Setting the Standard

What We Do

Operations developed to deliver the highest standards in sterile compounding

Our Pharmacy

As pain specialists, you’re entrusted to deliver relief that is both effective and safe, and you understand that a single medication of questionable quality can be the difference between successful outcomes and treatment failure. Hartley Medical embraces the exactness that is inherent in compounding intrathecal preparations. Our state-of-the-art pharmacy and equipment provide a compounding environment that performs at levels that exceed industry standards, delivering on our promise to do more for patients and pain physicians across the United States.
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Optimum Sterile Preparation Area

Industry Standard

Laminar-air-flow workbenches (LAFWs) w/ HEPA filters to produce Class-5 air quality for sterile compounding

Hartley Standard

Hartley LAFWs utilize ULTRA-low-particle air filters to provide Class-4 air quality. This superior level of filtration exceeds standards by a factor of 10.

Why it Matters

Greater filtration reduces possible contamination for particulates and microbials. For reference: the smaller the Class number, the higher the air quality.

Industry Standard

Buffer Room (where sterile compounding occurs) to maintain Class 7 air-quality conditions.

Hartley Standard

Hartley Medical maintains a Class 6 buffer room, exceeding USP <797> standards by a factor of 10

Why it Matters

A higher room-air quality reduces possible contamination from particulates and microbials, mitigating risk to patient safety.

Industry Standard

The sterile preparation areas must contain an adequate HEPA-filtered air system that changes out the air in the room a minimum of 30 times per hour.

Hartley Standard

Hartley Medical implements a HEPA filtration system that currently changes room air 180+ per hour.

Why it Matters

From a quality standpoint, 30 air changes per hour is very effective. However, enhancing the number of air changes significantly reduces contaminates in the air. Another layer of quality controls to minimize risk.

Industry Standard

Tempora eum minima praesentium autem sit omnis consequatur veritati

Hartley Standard

Quisquam harum et unde. Amet dicta minima optio non et aspernatur esse perspici

Why it Matters

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Our People

Preparing medications in a manner that eliminates potential contamination is critical in the process to ensure patient safety and the effectiveness of their medications. Proper training in aseptic technique is essential for our employees who are involved in sterile compounding. However, even with the best training, it is possible for individuals to become complacent or to develop bad habits over time. Hartley Medical has invested back into our operations, through additional equipment, staff, and processes to give us the ability to conduct ongoing individual and team assessments not currently addressed by industry standards in many facets, including random sampling to test, in our own facility lab, for sterility, endotoxins, and accuracy.
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Training & Evaluation

Industry Standard

Laminar-air-flow workbenches (LAFWs) w/ HEPA filters to produce Class-5 air quality for sterile compounding

Hartley Standard

Hartley LAFWs utilize ULTRA-low-particle air filters to provide Class-4 air quality. This superior level of filtration exceeds standards by a factor of 10.

Why it Matters

Greater filtration reduces possible contamination for particulates and microbials. For reference: the smaller the Class number, the higher the air quality.

Industry Standard

Buffer Room (where sterile compounding occurs) to maintain Class 7 air-quality conditions.

Hartley Standard

Hartley Medical maintains a Class 6 buffer room, exceeding USP <797> standards by a factor of 10

Why it Matters

A higher room-air quality reduces possible contamination from particulates and microbials, mitigating risk to patient safety.

Industry Standard

The sterile preparation areas must contain an adequate HEPA-filtered air system that changes out the air in the room a minimum of 30 times per hour.

Hartley Standard

Hartley Medical implements a HEPA filtration system that currently changes room air 180+ per hour.

Why it Matters

From a quality standpoint, 30 air changes per hour is very effective. However, enhancing the number of air changes significantly reduces contaminates in the air. Another layer of quality controls to minimize risk.

Industry Standard

Tempora eum minima praesentium autem sit omnis consequatur veritati

Hartley Standard

Quisquam harum et unde. Amet dicta minima optio non et aspernatur esse perspici

Why it Matters

Et labore ullam quia ut ipsa ut. Occaecati harum qui accusantium architecto. Iste qui ratione sed cupiditate quasi. Harum velit

Our Processes

Sterile compounding demands disciplined procedures for producing and examining the purity and accuracy of preparations. Hartley Medical employs in-house quality assurance and control specialists and equipment to ensure the tightest controls over our production processes. As a result, we’re able to test our medications, facilities, and compounding team more often and more thoroughly than any other organization in the industry. Demanding more from our team and clean rooms gives us the confidence of knowing our intrathecal medications are safe. As a patient or physician, you can be sure that anything that can be done to guarantee the highest level of quality, is being done.
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Testing

Industry Standard

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Hartley Standard

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Why it Matters

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Industry Standard

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Hartley Standard

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Why it Matters

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Industry Standard

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Hartley Standard

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Why it Matters

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Industry Standard

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Hartley Standard

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Why it Matters

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Why It Matters?

The optimal sterile compounding of intrathecal medications requires superior performance. Ensuring the safety of our therapeutics through highly qualified pharmacists and technicians, as well as the most advanced facilities and technology, is critical to your patients' health and the success of targeted drug therapy.

Greater Control
Greater Safety
Greater Peace of Mind