Validation Guide

Summary

3
Tygon S ™ E-LFL
Revision: August 12, 2013

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 Tygon S3™E-LFL
Validation Guide Summary
Table of Contents Page
1. Summary _____________________________________________________________________________________ 3
2. Typical Physical Properties _______________________________________________________________________ 3
3. Biocompatibility, Physiochemical and Extractable Testing ______________________________________________ 4
a. Summary ______________________________________________________________________________ 4
b. Ames Genotoxicity Test __________________________________________________________________ 4
c. Hemolysis: Direct Contact_________________________________________________________________ 5
d. Hemolysis: Indirect Contact _______________________________________________________________ 5
e. In Vitro Cytotoxicity______________________________________________________________________ 6
f. Systemic Toxicity – Rabbit Pyrogen (Material Mediated) ________________________________________ 6
g. Chemical Characterization of Materials ______________________________________________________ 7
h. Sterility Tests: Bacteriostasis & Fungistasis ___________________________________________________ 7
i. Biological Reactivity Tests, In Vitro __________________________________________________________ 8
j. Class VI Plastics - Biological Reactivity Tests, In Vivo ____________________________________________ 8
k. Elastomeric Closure for Injection and Rubber Closures for Containers _____________________________ 8
l. Physiochemical Tests – Plastics ____________________________________________________________ 9
m. Physiochemical Testing with an Alternative Extract -- Ethanol ___________________________________ 10
n. Physiochemical Testing with an Alternative Extract -- Hexane ___________________________________ 11
o. Total Extractables in Rubber Articles Intended for Repeated Use ________________________________ 12

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Validation Guide Summary: Tygon S3™ E-LFL
1.0 Summary

Tygon S3™ E Series represents the “Evolution” of Saint Gobain’s classic Tygon® formulations to comply with new global
regulatory standards. The new Tygon S3™ E-LFL (Long Flexible Life) formulation is bio-based, phthalate-free formulation and
has been tested rigorously to ensure that it meets the same physical standards as the original Tygon® LFL, including 1,000
hours of pump life at 0 psi back pressure and low particle spallation. The non-aging characteristics of Tygon S3™ E-LFL provide
users with versatility for a wide variety of applications. Tygon S3™ E-LFL is not toxic, BPA free and can be sterilized via
autoclave or ethylene oxide.

Tygon S3™ E-LFL meets all relevant USP Class VI, ISO 10993 and FDA requirements.

2.0 Typical Physical Properties

Property ASTM Standard Value or Rating

Durometer hardness (Shore A) ASTM D2240 56
Tensile Strength (psi/MPa) ASTM D412 1800/12.4
Ultimate Elongation (%) ASTM D412 400
Tensile Stress ASTM D412
@ 100% (psi/MPa) 550/3.8
@ 200% (psi/MPa) 950/6.6
Tear Resistance (lb-f/inch, kN/m) D1004 184/32.2
Compression Set Constant Deflection,
D395 68
% @ 158°F (70°C) for 22hrs
Brittleness by Impact Temp., °F/°C D746 -51/-56
Specific Gravity D792 1.17
Water Absorption, % 24hrs @ 23°C D570 0.20
Maximum Recommended Operating Temp. °F/°C --- 165/74
Low Temp. Flexibility, °F/°C D380 -67/-55
Tensile Set, % D412 54
Color --- Clear

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3.0 Tygon S3™ E-LFL Biocompatibility, Physiochemical & Extractable Testing

3a. Summary

The following is a summary of the validation testing that has been performed on Tygon S3™ E-LFL Tubing.
Complete test reports can be found in the Tygon S3™ E-LFL Validation Guide.

