USP 797/800 Cleanroom Cleaning Services
Inspection-ready environmental control for sterile compounding suites. Reduce survey risk with compliant protocols and complete documentation.
Pain Points We Solve
Common compliance headaches that pharmacy directors face — and how we eliminate them
Documentation Fatigue
The revised 797 expects rigorous SOPs, training records, and traceable logs.
We deliver survey-ready documentation packets including daily task logs, sporicidal schedules, lot numbers, dwell times, and CAPA linkage.
Staff Time & Training
Pharmacy staff aren't trained for monthly deep cleaning and don't have time.
Our trained technicians handle rigorous cleaning after hours and weekends, freeing your staff for patient care.
Sampling Coordination
Monthly surface sampling is required but challenging to manage.
We integrate with your sampling program, providing pre-written sampling plans and trending support.
Comprehensive Cleanroom Cleaning Programs
Customized service tiers built around your facility's needs and compliance requirements
Monthly Deep Cleaning
Rigorous monthly cleaning performed after hours. Our team applies EPA-registered sporicidal agents with documented dwell times, cleans all surfaces floor-to-ceiling, and delivers a complete documentation packet.
- Floor-to-ceiling sporicidal treatment
- Ceiling tile and HEPA vent face cleaning
- Complete SOP-driven documentation
- Before/after photo documentation
- Lot numbers and dwell time records
- CAPA-linked reporting
Ongoing Maintenance Cleaning
Daily and weekly USP-compliant cleaning to maintain your controlled environment between deep cleaning cycles. Consistent protocols executed by trained cleanroom technicians.
- Daily wipe-downs of critical surfaces
- Weekly mopping with approved agents
- Ante-room and buffer room protocols
- Pass-through and laminar flow hood exteriors
- Consistent cleaning logs
- Staff training coordination
Emergency Decontamination
Rapid response remediation for contamination events, failed viable air or surface samples, or post-construction cleanup within cleanroom environments.
- 24/7 DFW metro emergency response
- Full sporicidal remediation
- Root cause support documentation
- Post-remediation verification cleaning
- CAPA documentation assistance
- Expedited turnaround
Add-On Services
Extend your cleanroom compliance program with specialized support
Surface Sampling Support
Pre-written sampling plans, trending templates, and coordination with your lab for monthly viable surface and air sampling.
Smoke Testing Assistance
Support during ISO certification smoke studies — ensuring your cleanroom maintains unidirectional airflow and proper pressure differentials.
Training Support
Competency-based gowning and cleaning training modules for your pharmacy staff, aligned to USP requirements.
Comprehensive Compliance Coverage
Our protocols are purpose-built to address the specific requirements of each regulatory body
USP 797 Compliance
Our cleaning protocols directly address the revised USP General Chapter 797 requirements for sterile compounding environments, including required sporicidal agent rotation, cleaning frequencies for ISO 5/7/8 areas, documented dwell times, and segregated compounding area (SCA) cleaning standards.
USP <800> Compliance
We follow USP <800> guidelines for handling hazardous drug residue in containment areas. Our technicians use appropriate PPE, approved deactivation and decontamination agents, and maintain separate cleaning workflows for HD areas.
Texas State Board of Pharmacy (TSBP)
Our services align with TSBP Rule §291.133 requirements for pharmacy cleanroom maintenance, including proper cleaning documentation, staff training records, and environmental monitoring support.
Joint Commission Readiness
We prepare your facility for Joint Commission surveys with survey-ready documentation, consistent cleaning protocols, and CAPA-linked reporting that demonstrates ongoing compliance.
Schedule Your Free Gap Assessment
Let us evaluate your current cleanroom cleaning program against USP 797/800 requirements and identify compliance gaps — at no cost.