Drug products and devices may be rendered sterile by physical or chemical means, yet still pose a serious threat to patient safety, due to the lingering presence of pyrogenic residue.\u00a0 Pyrogens are substances which can lead to severe signs of inflammation, shock, multiorgan failure, and sometimes even death in humans. The lipopolysaccharide layer of Gram negative bacteria is pyrogenic, and when the origin is bacterial the pyrogen is called an endotoxin.\u00a0 Endotoxins are highly stable, resistant to heat and dessication, and are released and remain present long after bacteria are killed.\u00a0 We confirm the absence of endotoxin in compounded sterile products by following methods outlined in USP <85> Bacterial Endotoxin Test<\/a>.<\/p>\n The use of clean materials is necessary to ensure that there is no endotoxin in the finished product.\u00a0 These materials not only include the water, excipients and API\u2019s that make the CSP itself but also the glass and metal used to mix, distribute and contain it.<\/p>\n Glass and metal vectors are rendered pyrogen free by heating them in a dry heat oven.\u00a0 A typical depyrogenation cycle is 250\u00b0C for 30 minutes.\u00a0 The effectiveness of deyprogenation is not just a factor of time and temperature but also dependent upon load patterns, size of glassware, consistency of heat generation and other factors.\u00a0 USP <797> Pharmaceutical Compounding \u2013 Sterile Preparations<\/a>, requires that the effectiveness of the dry heat depyrogenation be established initially upon cycle inception and verified annually.\u00a0 Efficacy is verified through the use of Endotoxin Challenge Vials (ECV), to demonstrate that the cycle is capable of achieving a ><\/u> 3 log reduction in endotoxins.<\/p>\n The ECVs are placed throughout the oven load, focusing on cold spots that were uncovered during temperature mapping.\u00a0 These ECV are typically glass vials spiked with about 10 4<\/sup> Endotoxin Units per vial and allowed to dry.\u00a0 At the end of the cycle, once the glassware has cooled, the ECV are recovered and assayed for endotoxin.<\/p>\n Endotoxin recovery from the ECV is a critical step and should not be attempted by a laboratory until it has validated the recovery process.\u00a0 Atlas Analytical provides pharmacies with validated ECV\u2019s in a variety of formats, most common is the 10 mL vial.\u00a0 We have demonstrated stability and recovery efficiency on the lots we produce.<\/p>\n Atlas Analytical <\/a>offers its clients a turnkey solution.\u00a0 We ship an ECV kit to the pharmacy, complete with cooler, gel pack, handling instructions and certificates of analysis.\u00a0 The pharmacy processes the ECVs according to their procedure and returns them to us for evaluation.\u00a0 We provide a report detailing control and processed values and log reduction after processing.\u00a0 (610) 866-7272<\/p>\n Some pharmacies have been asked to demonstrate the shelf life of their depyrogenated glassware.\u00a0 We can use our extraction techniques on glassware that has been held for periods of time, to determine if glassware packaging adequately prevents endotoxin contamination over time.<\/p>\n Atlas Analytical<\/a> is an FDA registered cGMP facility located in the Tampa Bay region of Florida.\u00a0 Atlas Analytical supports compounding pharmacies with complete chemistry, microbiology and consulting services.<\/p>\n CALL OR EMAIL FOR OVEN VALIDATION KIT<\/p>\n (352) 610-4367\u00a0 \u00a0info@atlasanalytical.com<\/a><\/p>\n![\"depyrogenation](\"http:\/\/focus-lab.com\/blog\/wp-content\/uploads\/2020\/02\/endotoxin-300x277.jpg\")
![\"\"](\"http:\/\/focus-lab.com\/blog\/wp-content\/uploads\/2020\/02\/horseshoe-crab-1255213-300x203.jpg\")
<\/p>\n