Cleanroom Compliance Isn’t Just a One-Time Build.
It’s a Long-Term Commitment.
Performance-Based Modular Cleanrooms Built for USP <797> & <800> Compliance
Even well-designed cleanrooms can drift out of compliance through airflow variation, operational strain, or unnoticed performance gaps.
QleanAir combines high-performance cleanroom environments with data-driven insight, helping you identify, quantify, and control risk through our CompliGrade™ and Total Cost of Ownership (TCO) analysis, so your facility stays compliant, inspection-ready, and fully operational long after installation.
Most Cleanroom Decisions Are Made on Build Cost.
The Real Risk Shows Up Later.
Cleanroom projects are often evaluated based on upfront cost and initial certification. But long-term performance is where risk, and cost, actually emerges.
Small gaps in design, airflow control, or material performance don’t stay small. Over time, they can lead to:
- Airflow and pressure drift that compromises sterile integrity
- Failed inspections that trigger costly remediation cycles
- Workflow disruptions that impact staff efficiency and patient care
- Rebuilds and revalidation caused by inflexible or outdated designs
Contamination Risk
Inspection Failures
Operational Disruptions
Ongoing Maintenance & rebuilds
These hidden costs are measurable, and overlooking them can lead to repeated failures, unexpected downtime, and higher long-term spend.
QleanAir helps you understand the risk upfront, so you can make better decisions before it impacts your operations.
The QleanAir Advantage
Most cleanrooms are designed for certification day. QleanAir designs for every day after.
Our modular, engineered solutions are built to perform in real pharmacy environments, where workflows evolve, demand increases, and compliance must hold under pressure. From initial design through ongoing monitoring, we help you stay aligned, informed, and in control.
Engineered for Real Operations – Designed around actual pharmacy workflows, not ideal conditions, so performance holds in daily use.
Compliance That Lasts – Maintain consistent airflow, pressure, and control as operational demands change supporting ongoing USP <797> and <800>compliance.
Quantified Risk & Cost – Make informed decisions with CRI™ and TCO insights that prioritize what matters most.
Lower Operational Risk- Fewer failures, fewer interventions, and greater confidence during inspections.
Lifecycle Accountability – A partner from assessment through ongoing performance, not just installation.
“What is the risk costing your organization over the next five to ten years?”
QleanAir helps shift the conversation toward risk reduction, operational continuity, and financial stewardship.
Experience a QleanAir Cleanroom in Action
Turn Compliance Risk Into Clear, Measurable Decisions
Most teams rely on gap analyses to assess USP <797> and <800> readiness. But gap lists alone don’t tell you what matters most, or what the consequences will be over time.
QleanAir transforms those findings into clear, prioritized insight so you can act with confidence, align stakeholders, and avoid costly surprises.
Compliance Risk Index™ (CRI)
Turn compliance gaps into a prioritized, measurable risk score.
- Identifies highest-impact risks across airflow, pressure, filtration, and workflow
- Weighs severity and likelihood – not just presence of gaps
- Creates a clear, defensible way to prioritize action
- Aligns clinical, facilities, and leadership teams around action
Total Cost of Ownership (TCO)
Reveals the full financial impact of cleanroom decisions over time
- Defines total operational cost across the asset’s full lifespan
- Exposes the hidden cost of lower upfront solutions with higher maintenance over time
- Enables side-by-side comparison of design approaches based on lifecycle performance
- Brings clarity to long-term investment decisions, not just initial build cost
Together, CRI™ and TCO help organizations act earlier, reduce long-term risk, and make more confident operational decisions.
gap analysis
CRI Score
TCO Projection
Action Plan
This isn’t just analysis, it’s a decision framework.
QleanAir works with your team to interpret results, prioritize next steps, and guide implementation, so improvements aren’t just identified, but executed and sustained over time.
A Smarter Way to Manage Cleanroom Performance – From Day One Forward
Cleanroom performance isn’t static. It evolves with your operations, staff, and regulatory demands.
QleanAir provides a clear, structured path to not only achieve compliance, but sustain it – combining engineering, data, and ongoing support at every stage.
Assess
Identify where risk exists today.
Evaluate gaps that could impact compliance with USP <797>, <800>, safety, or performance.
Quantify
Understand what those gaps actually mean.
Use CRI™ and TCO to prioritize risk and project long-term impact.
Design & Implement
Build a solution aligned to real-world use.
Use computational fluid dynamics (CFD) modeling to remove guesswork and design based on real airflow behavior, not assumptions.
Deliver modular cleanrooms tailored to workflows, regulations, and future needs.
Maintain & Optimize
Sustain performance as conditions change.
Ongoing monitoring, maintenance, and recertification support ensure lasting compliance.
This is where QleanAir is different.
We don’t step away after installation – we stay engaged to help you manage performance, adapt to change, and maintain compliance over time.
OUTCOMES
This Lifecycle approach ensures your cleanroom is compliant, not just at installation, but every day after.
Cleanroom Solutions Designed for Healthcare Environments
Trusted by Industry Leaders for Over 30 Years
QleanAir has been delivering innovation in regulated environments for more than three decades, helping healthcare organizations achieve compliance, reduce risk, and maintain performance over time.
- Deep experience in cleanroom design and lifecycle services
- Proven results across hospitals, IDNs, and compounding environments
- Expertise in regulatory alignment, performance optimization, and operational continuity
- Experience extending beyond healthcare: advanced manufacturing environments, large-scale infrastructure systems, highly controlled public spaces
Featured Case Studies
Measurable Outcomes Across Healthcare Environments
- Multi-site health system reduced recertification failures by 35%
- Hospital pharmacy improved inspection readiness within one cycle
Start With Clarity
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