Biomedical Engineering Reference
In-Depth Information
6
Connectors
and Transfers
Angels are spirits, flames of fire; they are higher than man, they have wider
connections.
Matthew Simpson
Disposable components came into use first in the field of connectors and
lines, as it was difficult to clean them. Unlike hard piping, the flexible tub-
ing incorporated into disposable transfer lines does not require costly and
time-consuming cleaning and validation. This allows manufacturers to
quickly change process steps or convert over to a new product. This is a
key advantage for multiple product facilities in which process requirements
change depending on the drug being produced. Innovative manufacturers
now incorporate disposable tubing assemblies throughout the bioprocess
from seed trains to final fill applications. Additional cost savings result from
reduced labor, chemical, water, and energy demands associated with clean-
ing and validation.
Modern bioprocessing facilities scale up inoculum from a few million cells
in several milliliters of culture to production volumes of thousands of liters.
This process requires aseptic transfer at each point along the seed train.
Traditional bioprocessing facilities accomplish scale-up using a dedicated
series of stainless steel bioreactors linked together with valves and rigid tub-
ing. For these systems, to prevent contamination between production runs,
a clean-in-place (CIP) system is designed into each bioreactor, vessel, and
piping line to remove any residual materials. These CIP and steam-in-place
(SIP) systems require extensive validation testing, and the valves and piping
contained in these systems can create additional validation challenges.
Advances in disposable technology allow bioprocess engineers to replace
most storage vessels and fixed-piping networks with disposable storage sys-
tems and tubing assemblies. Disposables eliminate the need for CIP valida-
tion for many components and reduce maintenance and capital expense by
eliminating expensive vessels, valves, and sanitary piping assemblies.
While total disposable systems are not always possible, there is a transition
taking place and often there is a need to connect a disposable system with
stainless steel vessels. Disposable media storage systems are routinely man-
ufactured for volumes from 20 to 2,500 L. Media storage systems arrive at the
bioprocess facility sterilized by gamma irradiation and often are fitted with
integrated filters, sampling systems, and connectors. Using an SIP connector
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