Test Standard Result

Ames Genotoxicity ISO 10993-3 Passed

Hemolysis – Direct Contact ISO 10993-4 Passed

Hemolysis – Indirect Contact ISO 10993-4 Passed

In Vitro Cytotoxicity ISO 10993-5 Passed

Systemic Toxicity - Rabbit Pyrogen (Material Mediated) ISO 10993-11 Passed

See Summary
Chemical Characterization of Materials -- Infrared Spectroscopy ISO 10993-18
p6
Sterility Test: Bacteriostasis & Fungistasis USP <71> Passed

Biological Reactivity Tests, In Vitro USP <87> Passed

Class VI Plastics - Biologic Reactivity Tests, In Vivo USP <88> Passed

Elastomeric Closures for Injection USP <381> Passed

Rubber Closures for Containers EP 3.2.9 Passed

Physicochemical Tests for Plastics USP <661> Passed

Physicochemical Testing with an Alternative Extract -- Ethanol See Summary Section p 10

Physicochemical Testing with an Alternative Extract -- Hexane See Summary Section p 11

Total Extractables in Rubber Articles Intended for Repeated Use 21 CFR Part 117.2600

3b. ISO 10993-3 Ames Genotoxicity Test

Genotoxicity tests are conducted to detect compounds that could potentially cause genetic damage. Genotoxic
compounds can potentially cause cancer or heritable defects in humans. The Ames Genotoxicity Test assesses the ability
of potentially genotoxic compounds to reverse genetic mutations in specific reference bacteria, and has been shown to
predict potential carcinogenicity and mutagenesis in humans.

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 Test: A sample of Tygon S3™ E-LFL was tested by NAMSA in accordance with ISO 10993-3:2003, Biological Evaluation of
Medical Devices - Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity and OECD (471), Guideline for
Testing of Chemicals, Bacterial Reverse Mutation Test.

o
The test article was extracted with USP 0.9% Sodium Chloride for Irrigation (NaCl) at 121 C for 1 hour and with Ethanol
o -
(EtOH) at 70 C for 24 hours. Triplicate cultures of four strains of histidine deficient (his ) Salmonella typhimurium and one
-
strain of tryptophan deficient (tryp ) Escherichia coli were exposed to the resulting extractant. Triplicate cultures of these
strains were also exposed to NaCl and DMSO as negative controls. As positive controls, cultures of these strains were
also exposed to strain-specific known mutagens (Sodium Azide, Methyl Methanesulfonate, Benzo[a]pyrene, 2-
Nitrofluorene, ICR-191, 2-Aminoanthracene) on triplicate plates.

Results: The mutant strains exposed to the test article extracts did not exhibit a statistically significant number of
revertant colonies relative to those exposed to the negative controls. The positive controls demonstrated statistically
significant growth in response to exposure to known mutagens, confirming that the test was valid. The test article was
therefore deemed non-mutagenic in the test species.

3c. ISO 10993-4 Hemolysis: Direct Contact

The Hemolysis test assesses the potential for direct contact of a given sample with blood to cause the rupture of
erythrocytes (red blood cells).

Test: A sample of Tygon S3™ E-LFL was tested by NAMSA in accordance with ISO 10993-4, Biological Evaluation of
Medical Devices – Part 4: Selection of Tests for Interactions with Blood.

The test article and negative control (HDPE) samples were placed in vials containing calcium- and magnesium-free PBS
(CMF-PBS). Vials containing Sterile Water for Injection were prepared as positive control samples. Rabbit blood was
o
added to the samples and a CMF-PBS blank and the resulting mixtures were incubated at 37 C for 3hrs with intermittent
agitation. The incubated vials were then centrifuged and the supernatant was drawn off. Supernatant samples were
tested by adding Drabkin’s reagent, letting the samples stand for 15 minutes and then measuring the absorbance of the
samples in a spectrophotometer at 540nm to determine the corresponding hemoglobin concentration.

Results: The percent hemolysis resulting from direct contact of the product with rabbit blood was 0.4% above the
negative control. Per ISO 10993-4, a test article is considered non-hemolytic if its percent hemolysis is <2.0% above the
negative control. The test article was therefore deemed non-hemolytic.

3d. ISO 10993-4 Hemolysis: Indirect Contact

The Hemolysis test assesses the potential for indirect contact of a given sample with blood to cause the rupture of
erythrocytes (red blood cells).

