Biomedical Engineering Reference
In-Depth Information
One of earliest entries in the field of aseptic filters was Pall Kleenpak
Sterile Connector.
AseptiQuik™ Connectors (
www.colder.com
)
provide quick and easy ster-
ile connections, even in nonsterile environments. AseptiQuik's “click-pull-
twist” design enables users to transfer media easily with less risk of operator
error. The connector's robust design provides reliable performance without
the need for clamps, fixtures, or tube welders. Biopharmaceutical manufac-
turers can make sterile connections with the quality and market availability
they expect from the leader in disposable connection technology.
stedim.com
)
is a disposable device, composed of presterilized female and
male coupling body, that allows a sterile connection in biopharmaceuti-
cal manufacturing processes. The Opta
®
SFT-I Connector is supplied with
Flexel
®
3D, Flexboy
®
bags, and transfer sets as part of integrated Sartorius
Stedim Biotech Fluid Management assemblies. Opta SFT-I is available with
a
1
/
4
,
3
/
8
, and
1
/
2
in. hose barb. The Opta
®
SFT-D is available as individual
device for end-user assembly with TPE tubing and autoclave sterilization.
They are quick, easy to use, and are backed by extensive validation work as
well as 100% in-house integrity testing.
Pall Corporation (
www.pall.com
) is expanding its line of Kleenpak™
Aseptic Connectors with two new sizes:
1
/
4
and
3
/
8
in. The new sizes enable
vaccine manufacturers to apply the safety and efficiency benefits of instant
aseptic connections throughout more of their disposable operations to help
speed time to market and comply with GMPs. Pall revolutionized the asep-
tic connection process by shortening the time needed for connection from
15 minutes to seconds when it introduced its
1
/
2
-in. Kleenpak Connector.
The addition of the two new Kleenpak Connector sizes increases flexibility
to implement aseptic connections in more applications to improve dispos-
able processing efficiency. This is especially important to complex vaccine
production, which often requires a greater number of connection steps. The
Kleenpak Connector is easy-to-use and projects an audible snap to signify
that a sterile connection has been established.
ReadyMate Disposable Aseptic Connector (DAC) from GE Healthcare
(
www.gelifesciences.com
) provides connections for high-fluid throughput
and offers a secure, simple, and economical connection for upstream and
downstream applications. DAC connectors can be autoclaved or gamma
radiated, and can be part of a sterile circuit. The connectors can be used to
connect unit operations and assemblies. DAC connectors and their compo-
nents are manufactured in compliance with the cGMPs of the FDA and ISO
9000-2000. ReadyMate is a genderless, intersize connectable disposable asep-
tic connector. There are four hose barb sizes (
3
/
4
,
1
/
2
,
3
/
8
, and
1
/
4
in.), mini TC,
and TC that all interphase. It has a genderless design, user-friendly sanitary
coupling, easy to use with Tip'n'latch, complies with USP Class VI, and can
be sterilized by radiation or autoclave. The main advantages of using the Bio
Quate connector include simple setup, rapid connection, direct connection of
