20mm 4.0ml, 4.5ml, 8.0ml, 9.0ml and 100ml albumin saline w/phenol vials are sterile, certified depyrogenated and sealed and contain .9% Sodium Chloride, .03% normal serum albumin, (human) .4% Phenol (preservative) and water for injection. Vials are Type 1 borosilicate assembled with butyl stoppers and the cap colors vary.
The sterilization process is performed in an FDA inspected facility, operating to cGMP compliance and the sterilization processes are carried out under strict Class 100 regulations.
Assembled units are free of all endotoxins and meet the FDA's mandated 14-day sterility testing protocol.
Certifications of Analysis are available upon request.