For hospital pharmacies preparing compounded sterile preparations, maintaining a controlled and properly designed environment is critical to patient safety. USP <797> establishes standards for the preparation of compounded sterile preparations (CSPs), helping pharmacies minimize the risk of contamination and maintain the quality of sterile medications.
But USP <797> compliance isn't simply about what happens during the compounding process. **The facility itself plays an important role.
What Is USP <797>?
USP <797> is a set of standards that establishes minimum requirements for the preparation of compounded sterile preparations. These standards address areas such as personnel training and competency, facility and engineering controls, environmental monitoring, testing, and quality assurance.
For a hospital pharmacy, this can apply to sterile medications prepared for patients, including IV medications and other compounded sterile preparations.
The purpose is straightforward: help protect patients by reducing the risk of contamination and supporting the quality and safety of compounded sterile preparations.
The current revised USP <797> became official on November 1, 2023, making it increasingly important for hospitals to understand how their facilities and processes align with the applicable requirements.
Why Does USP <797> Matter?
Consider what happens inside a hospital pharmacy. Medications may be prepared for direct administration to patients, sometimes through intravenous routes.
Because these preparations can bypass many of the body's natural defenses, controlling the environment in which they are prepared is essential.
USP <797> addresses much more than simply how a pharmacist or technician prepares a medication. It considers the broader system surrounding sterile compounding, including:
* Personnel training and competency
* Facility design
* Engineering controls
* Environmental monitoring
* Cleaning and contamination control
* Testing and certification
* Quality assurance
This means that maintaining a sterile compounding environment requires coordination between pharmacy operations, facility design, engineering, testing, and ongoing maintenance.
Why Does Facility Design Matter?
A compliant sterile compounding environment cannot simply be created by putting a HEPA filter into an ordinary room.
The facility must be thoughtfully designed around the pharmacy's processes and applicable requirements.
Important considerations can include:
-Airflow
Controlled airflow helps maintain the appropriate environmental conditions and reduce the movement of contaminants within the facility.
-Pressure Relationships
The relationship between rooms and spaces can be an important part of contamination control. Proper pressure differentials help control the movement of air between areas.
-Environmental Conditions
Temperature, humidity, and other environmental parameters need to be appropriately controlled and monitored for the facility's intended use.
-Personnel Flow
How pharmacists and technicians enter, gown, and move through controlled areas should be considered during the design process.
- Material and Product Flow
Supplies, materials, and compounded preparations need to move through the facility in a way that supports contamination-control strategies.
-Surfaces and Finishes
Walls, floors, ceilings, work surfaces, and other materials should be selected and constructed to support cleaning, durability, and contamination control.
-Engineering Controls
The facility's engineering systems and equipment must work together to support the intended sterile-compounding environment.
Good cleanroom design starts with understanding the process that will take place inside it.
Building the Cleanroom Is Only the Beginning
One of the most important distinctions for hospital facilities is that constructing a cleanroom does not automatically demonstrate that the environment is performing as intended.
Once construction is complete, the facility may require testing and certification to verify that critical environmental parameters meet applicable requirements.Depending on the facility and its specific requirements, testing may include:
* HEPA filter integrity testing
* Airflow testing
* Airflow visualization and smoke studies
* Particle counting
* Pressure differential testing
* Temperature and humidity testing
* Recovery testing
* Environmental monitoring
These activities provide documented evidence that the controlled environment is functioning as designed and help facilities maintain their environmental state of control over time.
How Cleanetics Helps?
This is where Cleanetics takes a lifecycle approach to cleanroom services.
Rather than simply building a room and walking away, Cleanetics can support the facility throughout the cleanroom lifecycle—from the initial planning stages through ongoing operation and maintenance.
-Consultation
Cleanetics works with facility and pharmacy teams to understand their needs, processes, space requirements, and applicable considerations.
-Design
The cleanroom is designed around the facility's intended use, process flows, environmental requirements, and contamination-control strategy.
Construction
-Cleanetics provides cleanroom construction and renovation services designed to bring the planned environment to life.
Certification-
Following construction, Cleanetics provides testing and certification services to evaluate critical environmental parameters and verify performance.
Environmental Monitoring-
Cleanetics can help facilities continuously monitor important environmental conditions and maintain documented control over the environment.
Maintenance-
Ongoing preventative maintenance helps keep critical systems operating properly and supports the facility's continued state of control.
One Partner. Every Stage.
For hospitals planning a new sterile compounding pharmacy or considering a renovation, having multiple companies responsible for different pieces of the project can create unnecessary complexity.
Cleanetics' approach is designed to bring those services together
Design Build Certify Monitor Maintain
From the initial consultation to ongoing facility support, Cleanetics helps hospitals develop and maintain controlled environments designed around their sterile compounding needs.
Planning a USP <797> Facility?
Whether you're considering a new hospital pharmacy, renovating an existing sterile compounding space, or looking for ongoing cleanroom certification and environmental monitoring support, Cleanetics can help you understand the requirements and determine the right approach for your facility.
One partner. Every stage.
Cleanetics services are designed to support applicable USP <797> and other regulatory requirements. Facility compliance depends on the complete implementation of applicable standards, procedures, personnel practices, testing, and quality systems.