Technical Brief
                                                                                                  FluoroFlask® Technology




FluoroFlask® single-layer fluoropolymer                                         process as a 6-port, 1.3 gallon flask with .060"
technology provides a high-purity, robust fluid                                 thickness for use as a mixing container. The
packaging solution for a wide range of                                          same process is applied to produce both.
applications.
                                                                                    Wall Thickness                 .006"-.060"
An economic, high-performance alternative to
conventional multilayer bladder products,                                           Inside Diameter                .5"-12.0"
FluoroFlask® offers significant advantages with                                     Length                         2"-14"
the innovative use of engineering grade, high-
temperature fluoropolymer materials.                                                Width                          .5"-12"
                                                                                    Volume                         Up to 1.3 gallon
FluoroFlask®
products are
produced using a                                                                Industry Applications
specialized high-                                                               In the semiconductor industry, FluoroFlask®
temperature process                                                             products are a more robust solution with greater
that greatly minimizes                                                          purity and less leakage that conventional
or even eliminates                                                              products. For chemical packaging (photo-resist
post mold welding                                                               and micro electronic chemical delivery
steps to improve                                                                systems), chemical inertness and low
efficiency when                                                                 permeation rates benefit high purity and low
compared to                                                                     particle contamination requirements in nitric
conventional film                                                               acid (HN03) and other aggressive solvents.
seam and fittings as a
welded assembly                                                                 High purity and inert chemical properties also
operation. The ability                                                          benefit biopharmaceutical applications. Other
to seal the material                                                            attributes include low to high temperature
during processing                                                               cycling for processing drug batches, optical
reduces the need for                                                            clarity and fast, high-volume production.
post-welding
assembly operations. Tube fittings or ports can                                 In drug manufacturing, final-fill equipment and
be incorporated in the design and formed directly                               chromatography vials or protein columns
on the product during processing.                                               benefit from optical clarity as well as low protein
                                                                                adsorption and chemical inertness.
Product Flexibility
FluoroFlask® products are created through a                                     Processes that require freezing or low
proprietary process that manipulates                                            temperatures can benefit from the ability of
fluoropolymers into a formed product with thin to                               FluoroFlask® materials to maintain properties
thick wall sections. The unique properties of this                              during temperature cycling.
process enable us to produce a molded product,                                  Single use biopharmaceutical applications
inclusive of various shapes, thicknesses, and                                   include process vessels for lyophilization
sizes manufactured to meet individual customer’s                                (freeze dry) and freeze-thaw, upstream protein
requirements.                                                                   mixing chamber liners and vessels used in
For instance, an open end, 2-inch long cylinder                                 batch development, and downstream fill and
with a wall thickness of .006" for single-use                                   packaging.
injections can be created utilizing the same

There is no implied warranty of merchantability or fitness for any particular purpose. The exclusive remedy is replacement of defective parts, or at our
option, refund of the purchase price. All damages exceeding the purchase price are excluded, whether consequential or otherwise and regardless of
cause. The user is responsible for design suitability and part testing in your assembly is always recommended. © FAST Group Houston Inc.
Technical Brief
                                                                                                                              FluoroFlask® Technology




Testing Results:

                                                                                          PGMEA Particle Analysis
                          PGMEA Bottle PGMEA Bottle PGMEA Bottle




                                                                   0.2um
                                                        3




                                                                   0.5um


                                                                   0.2um
                                           2




                                                                   0.5um
                                                                                                                                      Day 90
                                                                                                                                      Day 60
                                                                   0.2um
                                                                                                                                      Day 30
                              1




                                                                                                                                      Day 0
                                                                   0.5um


                                                                           0       10       20         30           40         50     60             70
                                                                                                            Ct/mL


                                                                                        Cyclohexanone Particle Count
          Cyclohexanone




                             0.2um
             Bottle 3




                             0.5um
          Cyclohexanone




                             0.2um
             Bottle 2




                                                                                                                                              Day 180
                             0.5um                                                                                                            Day 150
                                                                                                                                              Day 120
                                                                                                                                              Day 90
          Cyclohexanone




                             0.2um                                                                                                            Day 60
             Bottle 1




                                                                                                                                              Day 30
                                                                                                                                              Day 7
                             0.5um                                                                                                            Day 0

                                                                   0           2   4        6      8         10          12     14   16         18        20
                                                                                                            Ct/mL


There is no implied warranty of merchantability or fitness for any particular purpose. The exclusive remedy is replacement of defective parts, or at our
option, refund of the purchase price. All damages exceeding the purchase price are excluded, whether consequential or otherwise and regardless of
cause. The user is responsible for design suitability and part testing in your assembly is always recommended. © FAST Group Houston Inc.
Technical Brief
                                                                                                  FluoroFlask® Technology




                            GC-MS Chromatograms for Cyclohexanone + Coupons Day 60



Summary of the GC-MS results for Cyclohexanone Blank and Cyclohexanone Coupon #1-3 Day-60
samples.