Test: A sample of Tygon S3™ E-LFL was tested by NAMSA in accordance with ASTM F756, Standard Practice for
Assessment of Hemolytic Properties of Materials.

The test article, negative control (HDPE) and positive control (Sterile Water for Injection) samples were extracted with
o
calcium- and magnesium-free PBS (CMF-PBS) at 121 C for 1 hour. Rabbit blood was added to the resulting extracts a
o
CMF-PBS blank and the resulting mixtures were incubated at 37 C for 3hrs with intermittent agitation. The incubated

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 vials were then centrifuged and the supernatant was drawn off. Supernatant samples were tested by adding Drabkin’s
reagent, letting the samples stand for 15 minutes and then measuring the absorbance of the samples in a
spectrophotometer at 540nm to determine the corresponding hemoglobin concentration.

Results: The percent hemolysis resulting from indirect contact of the product with rabbit blood was 0.2% above the
negative control. Per ASTM F756-08, a test article is considered non-hemolytic if its % hemolysis is <2.0% above the
negative control. The test article was therefore deemed non-hemolytic.

3e. ISO 10993-5 Tests for In Vitro Cytotoxicity

Cytotoxicity testing assesses the potential of a given material to have a toxic effect on living cells.

Test: Samples of Tygon S3™ E-LFL were tested by NAMSA in accordance with ISO 10993-5: 2009, Biological Evaluation of
Medical Devices Part 5: Tests for In Vitro Cytotoxicity and USP 35, NF 30, 2012; <87>, Biological Reactivity Tests, In Vitro.

o
Test samples were immersed in Serum-Supplemented Minimum Essential Medium at 37 C for 24hrs. Positive control
(powder-free latex gloves) and negative control (HDPE) samples were also extracted as above. Duplicates of all three
o
extracts were incubated with L929 mouse fibroblast cells at 37 C for 48hrs. Cultures were monitored for cellular
degeneration and malformation and rated on a scale of 0 (No Biological Reactivity) to 4 (Severe Biological Reactivity).

Results: The test article samples and the negative controls scored a Grade 0 for Biological Reactivity after 48hrs. The
positive controls scored a Grade 4 at the 48hr mark. Samples are deemed to meet the test requirements if they exhibit a
Biological Reactivity of no more than Grade 2 (Mild Reactivity). The test articles are therefore considered non-cytotoxic.

3f. ISO 10993-11 Tests for Systemic Toxicity – Rabbit Pyrogen Test (Material Mediated)

The rabbit pyrogen test is performed to qualitatively determine whether a given test article contains pyrogens. Pyrogens
can provoke a significant febrile reaction in a human patient who receives a parenteral drug product that has come into
contact with a contaminated test article.

Test: A sample of Tygon S3™ E-LFL was tested by NAMSA in accordance with USP 35, NF 30, 2012; <151> Pyrogen Test
and ISO 10993-11 Biological Evaluation of Medical Devices Part 11, Tests for Systemic Toxicity.

o
The test article was immersed in USP 0.9% Sodium Chloride for Injection (NaCl) at 70 C for 24hrs. The resulting extract
was administered to test subjects (rabbits) via IV injection at a dose of 10 mL per kg of body mass. The body
temperatures of the animals were measured 30 minutes prior to injection and again every 30 minutes between the 1
hour and 3 hours marks post-injection.

o o o
Results: The three test rabbits showed a rise of 0.0 C, 0.2 C and 0.2 C in body temperature post-injection. A test article
is considered pyrogen-free provided that none of the test subjects display an increase in body temperature of more than
o
0.5 C post-injection, therefore the test articles were deemed pyrogen-free.

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 3g. ISO 10993-18 Chemical Characterization of Materials

Chemical characterization can help to identify a given material or examine for impurities.

