Cleanroom Solutions
A Cleanroom Solution That Reduces Risk, Not Just Meets Requirements
Cleanrooms are expected to perform under real conditions, not ideal ones. Daily use, changing workflows, and operational pressure all affect performance over time.
QleanAir intentionally designs modular cleanrooms to maintain compliance under real-world operating conditions, not just pass certification.
We help hospitals, health systems, and compounding pharmacies maintain control, protect staff and patients, and keep operations running without disruption.
Why This Matters
Most cleanrooms are built to pass certification.
The real challenge is what happens after.
Small issues like airflow drift or workflow misalignment often go unnoticed until they lead to failed inspections, remediation, or downtime.
QleanAir helps you stay ahead of those problems so you can:
Why Modular Cleanrooms Optimize Healthcare Environments
Traditional stick-built cleanrooms can be difficult to modify, disruptive to update, and expensive to remediate as operational needs change.
QleanAir modular cleanrooms are intentionally designed for flexibility, scalability, and long-term operational performance.
Benefits of Modular Cleanroom Design
- Faster deployment timelines
- Reduced disruption to ongoing operations
- Flexible future expansion and upgrades
- Controlled installation process
- Easier long-term adaptation
- Improved scalability for changing demand
This helps healthcare organizations adapt more efficiently as operational and regulatory needs evolve.
Cleanroom Risk Builds Over Time. It Doesn’t Fail All at Once
Why QleanAir Is a Different Kind of Cleanroom Partner
Most cleanroom providers focus on getting you to certification.
That’s where their job ends.
That’s often where long-term operational challenges begin.
QleanAir focuses on how your cleanroom performs over time, not just how it performs on inspection day.
What this means for you:
- You’re not left managing performance on your own
- You can see and prioritize risk before it becomes a problem
- You make decisions based on long-term impact, not just upfront cost
- You have a partner who stays involved as your needs evolve
A Lifecycle Approach to Cleanroom Performance
QleanAir supports cleanroom performance across the full operational lifecycle — from design and implementation through validation, maintenance, and future upgrades.
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Intentional Design: Prevent Risk Before It Starts
Many cleanroom issues start at the design stage but don’t show up until later.
We understand the science behind how air moves around people, processes, and equipment. We design with this in mind, influencing the way the air moves
Computation Dynamic Fluid Model.
QleanAir designs with long-term performance in mind, so you’re not fixing problems after the fact.
Capabilities:
- Airflow modeling
- Contamination control planning
- Classification alignment (USP <797>, USP <800>, ISO 14644, cGMP)
- System-wide design approach
Operational Outcomes:
- Fewer compliance issues after installation
- A cleanroom that supports how your team actually works
- Stronger alignment with USP <797>, <800>, and ISO standards
- Less risk of redesign or costly corrections
Installation: Reduce Startup Risk
A cleanroom that looks right on paper can still fall short during installation.
QleanAir manages implementation closely so your system performs as expected from day one.
Capabilities:
- Onsite deployment
- System integration
- Commissioning and startup
- Stakeholder coordination
Operational Outcomes:
- Faster, smoother path to operation
- Fewer installation-related surprises
- Less strain on your internal teams
- Confidence that everything is working as intended
Validation: Eliminate Inspection Surprises
Validation is where many teams discover problems too late.
QleanAir helps you prepare ahead of time so there are no surprises when it matters most.
Capabilities:
- ISO classification testing
- USP compliance verification
- Environmental monitoring
- Documentation and reporting
Operational Outcomes:
- Higher likelihood of passing inspections the first time
- Clear, complete documentation
- Optimizing visibility into system performance
- Reduced risk of delays or corrective actions
Preventative Maintenance: Prevent Performance Drift
Cleanroom performance doesn’t stay static. Without consistent oversight, small issues can turn into major disruptions.
QleanAir helps you stay in control.
Capabilities:
- Preventive maintenance
- Recertification support
- Ongoing monitoring
- Rapid-response service
Operational Outcomes:
- Fewer unexpected failures
- Less downtime and disruption
- More predictable performance
- Ongoing confidence in compliance
Upgrades: Adapt Without Rebuilding
When standards change or demand increases, full replacement isn’t always the right answer.
QleanAir helps you make targeted improvements that reduce risk and extend the life of your cleanroom.
Capabilities:
- USP-driven upgrades
- Capacity expansion
- Performance optimization
- Risk-based prioritization
Operational Outcomes:
- Maintain compliance without rebuilding
- Improve performance where it matters most
- Minimize disruption to operations
- Make smarter, risk-based upgrade decisions
“The product is exceptional, the team is highly collaborative, responsive and a pleasure to work with…the QleanAir team has always gone above and beyond with their service level to assist. Highly recommend the product and the team.”
— Megan Matack, PharmD, DPLA
Director of Pharmacy, Acute Care, Children’s Minnesota
Traditional Approach vs. QleanAir
Traditional Approach:
- Built to pass initial inspection
- Limited visibility after installation
- Reactive fixes after issues occur
- Focus on lowest upfront cost
QleanAir
- Intentionally designed & built for long-term compliance and performance
- Risk visibility through CRI™
- Lifecycle support and monitoring
- Total Cost of Ownership clarity (TCO)
Case Study
Outcome: “Modular cleanrooms were considered by most participants to be a better long-term option, based on quality and lifetime costs…”
FAQs
We intentionally design your cleanroom to align with USP requirements from the start and stay involved after installation to help maintain airflow, pressure, and contamination control as conditions change.
Most providers focus on getting you through certification. We focus on helping you stay compliant long-term, using tools like CRI™ and TCO to guide decisions and reduce risk.
Yes. We regularly help improve existing cleanrooms through upgrades, optimization, and targeted improvements that reduce risk without full replacement.
We continue supporting your cleanroom with maintenance, monitoring, and recertification so performance stays consistent over time.
We identify risks early, prioritize them based on impact, and stay involved to help you manage them before they lead to failures or costly disruptions.
- Before Initial Use
- Biannual (Every 6 Months)thereafter
- When changes or repairs occur that effect airflow or ISO classification
- Trigger Events such as HVAC repairs, structural modifications, and any incident or failures that compromises room containment and/or air pressures
- Poor Facility Design and Construction failures
- Airflow and Pressure Failures
- Engineering & Environmental Control Failures
- ISO Classification & Certification Failures
- Cleaning and Disinfection Procedures Failures
- Documentation and SOP Failures
- Environmental Monitoring Failures
Installation depends on the complexity of the build, location, and scope. Also, a large contributing factor is site prep and facility readiness before the cleanroom delivery. Modular systems are largely prefabricated before arriving onsite, which reduces construction disruption, increases build efficiencies while compressing timelines, and minimizes construction waste and downtime.