1. American Fluoroseal Corporation (AFC) Manufacturer of inert, non-reactive bags and pouches

2. AFC is for cryogenic containment… for transparent containment… for gas permeable containment… AFC will make bags to meet your specifications

3. The AFC Mission is to design and build containers that are inert reliable gas permeable.and,,

4. 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.

5. Products and Processes

6. 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, non- reactive environment. The bags are virtually impermeable to water, but still allow O 2 and CO 2 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. Other Products Incubation cassette RFID Reader/Writer Kit RFID Chip

12. Other Products Centrifuge Insert Cone Shape with Centrifuge bucket (not available) Centrifuge Insert Cylindrical Halves Shape with Centrifuge bucket (not available) AFC-4 Impulse Heat Sealer AFC Packworld Heat Sealer

13. So what makes our bags special?

14. 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.

15. 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.

16. Our bags are also transparent to ultraviolet, visible and infrared light. This allows both visual and microscopic observations to be made.

17. 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.

18. 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!

19. 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.

20. Quality is important to us, so the bags and associated fittings and tubings are made with United States Pharmacopeia (USP) Class VI materials.

21. 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.

22. 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.

23. 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.

24. Our bags are special because we care.

25. 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

26. 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

27. 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.

28. 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. Our Location

29. 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: info@toafc.com www.toAFC.com

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