• Clean techniques and state of the art manufacturing processes
• Tested for RNase, DNase, Extractables, and endotoxin (Pyrogen)
• Inspected for visual, dimensional, and functional attributes
• Pre-sterilized meet ANSI/AAMI/ISO 11137, certified to SAL of 10-6
RNase/DNase/DNA Testing
Testing is by electrophoresis or PCR. Test sensitivity: RNase – 10-9 Kunitz Units/ ul; DNase – 10-6 Kunitz Units/ ul; DNA – 30pg. Product must be free of detectable contamination.
Lot Traceability
We offer to our customers lot-specific Certificates of Compliance upon request, or directly from our website.