Ensuring Compliance with USP <797> and USP <800>: Why They Matter and How Eurofins Built Environment Testing Can Help

Creating safe environments in pharmaceutical compounding and hazardous drug handling is critical to protecting both patients and healthcare workers. While the standards set by the United States Pharmacopeial Convention - USP <797> and USP <800> - are often mentioned together, they focus on very different goals.

USP <797> is about ensuring sterile preparations for patient safety, while USP <800> prioritizes worker safety when dealing with hazardous drugs (HDs). At Eurofins Built Environment Testing, we help facilities meet the requirements of both standards with tailored testing, training, and environmental monitoring solutions.

Let’s break down what each standard means - and why they’re so important.

USP <797>: Keeping Medications Sterile for Patient Safety

When it comes to sterile compounding, precision and cleanliness aren’t optional - they’re the difference between safety and contamination. USP <797> sets clear requirements for how compounded medications must be prepared to ensure they’re free of microbial contaminants.

To achieve this, compounding facilities need to maintain strict environmental conditions, test their personnel, and consistently monitor cleanroom performance.

What does this look like in practice?

Compounding areas are held to specific ISO classifications:

• In an ISO Class 5 cleanroom, where the actual compounding happens, the air must contain no more than 1 viable colony-forming unit (cfu) per cubic meter.
• Supporting areas, like ISO Class 7, allow slightly higher levels, but they still need rigorous testing to stay within limits.

To keep everything under control, cleanroom surfaces and air must be tested regularly, and the people doing the work need to be fully trained and monitored. This includes gloved fingertip tests (GFT), where personnel prove they can properly maintain sterility, and media fill tests, which simulate the compounding process to ensure aseptic technique.

At Eurofins Built Environment Testing, we make it easier for facilities to meet USP <797> by offering comprehensive testing solutions, including:

• Air and surface microbial testing to confirm cleanroom compliance.
• Tools like the Enverify™ Surface Sampling Competency Test Kit to verify personnel performance.
• Support for media fill and GFT testing to ensure your team is ready to meet the challenge of sterile compounding.

With Eurofins Built Environment Testing’ support, your compounding facility can confidently deliver sterile medications, keeping patients safe and operations fully compliant.

USP <800>: Protecting Healthcare Workers from Hazardous Drug Exposure

On the other side of the coin is USP <800>, which is all about safeguarding people who work with hazardous drugs (HDs). These drugs, while essential in healthcare, can cause serious health risks if workers are exposed - including cancer, reproductive issues, and organ damage.

Pharmacists, nurses, and custodial staff are among those most at risk. Even small amounts of HD residues on surfaces or particles in the air can be harmful, which is why USP <800> sets strict guidelines for handling, cleaning, and monitoring.

How do facilities stay compliant?

It starts with regular testing to assess and minimize exposure risks. This means:

• Surface residue testing to ensure hazardous drugs aren’t lingering on work surfaces, equipment, or floors.
• Airborne particle sampling to evaluate whether HDs are escaping into the air and being inhaled by workers.

Facilities must also implement strict controls - like proper PPE, specialized engineering systems, and rigorous cleaning protocols - to keep exposure levels as low as possible.

Eurofins Built Environment Testing helps facilities meet these standards by offering tailored testing solutions, including:

• Monitoring for HD residues on surfaces to confirm that cleaning processes are effective.
• Airborne exposure assessments to identify risks and verify controls are working.
• Customized protocols to address unique facility challenges and needs.

The goal of USP <800> is simple but vital: to protect the people who handle hazardous drugs every day. Eurofins Built Environment Testing works alongside you to ensure your team is safe and your operations meet every requirement.

USP <797> vs. USP <800>: Two Standards, Two Purposes

While both standards aim to improve safety, their focus is very different:

• USP <797> ensures that sterile medications are free from contamination to protect patients.
• USP <800> focuses on reducing hazardous drug exposure to protect healthcare workers.

From air and surface sampling to personnel testing, Eurofins Built Environment Testing provides the tools, expertise, and support you need to meet both standards with confidence.

Why Partner with Eurofins Built Environment Testing?

At Eurofins Built Environment Testing, we understand the challenges of maintaining compliance in fast-paced healthcare and pharmaceutical environments. Our experienced teams and state-of-the-art facilities provide reliable testing and monitoring solutions for both USP <797> and <800>.

With Eurofins Built Environment Testing on your side, you can:

• Ensure your compounded medications are prepared safely and compliantly.
• Protect your healthcare workers from hazardous drug risks.

We’re here to make compliance straightforward, effective, and stress-free - so you can focus on what matters most: delivering safe, high-quality care.