Featuring Endosafe® MCS – Cutting Edge Technology at Pharmetric Laboratory.
We perform Endotoxin Testing using USP and we test based on calibrations to 0.125Units that have a positive control per USP.
Endotoxins are bacterial pyrogens, and include lipopolysaccharide (LPS) molecules found as part of the cell wall of gram negative bacteria. Endotoxins are released upon bacterial cell lysis. They are ubiquitous in nature, i.e., all matter generally has cell wall fragments of gram negative bacteria. Further, endotoxins are potent and stable. Pyrogenic dose can be in the nanogram per kilogram (ng/kg) range, and they have the ability to retain endotoxic properties under all but extreme conditions, and can pass certain filters. Thus, there is a potential of endotoxin presence in parenteral solutions. Remember, an injectable solution can be sterile, but at the same time be pyrogenic, if dead gram negative bacterial cellular debris is present.
Compounding pharmacists achieve non-pyrogenic condition by avoidance of bioburden during the compounding process, and implementation of depyrogenation procedures (e.g., glassware). 21 CFR 211.94(c) states that parenteral products must be sterile and free from pyrogens. Assurance of products meeting endotoxin limits is through endotoxin testing of final product (USP <85>). USP <85> discusses three techniques for the bacterial endotoxins test: the gel clot technique, the turbidimetric technique, and the chromogenic technique. FDA prefers photometric methods that enable rapid, objective, and well-documented results.
Scientists(s) sought to eliminate technical flaws and weaknesses of the gel-clot technique and early photometric bacterial endotoxin test methods by creating a new test platform upon which reagents are dried. Polystyrene cartridges containing pre-calibrated reagents that have known reaction times with reference standard endotoxin were created, along with specific spectrophotometers to read from the cartridges. An archived standard curve was created for each cartridge from the known reference standard endotoxin values so that preparation of daily standard curves is unnecessary. In 2006, FDA approved this photometric cartridge method.
Pharmetric Laboratory has recently acquired this cutting edge multiple-cartridge technology for its endotoxin testing of finished product (USP <85>) and for effectiveness testing of dry heat depyrogenation cycles (USP <797> and <1211>, Depyrogenation <1228>). The ultimate in simplicity and speed, the cartridges offer a 15-minute endotoxin assay utilizing an FDA-licensed compendial-compliant kinetic chromogenic testing solution. Why settle for outdated technology. Pharmetric Laboratory strives to stay cutting edge! We look forward to serving your endotoxin testing needs now and into the future!
Feel free to contact us with any questions.