Stirred Single-Use Bioreactor

What is the Stirred Single-Use Bioreactor?

A stirred single-use bioreactor mixes the culture with an impeller mounted in or coupled to a disposable bag, giving higher oxygen transfer than rocking designs. It suits demanding cell culture at clinical and production scale.

Overview

A stirred single-use bioreactor fits a pre-sterilized bag into a stainless support that carries the motor, jacket and control hardware. The impeller is either magnetically coupled across the bag film or mounted on a shaft that seals through the bag, and baffles or a shaped film promote top-to-bottom mixing. Gas is introduced through a sparger at the base and leaves through a vent filter, and oxygen transfer is adjusted by agitation, gas flow, oxygen fraction or headspace pressure. Temperature is controlled through the support jacket or an external heating system, and single-use pH and dissolved oxygen sensors are built in. Bags range from small development volumes to about 2,000 litres, and because the fluid path is new each batch, changeover is fast and cleaning validation is avoided.

How does it work?

A single-use bioreactor replaces the product-contact fluid path with a pre-sterilized bag, tubing set, filters and connectors, while the hardware provides mixing, temperature control, sensors and pumps. The bag is irradiated by the supplier, so no cleaning or sterilization is needed before use, and it is discarded after the batch. Mixing is provided by a magnetically coupled impeller, a rocking platform or orbital shaking, depending on the design, and gas exchange occurs through a sparger or a gas-permeable film. Single-use pH and dissolved oxygen sensors are built into the bag or connected as patches and read by reusable transmitters. Because the fluid path is new each time, changeover is fast and cross-contamination between products is limited, but extractables and leachables, bag integrity, pressure and volume limits and supply continuity must all be managed.

What are the key features?

• Disposable bag with magnetic or shaft-mounted impeller
• Stainless support with temperature control
• Sparger with oxygen enrichment and pressure options
• Built-in single-use pH and dissolved oxygen sensors
• Fast changeover without cleaning validation

What are the technical specifications?

A typical stirred single-use bioreactor configuration offers working volume of 1–2,000 L, bag material of Multi-layer polyethylene film, sterilization of Gamma irradiation 25–40 kGy, agitation of Magnetic or shaft drive, 10–300 rpm, aeration of Sparged with O2 enrichment option and temperature range of 10–50 °C, ±0.2 °C. 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 Single-Use Bioreactor is used in clinical batch production, monoclonal antibody manufacturing, cell culture process development and multi-product facilities. Across the wider Single-Use Bioreactors class, laboratories also deploy it for clinical and multi-product manufacturing, monoclonal antibody production and cell therapy manufacturing.

Which standards and certifications apply?

Relevant standards and methods include EU GMP Annex 1, EU GMP Annex 11, 21 CFR Part 11, ISO 11137, USP <661>, USP <665>, BPOG extractables guidance, ISO 13485 and IEC 61010-1. Certification candidates for this model are CE, ISO 13485 manufacturing and ISO 11137 sterilization; each is to be confirmed for the specific configuration before shipment, and certificates are supplied only where they have been issued.

Inspect bags and tubing on receipt and before fitting, and perform the specified integrity check. Follow the supplier instructions for installation, inflation and leak testing, and avoid sharp edges that could puncture the film. Verify single-use sensor performance against offline measurements, because calibration may drift during long runs. Manage lot changes and supplier updates through change control, since these can affect performance. Handle the bag assembly with clean gloves and aseptic technique at connections, and store bags within the specified temperature and humidity range. Record bag lot numbers with each batch, and dispose of used bags according to local biohazard regulations.

How do I select the right Stirred Single-Use Bioreactor?

Choose a stirred single-use bioreactor for high oxygen demand and scale-up from development to production. In an RFQ specify volume range, bag film and sensor options, drive type, agitation and aeration capability, pressure limits and extractables and leachables documentation.

How does it compare with other Single-Use Bioreactors variants?

Choose the mixing principle from the culture and scale: stirred bags give higher oxygen transfer for demanding cells, rocking and orbital designs are gentler for shear-sensitive cultures and smaller volumes, and airlift and perfusion formats add specific capabilities. Confirm the working volume range and the bag sizes available, and check that the oxygen transfer rate meets the peak demand of your process. Verify which sensors are single-use and how they are calibrated, and check that the bag geometry matches your mixing and sampling needs. Review extractables and leachables data, bag integrity test methods, pressure ratings and storage and shelf life. Decide whether a reusable or disposable sensor path suits your facility, and confirm that the packaging, aseptic connectors and supply agreements fit your clinical or commercial timeline.