Cleanroom Performance ,
Testing & Certification

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Cleanroom Performance ,Testing & Certification

Request a Quote

Health Systems Sciences (HSS) — Ensuring Safe, Reliable, and Compliant Controlled Environments

HSS provides comprehensive cleanroom performance testing, certification, and monitoring services to support sterile compounding pharmacies, laboratories, research facilities, and healthcare environments. We ensure your controlled spaces meet regulatory performance standards, maintain consistent environmental control, and remain safe for personnel, products, and patients.

As a Service-Disabled Veteran–Owned Small Business (SDVOSB) with nationwide experience, HSS delivers responsive scheduling, clear documentation, and defensible test data suitable for internal QA programs and external regulatory review.

Scientist in a lab coat and protective gear preparing samples in a laboratory.

Core Cleanroom Certification
Services

Core Cleanroom Certification
Services

Performance Testing & System Verification

ISO 5 / 7 / 8 room classification

Airflow velocity measurement & balancing

Air change rate (ACH) calculation

Temperature & humidity performance checks

Pressure differential & directional airflow verification

Filter integrity and HEPA leak testing (scanning / DOP / PAO)

Engineering Control & Equipment Certification

Biological Safety Cabinets (BSCs)

Laminar Flow Workstations (LAFWs)

Compounding Aseptic Isolators (CAIs / CACIs)

Clean Bench & Pharmacy PEC testing

Certified to NSF 49, CETA CAG-003-2006, and manufacturer specifications

Environmental Monitoring (EM) Programs

Environmental Monitoring (EM) Programs

Non-viable airborne particle counting

Viable air and surface sampling

Post-compounding surface cleanliness verification

Trend reporting, action levels, and corrective response guidance

Standards & Regulatory Alignment

Standards & Regulatory Alignment

Our cleanroom performance testing aligns with:

  • USP 797 – Sterile Compounding
  • USP 800 – Hazardous Drug Handling
  • CETA CAG-003-2006 – Certification of Sterile Compounding Facilities
  • ISO 14644 – Cleanroom performance standards
  • NSF 49 – Biological Safety Cabinet standards
  • ASHRAE & ACGIH indoor air quality reference guidelines

This ensures your certification reports stand up to Joint Commission, State Board of Pharmacy, VA/DoD, OSHA, and internal audit requirements.

Facilities We Support

Hospital & Outpatient Pharmacies

503A Sterile Compounding Pharmacies

Oncology & Infusion Centers

Academic & Research Laboratories

VA Medical Centers & DoD Healthcare Facilities

Clean manufacturing, testing & biomedical environments

Pharmacists in lab coats discussing products in a pharmacy, holding medication boxes.

Why Partner with HSS

Why Partner with HSS

Benefit to Your Facility

  • Reliable testing and consistent results every service visit.
  • No jargon — practical recommendations and corrective steps.
  • Defensible Environmental Monitoring results and documentation.
  • Flexible scheduling with minimal downtime or workflow disruption.
  • Meets set-aside and subcontracting participation requirements.

Strength

  • Experienced Technicians & Cleanroom Specialists

  • Clear, Actionable Reporting
  • Accredited Laboratory Partnerships

  • Nationwide Response Capability

  • SDVOSB Status