This comprehensive guide explores everything hospital pharmacy managers, infection control specialists, and facility directors need to know about USP 797/800 cleaning protocols, from understanding the regulations to implementing effective cleaning procedures.
Understanding USP 797 and USP 800: Why They Matter
What is USP Chapter 797?
USP Chapter 797 establishes standards for pharmaceutical compounding of sterile preparations. The chapter provides enforceable guidelines designed to prevent harm and death to patients that could result from microbial contamination, excessive bacterial endotoxins, variability in intended strength, and incorrect ingredients in compounded sterile preparations (CSPs).
Key areas covered by USP 797 include:
- Personnel training and qualification requirements
- Cleanroom facility design and engineering controls
- Environmental monitoring and testing
- Cleaning and disinfection procedures
- Beyond-use dating for compounded preparations
What is USP Chapter 800?
USP Chapter 800 specifically addresses the handling of hazardous drugs (HDs) to protect healthcare workers, patients, and the environment. This chapter focuses on minimizing exposure to hazardous drugs throughout the entire drug handling process, from receipt to disposal.
USP 800 requirements include:
- Containment strategies for hazardous drug handling
- Facilities and engineering controls for HD compounding
- Personal protective equipment (PPE) standards
- Environmental controls and monitoring
- Deactivation, decontamination, and cleaning procedures
- Spill management protocols
The Intersection: Why Both Matter for Hospital Pharmacies
While USP 797 focuses on maintaining sterility to protect patients from contamination, USP 800 protects healthcare workers from hazardous drug exposure. Hospital pharmacies must comply with both sets of standards simultaneously, creating complex cleaning and maintenance requirements that demand specialized knowledge and procedures.
Classification of Compounding Areas and Cleaning Requirements
Understanding the different ISO classifications helps determine appropriate cleaning protocols and frequency.
ISO Class 5 (Formerly Class 100)
ISO Class 5 environments include primary engineering controls (PECs) such as biological safety cabinets (BSCs) and compounding aseptic isolators (CAIs). These are the most critical areas where compounding actually occurs.
Cleaning requirements:
- Cleaned before each compounding session
- Cleaned after spills or contamination events
- Disinfected with sterile, non-shedding wipes and appropriate agents
- Documented after each cleaning event
ISO Class 7 (Formerly Class 10,000)
ISO Class 7 areas serve as buffer rooms or segregated compounding areas where the ISO Class 5 PEC is located. These rooms act as a barrier between the general pharmacy area and the critical compounding zone.
Cleaning requirements:
- Daily cleaning of all surfaces
- Detailed cleaning at least monthly
- Floor cleaning with appropriate methods and agents
- Regular monitoring of particle counts and microbial contamination
ISO Class 8 (Formerly Class 100,000)
ISO Class 8 encompasses ante-rooms where personnel perform hand hygiene, garbing, and other preparatory activities before entering the buffer room.
Cleaning requirements:
- Daily surface cleaning
- Regular floor maintenance
- Periodic deep cleaning
- Environmental monitoring as required
Essential Cleaning Agents and Disinfectants
Selecting the right cleaning agents is critical for both compliance and effectiveness.
Sterile 70% Isopropyl Alcohol (IPA)
The most commonly used disinfectant in compounding areas, sterile 70% IPA provides:
- Broad-spectrum antimicrobial activity
- Rapid evaporation
- No residue when properly applied
- Cost-effectiveness
Limitations: Not sporicidal, limited effectiveness against certain organisms, and can damage some surfaces with repeated use.
Sporicidal Agents
USP 797 requires the use of a sporicidal agent at least monthly in ISO Class 5 and 7 areas. Common options include:
- Sodium hypochlorite (bleach) solutions
- Peracetic acid-based products
- Hydrogen peroxide-based cleaners
- Commercial sporicidal disinfectants approved for pharmaceutical use
Hazardous Drug Decontamination Agents
For USP 800 compliance in areas handling hazardous drugs, specialized decontamination agents must be used:
- Sodium hypochlorite solutions (appropriate concentrations)
- Commercial HD deactivating products
- Peroxide-based decontaminants
Critical consideration: The cleaning agent must be appropriate for the specific hazardous drugs being handled and must not create additional hazards through chemical interactions.
