In the past ten years there have been several advances in single-use Sterile, disposable technologies, such as bag chambers, connectors, tubing, filling needle manifolds, and filter capsule, either as individual entities or complete systems. These single-use systems have challenged the established cycle of re-using equipment (primarily stainless steel) and which promises a new paradigm for pharmaceutical manufacturing.
In a new article Tim Sandle outlines a strategy for pharmaceutical companies wishing to adopt, or increase their use of, single used sterile disposable technologies.
“The paradigm is achieved through the adoption of single-use technologies in order to reduce the concerns of time, costs and non-sterility by enabling pharmaceutical organisations to move away from equipment which needs to be sterilised or consumables which are recycled or pose a risk with their transfer into cleanrooms, and to the adoption of disposable and single-use sterile items.
Single-use technologies include tubing, capsule filters, single-use ion exchange membrane chromatography devices, single-use mixers, and bioreactors, product holding sterile bags in place of stainless steel vessels (sterile fluid containment bags), connection devices and sampling receptacles. This article considers the advantages of implementing single-use technology and outlines a framework that can be used as a strategy for the implementation process.”
The reference is:
Sandle, T. (2018) Strategy for the adoption of single-use technology, European Pharmaceutical Review, 23 (1): 43-45
Posted by Dr. Tim Sandle
