American Fuoroseal Company (AFC)

Report
American Fluoroseal Corporation
(AFC)
Manufacturer of inert, non-reactive
bags and pouches
AFC is for cryogenic containment…
for transparent containment…
for gas permeable containment…
AFC will make bags to meet your specifications
The AFC Mission is to design
and build containers that are
inert ,
reliable ,
and gas permeable.
AFC Overview
• AFC manufactures bags for bioprocessing and
storage
• AFC products meet FDA requirements for clinical
use.
• AFC bags and the fittings on them are made from
FluoroEthylene Propylene (FEP).
• AFC bags are welded at the edges using a laser,
which can be programmed to follow any shape that
can be drawn.
• The bags have rounded corners to prevent loss of
cells and to eliminate the possibility of sharp corners
forming when the contents are frozen.
Products and Processes
Culture Bags
• AFC manufactures VueLife® bags to contain cell
cultures.
• They offer a closed system with sterile, dockable tubing
for fluid transfer.
• The FEP plastic provides superior gas transfer for cell
viability, while maintaining the cells in an inert, nonreactive environment.
• The bags are virtually impermeable to water, but still
allow O2 and CO2 to penetrate through the surface.
• The optically clear surface allows the viewer to observe
cell conditions visually and under a microscope.
• Biological or chemical samples can be autoclaved or
frozen in liquid nitrogen within the AFC bag.
• Although flexible, these bags are strong enough to use
as a centrifuge bag and are unaffected between the
temperatures of +200°C and -196°C.
Freezing Bags
• The KryoSure® bags and pouches are designed for the safe
storage of valuable biologicals, tissues, and samples in
liquid nitrogen.
• They are constructed of a unique material consisting of FEP
fluoroplastic film, which is laser welded together using
AFC’s patented process.
• This provides the bag with extreme strength and safety to
your valuable samples.
• The FEP plastic remains totally flexible in liquid nitrogen
while maintaining your sample in an inert, non-reactive
environment free from leachables or extractables.
• It is optically clear, so the user may visually observe the
condition of the enclosed sample.
• These bags and pouches are heat sealable using the sealer
available from AFC; and both standard and custom designs
are offered to suit your particular needs.
Overwraps – Kapton Peel Pouches
• The KryoVue® Kapton Peel Pouch is an overwrap, chevron
shaped “peel pouch” used for cryogenic storage.
• The Peel Pouches are constructed using a unique bi-layer
film consisting of an outer layer of high strength polyimide
laminated to an inner layer of FEP fluoroplastic.
• This film is impermeable, chemically resistant and
transparent with a light amber tint.
• These are made without adhesives and can be made with or
without a vacuum port.
• These bags are designed to protect products from contact
with liquid nitrogen while stored in it. They remain flexible
and will not fracture in liquid nitrogen.
• They have a remarkable temperature range, from -200°C to
+200°C.
Adherent Cell Bags
• Adherent-Cell Bags, or AC Bags, are used in
those applications where it is desirable to have a
cell adhered to a bag.
• They will also allow biologics like Retronectin and
Fibronectin to adhere.
• We can treat any of our bags so that they have
this adherent property.
• The adherence is strong enough to localize cells
during transduction.
• AFC has mastered the difficult process of giving
the AC bags an adherent quality.
• The expense of this process is offset by the
convenience of the bag.
Tubing and Fittings
AFC produces Sterile
Connecting Device compatible
tubing adapter sets for use
with the VueLife® and
KryoSure® products, and other
systems. In addition to standard adapter
sets, custom configurations can be
made to meet your specific
applications.
Other Products
RFID Reader/Writer
Kit
Incubation cassette
RFID Chip
Other Products
Centrifuge Insert Cylindrical Halves
Shape with Centrifuge bucket (not
available)
AFC-4 Impulse Heat Sealer
Centrifuge Insert Cone Shape with
Centrifuge bucket (not available)
AFC Packworld Heat Sealer
So what makes our bags special?
What makes our bags special?
They are inert, so the bag does not
interact with any biologic process. Since
they are inert, they also do not sequester
biologics or biologic products. Nutrients
and signaling cytokines are also absorbed
by the cells, not the bag.
What makes our bags special?
One of the most important and unique
qualities in our bags is their durability in
liquid nitrogen. They do not become brittle
in liquid nitrogen and can withstand
temperatures between -200°C to +200°C.
What makes our bags special?
Our bags are also transparent to
ultraviolet, visible and infrared light. This
allows both visual and microscopic
observations to be made.
What makes our bags special?
We also custom make the bags to your
specifications. There are infinite shapes
and sizes that your bag can take. These
countless options help us better give you a
product that fits your individual needs.
What makes our bags special?
The bag can take on almost any shape
that can be drawn and the maximum bag
volumes range from 1 milliliter to 18,000
milliliters. Our bags can be designed
without sharp corners or with no corners at
all!
What makes our bags special?
Our extensive stock of accessories for our
bags offers everything you could possibly
need. Our bags can be fitted with virtually
any connector we offer; and we also offer
stock cocks, adapters, male and female
fittings, swabbable valves, and much more
just for your bags.
What makes our bags special?
Quality is important to us, so the bags and
associated fittings and tubings are made
with United States Pharmacopeia (USP)
Class VI materials.
What makes our bags special?
And since we realize how important the
quality of the bag is to you, we individually
test each bag to insure 100% reliability.
We also supply them sterile and
individually wrapped.
What makes our bags special?
Our laser sealing process is extremely
reliable, welding the bag together and
making a seal as strong as the bag. This is
a lot different and a lot stronger than
zippering, buttoning or clamping.
What makes our bags special?
Our bags can have tubing installed for
sterile docking, and the port and luer
fittings on our bags are monolithic with the
bag. Our bags can also be autoclaved.
What makes our bags special?
Our bags are special because we care.
Aerospace
In 1998, NASA commissioned AFC to
build bags for the International Space
Station and space shuttles. The bags
are being used to hold drinking water
and waste as well as samples for
analysis and chemical scientific
experiments.
Photo courtesy of NASA Discovery mission
Aerospace
NASA’s confidence in our company to
provide outstanding products is something
we hold very highly and hope to transfer to
every customer we interact with.
Photo courtesy of NASA Discovery mission
Regulations
• AFC manufactures bags and tubing sets in
compliance with the United States Code of
Federal Regulations.
• AFC maintains Design History Files, Device
Master Records and Device History Records on
all bags and tubing sets that AFC manufacturers.
• These records include all the information required
by the Code of Federal Regulations for medical
products relating to materials and manufacturing.
• AFC products are regulated under medical device
regulations, including annual registration, listing of
devices, good manufacturing practices, labeling,
and the misbranding and adulteration provisions
of the Act.
Our Location
AFC is conveniently located in Olde Town,
Historic Gaithersburg. Since 1982 we have
handled both national and international
orders. We moved to our new location in
Gaithersburg in 1996 and now offer online,
fax, and telephone ordering.
To Order Our Products
American Fluoroseal Corporation
431-A East Diamond Ave
Gaithersburg, MD 20877
Tel: (301) 990-1407
Toll free (USA only): 1-800-360-1050
Fax: (301) 990-1472
Email: [email protected]
www.toAFC.com
The End

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