Component Material:
Vial:
Virgin Polypropylene, meets USP, Class VI requirements for plastic containers and closures.
Cap:
Virgin Polypropylene, meets USP, Class VI requirements for plastic containers and closures. Heavy metal free (meets CONEG req.) color concentrate.
Sterilization:
This lot has been irradiated and dosimetrically released based on the Sterilization of healthcare products-Requirements for validation and routine control-Radiation sterilization.
Sterility Assurance Level: SAL 10-5
RNase / DNase Testing
This product has been tested and is free of any detectable RNase / DNase contamination.
Pyrogens:
The product has been tested and has met the criteria established in ANS/AAMI ST 72:2002(R) 2010: Bacterial endotoxins- Test methodologies, routine testing, and alternative to batch testing. Results: less than 0.1 EU/ml