In 2012, a tragic outbreak of fungal meningitis linked to the New England Compounding Center (NECC) highlighted the devastating consequences of improper sterile compounding practices. Over 100 patients died, and hundreds more were injured due to contaminated steroid injections.
This incident underscores the importance of stringent adherence to sterile compounding protocols to ensure patient safety and prevent these kinds of catastrophic outcomes.
In addition, the owner and four former employees of NECC were convicted of federal criminal charges, which only further emphasizes the gravity of maintaining rigorous standards.
Is Your Pharmacy’s Cleanroom Compliant?
What is Sterile Compounding?
Sterile compounding, a specialized pharmacy practice focused on preparing injectable and infusible medications like IV meds, utilizes a sterile, controlled environment to eliminate biological contamination and ensure patient safety.It requires a cleanroom with regulated air quality, pressure, and temperature, along with strict staff hygiene and attire protocols. By maintaining these high standards, sterile compounding ensures that these medications are safe and effective for patients.
Examples of Sterile Compounding Preparation & Processes:
- Establishing the Beyond-Use Date (BUD): The BUD is the date after which a compounded sterile preparation (CSP) must not be used. It is determined based on the chemical stability and sterility of the preparation.
- Maintaining High Air Quality: This involves ensuring that the air quality in the compounding area meets ISO Class 5 standards or better.
- Prioritizing Facility Design: The design of the compounding area must include features that reduce the risk of contamination, such as HEPA filters and unidirectional airflow.
- Frequency of Monitoring the Environment: Environmental monitoring should be conducted regularly, with air sampling, surface sampling, and certification of the cleanroom environment at specified intervals.
- Key Components of a Sterile Compounding Program
Sterile compounding is a critical practice within pharmacy, allowing for the creation of customized medications for patients with specific needs. To ensure the safety and efficacy of these medications, a comprehensive program is essential. This program rests on three key pillars:
- Design and Functionality of Compounding Rooms: The physical environment where compounding occurs plays a vital role in maintaining sterility.
- Training and Competency of Personnel: A well-trained team is crucial for understanding and implementing proper aseptic technique.
- Common Governing and Accrediting Bodies: Following established guidelines and undergoing regular inspections ensures compliance with best practices.
Design and Functionality of Compounding Rooms
The design and functionality of compounding rooms are crucial to maintaining a sterile environment. The rooms must be equipped with proper HVAC systems that ensure consistent air quality, pressure, temperature, and humidity. Specific requirements include:
- Air Exchanges: The air must be turned over at least 30 times per hour.
- Humidity Control: Humidity should be kept below 60%. USP 4.2 facility design states that the cleanroom suite should be maintained at a temperature of 20 degrees Celsius or cooler and a relative humidity of 60% or below to minimize the risk of microbial proliferation and to provide comfortable conditions
- Temperature: The temperature should be maintained at less than 68 degrees Fahrenheit to inhibit bacterial growth.
- Monitoring: The compounding room must be tested every six months as required by USP 797 to ensure it’s functioning as intended and is compliant. Daily or continuous monitoring of temperature, humidity, and pressure is essential to keep track of environmental conditions.
Training and Competency of Personnel
Training is essential not only for the designated person overseeing the sterile compounding program but for the entire pharmacy compounding team. Comprehensive training programs should include:
- Initial Training: Covering the basics of sterile compounding, aseptic techniques, and the importance of maintaining a sterile environment
- Ongoing Competency Assessments: Regular evaluations to ensure that all personnel remain proficient in their skills
- Specialized Training for Designated Personnel: In-depth training on regulatory requirements, environmental monitoring, and quality assurance for the Designated Person who will be responsible for overseeing the entire operation
Common Governing and Accrediting Bodies
While USP 797 is the main guideline for sterile compounding, other governing and accrediting bodies provide additional recommendations and requirements. These include:
- The Joint Commission: The Joint Commission provides accreditation and emphasizes the importance of maintaining sterile compounding standards.
- Centers for Medicare & Medicaid Services (CMS): CMS offers guidelines and inspections to ensure compliance with federal standards.