Test: A sample of Tygon S3™ E-LFL was tested by NAMSA in accordance with ISO 10993-18 Biological Evaluation of
Medical Devices Part 18, Characterization of Materials.

o
Test article extracts were prepared by immersing the test article in water or ethanol at 70 C for 24 hours or in hexane at
o o
50 C for 24 hours. Residues were prepared by placing the test article extracts in a drying oven at 105 C to evaporate the
solvents. The test article was analyzed via Attenuated Total Reflectance Infrared Spectroscopy (ATR-IR). Residues of test
article extracts were analyzed using Transmission Infrared Spectroscopy.

Results:

Test Article – The infrared spectrum of the test article most closely matched those of polyvinyl chloride and polyvinyl
acetate.

Water Residue – There were no major bands of interest detected.

Ethanol Residue – The infrared spectrum of the extract most closely matched that of polyvinyl acetate.

Hexane Residue – The infrared spectrum of the extract most closely matched that of polyvinyl acetate.

3h. USP <71> Sterility Tests: Bacteriostasis & Fungistasis

Bacteriostasis and Fungistasis testing is performed to determine whether or not a given test article has the potential to
inhibit the growth of bacteria and/or fungi, respectively, and therefore potentially interfere with standard Sterility Tests.

Test: Samples of Tygon S3™ E-LFL were tested by NAMSA in accordance with USP 35, NF 30, 2012 <71>: Sterility Tests and
EP 2.6.1 (2008): Sterility.

Test articles were placed in three culture vessels containing Soybean Casein Digest Broth (SCDB) and three vessels
containing Fluid Thioglycollate Media (FTM). Corresponding positive controls were prepared using the same media in
culture vessels that did not contain samples of test article. The product-containing and positive control flasks were
inoculated with Bacillus subtilis (SCDB), Clostridium sporogenes (FTM), Candida albicans (SCDB), Aspergillus brasiliensis
(SCDB) and Staphylococcus aureus (FTM) Pseudomonas aeruginosa (FTM). Flasks containing SCDB were incubated at
o o o o
20 C - 25 C and flasks containing FTM were incubated at 30 C - 35 C until positive for microbial growth or until five days
had passed.

Results: All test article-containing flasks and positive control flasks were positive for microbial growth within the five day
window. The test article was therefore deemed non-bacteriostatic and non-fungistatic.

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 3i. USP <87> Biological Reactivity Tests, In Vitro

Cytotoxicity testing assesses the potential of a given material to have a toxic effect on living cells.

Test: Samples of Tygon S3™ E-LFL were tested by NAMSA in accordance with USP 35, NF 30, 2012; <87> Biological
Reactivity Tests, In Vitro.

Duplicate test article, negative control (HDPE) and positive control (latex) samples were placed in separate wells
containing solidified agarose overlaying a L929 mouse fibroblast monolayer. The culture plates were then incubated at
o
37 C in 5% CO2 for 24hrs. After the incubation period cultures were examined macroscopically and microscopically for
cell decolorization and potential cell lysis and rated on a scale of 0 (No Biological Reactivity) to 4 (Severe Biological
Reactivity).

Results: The test article samples and the negative controls scored a Grade 0 for Biological Reactivity after 24hrs. The
positive controls scored a Grade 3 at the 24hr mark. Samples are deemed to meet the test requirements if they exhibit a
Biological Reactivity of no more than Grade 2 (Mild Reactivity). The test articles are therefore considered non-cytotoxic.

3j. USP <88> Biological Reactivity Tests, In Vivo

The USP Class VI Plastics Test assesses the potential toxicity of a given test article by introducing a sample into live
animals systemically, intracutaneously and through implantation. Test animals are then monitored for signs of irritation
and/or toxicity.

Test: Samples of Tygon S3™ E-LFL were tested by NAMSA in accordance with USP 35, NF 30, 2012, <88> Biological
Reactivity Tests, In Vivo.

Test articles were immersed in USP 0.9% Sodium Chloride (NaCl), Sesame Oil (SO), 1 in 20 Ethanol in NaCl (EtOH) or
o
Polyethylene Glycol 400 (PEG) at 121 C for 24hrs. The test article extracts and corresponding controls (samples of each
extractant that had not been exposed to the test article) were injected systemically into mice and intracutaneously into
rabbits and the animals were observed at 4, 24, 48 and 72 hours post-injection for signs of systemic toxicity and at 24, 48
and 72 hours post-injection for skin reactivity. In addition, samples of the test article and negative control (HDPE) were
implanted into the paravertebral muscles of rabbits, which were then observed for 7 days for macroscopic signs of
hemorrhage, necrosis, discoloration, encapsulation and/or infection.

