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

Area of Science:

• Pharmaceutical Compounding
• Microbiology
• Quality Control

Background:

• Compounded sterile preparations (CSPs) require rigorous testing to ensure patient safety.
• High-risk CSPs necessitate validated endotoxin testing to meet United States Pharmacopeia (USP) standards.
• Existing endotoxin testing methods may not be optimal for large-batch compounding.

Purpose of the Study:

• To verify and implement an efficient bacterial endotoxins test (BET) for high-risk CSPs.
• To ensure compliance with USP <797> finished-preparation release test requirements.
• To establish a reliable method for routine endotoxin testing in an institutional pharmacy.

Main Methods:

• An automated photometric BET utilizing dried Limulus amebocyte lysate cartridges was selected.
• Test conditions were verified for each CSP, including determination of pharmacopeial endotoxin limits and limit dilutions.
• Standard procedures for analyst training and methodology maintenance were approved.
• Endotoxin recovery was measured using positive controls in sterile water dilutions for each CSP.

Main Results:

• The automated BET met all pharmacopeial requirements for bacterial endotoxins.
• Specific endotoxin limits were met for cardioplegia (0.5 EU/mL) and epidural solutions (0.05 EU/mL).
• All CSPs demonstrated detection limits well within compendial requirements.
• The first year of implementation yielded exclusively pyrogen-free results.

Conclusions:

• A verified and implemented photometric endotoxins test provides an efficient method for high-risk CSPs.
• Pyrogen-free results confirm the effectiveness of aseptic techniques, equipment, and raw material quality.
• The validated BET ensures the safety and quality of compounded sterile preparations in institutional settings.