PURPOSE: 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. SUMMARY: 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 well within compendial requirements. All test results collected during the first year of implementation were pyrogen free, which provided compelling evidence of appropriate application of aseptic technique, appropriate selection of equipment and methods, and the nonpyrogenic quality of powders used in compounding at the pharmacy. CONCLUSION: A photometric endotoxins test that met all requirements of the BET was verified and implemented for high-risk-level CSPs prepared in an institutional pharmacy.
PURPOSE: 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. SUMMARY: 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 well within compendial requirements. All test results collected during the first year of implementation were pyrogen free, which provided compelling evidence of appropriate application of aseptic technique, appropriate selection of equipment and methods, and the nonpyrogenic quality of powders used in compounding at the pharmacy. CONCLUSION: A photometric endotoxins test that met all requirements of the BET was verified and implemented for high-risk-level CSPs prepared in an institutional pharmacy.