Orbital-Shaken Single-Use Bioreactor

What is the Orbital-Shaken Single-Use Bioreactor?

An orbital-shaken single-use bioreactor mixes cultures in a bag or tube on a shaking platform, giving good oxygen transfer at small volumes. It suits high-throughput screening, clone selection and early process development.

Overview

An orbital-shaken single-use bioreactor uses a platform that moves in a circular orbit to generate a swirling motion inside a bag, tube or multi-well plate. The movement creates surface renewal and mixing, giving oxygen transfer rates that exceed static culture and approach small stirred vessels, especially in tube and microwell formats where surface-to-volume ratios are high. Temperature is controlled by an incubator or heated deck, and gas composition can be controlled in chambered systems to regulate pH and dissolved oxygen. Formats range from single bags of a few hundred millilitres to arrays of tubes or wells for parallel experiments. The single-use fluid path makes setup simple, and the format suits screening many conditions, cloning and early process development before larger bioreactors are used.

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?

• Orbital shaking platform for swirling mixing
• Bag, tube and multi-well formats
• Good surface renewal at small volumes
• Optional gas composition control in chambered systems
• Simple single-use setup for parallel work

What are the technical specifications?

A typical orbital-shaken single-use bioreactor configuration offers working volume of 5 mL–50 L, mixing principle of Orbital shaking, shaking speed of 30–300 rpm, orbit diameter of 3–50 mm, temperature range of Ambient +5 to 50 °C and formats of Bags, tubes, multi-well plates. 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 Orbital-Shaken Single-Use Bioreactor is used in high-throughput process screening, clone and media selection, early development culture and small-scale protein expression. 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 9001 manufacturing and ISO 13485 manufacturing; 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 Orbital-Shaken Single-Use Bioreactor?

Choose an orbital-shaken system for parallel screening and small-volume work where flexibility matters more than precise control. In an RFQ specify volume range, format, shaking speed and orbit, temperature and gas control, and the sensor options provided.

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.