Compliance & Certifications
Cleanroom Compliance That Lasts Beyond Certification
Cleanrooms don’t fail all at once. Performance drifts. Conditions change. Small gaps build into larger issues.
QleanAir helps you stay compliant with USP <797>, USP <800>, and other regulatory standards by focusing on how your cleanroom performs over time, not just how it performs on day one.
The result is fewer failures, fewer disruptions, and more confidence every time you’re inspected.
We help you:
Built Around the Standards You’re Accountable To
USP <797> – Sterile Compounding
Supports airflow, environmental control, and contamination prevention for sterile compounding.
Your advantage:
- More stable environments
- Reduced contamination risk
- Greater inspection confidence
USP <800> – Hazardous Drug Handling
Ensures proper containment and exposure control. Supports airflow, environmental control, and contamination prevention for sterile compounding.
Your advantage:
- Safer conditions for staff
- Reduced compliance exposure
- Greater inspection confidence
ISO 14644 – Cleanroom Classification
Defines performance standards for air quality and particulate control.
Your advantage:
- Measurable, consistent performance
- Easier validation and recertification
cGMP – Process and Quality Control
Supports consistency, documentation, and operational integrity.
Your advantage:
- Stronger process control
- Better audit outcomes
- More reliable operations
FDA & State Board Alignment
Supports compliance across federal and state requirements.
Your advantage:
- Fewer gaps across jurisdictions
- More confidence during audits
Make Compliance Easier to Manage Every Day
Most cleanroom providers leave compliance management to your team after installation.
QleanAir helps you build structure around it so it’s easier to maintain.
How We Support You
- Standard operating procedures (SOPs)
- Documentation and traceability
- Audit and inspection preparation
- Ongoing compliance alignment
What You Gain
- Clear processes your team can rely on
- Documentation that supports inspections
- Better audit readiness
- Less last-minute scrambling
Protect Your Staff, Your Patients, and Your Operation
Compliance isn’t just about meeting standards. It’s about reducing real-world risk.
QleanAir integrates safety into cleanroom performance, not as an afterthought, but as part of the system.
How It’s Delivered
- Stable airflow and environmental control
- Hazardous drug containment strategies
- Cleanroom layouts that support safe workflows
- Ongoing monitoring to catch issues early
What This Means for You
- Reduced exposure risk for staff
- Safer handling of hazardous drugs
- Greater protection for patients
- More confidence in your environment
Built for Long-Term Compliance, Not Just Project Completion
Many cleanroom providers are structured around delivering a project.
Once installation is complete, responsibility shifts back to you.
QleanAir is structured differently.
Typical Industry Approach
- Designed to meet requirements at handoff
- Limited visibility after installation
- Reactive response to issues
- Compliance managed internally
QleanAir Approach
- Designed for sustained compliance
- Ongoing visibility into performance and risk
- Proactive identification of issues
- Lifecycle support from design through operation
What That Means for You
- Fewer surprises after certification
- Better control over compliance risk
- More predictable performance
- Lower total cost over time
Qualified to Support Regulated Environments
QleanAir maintains certifications and affiliations that support our work in healthcare and controlled environments.
OPM (Preapproval of Manufacturer’s Certification)
Stay Ahead of Compliance Instead of Catching Up
Waiting until something fails is expensive.
QleanAir helps you identify risks early, understand their impact, and address them before they turn into failed inspections or operational disruption.
With tools like CRI™ and TCO, you can:
- Prioritize what actually matters
- Make better decisions faster
- Align teams around clear data
- Reduce long-term compliance risk
Know Where You Stand Before It Becomes a Problem
Most compliance issues are preventable if you catch them early.
QleanAir gives you the visibility and support to stay in control.