What is single-use technologies?
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 is single-use system in pharma?
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.
What is single-use biomanufacturing?
Advantages of single-use technologies for biomanufacturing This means that there are no cleaning, sanitization, or sterilization steps and it means that the company saves money on the chemicals used for cleaning, and on the equipment and energy that it takes to generate pure water and clean steam.
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.
What is single-use manufacturing?
Single-use manufacturing now involves the production of relatively complex disposable devices used in surgical procedures such as electrosurgery. Razor blades and their holders are another example. Such devices are usually complex items intended for a single use, as opposed to simple disposables.
What is a bioreactor bag?
The bags are made of multilayer polymer films and arrive gamma-sterilized from suppliers. The lining of the bioreactor bag that comes in contact with the cell culture is typically polyethylene. The bag is then encased in a more sturdy structure, typically a rocker, cuboid, or steel cylinder.
What is single use manufacturing?
What is single use assembly?
A single-use assembly is a ready-to-use custom-made all-in-one solution made from different plastic components that are assembled into one whole, based on a customer-specific design.
What is single-use design?
Single Use Design Tool™ PM Group’s Single-Use Design Tool™ is a unique innovation. It allows the mapping of a complete single-use process within a single drawing. The tool identifies opportunities for standardisation and potential connectivity issues. It also supports improved tubing management design.
Does the single-use bioreactor possible?
Single-use bioreactors are currently available with up to a volume of about 1000 L; that’s why scale up is limited compared to conventional bioreactors.
What are the cons of single-use bioreactor technology?
Disadvantages:
- Limitation in liquid transfer.
- Scalability is an issue: larger-scale bioreactor bags are needed than are available.
- Expensive to use:repetitive purchases required.
- Performance is not completely proven: new technology.
- Slight increase in variable costs per run.
How much does a single-use bioreactor cost?
At an average price of approximately $3000 per IO, these reductions can translate to significant savings in installation costs. In many cases—not including high batch-frequency op- erations—single-use technology compares favorably to stainless-steel equipment in terms of cost.