- American Society of Health-System Pharmacists (ASHP): ASHP provides resources and guidelines for best practices in sterile compounding.
- State Boards of Pharmacy: Each state may have additional regulations and inspections to ensure compliance with USP standards.
- FDA: The FDA plays a crucial role in ensuring the quality of medications and will conduct pharmacy inspections.
Best Practices Around Sterile Compounding Procedure
The sterile compounding procedure is meticulous and requires specific techniques to ensure contaminants are not introduced. The overall process involves moving from the “dirty side” to the “clean side” in a step-by-step manner. While the following is by no means an exhaustive list, these are some of the key steps to be followed:
- Removing Contaminated Clothing: Personnel must have appropriate attire and remove any clothing that could introduce contaminants into the sterile environment (i.e. remove jewelry, no cosmetics, no nail products).
- Washing Hands: Thorough handwashing is essential to remove any potential contaminants.
- Gowning and Garbing: Proper gowning includes wearing sterile gloves, gowns, masks, hair covers, shoe covers, etc.
- Entering the Buffer Room: Personnel enter the buffer room, where the air quality is controlled, and further gowning may take place.
- Gloving Up: Sterile gloves are worn, and alcohol is used to clean the gloves.
- Sterilizing Equipment: All equipment and materials must be wiped down with sterile alcohol before entering the compounding room.
- Compounding: Compounding must be done in an IV suite under a laminar flow hood or in a contained isolator that provides a restricted access barrier. At the start and end of the shift and throughout the process, cleaning and wiping down the work areas must be completed to maintain sterility. This careful attention to detail ensures that the final compounded product is safe for patient use.
Recent Updates and Trends
Since the enforcement of the updated USP 797 standards in November 2023, accrediting bodies such as The Joint Commission, have increased their scrutiny and review of sterile compounding practices.
They will be expanding their focused inspections directly in pharmacies, observing compounding processes, reviewing training, testing, and monitoring of the rooms, and documentation to verify compliance. This shift underscores the importance of real-time adherence to standards and the need for constant vigilance and quality assurance in sterile compounding programs.
Action Points for Hospital Executives
- Invest in Proper Facility Design: Ensure that the compounding room has a properly operating air handling system (a dedicated system for the IV room is best practice) and is designed to minimize contamination risks.
- Allocate Resources for Training: Provide continuous education and competency validation for staff involved in sterile compounding.
- Implement Robust Cleaning and Monitoring: Establish daily and monthly cleaning and monitoring protocols and ensure regular external certification of the compounding environment.
- Develop a Quality Assurance Plan: Create a comprehensive plan with clear metrics to measure compliance and effectiveness, involving regular reporting to quality and infection prevention teams.
By addressing these key areas, hospital executives can ensure their sterile compounding programs are effective, compliant, and ultimately, safe for patients.
Sterile compounding is a complex but vital aspect of hospital pharmacy practice. Ensuring the safety and sterility of compounded medications requires significant investment in facility design, personnel training, and ongoing monitoring. By adhering to stringent standards and maintaining a robust quality assurance program, hospitals can safeguard patient health and prevent incidents like the NECC tragedy.
If you need help ensuring your hospital is following sterile compounding regulations, reach out to speak with a member of our team.
Is Your Pharmacy’s Cleanroom Compliant?
About the Author
Dana Fox, Pharm. D., Director of Quality and Compliance
Dr. Dana Fox joined CompleteRx in 2003 and is the Director of Quality and Compliance. In his role, Dana oversees the compliance assessments and solutions and the quality improvement solutions – such as pharmacy implementations and processes changes – to meet the needs of hospitals and pharmacists across the country.
Dana previously served as Director of Pharmacy for a health system in Atlanta, Georgia and has over 22 years of experience in hospital pharmacy management and operations including operational and process improvements, implementation of automation, 340B, pharmaceutical purchasing and medication safety.
Dana received his Pharm.D. from University of Illinois at Chicago and completed a two-year health system pharmacy administration degree at University of Wisconsin Health. He has completed Six Sigma Green Belt training with Purdue University.
