Adapting to USP 800 Cleanroom Regulations: Challenges and Solutions for Healthcare Facilities
Diseases & Cure

Adapting to USP 800 Cleanroom Regulations: Challenges and Solutions for Healthcare Facilities

USP 800 is a set of regulations developed by the United States Pharmacopeial Convention to ensure the safe handling of hazardous drugs in healthcare settings. Compliance with these regulations is mandatory for all healthcare facilities that handle hazardous drugs, including hospitals, pharmacies, and clinics.

However, adapting to USP 800 regulations can be a significant challenge for healthcare facilities, requiring significant changes to facility design, equipment, and procedures.

This article will explore the challenges that healthcare facilities face when adapting to USP 800 regulations, as well as solutions and strategies that can help organizations successfully comply with these essential safety standards.

Adapting to USP 800 Cleanroom Regulations

USP 800 outlines guidelines for the design and operation of cleanrooms. Compliance with USP 800 is mandatory for all healthcare facilities that handle hazardous drugs.

According to American Cleanroom Systems, USP 800 regulations have introduced changes for handling hazardous drugs (HD) that can impact cleanroom compliance. These changes include the need for negative pressure rooms and biological safety cabinets (BSCs), as well as warning signs and demarcation lines to indicate hazards.

Additionally, there are new requirements for labeling, storage, and pass-throughs that need to be taken into account. Adapting to these regulations can be challenging for healthcare facilities, requiring significant changes to facility design, equipment, and procedures. However, failure to comply with USP 800 can result in serious health risks to healthcare workers and patients.

Compliance Challenges

Healthcare facilities face several challenges when adapting to USP 800 regulations. One of the most significant challenges is a lack of resources, including funding and personnel, to implement the necessary changes to facility design, equipment, and procedures. Another challenge is a lack of training and expertise among healthcare staff, who may not be familiar with the requirements of USP 800.

Additionally, healthcare facilities must navigate complex regulations and guidelines, which can be difficult to interpret and apply. These factors can make it challenging for healthcare facilities to comply with USP 800, highlighting the need for effective strategies and solutions to support compliance efforts.

Risk Assessments

Conducting a thorough risk assessment is essential for healthcare facilities to comply with USP 800 regulations. A risk assessment helps identify potential hazards associated with the handling of hazardous drugs and allows healthcare facilities to develop appropriate strategies to mitigate these risks.

By evaluating the risks associated with each stage of the drug handling process, from receipt to disposal, healthcare facilities can identify areas that require additional safety measures, such as the use of personal protective equipment or the installation of specialized ventilation systems.

A thorough risk assessment also ensures that healthcare facilities are adequately prepared to respond to emergencies and unexpected events, such as spills or leaks of hazardous drugs.

Facility Design and Construction

Achieving compliance with USP 800 cleanroom regulations heavily relies on the design and construction of the facility. It’s crucial to note that USP 800 cleanrooms are not adjustable once established.

Cleanrooms must be designed to maintain appropriate airflow and ventilation to minimize the risk of exposure to hazardous drugs. Airlocks and negative pressure rooms are also essential to prevent the spread of hazardous drugs throughout the facility.

Cleanroom surfaces must be smooth, non-porous, and easy to clean to reduce the risk of contamination. Other design considerations include the location of the cleanroom within the facility, the size of the room, and the placement of equipment and supplies. By adhering to these design and construction requirements, healthcare facilities can ensure that their cleanrooms provide a safe and effective environment for handling hazardous drugs.

According to Nuaire, designing a hazardous drug (HD) cleanroom involves several considerations, including physical infrastructure and equipment. The design consideration also includes workflow requirements, such as storage, receiving, and procedural needs.

While regulatory guidance is specific, each HD cleanroom must be tailored to the facility’s unique conditions and limitations. As a result, not all HD cleanrooms will be identical, and design variations will be necessary to meet regulatory compliance and ensure safety.

PPE Selection and Use

Properly selecting and using personal protective equipment (PPE) is crucial for achieving USP 800 compliance. Healthcare workers must be trained on how to select and use appropriate PPE to minimize the risk of exposure to hazardous drugs. The selection of PPE should be based on the specific task and level of risk involved.