Step-by-Step Cleaning Procedures
Daily Cleaning Protocol for ISO Class 5 PECs
Before each compounding session:
- Remove all items from the PEC work surface
- Using sterile, low-lint wipes saturated with sterile 70% IPA, clean all interior surfaces using overlapping strokes
- Start from the back of the cabinet and work forward
- Clean the work surface last
- Allow surfaces to air dry completely
- Document the cleaning event
After each compounding session:
- Properly dispose of all waste materials
- Remove any spills immediately with appropriate cleaning agents
- Wipe down all surfaces with sterile 70% IPA
- Allow to air dry
- Document completion
Weekly Cleaning Requirements
Beyond daily maintenance, weekly cleaning should include:
- Detailed cleaning of all PEC interior surfaces including sides, back, and ceiling
- Cleaning of pass-through chambers
- Inspection and cleaning of air intake and exhaust grilles (following manufacturer guidelines)
- Floor cleaning in buffer and ante-rooms with appropriate agents
- Cleaning of storage areas and shelving
Monthly Deep Cleaning
Monthly procedures should incorporate:
- Application of sporicidal agent to all ISO Class 5 and 7 surfaces
- Detailed cleaning of walls, ceilings, and floors in controlled areas
- Cleaning of light fixtures and ceiling tiles (if applicable)
- Inspection and cleaning of HEPA filter housings (exterior only)
- Comprehensive documentation of all activities
Cleaning for Hazardous Drug Areas (USP 800 Compliance)
Deactivation vs. Decontamination vs. Cleaning
Understanding the hierarchy of hazardous drug surface treatment:
Deactivation: Rendering the hazardous drug inactive through chemical neutralization. This is the first step after HD exposure.
Decontamination: Removing or reducing hazardous drug contamination to safe levels. This follows deactivation.
Cleaning: Removing dirt, debris, and general contaminants. This is the final step in the process.
Containment Segregated Compounding Area (C-SCA) Cleaning
For facilities using C-SCAs for hazardous drug compounding:
- Immediate spill response: Follow facility spill kit procedures for HD spills
- Between compounding sessions: Deactivate and decontaminate all surfaces that may have contacted HDs
- Daily cleaning: Complete deactivation, decontamination, and cleaning of all C-SCA surfaces
- Documentation: Maintain detailed logs of all cleaning activities
Containment Primary Engineering Control (C-PEC) Maintenance
Biological safety cabinets and other C-PECs require:
- Pre-use surface decontamination
- Post-use decontamination and cleaning
- Use of appropriate decontamination agents for the specific HDs handled
- Regular certification and testing per manufacturer specifications
- Documented cleaning logs
Personnel Training and Competency
No cleaning protocol succeeds without properly trained personnel.
Initial Training Requirements
Staff responsible for cleaning compounding areas must receive comprehensive training covering:
- USP 797 and 800 requirements specific to their responsibilities
- Proper cleaning techniques and procedures
- Correct use of cleaning agents and disinfectants
- PPE requirements and proper donning/doffing procedures
- Documentation requirements
- Emergency procedures for spills and exposures
Ongoing Competency Assessment
Beyond initial training, facilities must:
- Conduct annual competency evaluations
- Provide retraining when procedures change
- Observe cleaning procedures periodically to ensure compliance
- Document all training and competency assessments
- Address deficiencies immediately with additional training
Garbing Requirements for Cleaners
Personnel cleaning ISO Class 7 and 8 areas must follow the same garbing requirements as compounding personnel, including:
- Hair and facial hair covers
- Shoe covers
- Gowns or coveralls appropriate for the area
- Gloves (doubled for hazardous drug areas)
- Face masks and eye protection when required
Environmental Monitoring and Verification
Cleaning effectiveness must be verified through environmental monitoring.
Surface Sampling
Regular surface sampling helps verify cleaning efficacy:
- Viable surface sampling: Using contact plates or swabs to detect microbial contamination
- Non-viable particle sampling: Measuring particle counts in the air and on surfaces
- Hazardous drug wipe sampling: For USP 800 compliance, verifying that HD contamination is below established limits
Frequency of Monitoring
Monitoring frequency depends on risk level and compounding volume:
- ISO Class 5 areas: At least every six months (or more frequently based on volume)
- ISO Class 7 buffer rooms: At least every six months
- ISO Class 8 ante-rooms: As determined by facility policy
- Hazardous drug areas: According to facility risk assessment and USP 800 requirements
Interpreting Results and Taking Action
When monitoring reveals issues:
- Investigate the root cause immediately
- Implement corrective actions (enhanced cleaning, procedural changes, equipment maintenance)
- Re-sample to verify corrective actions were effective
- Document all findings and actions taken
- Adjust cleaning procedures if patterns emerge
Common Compliance Pitfalls and How to Avoid Them
Insufficient Documentation
Problem: Cleaning activities aren't documented or documentation is incomplete.
