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 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

As pain specialists, you’re entrusted to deliver relief that is both effective and safe, and you understand that a single medication of questionable

Hartley Standard

As pain specialists, you’re entrusted to deliver relief that is both effective and safe, and you understand that a single medication of questionable

Why it Matters

As pain specialists, you’re entrusted to deliver relief that is both effective and safe, and you understand that a single medication of questionable

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 (ULPA) filters to provide Class-4 air quality. This superior level of filtration exceeds industry 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

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

Hartley Standard

Exceeding USP <797>. Our HEPA filtration system currently supplies 160+ air changes per hour.

Why it Matters

Enhancing the number of air changes significantly reduces contaminates in the air which ultimatle reduces risk

Industry Standard

No established requirement

Hartley Standard

Hartley Medical's compounding facilities, systems, and processes have been inspected and certified by the National Association of Boards of Pharmacy (NABP)

Why it Matters

Experiencing multiple agencies surveys or inspections demonstrates competence.

Industry Standard

Cleanroom facilities continuously monitored for pressure differential and documentation of daily review (i.e. Daily Log). Daily temperature moniotring or use continuous device

Hartley Standard

Cleanroom facilities continuously monitored for temperature and pressure. Daily log created.

Why it Matters

Any deviation, at night or weekend are discovered and remedied to ensure optimal compounding environment

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

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.

Our People

It is the dedicated professionals who drive Hartley Medical's success. From experienced pharmacists and skilled technicians to dedicated account executives, our team is committed to excellence in patient care. With expertise, compassion, and a shared commitment to quality, we work collaboratively to deliver personalized solutions and exceptional service.

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Training & Evaluation

Industry Standard

As pain specialists, you’re entrusted to deliver relief that is both effective and safe, and you understand that a single medication of questionable

Hartley Standard

As pain specialists, you’re entrusted to deliver relief that is both effective and safe, and you understand that a single medication of questionable

Why it Matters

As pain specialists, you’re entrusted to deliver relief that is both effective and safe, and you understand that a single medication of questionable

Industry Standard

Personnel must undergo aseptic manipulations competency evaluation at least every 6 months for or more frequesntly depending on the type of compounding performed.

Hartley Standard

Hartley Medical staff perform media fills monthly.

Why it Matters

This is another layer of monitoring employees to mitigate risk and demonstrates aseptic competencies.

Industry Standard

Fingertip testing shall be performed with every aseptic manipulations competency evaluation; at least every 6 months for or more frequesntly depending on the type of compounding performed.

Hartley Standard

Finger tip assessment performed daily, under dynamic conditions.

Why it Matters

Hartley Medical exceeds this requirement by performing fingertip testing on a daily basis under dynamic conditions.

Industry Standard

At least every 12 months must demonstrate ability to achieve and maintain sterility.

Hartley Standard

Each compounding professional must prepare three different sterile preparations, which are tested for sterility, endotoxins, and potency prior to release for patient compounding.

Why it Matters

This provides greater documentation to substantiate that staff can compound sterile preparations aseptically and accurately.

Industry Standard

No established requirements

Hartley Standard

Verification of all compounding systems and processes by independent internal quality assurance specialists, with built in redundancies.

Why it Matters

Our Processes

Sterile compounding demands disciplined procedures for producing and examining the purity and accuracy of preparations. Explore the meticulous processes that underpin our operations, from rigorous quality assurance protocols to efficient workflow management. At Hartley Medical, we prioritize precision, consistency, and compliance at every step of the compounding and dispensing process. Our streamlined processes ensure accuracy, reliability, and timely delivery. 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

As pain specialists, you’re entrusted to deliver relief that is both effective and safe, and you understand that a single medication of questionable

Hartley Standard

As pain specialists, you’re entrusted to deliver relief that is both effective and safe, and you understand that a single medication of questionable

Why it Matters

As pain specialists, you’re entrusted to deliver relief that is both effective and safe, and you understand that a single medication of questionable

Industry Standard

Personnel must undergo aseptic manipulations competency evaluation at least every 6 months for or more frequesntly depending on the type of compounding performed.

Hartley Standard

Hartley Medical staff perform media fills monthly.

Why it Matters

This is another layer of monitoring employees to mitigate risk and demonstrates aseptic competencies.

Industry Standard

Fingertip testing shall be performed with every aseptic manipulations competency evaluation; at least every 6 months for or more frequesntly depending on the type of compounding performed.

Hartley Standard

Finger tip assessment performed daily, under dynamic conditions.

Why it Matters

Hartley Medical exceeds this requirement by performing fingertip testing on a daily basis under dynamic conditions.

Industry Standard

At least every 12 months must demonstrate ability to achieve and maintain sterility.

Hartley Standard

Each compounding professional must prepare three different sterile preparations, which are tested for sterility, endotoxins, and potency prior to release for patient compounding.

Why it Matters

This provides greater documentation to substantiate that staff can compound sterile preparations aseptically and accurately.

Industry Standard

No established requirements

Hartley Standard

Verification of all compounding systems and processes by independent internal quality assurance specialists, with built in redundancies.

Why it Matters

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