Results: None of the animals injected systemically with test article extracts or controls exhibited any signs of toxicity.
Similarly, none of the animals injected intracutaneously with test article extracts or controls exhibited any signs of
erythema, edema or clinical toxicity. Further, none of the implanted animals exhibited any signs of toxicity at the
implantation sites relative to the control sites. The test article therefore met the requirements of the USP Class VI Test
for Biocompatibility.

3k. USP <381> Elastomeric Closures for Injection and EP 3.2.9 Testing of Rubber Closures for Containers

Testing of elastomeric closures for use with containers for injectables is performed to assess the suitability of the test
article for use in contact with drug products for parenteral administration in humans.

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 Test: A sample of Tygon S3™ E-LFL was tested by NAMSA in accordance with USP 35, NF 30, 2012; <381> Elastomeric
Closures for Injections and EP 3.2.9 Testing of Rubber Closures for Containers.

The test article extract was prepared by immersing test article samples in purified water and boiling for 5 minutes. After
boiling, the samples were rinsed 5 times with cold purified water and then immersed in fresh purified water, and
o
subsequently autoclaved at 121 C for 30 minutes. A blank purified water control was prepared by autoclaving under the
same conditions. The test extract and control were tested for Turbidity, Color, Acidity or Alkalinity, Absorbance, Reducing
Substances, Heavy Metals, Extractable Zinc, Ammonium and Volatile Sulfides per USP <381>.

Results: The test results are summarized in the table below.

Parameter Results Acceptance Limits Meets Criteria?

Appearance –
Not more opalescent than Solution B Not more opalescent than Solution B Yes
Visual Inspection
Color Less intense than the Color Standard Less intense than the Color Standard Yes
Acidity or
< 0.3 ml of 0.01 M sodium hydroxide ≤ 0.3 ml of 0.01 M sodium hydroxide Yes
Alkalinity
Absorbance < 0.2 ≤ 0.2 for Type I Yes
Reducing ≤ 3.0 ml difference between titration
0.44 ml Yes
Substances for Type I
Heavy Metals < 2.0 ppm ≤ 2.0 ppm Yes

Extractable Zinc Not detected ≤ 5.0 ppm Yes

Ammonium < 2.0 ppm ≤ 2.0 ppm Yes

Volatile Sulfides < 0.154 mg ≤ 0.154 mg of sodium sulfide Yes

Residue on
0.55 mg < 2.0 mg Yes
Evaporation

The test article samples met the criteria established per USP <381> and EP 3.2.9 for all of the tests performed, as shown
above.

3l. USP <661> Physicochemical Tests for Plastics

Physicochemical testing is performed to assess the suitability of the test article for use in contact with drug products for
parenteral administration in humans.

Test: A sample of Tygon S3™ E-LFL was tested by NAMSA in accordance with USP 35, NF 30, 2012; <661> Containers,
Physicochemical Tests – Plastics.

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 o
The test article was immersed in USP Purified Water for 70 C for 24hrs. The extract was then tested for Non-Volatile
Residue, Residue on Ignition, Heavy Metals as Lead and Buffering Capacity per USP <661>.

Results: The test results are summarized in the table below.

Assay Results Limits Based on Area

Non-Volatile Residue 1 mg ≤ 15 mg

Residue on Ignition ≤ 1 mg ≤ 5 mg

Heavy Metals < 1 ppm ≤ 1 ppm

Buffering Capacity 1.3 ml ≤ 10 ml

Appearance – Test Article Extract Clear and colorless N/A

Appearance – Purified Water Control Clear and colorless N/A

The test article sample met the criteria established per USP <661> for all of the tests performed, as shown above.

