Conformation endotoxin

After the product has been filled (and sealed) in its final product container. QC personnel then remove representative samples of the product and carry out tests to ensure conformance to final product specification. The most important specifications will relate to product potency, sterility and final volume fill, as well as the absence of endotoxin or other potentially toxic substances. Detection and quantification of excipients added will also be undertaken. Product analysis is considered in Chapter 7. 

U. Seydel and K, Brandenburg, in A. Nowotny, J. I. Spitzer, and E. J. Ziegler (Eds.), Endotoxin Research Series, Vol. 1, Cellular and Molecular Aspects of Endotoxin Reactions Conformations of Endotoxin and Their Relationship to Biological Activity, p. 61. Excerpta Medica, Elsevier, Amsterdam, 1990. 

Schromm, A.B., Brandenburg, K., Loppnow, H., Zahringer, U., Rietschel, E.Th., Carroll, S.F., Koch, M.H.J., Kusumoto, S., Seydel, U., The charge of endotoxin molecules influences their conformation and interleukin-6 inducing capacity. J Immunol 161 (1998) 5464-5471. 

Operate the system per applicable SOPs. Perform sampling as per the sampling procedure and schedule. Test steam condensate samples for conformance to current USP Water for Injection monograph (also endotoxin, sterility). 

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