     1. No organic impurities have been leached from the coupons based on the results.

     2. The samples and the blank contained more impurities compared to Day 0. Cyclohexanone is
        likely reacting with something in the environment where the samples have been stored.

     3. The shape of the mounds around 22-23 minutes looked a little different between samples.
        However, they contained the same impurities.




There is no implied warranty of merchantability or fitness for any particular purpose. The exclusive remedy is replacement of defective parts, or at our
option, refund of the purchase price. All damages exceeding the purchase price are excluded, whether consequential or otherwise and regardless of
cause. The user is responsible for design suitability and part testing in your assembly is always recommended. © FAST Group Houston Inc.
Technical Brief
                                                                                                  FluoroFlask® Technology




                                                           PGMEA Comparison

There are some minor differences between the coupon samples and the control. However, we are not
convinced that the coupons were shedding out organics—at least not up to this point (Day 60). No new
organic species were found in the coupon samples that are foreign to the control sample.

     1. The coupon samples contained roughly 3 times the amount of moisture found in the control.
        The coupons may be attracting moisture or releasing it.

     2. 1,2-Ethanediol, diacetate peak in the control was smaller than the ones from the coupon
        samples. We are not sure about this one. We think this is caused by the moisture found in the
        samples.




There is no implied warranty of merchantability or fitness for any particular purpose. The exclusive remedy is replacement of defective parts, or at our
option, refund of the purchase price. All damages exceeding the purchase price are excluded, whether consequential or otherwise and regardless of
cause. The user is responsible for design suitability and part testing in your assembly is always recommended. © FAST Group Houston Inc.
Technical Brief
                                                                                                  FluoroFlask® Technology




                                                        Protein Adsorption Chart




                                                             0.47
     bovine serum albumin                                                           0.98
          (BSA) 37°C                                                                                                                2
                                                                                                                1.6
                                                                           0.78

                                                                                                                            FluoroFlask® Irradiated
                                                         0.38
                                                                                                                            FluoroFlask®
                                                          0.4
                                                                                                                            Glass
 Immuno globulin G (IgG)                     0.12
                                                                                                                            Stedim 40
         37°C                                                0.48
                                                                                                                            Stedim 71
                                                      0.33
                                                                                                                            Evam
                                                      0.32


                                      0                    0.5                     1                    1.5                     2                    2.5
                                                                         Protein Adsorbed (ug/cm2)




There is no implied warranty of merchantability or fitness for any particular purpose. The exclusive remedy is replacement of defective parts, or at our
option, refund of the purchase price. All damages exceeding the purchase price are excluded, whether consequential or otherwise and regardless of
cause. The user is responsible for design suitability and part testing in your assembly is always recommended. © FAST Group Houston Inc.
Technical Brief
                                                                                                  FluoroFlask® Technology




                                                                                 Features
                DIW Particle Count Chart
                                                                                 • Single-layer gas and fluid barrier properties
                                                                                 • Physically tough, pin-hole resistant
                      0.2 Micron                 0.5 Micron                      • High-purity , non-leaching with no extractables
                     Particle Count             Particle Count                     detected
                         (n=19)                     (n=19)
                                                                                 • Low extractable levels of organic and inorganic
                                                                                   contaminants in PGMEA, DIW, and HNO3
                    Day 0        Day 7         Day 0        Day 7                • Stable and biochemically inert
                                                                                 • Plasticizer- and stabilizer-free
                                                                                 • Non-stick and non- adsorbent to protein molecules
    Average          2.58         1.53                                           • High temperature sterilization
                                                                                 • High-low temperature cycling (-165°F to 350°F)
                                                                                 • Optically clear product
     Median          2.00         1.00
                                                                                 • Gamma irradiation resistant (tested up to 25 kGy) for
                                                                                   physical properties and clarity
                                                  No Particles
           SD        1.68         0.96             Observed                      • UV and Flame resistant

  Maximum
                       8            4                                            Benefits
     Count
   Minimum
                       1            1                                            • Manufacturing process can easily adapt to the
      Count                                                                        required applications within multiple industries
                                                                                 • Efficient, high-volume production capability means
                                                                                   quick and reliable delivery to market
                                                                                 • Very smooth surface leading to exceptionally low
                                                                                   levels of biofilm adhesion
                                                                                 • Extremely low ionic and TOC leach-out for industries
                                                                                   such as medical, pharmaceutical, and semiconductor
                                                                                 • Reliably repeatable manufacturing processes ensure
                                                                                   consistency
                                                                                 • Fluoropolymers are often used to solve existing
                                                                                   problems or to develop new technology.
                                                                                 • Despite a relatively high cost, fluoropolymers have
                                                                                   frequently been used to substantially reduce
                                                                                   overall system cost.