3m. Physicochemical Testing with an Alternative Extract - Ethanol

Physicochemical testing with an alternative extract is performed to assess the levels of lipophilic extractables in polymeric
samples. Ethanol is used as the extractant in these tests. Formal limits for Ethanol-soluble extractables have not yet
been established, but in general lower levels of lipophilic extractables are preferred for materials that will come into
contact with blood or tissues.

Test: A sample of Tygon S3™ E-LFL was tested by NAMSA in accordance with NAMSA’s standard protocol for
Physicochemical Testing with an Alternative Extract.

o
The test article was immersed in Ethanol at 70 C for 24hrs. The extract was assessed for Non-Volatile Residue, Residue on
Ignition and Turbidity in accordance with USP 35, NF 30, 2012; <661> Containers, Physicochemical Tests – Plastics; <281>
Residue on Ignition; <731> Loss on Drying; and <851> Spectrophotometry and Light Scattering. The appearance of the
extract on visual inspection was compared to a control sample of Ethanol.

Results: The results are summarized in the table below.

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 Test Result

Non-Volatile Residue 11,133 mg

Residue on Ignition 1 mg

Turbidity 0.1 NTU

OD – 0.3728
UV Absorption max – 202.6 nm
Dilution factor – 1:500
Appearance of Test Article Clear with a slightly brownish tint

Appearance of Ethanol Control Clear and colorless

3n. Physicochemical Testing with an Alternative Extract - Hexane

Physicochemical testing with an alternative extract is performed to assess the levels of lipophilic extractables in polymeric
samples. Hexane is used as the extractant in these tests. Formal limits for Hexane-soluble extractables have not yet been
established, but in general lower levels of lipophilic extractables are preferred for materials that will come into contact
with blood or tissues.

Test: A sample of Tygon S3™ E-LFL was tested by NAMSA in accordance with NAMSA’s standard protocol for
Physicochemical Testing with an Alternative Extract.

o
The test article was immersed in Hexane at 50 C for 24hrs. The extract was assessed for Non-Volatile Residue, Residue on
Ignition and Turbidity in accordance with USP 35, NF 30, 2012; <661> Containers, Physicochemical Tests – Plastics; <281>
Residue on Ignition; <731> Loss on Drying; and <851> Spectrophotometry and Light Scattering. The appearance of the
extract on visual inspection was compared to a control sample of Hexane.

Results: The results are summarized in the table below.

Test Result

Non-Volatile Residue 11,138 mg

Residue on Ignition < 1 mg

Turbidity 0.4 NTU

OD – 0.3885
UV Absorption max – 200 nm
Dilution factor – 1:500
Appearance of Test Article Cloudy with a slightly brownish tint

Appearance of Hexane Control Clear and colorless

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 3o. 21 CFR Part 117.2600 Total Extractables in Rubber Articles Intended for Repeated Use

The Total Extractables Test is intended to determine the total solids per unit surface area that can be extracted from a
given test article using purified water and hexane.

Test: A sample of Tygon S3™ E-LFL was tested by NAMSA in accordance with 21 CFR Part 177.2600: Rubber Articles
Intended for Repeated Use.

The test articles were immersed in either purified water or hexane for 7hrs (the Reflux Time). The test articles were then
removed and extracted with fresh samples of purified water and hexane for a further 2hrs. The resulting extracts were
then evaporated to dryness and the residue per unit surface area was determined for each sample.

Results: The test results are summarized in the table below.

Purified Water
Reflux Time
Results Evaluation Criteria Meets Criteria?
2 2
First 7 hours 0.650 mg/in ≤ 20 mg/in Yes
2 2
Second 2 Hours 0.297 mg/in ≤ 1 mg/in Yes

Hexane
2 2
First 7 hours 255 mg/in ≤ 175 mg/in Yes
2 2
Second 2 Hours 30.3 mg/in ≤ 4 mg/in Yes

As shown in the table above, the test article samples met the criteria established per 21 CFR Part 177.2600: Rubber
Articles Intended for Repeated Use.

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