|
|
 |
The American
Fluoroseal Corporation
Warrants these facts AFC certifies
that AFC bags are made with pure USP Class VI FluoroEthylene
Propylene (FEP) fluoroplastic, and that AFC bags are not coated or
made with laminates of any nature. AFC bags have no leachable
materials.
Afc bags have been tested for extractables with hexane extraction
for 24 hours at 50 degrees Celsius and found to have no detectible
turbidity, no detectable non-volatile residue, or UV absorption in
the extract and no detectible residue upon ignition. AFC bags have
no detectible extractables. Hexane is used to evaluate lipophilic
extractables in polymers. Products that are low in hexane soluble
extractables are preferred for use in devices contacting blood and
tissues.
AFC bags have been tested for extractables with isopropyl alcohol
extraction for 24 hours at 70 degrees Celsius and found to have no
detectible extractables. Products that are low in isopropyl alcohol
soluble extractables are preferred for use in devices contacting
blood and tissues. AFC bags have no detectible extractables.
AFC bags have been tested for extractables with water extraction for
24 hours at 70 degrees Celsius and found to have no detectible
extractables. Products that are low in water soluble extractables
are preferred for use in devices contacting blood and tissues. AFC
bags have no detectible extractables.
AFC certifies that AFC standard bags will not bind, adhere or adsorb
any known chemical or biologic.
AFC certifies that the interior of AFC Adherent Cell (AC) bags (not
standard bags) have been exposed to electronic corona discharge and
those interior surfaces will reversibly bind those entities that can
attach to weakly hydroscopic surfaces.
AFC certifies that AFC bags do not react with DMSO or with any other
chemical, solvent, or biologic at temperatures below 100 degrees
Celsius.
AFC certifies that AFC bags have not been exposed to Ethylene Oxide
(ETO) or any other fumigant at any time during or after manufacture.
AFC sterilizes AFC bags by wet steam autoclave sterilization to
achieve a Sterility Assurance Level of 1e10-6.
AFC certifies that AFC bags remain flexible and will not crack at
low temperatures, including immersion in liquid nitrogen.
AFC certifies that AFC maintains Device Masterfiles with the Food
and Drug Administration for its KryoSure bags for cryopreservation.
AFC certifies that AFC maintains Device Masterfiles with the Food
and Drug Administration for its VueLife bags for the culture and
storage of leukocytes.
Herbert M. Cullis, President
American Fluoroseal Corporation
431-A East Diamond Avenue
Gaithersburg, Maryland 20877
|
|
|
|