Solution: Implement standardized cleaning logs with clear requirements for what must be recorded (date, time, cleaner's initials, areas cleaned, agents used, observations). Make documentation part of the cleaning procedure itself.
Inappropriate Cleaning Agents
Problem: Using non-sterile products in ISO Class 5 areas or using incompatible chemicals in hazardous drug areas.
Solution: Develop a clearly defined list of approved cleaning agents for each area type. Provide training on why specific agents are required and ensure only approved products are stocked in compounding areas.
Inadequate Contact Time
Problem: Disinfectants are wiped away immediately without allowing proper contact time for effectiveness.
Solution: Train staff on required contact times for each cleaning agent. Post contact time requirements in cleaning areas. Observe procedures to ensure compliance.
Inconsistent Technique
Problem: Cleaning procedures vary between staff members or shifts.
Solution: Develop written standard operating procedures (SOPs) with step-by-step instructions. Use visual aids and checklist tools. Observe and competency-assess all staff regularly.
Neglecting High-Touch Surfaces
Problem: Focusing only on obvious surfaces while neglecting handles, light switches, keyboards, and other frequently touched areas.
Solution: Create comprehensive cleaning checklists that specifically include all high-touch surfaces. Conduct periodic audits to verify complete coverage.
Developing Your Cleaning Program
Creating Standard Operating Procedures
Effective SOPs for cleaning should include:
- Purpose and scope: What areas are covered and why
- Responsibilities: Who performs each task
- Materials needed: Complete list of supplies and equipment
- Step-by-step procedures: Detailed instructions with photos or diagrams
- Safety precautions: PPE requirements and hazard information
- Quality control: How effectiveness is verified
- Documentation requirements: What records must be maintained
- References: Relevant USP chapters and facility policies
Establishing a Cleaning Schedule
A comprehensive master cleaning schedule should:
- List all areas requiring cleaning
- Specify cleaning frequency (daily, weekly, monthly, etc.)
- Identify responsible personnel
- Note which cleaning agents to use for each task
- Include monitoring and verification activities
- Allow space for documentation of completion
Quality Assurance and Continuous Improvement
Build quality into your program through:
- Regular internal audits of cleaning procedures
- Trending of environmental monitoring data
- Staff feedback mechanisms
- Procedure updates based on new evidence or guidelines
- Benchmarking against industry best practices
- Engagement with professional organizations and regulatory bodies
Working with Professional Cleaning Services
Many hospitals partner with specialized cleaning companies for compounding area maintenance.
What to Look for in a Service Provider
When selecting a cleaning service for pharmacy compounding areas:
- USP 797/800 expertise: Demonstrated knowledge and experience with pharmaceutical compounding environments
- Trained personnel: Staff with proper training in sterile technique and hazardous drug handling
- Appropriate certifications: Relevant industry certifications and insurance
- Quality documentation: Robust cleaning logs and verification processes
- Local presence: Ability to respond quickly to urgent needs
- References: Proven track record with similar healthcare facilities
Questions to Ask Potential Vendors
Before engaging a cleaning service:
- What specific experience do you have with USP 797 and 800 requirements?
- How do you train and certify your staff for pharmaceutical cleanroom work?
- What cleaning agents and protocols do you use, and why?
- How do you document and verify cleaning effectiveness?
- What is your response time for emergency cleaning or spill response?
- Can you provide references from hospital pharmacies you currently serve?
- How do you stay current with changing USP requirements?
- What quality assurance processes do you have in place?
Maintaining Oversight
Even with a contracted service, the pharmacy maintains ultimate responsibility for compliance:
- Review cleaning logs regularly
- Conduct periodic observations of cleaning procedures
- Verify environmental monitoring results
- Maintain open communication with the service provider
- Address issues promptly
- Include cleaning service performance in quality improvement initiatives
The Business Case for Compliance
Investing in proper USP 797/800 cleaning isn't just about following regulations—it makes financial and operational sense.
Risk Mitigation
Inadequate cleaning can lead to:
- Patient harm from contaminated preparations
- Healthcare worker exposure to hazardous drugs
- Regulatory citations and corrective action requirements
- Facility closure or restrictions on compounding
- Legal liability and potential litigation
- Damage to institutional reputation
The cost of prevention through proper cleaning is minimal compared to the potential costs of failure.
