Sterile buffered saline solution: HyClone phosphate buffered saline solutions are filtered through final 0.1 μm pore-size filters. Filter integrity tests are performed both before and after filtration. Aseptic fills are performed in a class 100 clean room. Each lot is subjected to sterility testing, which is performed using the membrane filtration method described in the current U.S. Pharmacopeia (USP).
Additional testing: HyClone PBS solutions are subjected to stringent quality control testing to ensure product performance and lot-to-lot consistency. The phosphate buffered saline solutions are tested for pH, osmolality, and endotoxin. Each lot is also tested using a cytotoxicity assay.
