Automated endotoxin testing program for high-risk-level compounded sterile preparations at an institutional compounding pharmacy

American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists
James F CooperDonald Smith

Abstract

An endotoxin testing program for high-risk-level compounded sterile preparations (CSPs) was verified for compliance with finished-preparation release test requirements of United States Pharmacopeia chapter 797 and implemented at an institutional compounding pharmacy. An efficient bacterial endotoxins test (BET) was sought for finished-preparation testing of high-risk-level CSPs prepared in batches of > or =25 units. An automated photometric BET was selected that utilized dried, pre-calibrated Limulus amebocyte lysate cartridges rather than liquid reagents and standards. Endotoxin testing began after verifying test conditions for each CSP and approving a standard procedure for training BET analysts and maintaining uniform methodology. A pharmacopeial endotoxin limit and limit dilution were determined for each CSP. The majority of CSPs included patient-controlled analgesia solutions, epidural analgesia solutions, and cardioplegia solutions. BET conditions were verified by measuring the recovery of endotoxin positive controls in sterile water dilutions for each CSP. Cardioplegia solutions met an endotoxin limit of 0.5 EU/mL, and epidural bags had an intrathecal endotoxin limit of 0.05 EU/mL. All other CSPs had detection limits wel...Continue Reading

References

Feb 1, 1995·The Annals of Thoracic Surgery·L A RobinsonT A Galbraith
Dec 31, 2002·American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists·James F Cooper, Laura A Thoma

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Citations

Aug 19, 2015·The Journal of Veterinary Medical Science·Yohko SuzukiJeffrey Lakritz
Mar 20, 2015·The Journal of Veterinary Medical Science·Kazuyuki SuzukiJeffrey Lakritz
Jan 29, 2013·Pain Practice : the Official Journal of World Institute of Pain·Joseph V PergolizziJo Ann LeQuang
Feb 24, 2016·The Journal of Veterinary Medical Science·Yukari SotohiraMitsuhiko Asakawa
May 10, 2017·The Journal of Veterinary Medical Science·Yukari SotohiraMitsuhiko Asakawa
Mar 27, 2018·Gut·UNKNOWN European Study Group on Cystic Tumours of the Pancreas
Jun 14, 2019·The Journal of Veterinary Medical Science·Yasunobu NishiKazuyuki Suzuki
Nov 25, 2018·Neuropharmacology·Jelena TosicVladimir Trajkovic

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