There is no implied warranty of merchantability or fitness for any particular purpose. The exclusive remedy is replacement of defective parts, or at our
option, refund of the purchase price. All damages exceeding the purchase price are excluded, whether consequential or otherwise and regardless of
cause. The user is responsible for design suitability and part testing in your assembly is always recommended. © FAST Group Houston Inc.

Technical brief fluoro flask technology today

  • 1.
    Technical Brief FluoroFlask® Technology FluoroFlask® single-layer fluoropolymer process as a 6-port, 1.3 gallon flask with .060" technology provides a high-purity, robust fluid thickness for use as a mixing container. The packaging solution for a wide range of same process is applied to produce both. applications. Wall Thickness .006"-.060" An economic, high-performance alternative to conventional multilayer bladder products, Inside Diameter .5"-12.0" FluoroFlask® offers significant advantages with Length 2"-14" the innovative use of engineering grade, high- temperature fluoropolymer materials. Width .5"-12" Volume Up to 1.3 gallon FluoroFlask® products are produced using a Industry Applications specialized high- In the semiconductor industry, FluoroFlask® temperature process products are a more robust solution with greater that greatly minimizes purity and less leakage that conventional or even eliminates products. For chemical packaging (photo-resist post mold welding and micro electronic chemical delivery steps to improve systems), chemical inertness and low efficiency when permeation rates benefit high purity and low compared to particle contamination requirements in nitric conventional film acid (HN03) and other aggressive solvents. seam and fittings as a welded assembly High purity and inert chemical properties also operation. The ability benefit biopharmaceutical applications. Other to seal the material attributes include low to high temperature during processing cycling for processing drug batches, optical reduces the need for clarity and fast, high-volume production. post-welding assembly operations. Tube fittings or ports can In drug manufacturing, final-fill equipment and be incorporated in the design and formed directly chromatography vials or protein columns on the product during processing. benefit from optical clarity as well as low protein adsorption and chemical inertness. Product Flexibility FluoroFlask® products are created through a Processes that require freezing or low proprietary process that manipulates temperatures can benefit from the ability of fluoropolymers into a formed product with thin to FluoroFlask® materials to maintain properties thick wall sections. The unique properties of this during temperature cycling. process enable us to produce a molded product, Single use biopharmaceutical applications inclusive of various shapes, thicknesses, and include process vessels for lyophilization sizes manufactured to meet individual customer’s (freeze dry) and freeze-thaw, upstream protein requirements. mixing chamber liners and vessels used in For instance, an open end, 2-inch long cylinder batch development, and downstream fill and with a wall thickness of .006" for single-use packaging. injections can be created utilizing the same There is no implied warranty of merchantability or fitness for any particular purpose. The exclusive remedy is replacement of defective parts, or at our option, refund of the purchase price. All damages exceeding the purchase price are excluded, whether consequential or otherwise and regardless of cause. The user is responsible for design suitability and part testing in your assembly is always recommended. © FAST Group Houston Inc.
  • 2.
    Technical Brief FluoroFlask® Technology Testing Results: PGMEA Particle Analysis PGMEA Bottle PGMEA Bottle PGMEA Bottle 0.2um 3 0.5um 0.2um 2 0.5um Day 90 Day 60 0.2um Day 30 1 Day 0 0.5um 0 10 20 30 40 50 60 70 Ct/mL Cyclohexanone Particle Count Cyclohexanone 0.2um Bottle 3 0.5um Cyclohexanone 0.2um Bottle 2 Day 180 0.5um Day 150 Day 120 Day 90 Cyclohexanone 0.2um Day 60 Bottle 1 Day 30 Day 7 0.5um Day 0 0 2 4 6 8 10 12 14 16 18 20 Ct/mL There is no implied warranty of merchantability or fitness for any particular purpose. The exclusive remedy is replacement of defective parts, or at our option, refund of the purchase price. All damages exceeding the purchase price are excluded, whether consequential or otherwise and regardless of cause. The user is responsible for design suitability and part testing in your assembly is always recommended. © FAST Group Houston Inc.
  • 3.