However, ensuring compliance can be challenging due to discomfort, availability, and inconsistent use. Healthcare facilities need to provide appropriate PPE, conduct regular training sessions, and monitor compliance to minimize the risk of exposure to hazardous drugs.

Staff Training

Comprehensive training is crucial for ensuring staff compliance with USP 800 regulations. All personnel who handle hazardous drugs should receive appropriate training on safe handling procedures, proper use of PPE, and how to respond to accidental exposure or spills.

Training should be ongoing and include regular refresher courses to ensure that staff remains up-to-date with the latest guidelines and best practices. Staff should also be trained on the importance of reporting any incidents of exposure or near-misses to promote a culture of safety and accountability.

Equipment and Technology

Selecting appropriate equipment and technology is essential for ensuring USP 800 compliance. Closed-system drug transfer devices (CSTDs) are recommended for handling hazardous drugs to prevent exposure and contamination.

These devices allow for the safe transfer of drugs from one container to another without exposing staff to hazardous drugs or releasing them into the environment. Other technology, such as air filtration systems, can also help to maintain a clean and safe environment.

It is important to regularly assess and update equipment and technology to ensure that it remains effective and up-to-date with current regulations and best practices.

Cleaning and Disinfection

USP 800-compliant cleanrooms require a specific cleaning and disinfection process to maintain a safe environment for personnel working with hazardous drugs. Healthcare facilities must implement a cleaning and disinfection program that is consistent with the facility’s risk assessment and includes appropriate procedures and products for cleaning and disinfecting surfaces and equipment.

The program should also specify the frequency of cleaning and disinfection, which will vary depending on the risk level and frequency of drug handling. Healthcare facilities should use EPA-registered disinfectants that are effective against the specific pathogens and organisms of concern in their facility.

Record-Keeping and Documentation

Record-keeping and documentation are crucial aspects of USP 800 compliance. Healthcare facilities must keep detailed records of all activities related to the handling of hazardous drugs, including receiving, storing, compounding, administering, and disposing of them.

These records must include information on the drugs’ identity, dosage, and handling procedures. The facility must also document staff training and competency, risk assessments, cleaning and disinfection schedules, and any incidents or spills.

Accurate record-keeping ensures that the facility can demonstrate compliance with USP 800 regulations and provides a record of its efforts to maintain a safe and effective environment for handling hazardous drugs.

Solutions and Strategies

According to Yahoo! Finance, cleanrooms are increasingly being utilized in the healthcare industry to enhance the safety and quality of medical supplies, protect employees’ health and safety, and address environmental concerns. The growth of the cleanroom technology market in this industry is driven by favorable regulations governing the use of cleanroom technologies.

The global cleanroom technology market generated sales of US$4.4 billion in 2021, and it is projected to expand at a compound annual growth rate of 7.6% between 2022 and 2032, driven by the construction of additional cleanroom facilities.

Healthcare facilities face significant challenges when adapting to USP 800 regulations. However, successful strategies and solutions have been implemented to ensure compliance. These include cross-functional teams that collaborate to implement and maintain compliance, ongoing training programs that educate personnel on proper handling and PPE use, and technology upgrades such as closed-system drug transfer devices.

Healthcare facilities can also adopt an “assessment and remediation” approach that involves identifying hazards and developing appropriate mitigation strategies. With proper planning and implementation, healthcare facilities can successfully adapt to USP 800 regulations while ensuring the safety of their staff and patients.


According to Cleanroom Technology, when setting up a cleanroom, standard guidelines to consider include service requirements, site selection, design, construction methods, and safety. The ISO 14644-1 classification standard is used to determine the particle concentration levels in a cleanroom, but it does not specify a particular design. Hospital pharmacies comply with the U.S. Pharmacopeia Standard 797 and 800 (USP 797/USP 800).

The USP 800 guidelines are a great resource for healthcare facilities but can be difficult to implement. The good news is that there are many solutions and strategies available to help your facility comply with these regulations.

By taking an inventory of your current operations and creating an improvement plan, you can ensure that your facility meets all cleanliness requirements while running smoothly.