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| We've done the testing for you. NNI has
completed extensive biological testing on our PETG Square Media Bottles; here
is a summary to facilitate your validation process.
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Biological Testing - Summary
PETG polyethylene terephthalate copolyester
Results
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| FDA-Food Contact Compliance Testing
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21 CFR 177.1315(b)(1)
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| USP 23 Class VI,Section 88
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Pass
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| Mem Elution Cytotoxicity Assay(WI38 Cell Line)
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Pass
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| In Vitro Hemolysis (Tennessee Method)
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Pass
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| European Pharmacopeia Abnormal Toxicity test (modified)
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Pass
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| USP 23 <661> Testing
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Pass
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| Non-Pyrogenic (LAL Gel-clot)
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Pass
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Detailed physical and biological testing data can be obtained from NNI by
calling 1-800-625-4327 and request information on NALGENE® Resin
Validation Binders. These binders provide comprehensive reports which verify
and validate the use of NALGENE® brand products in pharmaceutical and
biotechnology applications.
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