What is single-use technology?

Single-use technologies include tubing, capsule filters, ion exchange membrane chromatography devices, mixers, bioreactors, product holding sterile bags in place of stainless steel vessels (sterile fluid containment bags), connection devices and sampling receptacles.

What are single-use components?

Single-use equipment can include presterilized, disposable bags, tubing, fittings, and connectors. Bioreactor volumes up to 2,000 L are also available for completely single-use cell culture processes.

What is single-use bioreactor technology?

A single-use or disposable bioreactor is a bioreactor with a disposable bag instead of a culture vessel. Single-use bioreactors allow processors to implement the use of disposable technology, such single-use bags, in manufacturing process steps that had previously been reserved for stainless steel equipment.

What are the key considerations for validating single-use systems?

The key consideration for the validation of single-use systems is the recognition that much of the ownership of the quality systems will lie with the selected system’s vendor. Additionally, as stated above, if the systems are part of standard packages then this also needs to be factored into the validation approach.

How are single use systems used in biopharmaceutical manufacturing?

Single-use systems (SUS) refers to biopharmaceutical manufacturing (bioprocessing) equipment designed to be used once (or for a single manufacturing campaign) and then discarded. 1 Generally, SUS equipment is composed primarily of plastic components that have been sealed and sterilized using gamma irradiation.

Which is the single use facility in bioprocessing?

But single-use facilities will come to dominate bioprocessing in terms of number of facilities, process lines, bioprocessing professionals’ work, and the number of products manufactured, especially at clinical scales.

How are single use technologies used in bioproduction?

Single-use technologies are used throughout the bioproduction workflow, from buffer and media preparation, to bioreactor cultures for vaccines, and to the storage and shipping of intermediates and bulk biologics.

Which is the best technology for bioprocessing?

Which technology is the best for bioprocessing? Stainless steel is the old favourite and boasts a long history in biopharma manufacturing, but single-use systems offer reduced cleaning and validation – and are gaining ground fast.