Operational Efficiency
A well-designed cleaning program contributes to:
- Predictable compounding operations
- Reduced waste from contamination events
- Better staff morale through demonstrated commitment to safety
- Streamlined regulatory inspections
- Improved patient outcomes and satisfaction
Return on Investment
Consider the value of:
- Avoiding even a single patient safety event
- Preventing regulatory action that could limit compounding capacity
- Maintaining uninterrupted operations
- Protecting staff health and reducing workers' compensation claims
- Building a reputation for quality and safety
Preparing for Regulatory Inspections
State boards of pharmacy and accrediting bodies regularly inspect compounding facilities.
What Inspectors Look For
Common focus areas include:
- Documented cleaning procedures (SOPs)
- Cleaning logs showing consistent compliance
- Environmental monitoring data and trending
- Personnel training records
- Appropriate cleaning agents and supplies
- Physical condition of facilities
- Proper waste segregation and disposal
- Knowledge demonstration by staff
Documentation Best Practices
Maintain inspection-ready documentation by:
- Keeping cleaning logs for at least three years (or per state requirements)
- Organizing records logically and accessibly
- Maintaining current SOPs with revision history
- Documenting all training and competency assessments
- Trending environmental monitoring data
- Recording all corrective actions taken
Common Citation Issues
Be prepared to address frequently cited deficiencies:
- Incomplete or missing cleaning logs
- Failure to use sporicidal agents at required frequency
- Inadequate cleaning procedures in SOPs
- Lack of documented personnel training
- Environmental monitoring failures without documented investigation
- Inappropriate cleaning agents or techniques
Future Trends in Pharmacy Compounding Cleaning
The field continues to evolving with new technologies and approaches.
Emerging Technologies
Innovations improving cleaning effectiveness and verification:
- Hydrogen peroxide vapor systems: Automated room decontamination
- UV-C light disinfection: Supplemental germicidal treatment
- ATP bioluminescence monitoring: Rapid verification of cleaning effectiveness
- Automated surface samplers: More consistent environmental monitoring
- Digital documentation systems: Electronic logs and real-time tracking
Regulatory Evolution
Stay informed about:
- Ongoing revisions to USP chapters
- State-level adoption timelines and variations
- New guidance from FDA and professional organizations
- Emerging best practices from research and experience
- International standards development
Sustainability Considerations
Healthcare organizations increasingly focus on:
- Environmentally responsible cleaning agents
- Waste reduction strategies
- Energy-efficient facility design
- Sustainable supply chain choices
- Balancing environmental goals with patient safety requirements
Conclusion: Building a Culture of Compliance and Safety
Successful USP 797/800 cleaning programs extend beyond checking boxes on a compliance list. They reflect an organizational commitment to patient safety, worker protection, and operational excellence.
The most effective programs share common characteristics:
- Leadership engagement: Senior leadership understands and supports the program
- Adequate resources: Sufficient budget, staffing, and equipment
- Comprehensive training: All personnel understand their role in maintaining compliance
- Consistent execution: Procedures are followed every time, not just when convenient
- Continuous improvement: Data is analyzed and processes are refined based on findings
- Team collaboration: Pharmacists, technicians, cleaning staff, and facility managers work together
Whether you're establishing a new compounding operation or refining an existing program, prioritizing proper cleaning and environmental control protects everyone—patients, staff, and your organization.
Partner with Experts in Pharmaceutical Cleanroom Maintenance
At Nano Clean Decon, we specialize in USP 797 and USP 800 compliant cleaning for hospital pharmacies and compounding facilities throughout the Boston area. Our trained technicians understand the critical importance of maintaining sterile compounding environments and protecting healthcare workers from hazardous drug exposure.
Our services include:
- Daily, weekly, and monthly cleaning programs tailored to your facility
- Emergency spill response and decontamination
- Environmental monitoring coordination and support
- Documentation and compliance assistance
- Staff training and education
Why choose Nano Clean Decon?
- Specialized expertise in pharmaceutical compounding environments
- Trained, certified staff with demonstrated competency
- Comprehensive documentation and quality assurance
- Responsive service with local presence
- Commitment to your compliance and safety goals
Contact us today to discuss how we can support your pharmacy's cleaning and compliance needs. Together, we can create a safer environment for compounding sterile preparations and handling hazardous drugs.
Nano Clean Decon Boston
Specialized Pharmaceutical Cleanroom Services