Cleanroom Performance Testing & Certification
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.
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
- Non-viable airborne particle counting
- Viable air and surface sampling
- Post-compounding surface cleanliness verification
- Trend reporting, action levels, and corrective response guidance
- Personnel monitoring including glove fingertip and gowning assessment
Standards & Regulatory Alignment
Our cleanroom performance testing aligns with globally recognized standards and regulations — ensuring your certification reports withstand scrutiny from any regulatory body.
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
Compliance reports accepted by: Joint Commission · State Board of Pharmacy · VA / DoD · OSHA · Internal Audit Programs
Facilities We Support
Why Partner with HSS
From initial scheduling to final report delivery, HSS brings veteran-owned accountability, technical depth, and nationwide reach to every cleanroom certification project.
Experienced Technicians & Cleanroom Specialists
Reliable testing and consistent results every service visit.
Clear, Actionable Reporting
No jargon — practical recommendations and corrective steps.
Accredited Laboratory Partnerships
Defensible Environmental Monitoring results and documentation.
Nationwide Response Capability
Flexible scheduling with minimal downtime or workflow disruption.
SDVOSB Status
Meets set-aside and subcontracting participation requirements.
Service-Disabled Veteran–Owned Small Business
As a certified SDVOSB, HSS fulfills set-aside and subcontracting requirements for federal healthcare and VA / DoD facilities.
Ready to Schedule Your Cleanroom Certification?
Contact our team to discuss your facility needs and get a customized quote.