The Importance of Endotoxins and Bacterial Endotoxin Testing (BET), Part II

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Introduction

At Hartley Medical Pharmacy, we place a strong emphasis on Bacterial Endotoxin Testing (BET) to ensure the safety and efficacy of our parenteral compounded solutions. By 2003, my extensive experience with intrathecal drug therapy led me to enhance our endotoxin testing capabilities significantly. This article delves into the reasons behind our rigorous BET practices and the sophisticated equipment we use.

Advanced Endotoxin Testing with PYROSKINETIX

The PYROSKINETIX FLEX Instrument

To elevate our testing standards, I invested in the PYROSKINETIX FLEX instrument from Associates of Cape Cod. This sophisticated device not only detects the presence of endotoxins, but also quantifies their levels with high precision. Unlike its predecessors, PYROSKINETIX FLEX requires a standard curve of six data points and submits samples in duplicate, both spiked and unspiked, to ensure accurate results.

Superior to Generic Testing Kits

While many contract labs and pharmacists use simplified endotoxin testing kits, these generic versions often do not adhere to US guidelines and may yield false negatives. In contrast, PYROSKINETIX FLEX offers a much more refined and reliable testing method, which is why we chose to invest in this advanced equipment.

Commitment to High Standards

Why We Invested in Advanced Equipment

So, why purchase expensive, non-mandatory equipment. The answer is simple: it was the right thing to do. This investment allowed us to enhance our testing program, enabling us to test more frequently, extensively, and effectively. Our BET program operates well within accepted safety standards, with a detection level improved from 0.03 Endotoxin Units (EU) per milliliter to an impressive 0.001 EU per milliliter.

Rigorous Testing Practices

Our commitment to rigorous testing practices means that we perform BET more frequently and with greater accuracy than many other compounding pharmacies. This dedication ensures that our intrathecal drugs meet the highest safety standards, helping everyone without causing harm.

Proud of Our Program

Expertise and Training

We are particularly proud of our endotoxin testing program and the highly trained technicians who run it. Our staff's expertise, combined with our advanced equipment, allows us to deliver the safest possible intrathecal drugs to our patients.

Ensuring Safety and Efficacy

Hartley's priority is to ensure that its compounded solutions are thoroughly tested for endotoxins, providing peace of mind to both clinicians and patients. Our advanced BET practices are a testament to our commitment to safety and quality in intrathecal drug therapy and reflects our unwavering commitment to patient safety and high-quality pharmaceutical care. By utilizing the PYROSKINETIX FLEX instrument and adhering to stringent testing protocols, we ensure that our intrathecal drugs are safe and effective. For more information on our testing practices and drug reviews, visit Hartley Medical's Knowledge Center or contact our team, directly.