USP 797 & USP 800 Cleanroom
Certification Services

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USP 797 & USP 800 Cleanroom Certification Services

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Health Systems Sciences (HSS) — Ensuring Safe Sterile & Hazardous Drug Compounding

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

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

Two scientists in protective suits examining samples under a microscope in a lab.

USP 800 Hazardous Drug Handling & Containment

  • 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

USP 800 Hazardous Drug Handling & Containment

  • 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

Documentation & Compliance Support

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

Scientist in protective gear filling out paperwork in a cleanroom environment

Who We Serve

Hospital Pharmacies

Oncology & Infusion Clinics

Academic Medical Centers

503A Compounding Pharmacies

VA & DoD Healthcare Facilities

Specialty and Outpatient Pharmacies

Why Facilities Choose HSS

Why Facilities Choose HSS

Benefit to You

  • Safe, consistent, compliant certification every visit.
    Defensible data for regulatory review.
  • Straightforward guidance without jargon.
  • Meets set-aside participation requirements for federal healthcare systems.

Strength

  • Experienced Cleanroom & Pharmacy Technicians
  • Accredited Laboratory Partnerships
  • Clear, Actionable Reporting
  • SDVOSB Nationwide Support