What are disposable technologies?

What are disposable technologies?

INTRODUCTION. Use of disposable technology – from pump systems to filling needles – is gaining traction in the clinical manufacturing of injectable drugs. Traditional stainless-steel equipment is expensive, takes a long time to procure, and requires lengthy qualification/cleaning validation.

What are single-use systems?

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

What is single-use technology Biopharma?

In the biopharma industry, single-use technologies are disposable products which are intended for one-time use. Typically, these disposable products are made of various types of plastic which can be in any of the following forms: Polyethylene – a common type of plastic used in clear films and bags.

What is a 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 the downsides of using single-use tools?

The Disadvantages of Single-Use Technologies

  • Difficulty in efficiently producing in bulk.
  • Having to rely on vendors.
  • Higher consumables cost.
  • Inventory storage.
  • Lot/material tracking.
  • Vendor-initiated change controls.
  • Limited number of gamma irradiation facilities.

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. More complex disposable products are used in systems for specialized or boutique drug production and may include disposable filters, electronics, and sensors.

What are bioreactors used for?

A bioreactor is a complex system, designed to produce compounds and substances with the help of cells or whole organisms. These compounds are then used as finished products, such as beer, or are treated in additional processing steps in order to get an isolated compound such as vaccines or proteins.

What is a stainless steel bioreactor?

The Applikon Stainless Steel bioreactor range is divided into a microbial range and a cell culture range of volumes. The microbial systems have an aspect ratio of 3.0 at total volume while the cell culture systems have an aspect ratio of 1.5 at total volume.

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