USP 797 and USP 800
Air Pressure Compliance

USP 797 and USP 800 Air Pressure Compliance

Regulatory compliance for pharmacies is evolving, and pharmacy leaders need to be ready for greater focus on air pressure compliance. This article will highlight how the USP is shifting and what steps pharmacists can take to be prepared when the Board of Pharmacy or Joint Commission auditors arrive. 

USP 707 and USP 800 are two sets of regulations that have been developed by the United States Pharmacopeia (USP) to guarantee optimal safety and sterility in a number of pharmaceutical and healthcare facilities. 

First of all, USP 797 outlines a set of guidelines on compounding sterile preparations. This simply refers to the preparation of medicine in a sterile setting to deter contamination. 

USP 797 includes various safety protocols for facility design, air quality, staff requirements, and other factors impacting their sterility and safety.

As such, air pressure regulation and control is a very key factor in this regulation as is the case with USP 800. 

USP 797 stipulates that compliant facilities must have a positive pressure environment. In other words, the air pressure within such a facility should be higher than that of its exterior.  This is normally achieved with a sophisticated HVAC controls system like Phoenix Controls or Distech.

These industry-leading controls providers have decades of experience in managing airflow to create the ideal pressure conditions to maximize safety by reducing the risk of hospital-acquired infections.  

A positive pressure environment helps deter contaminants from gaining entry into sterile compounding facilities through the doors, windows, or any other opening. Contaminants include mold, spores, bacteria, viruses, or any other element that may cause harm to a patient but is invisible to the naked eye. 

USP 800 involves itself in guaranteeing the safe handling of hazardous drugs (HDs). 

According to the National Institute for Occupation Safety and Health (NIOSH), HDs are the variety that exhibits any of the following characteristics: 

• Carcinogenicity
• teratogenicity
• reproductive toxicity
• organ toxicity 
• genotoxicity
• or drugs with a toxicity profile identified as hazardous 

USP 800 guidelines have been designed to ensure the proper handling of these kinds of drugs in order to protect both healthcare professionals and patients from exposure. Just like USP 797, USP 800 has very specific stipulations for air pressure control.

However, unlike the former, it requires a negative-pressure environment. In other words, the air pressure within a compliant facility must be lower than that of the exterior.  

This goes a long way in ensuring that hazardous drugs can’t penetrate into other areas in such facilities and potentially expose those who are there. 

As it is, USP 797 and USP 800 are extremely important regulations for guaranteeing the sterility and safety of pharmaceutical and healthcare facilities and compliance is mandatory in the US.

Organizations like Sonicu have extensive experience helping healthcare, life science, food production, and even advanced manufacturing facilities monitor their air pressure conditions to maximize safety and stay compliant with regulators. 

Our simple and affordable hardware coupled with the intuitive cloud-based software is trusted by hundreds of organizations thanks to its user-friendly ability to deliver immediate results and enduring return on investment. 

You can learn more about how our software helps compliance professionals in these case studies:

Boy Scouts: Protecting Campers from a Temperamental Walk-in Cooler

Problem: An aging walk-in cooler failed at a remote campground in Ohio, causing significant food loss and logistical challenges for the Boy Scouts.

Solution: Sonicu provided a system that was easy to install, connected with a mobile app, affordable for a non-profit budget, and automated the required manual logging.

Hamilton County, Indiana Health Department: Vaccine Monitoring

Problem: The need to protect vaccines from temperature excursions and meet state compliance requirements with an outdated analog system.

Solution: Implemented a new monitoring system with a mobile app and robust support, enhancing the management of remote COVID-19 vaccination programs.

Katherine Shaw Bethea Hospital: Pharmacy Monitoring for Remote Clinics

Problem: After a freezer failure led to a loss of drugs, the pharmacy director needed a reliable and simple monitoring solution for multiple remote clinics.

Solution: Adopted Sonicu's temperature monitoring system, enhancing audit readiness and deploying a mobile app to employees across clinics in Illinois.

