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Sterile Closures
We've done the testing for you. NNI has completed extensive biological testing on our Closures; here is a summary to facilitate your validation process.
Biological Testing - Summary
HDPE, High Density Polyethylene
Results
21 CFR-177.1520 Acceptable for food and beverage contact
USP 23 Class VI Pass
Non-cytototic (MEM Elution WI-38 Cells) Pass
Non-pyrogenic (LAL Gel-clot)(Sterile Products) Pass
USP 24 <661> Physicochemical Test Pass
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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