About American Fluoroseal Corporation (Afc)
American Fluoroseal Corporation (Afc) was founded by Herb Cullis, Charles Soodak and Bob Ulrich and incorporated in 1986 as a closely-held Maryland Corporation. Herb Cullis has been its President since 1997. Its scientific beginning came about as a result of the clinical need of cancer researchers at the National Institute of Health (NIH) to produce chemically inert containers for immune system blood cells. The bags were first developed for Fort Detrick in 1982.
Afc invented and patented a proprietary laser sealing, contact-free, manufacturing process for joining fluorocarbon plastic films together to make this bag type possible, creating unique blood component containers for over 25 years.
The process was specifically engineered and ingeniously designed through use of a computer controlled laser sealing technique. This technique made it possible to develop a new, inert, and very durable type of container. This technology resulted in the further advancement of a unique bag system to permit high quality closed system cell culture and transfer of blood components.
Afc is proud to be taking part in today's forth sector of cancer therapy (immunotherapy) with the development of our bag systems. Ultimately, this promising therapeutic technique is being advanced by the designs of our closed system containers for stem cell and immune cell cancer therapy.
Headquarters
Afc's administrative offices and manufacturing facilities are located at: 431 East Diamond Avenue, Gaithersburg, MD, 20877. Phone: 301 990-1407 Fax: 301 990-1472 E-mail: info@toafc.com
Products
Afc's primary products are made from fluorinated ethylene propylene (FEP). The products are principally comprised of various bags for cell culture and cryopreservation. The company manufactures and sells three Trademarked product lines:
VueLife® Culture Bags;
KryoSure® cryopreservation bags, and
KryoVue® cryopreservation overwrap pouches.
Additional products include tubing sets and accessories such as bar sealers, separation clamps, and centrifuge cassettes.
Technical Features
FEP is inert, transparent, tough, and flexible at extreme temperatures (+200°C and -200°C), therefore, Afc products are used extensively in aerospace, biotechnology, chemical manufacturing, forensics, medical products, cryopreservation, tissue and organ banking, and other applications. The best material found for cryopreservation is FEP. It stays flexible in liquid nitrogen, therefore eliminating the fear of breakage like other materials that become brittle, crack, and break when exposed to stress below their glass transition temperature. No other Class lV container material is known to remain flexible in liquid nitrogen making it well suited for cryo-storage of blood components.
The bags are permeable to oxygen and carbon dioxide but virtually impermeable to water; they remain flexible in liquid nitrogen, and have no known solvents. They contain no plasticizers, leachable, or extractable materials, and they do not stimulate any cellular or biologic activity. FEP transmits ultraviolet and infrared light making it ideal in light activation protocols. FEP does not dissolve or soften in DMSO, DMF, or any other solvent. Cells or other biologics do not bind to the bags. Covered ports alleviate the need for cumbersome over wraps. With proper support the bags may be used for centrifugation.
Afc bags are not wettable. Therefore stem cells and all other cells can grow without experiencing the unnatural effects of contact with a foreign surface. Naïve cells do not differentiate. Platelets do not stick. Surface receptors are not activated by Afc bags. However it is possible for the material to be made adherent, so for some cell therapy applications this advantage is possible. This is simply called an adherent cell bag, AC bag for short.
Specialty use
Many specialties incorporate the use of Afc bags. They include those involved in medical trials, clinical applications, NASA and the aerospace industry, and the chemical processing industry. Pathology clients use DNA-free Afc bags for forensic research. Afc overwraps are used for holding and protecting cord blood and tissues while in liquid nitrogen. Cytokines and other proteins will not bind to the interior surface of FEP bags regardless of its charge.
Afc offers both standard and custom shapes and sizes of bags and tubing sets for different types of research, shipping, and storage. Afc FEP bags are offered in sterile, non-sterile, adherent, and non-adherent versions. The products are sold through referrals and internet exposure.
Credentials
Afc maintains NASA manufacturing certifications, FDA registration, Quality Management Systems, Device Master Files, and 510(k) approvals. Afc manufactures under 21CFR regulations for GMP.