    Technical Brief FluoroFlask® Technology GC-MS Chromatograms for Cyclohexanone + Coupons Day 60 Summary of the GC-MS results for Cyclohexanone Blank and Cyclohexanone Coupon #1-3 Day-60 samples. 1. No organic impurities have been leached from the coupons based on the results. 2. The samples and the blank contained more impurities compared to Day 0. Cyclohexanone is likely reacting with something in the environment where the samples have been stored. 3. The shape of the mounds around 22-23 minutes looked a little different between samples. However, they contained the same impurities. There is no implied warranty of merchantability or fitness for any particular purpose. The exclusive remedy is replacement of defective parts, or at our option, refund of the purchase price. All damages exceeding the purchase price are excluded, whether consequential or otherwise and regardless of cause. The user is responsible for design suitability and part testing in your assembly is always recommended. © FAST Group Houston Inc.
  • 4.
    Technical Brief FluoroFlask® Technology PGMEA Comparison There are some minor differences between the coupon samples and the control. However, we are not convinced that the coupons were shedding out organics—at least not up to this point (Day 60). No new organic species were found in the coupon samples that are foreign to the control sample. 1. The coupon samples contained roughly 3 times the amount of moisture found in the control. The coupons may be attracting moisture or releasing it. 2. 1,2-Ethanediol, diacetate peak in the control was smaller than the ones from the coupon samples. We are not sure about this one. We think this is caused by the moisture found in the samples. There is no implied warranty of merchantability or fitness for any particular purpose. The exclusive remedy is replacement of defective parts, or at our option, refund of the purchase price. All damages exceeding the purchase price are excluded, whether consequential or otherwise and regardless of cause. The user is responsible for design suitability and part testing in your assembly is always recommended. © FAST Group Houston Inc.
  • 5.
    Technical Brief FluoroFlask® Technology Protein Adsorption Chart 0.47 bovine serum albumin 0.98 (BSA) 37°C 2 1.6 0.78 FluoroFlask® Irradiated 0.38 FluoroFlask® 0.4 Glass Immuno globulin G (IgG) 0.12 Stedim 40 37°C 0.48 Stedim 71 0.33 Evam 0.32 0 0.5 1 1.5 2 2.5 Protein Adsorbed (ug/cm2) There is no implied warranty of merchantability or fitness for any particular purpose. The exclusive remedy is replacement of defective parts, or at our option, refund of the purchase price. All damages exceeding the purchase price are excluded, whether consequential or otherwise and regardless of cause. The user is responsible for design suitability and part testing in your assembly is always recommended. © FAST Group Houston Inc.
  • 6.
    Technical Brief FluoroFlask® Technology Features DIW Particle Count Chart • Single-layer gas and fluid barrier properties • Physically tough, pin-hole resistant 0.2 Micron 0.5 Micron • High-purity , non-leaching with no extractables Particle Count Particle Count detected (n=19) (n=19) • Low extractable levels of organic and inorganic contaminants in PGMEA, DIW, and HNO3 Day 0 Day 7 Day 0 Day 7 • Stable and biochemically inert • Plasticizer- and stabilizer-free • Non-stick and non- adsorbent to protein molecules Average 2.58 1.53 • High temperature sterilization • High-low temperature cycling (-165°F to 350°F) • Optically clear product Median 2.00 1.00 • Gamma irradiation resistant (tested up to 25 kGy) for physical properties and clarity No Particles SD 1.68 0.96 Observed • UV and Flame resistant Maximum 8 4 Benefits Count Minimum 1 1 • Manufacturing process can easily adapt to the Count required applications within multiple industries • Efficient, high-volume production capability means quick and reliable delivery to market • Very smooth surface leading to exceptionally low levels of biofilm adhesion • Extremely low ionic and TOC leach-out for industries such as medical, pharmaceutical, and semiconductor • Reliably repeatable manufacturing processes ensure consistency • Fluoropolymers are often used to solve existing problems or to develop new technology. • Despite a relatively high cost, fluoropolymers have frequently been used to substantially reduce overall system cost. There is no implied warranty of merchantability or fitness for any particular purpose. The exclusive remedy is replacement of defective parts, or at our option, refund of the purchase price. All damages exceeding the purchase price are excluded, whether consequential or otherwise and regardless of cause. The user is responsible for design suitability and part testing in your assembly is always recommended. © FAST Group Houston Inc.