USP 800 CLEANROOM

How Bare Compounding Maintains USP <800> Cleanroom Compliance

Bare Compounding is dedicated to maintaining the highest safety standards when handling hazardous drugs. Our practices strictly follow USP <800> Hazardous Drugs – Handling in Healthcare Settings, ensuring protection for patients, staff, and the environment.

USP <800> is a chapter published by the United States Pharmacopeia that establishes standards for the safe handling of hazardous drugs (HDs) in healthcare settings. These standards apply to all personnel who receive, prepare, compound, administer, transport, or otherwise come into contact with hazardous medications.

USP <800> outlines requirements for:

• Personnel responsibilities and training
• Facility and engineering controls (including cleanrooms)
• Safe handling and compounding practices
• Deactivation, decontamination, and cleaning procedures
• Spill control and waste management
• Documentation and quality assurance

The purpose of USP <800> is to establish practice and quality standards that minimize exposure to hazardous drugs in healthcare environments. These standards are designed to:

• Protect patients receiving compounded medications
• Ensure worker safety for all healthcare personnel
• Reduce environmental contamination

The chapter defines processes to reduce the risk of exposure through proper handling, engineering controls, and procedural safeguards. It was developed by the USP Compounding Expert Committee with input from hazardous drug experts and collaboration with organizations such as the FDA and CDC (including NIOSH).

USP <800> applies to all individuals who may come into contact with hazardous drugs in healthcare settings, including:

• Pharmacists and pharmacy technicians
• Nurses and physicians
• Physician assistants
• Home healthcare workers
• Veterinarians and veterinary technicians

Any personnel handling hazardous drugs must:

• Receive proper training on hazardous drug handling
• Demonstrate competency and understanding of procedures
• Follow established safety protocols at all times

All staff are responsible for adhering to best practices, continually evaluating procedures, and ensuring that hazardous drug handling does not pose risks to patients, personnel, or the environment.

1. Personnel Training and Safety

All Bare Compounding staff who handle hazardous drugs undergo rigorous training in USP <800> standards, including proper use of personal protective equipment (PPE) and safe handling techniques.

2. Advanced Cleanroom and Engineering Controls

Our facility incorporates USP <800>-compliant cleanroom design and engineering controls to contain hazardous drugs and prevent exposure, including:

• Negative pressure environments
• Containment primary engineering controls (C-PECs)
• Proper ventilation and air filtration systems

3. Decontamination and Cleaning Procedures

We follow strict protocols for:

• Deactivation and decontamination of hazardous residues
• Routine cleaning and sanitization
• Prevention of cross-contamination

4. Spill Control and Waste Management

Bare Compounding maintains detailed procedures for:

• Safe handling of hazardous drug spills
• Proper disposal of hazardous waste
• Immediate response protocols to protect staff and environment

5. Documentation and Quality Assurance

We maintain comprehensive documentation to ensure compliance and traceability, including:

• Training records
• Cleaning and maintenance logs
• Compounding and handling procedures

Our quality assurance program ensures continuous monitoring and improvement.

USP <800> compliance is essential to ensuring a safe environment for everyone involved in the handling of hazardous drugs. Bare Compounding is committed to exceeding these standards to protect patients, healthcare workers, and the community.

Contact us today to learn more about how we comply to USP <800> standards.