Facilities where USP 797 and USP 800 Air Pressure Compliance is Required

There are many healthcare, pharmaceutical, and research facilities that must adhere to the rigors of USP 797 and USP 800 and/or other state or federal guidelines around air pressure integrity. Regulators are regularly citing organizations that fail to comply with these guidelines, including: 

• Hospitals and other healthcare centers like clinics and outpatient facilities which perform sterile compounding including using chemotherapy and other hazardous drugs have to ensure compliance with USP 797 and USP 800 to protect both patients and healthcare professionals from harm 
• Long-term care facilities including nursing homes and assisted living facilities that administer medicine to patients requiring sterile compounding or handling of hazardous drugs must comply with USP 797 and USP 800 to ensure patient safety. 
• Specialty pharmacies that handle and dispense hazardous drugs like chemotherapy medication and biologics have to comply with these regulations fully. 
• Research facilities where hazardous drugs are handled and manipulated including in animal and in-vitro studies must comply with USP 797 and USP 800 to protect personnel and preserve data integrity.

These case studies highlight a handful of businesses that turned to Sonicu for their air pressure monitoring needs: 

• Hancock Regional Hospital 
  https://www.sonicu.com/hancock-regional-hospital-case-study
• Hendricks Hospital 
  https://www.sonicu.com/hendricks-regional-hospital-case-study
• Exide Technologies: Air Pressure Differential for Construction 
  https://www.sonicu.com/exide-case-study

Air Pressure Monitoring Systems for USP 797 and USP 800 Compliance

There are numerous room pressure monitoring systems that are used to ensure compliance with USP 797 and USP 800. This includes 

• differential pressure sensors
• airflow sensors
• temperature and humidity sensors 
• and gas detection sensors

Compliance, infection control, risk management, and facilities professionals can pick the one that suits their individual needs and the particular compliance requirements of the facility in question. 

Taking the example of differential pressure monitoring systems, these are utilized to take readings of the air pressure differential between adjacent spaces within a facility. 

As previously noted, in USP 797-compliant facilities, positive pressure must be maintained to deter the entry of contaminants into that space. 

In USP 800-compliant facilities, negative pressure must be maintained to prevent hazardous drugs from gaining entry into other spaces. 

Should the pressure differentials at any time fall beyond the established limits,  these sensors can then alert the staff. Wireless, remote, and autonomous monitoring systems like Sonicu can also show trends over time that help facilities teams identify performance issues in their climate control system that need to be addressed. All at a fraction of the cost of expensive systems available from other systems. 

This not only prevents contamination and exposure risks, but ensures that the facility in question maintains compliance at all times. 

Many Sonicu customer conduct their own installation of the monitoring systems and work with our customer success managers to tailor their zones, groups and alert configurations to meet the exact needs of their organization. 

These brief videos show how easy it can be to install the ambient temperature and humidity as well as air pressure differential sensors. 

Installation Video: 

How easy it can be to install cold storage monitoring 

Installation Video: 

How to install an ambient temp and humidity monitoring kit

Cloud-based Air Pressure Monitoring Systems for USP 797 and USP 800 Air Pressure Compliance

Cloud-based solutions like Sonicu are widely acclaimed for offering more advantages to pharmaceutical and healthcare facilities, which must ensure compliance with USP 797 and USP 800. 

In the first place, this variety of air pressure monitoring sensors enables facility managers and staff to be in a position of monitoring pressure differentials and receive alerts on the same in real-time from anywhere at any time. 

This is particularly useful for multi-site facilities or those members of staff who might need to keep tabs on pressure differentials while they are offsite. 

The historical data reporting can also help organizations better understand how their climate control systems are performing over time. 

These systems also facilitate real-time data logging of pressure differentials. 

This enables the facility’s personnel to rapidly determine and resolve any deviations or issues that may arise. In turn, this is essential in helping greatly reduce downtime, and more importantly, avert any compliance violations. 

Thirdly, these systems store pressure differential data over time. 

