Biomedical Engineering Reference
In-Depth Information
Biosafe
®
Aseptic Transfer Disposable Bag: A complete range of Biosafe
Aseptic Transfer Bags, either gamma sterile or autoclavable, and the Biosafe
®
Rapid Aseptic Fluid Transfer (RAFT) System are designed to best fit require-
ments for aseptic transfer of components into clean rooms, isolators, or RABS
and for contained transfer of potent powders.
Biosafe
®
RAFT System: The RAFT system provides easy-to-use and reli-
able through-the-wall aseptic transfer of liquid between clean rooms of dif-
ferent environmental classification while ensuring a total confinement.
SART™ System: The SART System is designed to allow aseptic liquid
transfer between two areas with different containment classifications.
Special bags have therefore been developed, for example, the Biosafe
Rapid Aseptic Fluid Transfer (RAFT) system by Sartorius-Stedim, allow-
ing aseptic coupling to larger fluid containers and ports in addition to
fluid conduction.
Tube Sealers
When disconnecting an aseptic connection, the ends must be capped with
aseptic caps and this can be done under a laminar hood or by using tube
sealers; the examples of which include offerings from PDC (
www.pdcbiz.
com
)
, Saint-Gobain (
www.saint-gobain.com
), Sartorius-Stedim (
www.
sartorius-stedim.com
)
, GE Healthcare (
www.gelifesciences.com
)
, Terumo
(
www.terumotransfusion.com
), and SEBRA (
www.sebra.com
). Most of
these sealers can seal from 0.25 to about 1.5 in. tubes and take from 1-4
min to complete the seal. Most operate on an electrical heating element, but
electrical and radio frequencies are also used for sealing tubes. There is no
need for using a laminar flow hood for these operations. In most instances,
applying a crimper in two places and cutting the tube between the crimps
offers the cheapest solution.
Sampling
Sampling is a routine during manufacturing to ensure compliance by obtain-
ing these in process parameters such as pH, DO, OD, pCO2, etc. Most dispos-
able systems have one or more integrated sampling lines, which are partly
equipped with special sampling valves, sampling manifolds, or special sam-
pling systems. A popular disposable sample valve is the Clave connector
from ICU-Medical (
www.icumed.com
)
, which is also used in intravascu-
lar catheters for medical applications. It allows a sample to be taken with a
