USP 797 & USP 800 Cleanroom Certification Services
HSS provides full-scope certification and testing services to help healthcare facilities maintain compliance with USP 797 (sterile compounding) and USP 800 (hazardous drug handling).
We support safe compounding environments, proper engineering controls, and clear documentation that withstands regulatory scrutiny. As a Service-Disabled Veteran–Owned Small Business (SDVOSB), HSS supports VA Medical Centers, DoD facilities, academic hospitals, outpatient pharmacies, and compounding pharmacies nationwide.
Core Testing & Certification Services
Cleanroom & Controlled Environment Certification
- ISO 5 / 7 / 8 classification
- HEPA filter integrity testing (scan & leak testing)
- Airflow & velocity measurements
- Room pressurization & directional airflow verification
- Air change rate (ACH) calculation
- Temperature & humidity monitoring
Primary Engineering Control (PEC) Certification
- Biological Safety Cabinets (BSCs)
- Laminar Flow Hoods
- Compounding Aseptic Isolators (CAIs / CACIs)
- Tested to NSF 49, CETA CAG-003-2006, and manufacturer specifications
Environmental Monitoring (EM)
- Non-viable particle counting
- Viable air sampling (active and passive)
- Surface sampling after compounding activities
- Trend reporting, excursion investigation & corrective action guidance
USP 800 Hazardous Drug Handling & Containment
Comprehensive containment verification and monitoring to keep staff and patients safe from hazardous drug exposure.
- Negative-pressure room verification
- HD buffer & ante-room pressurization monitoring
- Hood and isolator containment performance testing
- Surface wipe sampling for hazardous drug residue (optional program setup)
- Workflow, storage, and PPE compliance alignment where applicable
Documentation & Compliance Support
Clear, defensible documentation that stands up to regulatory review and supports your quality assurance program.
- Certification reports with pass/fail results and corrective recommendations
- EM trend summaries for internal QA & regulatory audits
- Support for Joint Commission, State Pharmacy Boards, VA, DoD, and internal policy reviews
Who We Serve
Why Facilities Choose HSS
Experienced Cleanroom & Pharmacy Technicians
Safe, consistent, compliant certification every visit. Defensible data for regulatory review.
Clear, Actionable Reporting
Straightforward guidance without jargon.
Accredited Laboratory Partnerships
Accredited lab partnerships for reliable, traceable results.
SDVOSB Nationwide Support
Meets set-aside participation requirements for federal healthcare systems.
SDVOSB Certified
Service-Disabled Veteran–Owned Small Business — meets VA / DoD set-aside & subcontracting requirements
Ready to Schedule Your USP 797 / USP 800 Certification?
Contact our team to discuss your pharmacy's compounding environment and get a customized certification plan.