Biomedical Engineering Reference
In-Depth Information
Replacing these heavy three-way valve assemblies with single-use tube sets
and connectors eliminates cleaning, validation, and maintenance.
Single-use tubing assemblies can either be attached prior to equipment
sterilization with single-use SIP connectors (used as either steam access or
condensate drainage sites), or steamed separately, just prior to fluid trans-
fer. For vessel outlet, combining a number of single-use components into
the transfer line can create a robust system to ensure product safety. For
example, outlet transfer lines could incorporate a single-use SIP connector to
attach to the sterile holding tank. Then, a through-the-wall fluid transfer sys-
tem is used to bring a portion of the transfer line into the filling suite. Next,
a sterile connector is used to attach the transfer line to a separate portion of
the transfer line that has already been steamed onto the filling machine with
a single-use SIP connector. Finally, disconnecting the transfer lines using a
quick disconnect coupling that has been validated as an aseptic disconnect
enables the processor to confidently make an aseptic disconnection from the
storage vessel or bag.
The leader in sterile product filling systems remains Bosch Packaging,
among others. The following information was developed by Robert Bosch
Packaging Technology, Inc. (
www.boschpackaging.com
).
Robert Bosch Packaging Systems
Use of disposable components in product downstream processing and final
fill operations is increasing as the technology for performing these steps in
a single-use mode also increases. There is a high demand for systems that
support single-use purification, formulation, and filling operations. There
are several drivers for this. First is the desire to realize increased processing
efficiency through the elimination of preparative steps such as CIP and SIP
for product-contact equipment and parts. For example, presterilized single-
use tubing and bags can be used to replace stainless steel piping and tanks
that have to be cleaned and steamed between uses. Second is the reduction of
validation efforts related to the product path, in particular, the elimination of
cleaning validation. Products that are hard to clean, or are highly potent or
toxic, often require dedicated product-contact parts. This is because existing
cleaning processes are inconsistent or simply do not work to move certain
products to safe levels. Third is containment of toxic products. Disposable
systems can be removed, bagged, and disposed of without breaking con-
nections and exposing the environment to the product. Fourth is the desire
to match existing single-use upstream processes that are available for new
products, particularly, biopharmaceuticals and other protein-based drugs.
In the past, filling line equipment was commonly dedicated entirely to a
single product. However, this approach is no longer economically feasible
