Pre-Washed Ready to Sterilize Vial Stoppers
benefits for the food, pharmaceutical, biomedical, and critical analysis laboratory
QCVIALZ offers 13mm 20mm and 30mm vial stoppers that are pre-washed, then packaged into autoclave ready bags. CFU Bioburden and Endotoxin testing of our washed vial stoppers is then conducted by a US FDA and ISO 17025 certified facility in the USA. Once a batch of vial stoppers has been tested and approved, the RTS/RFS (Ready to Sterilize / Ready for Sterilization) vial stoppers are offered for sale with lot traceability and documented testing results for facilities that require cGMP documentation compliance. This
Why is Bioburden Testing of vial stoppers important?
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. QCVIALZ washed, ready for sterilization (RFS) vial stoppers have been tested by an ISO accredited testing facility here in the USA. To receive additional guidance on FDA compliance with human drug compounding, please visit the FDA website: https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding
Click Here for Bioburden Tested Stoppers RS (Ready to Sterilize) Vial Stoppers
What is Bacterial Endotoxin Testing?
Bacterial Endotoxin Testing (BET) is an in vitro assay for detection and quantification of bacterial endotoxins, which are 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. Ready for Sterilization (RS) vial stoppers by QCVIALZ RFS13 RFS20 and RFS30 series vial stoppers have BET performed by a US FDA and ISO 17025 facility.
BUY Bioburden and BET Tested Ready to Sterilize vial stoppers
Using the QCVIALZ pre-washed, tested, and documented ready to sterilize vial stoppers is one