications?

A typical stirred-tank stainless steel bioreactor configuration offers working volume of 50–20,000 L, material of 316L stainless steel, design pressure of 0.2–0.4 MPa, temperature range of 5–60 °C, ±0.2 °C, agitation of 20–500 rpm, impeller dependent and aeration of 0.1–2 vvm with O2 enrichment. 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 Stirred-Tank Stainless Steel Bioreactor is used in pilot and production cell culture, monoclonal antibody manufacturing, vaccine production and industrial fermentation. Across the wider Stainless Steel Bioreactors class, laboratories also deploy it for pilot and production bioprocessing, monoclonal antibody manufacturing and vaccine and viral vector production.

Which standards and certifications apply?

Relevant standards and methods include GB/T 150, ASME BPVC Section VIII, EU GMP Annex 1, EU GMP Annex 11, 21 CFR Part 11, 21 CFR Part 211, USP <661>, ISO 13485 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 before the first run, covering pressure, temperature and cleaning performance. Establish and validate clean-in-place and sterilize-in-place cycles, then confirm them periodically with rinse water conductivity, swabs or biological indicators as appropriate. Calibrate probes and verify their position so that readings reflect bulk conditions, and replace gaskets, seals and diaphragms on schedule. Monitor jacket and coil fouling, agitator seals and sparger condition, since these affect heat transfer, sterility and oxygen supply. Keep the automated control system under change control with audit trails enabled, and retain batch records, alarm logs and maintenance history.

How do I select the right Stirred-Tank Stainless Steel Bioreactor?

Choose a stirred tank for flexible mixing and high oxygen demand at pilot or production scale. In an RFQ specify working volume, design pressure and temperature, agitation power, aeration and oxygen enrichment, cleaning and sterilization design, and sensor and control requirements.

How does it compare with other Stainless Steel Bioreactors variants?

Choose stainless steel when you need repeated campaigns, higher pressure, intensive mixing or full sterilization at scale. Select the mixing principle from the cell type and oxygen demand, and confirm the design pressure and temperature against the sterilization method. Specify the material grade, surface finish and welding standard so that clean-in-place and sterilize-in-place are effective, and define the port list for probes, feeds, sampling, foam and cleaning devices. Decide whether the vessel needs a jacket, a coil or both, and check agitation power and gas handling against the expected oxygen uptake rate. Confirm control, data recording and audit-trail capability, and request design documents, material certificates, pressure test records and a qualification package.