Biomedical Engineering Reference
In-Depth Information
the help of peristaltic pumps. In Chapter 6, a review of the connectors, both
aseptic and otherwise, was presented.
ReadyCircuit assemblies comprise bags, tubing, and connectors. Together
with ReadyToProcess filters and sensors, ReadyCircuit assemblies form
self-contained bioprocessing modules that maintain an aseptic path and
provide convenience by removing time-consuming process steps associ-
ated with conventional systems. Bags, tube sets, filters, and related equip-
ment can be secured in appropriate orientations for efficient operation
using the ReadyKart mobile processing station. With an array of features
and optional accessories, the ReadyKart is designed to support a variety of
process-specific, fluid-handling needs.
ReadyToProcess Konfigurator lets one design fluid-handling circuits with
ease online. One enters the parameters to generate the design one needs; and
includes fast output of piping and instrument drawings (P&ID) drawings
and convenient Bill of Materials for simplified ordering.
ReadyMate connectors are genderless aseptic connectors that allow simple
connection of components, maintaining secure workflows and sterile integ-
rity. Additional accessories such as a tube fuser and sealer of thermoplastic
tubing support secure aseptic connectivity throughout the manufacturing
process.
ReadyToProcess filters are a range of preconditioned and ready-to-use car-
tridges and capsules for both cross-flow and normal flow filtration opera-
tions. It is factory prepared to WFI quality for endotoxins, total organic
carbon (TOC) and conductivity and sterilized via gamma radiation. They
enable simpler and faster bioprocessing with maximum safety.
Bioseparation
Once the expression phase ends, the first step of bioseparation starts.
In the case of bacterial expression, this would involve a continuous flow
centrifuge (e.g., New Brunswick Classroom Engineering Process Assistant
(CEPA) centrifuge,
www.nbsc.com/cepa.aspx
). Smaller volumes can be pro-
cessed in other standard centrifuges taking about 4-6 L in each run. At this
point in the development, we do not have a disposable centrifuge option
except the Centritech Cell II by Pneumatic Scale Angelus (
www.pneumatic-
scale.com/
)
that can process up to 120 L/h. It will require running several
centrifuges in parallel to process a typical 2,000-4,000 L run; this centrifuge,
however, is capable of separating animal cells as well.
The next stage for handling the cell mass would be to use an enzyme
method, a bead method, sonication, detergent, or solvent method.
Homogenization using a French Press is most common for large-scale pro-
cessing. At this time, there are no disposable mechanical systems available.
