 |
 |
|
|
|
 |
|
|
|
|
|
|
| We've done the testing for you. NNI has
completed extensive biological testing on our PET Square Media Bottles; here is
a summary to facilitate your validation process.
|
|
Biological Testing - Summary
PET Square Media Results
|
| FDA Food-Contact Compliance Testing
|
21 CFR 177.1315
|
| USP 23 Class VI,Section 88
|
Pass
|
| Mem Elution Cytotoxicity Assay(WI38 Cell Line)
|
Pass
|
| In Vitro Hemolysis (Tennessee Method)
|
Pass
|
| European Pharmacopeia Abnormal Toxicity test (modified)
|
Pass
|
| USP 23 <661> Testing
|
Pass
|
| Non-Pyrogenic (LAL Gel-clot)
|
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.
|
|
|
|
|
|
|
|
