Biomedical Engineering Reference
In-Depth Information
films and are mostly offered in cylindrical, conical, or cubical shapes. Often,
the shape is determined by the method of how these containers are stored or
stacked in outer containers that have the same shape, which allows a snug
fitting of the 3D bags. While a very large liner can always be brought into the
manufacturing area, the outer containers are at times built before the facility
is completed; companies offering modular construction of outer containers
would do well in the future if they offer an option of assembling an outer
container from smaller pieces.
To facilitate their use such as in buffer preparation, these outer containers
may be equipped with weight sensors, recirculation/mixing fluid manage-
ment, and temperature control if required. The temperature control can be
achieved in several ways, the cheapest one being wrapping them in blan-
kets that are temperature controlled, and the most expensive being to use
jacketed containers with circulating fluids. The weight measurement is of
greatest importance and, while most manufacturers would use a floor scale,
large-scale production requires installation of load cells in the outer contain-
ers to avoid moving the containers for weighing.
Transportation Container
Products at different stages of manufacturing often need to be transported
within the company or to remote locations to complete the process; finished
products are also shipped out to customers and this requires the selection of
safe, stable, and closed container systems that maintain sterility. Examples of
these containers include
Flexboy, Flexel 3D Palletank, and Celsius FFT products (
www.sarto-
Nalgene (
www.nalgene.com
)
Thermo Scientific (www.thermoscientific)
BioShell™ container system designed to protect single-use bags during
storage, handling, and shipping. High-purity, dual-density foam con-
struction can withstand multiple impacts at −70°C (
www.bio-shell.com
)
Disposable bags can be readily used to transport or store frozen products,
from cell culture as Working Class Bank (WCB) for direct introduction into
a bioreactor to shipping biological API; while flexible bags can survive tem-
perature variations, often it is difficult to detect damage to them during
transportation and, thus, they require a protective surface around them to
obviate this risk.
