ZICIS GROUP LLC offers both 13mm and 20mm vial stoppers that are Bioburden Tested and BET Tested (Bacterial Endotoxin Tested) by a US FDA and ISO 17025 certified facility in the USA. Our “Ready to Sterilize / Ready for Sterilization” (RFS series) vial stoppers are double bagged in autoclave ready sterilization bags with lot traceability for cGMP documentation compliance.

Bioburden Testing determines the number of colony forming units (CFU / microorganisms) present on a surface that has not yet been sterilized (autoclave sterilization, Ethylene Oxide, gamma-irradiation, etc). The US Code of Federal Regulations Chapter 21 211.110 (a)(6) clearly states that bioburden testing must be outlined and conducted according to written procedures during the processing of drugs. Click Here for Bioburden and BET Tested Stoppers

Bacterial Endotoxin Testing (BET) is an in vitro assay for detection and enumeration of bacterial endotoxins, a component of the cell wall of gram-negative bacteria. The BET must be performed for medical devices with direct or indirect contact to the cardiovascular system, lymphatic system, or cerebrospinal fluid. Also, the BET must be performed when manufacturing injectable pharmaceutical products. Our RFS13 and RFS20 series stoppers have BET performed by a US FDA and ISO 17025 certified facility. Click Here for Bioburden and BET Tested Vial Stoppers.