This certainly means they can deliver precise analytics and reporting capabilities on patterns and trends. Facility managers can then determine areas of concern or improvement to optimize their processes for compliance.

Even better, these solutions may be scaled up or down to suit the unique requirements of the facility. 

This may prove to be invaluable for facilities that are growing or changing or those which need to rapidly adapt to changing compliance requirements.

These systems may be easily integrated with other systems or platforms including building automation systems. In turn, this streamlines workflows and boosts efficiency.

Last but not least, cloud-based room pressure monitoring systems eliminate manual processes and deliver automated compliance reporting capabilities. 

Conclusion: Why Monitoring is Essential for USP 797 and USP 800 Compliance 

USP 797 and USP 800 air pressure compliance is essential to ensure the sterility of compounding facilities and eliminate the risks of exposure to hazardous drugs by patients and healthcare workers. 

There are many air pressure monitoring sensors to be had in the market, but investing in Sonicu sensors will deliver many essential characteristics, including 

• Affordability: Far less costly than many enterprise solutions 
• Simplicity: From installation and configuration to usage and support 
• Easy to scale across an organization

These systems not only eliminate manual processes, but also provide real-time alerts and data logging capabilities for analytics and reporting. While, at the same time, streamlining workflows and improving efficiency. 

You can learn more about how our software helps compliance professionals in these case studies:

Nomi Health: Fast installation, simple deployment

Problem: A rapidly growing healthcare technology startup needed to scale quickly and monitor cold chain storage devices nationwide.

Solution: Implement Sonicu's temperature probes with a central command center for enterprise visibility, allowing fast and easy training for reps across the country.

CleanSlate: Addiction Treatment Centers

Problem: A Boston-based addiction treatment center needed an affordable and simple monitoring solution for their facilities across the United States.

Solution: Choose Sonicu for its affordability and ease of self-installation, supporting the center's mission to manage growth and improve service delivery nationwide.

UHS: South Texas Health System, Edinburg

Problem: Fire alarm testing disrupted the environmental conditions in Operating Rooms, causing compliance and operational challenges.

Solution: Implemented Sonicu's environmental monitoring system, which allowed the facility manager to monitor conditions via a mobile app and resolve issues with the HVAC system triggered by fire alarms.

Why Automated Monitoring:

Hospitals have pharmaceuticals, vaccines, and other temperature-sensitive assets needing protection. These assets becoming too hot or cold can cost thousands and put patients at risk. Regulatory agencies require many departments to maintain records of temperature, air pressure humidity, and other settings throughout the hospital. This can add stress and tie up staff resources. 

Current Methods

Today, many facilities rely heavily on manual processes to maintain records and ensure compliance. This method can be labor-intensive and error-prone.  Data-Loggers are prevalent but still require someone to visit each storage area every day. 

Loggers assist with compliance but rarely identify problems until it’s too late.

Sonicu Solution

Sonicu’s solution is a fully scalable, cloud-based solution that automates your monitoring processes across all departments. With 24/7/365 continuous monitoring, we help you:

What We Offer

Sonicu provides monitoring for Temperature, Humidity, Sound, Pressure, Power, and a host of other points. Our flexible sensors can transmit data via 

• Wi-Fi
• 900 MHz 
• or Cellular

And also features “plug and play” implementation. 

SoniCloud software platform provides alarm handling, real-time and historical data views, and advanced algorithms to detect and alert potential equipment failure.

We help you stay compliant with Joint Commission, VFC, CDC, USP, FDA, and other state and federal regulatory agencies. 

Our system provides 24/7/365 monitoring at desired intervals. Each probe comes with a NIST certificate of traceability and is ISO-compliant. Our re-calibration program easily and cost-effectively keeps you compliant for years to come.  

“Sonicu has been a powerful tool to identify which units are behaving out of spec and get our team
to fix them before we have a serious issue.”
Tim Livesay, Director, Hancock Regional Hospital Pharmacy Director