Performance Qualification: Proven Results in Real Clinical Workflows

After completing Installation Qualification (IQ) and Operational Qualification (OQ), the final step of the validation process is Performance Qualification (PQ), where proof meets practice.

At this stage, UV Smart demonstrates that its UV-C disinfection devices perform reliably, safely, and effectively in real clinical environments. PQ closes the loop, confirming that what works in testing also delivers measurable infection-prevention results in everyday use.

What Is Performance Qualification (PQ)?

Performance Qualification (PQ) verifies that the UV Smart device performs consistently and effectively under normal hospital operating conditions, with the actual users, workflows, and devices it will disinfect.

As defined in the IMDRF/GHTF process validation guidance, “Performance Qualification (PQ) establishes, by objective evidence, that the process, when operated within established parameters, can perform effectively and reproducibly to produce a product meeting its predetermined specifications.”

For UV Smart, this means demonstrating that devices like the D25, D45, and D60, continue to deliver validated UV-C disinfection performance in daily clinical workflows across departments such as ENT, OB-GYN, ICU, Cardiology, and Radiology.

Why PQ Matters

While IQ and OQ confirm installation and operational performance, PQ shows how those validated capabilities translate to real-world reliability.

It’s avital step for infection prevention leaders and biomedical engineers who need evidence that:

• UV-C disinfection results remain consistent with manufacturer claims.
• Cycles are repeatable across multiple users and device types.
• Pre-clean conditions (add about pre-clean).
• Staff workflows align with validated standard operating procedures (SOPs).
• Documentation and audit trails are accurately generated during use.

These outcomes are often verified through chemical indicators (CIs), and cycle performance data, in cooperation with clinical staff.

To understand how PQ fits within compliance frameworks, UV Smart details the regulatory context in Current Laws and Regulations Regarding UV-C and The New MDR Regulation vs MDD.

How UV Smart Conducts PQ

During PQ,UV Smart works closely with hospital infection-prevention teams to confirm consistent, traceable results under normal working conditions.

The PQ process includes:

1. Workflow mapping – observing typical device disinfection routines (e.g., TEE, ENT, or ultrasound probes).
2. Cycle reproducibility testing – confirming repeated UV-C doses and results match validated OQ parameters.
3. Indicator testing – using CIs to confirm microbial and chemical disinfection thresholds are achieved.
4. User training validation – ensuring staff can operate devices safely and consistently.
5. Documentation review – verifying traceability logs, timestamps, and record exports for quality assurance.

Each PQ cycle produces objective evidence that UV Smart devices maintain validated efficacy even under daily clinical variations forming the final link in the validation chain.

For examples of PQ in practice, explore how hospitals integrate UV Smart systems in:

• The D45 for high-level disinfection of OBGYN ultrasound  probes.
• The D60 for fast, chemical-free high-level disinfection of channel-less devices such as ENT scope and TEE probes.
• The D25 for high-level disinfection of point-of-care UV-C.

From Validation to Confidence

By completing IQ, OQ, and PQ, healthcare facilities can document and demonstrate full process validation. Meeting the expectations of auditors, infection-prevention committees, and medical-device regulators is critical.

For hospitals, PQ doesn’t just check a compliance box; it provides confidence that their UV-C disinfection solution works day after day, device after device, under the pressures of real-world healthcare.

To support this, UV Smart offers ongoing resources in its UV Academy and publishes practical insights through its knowledge hub.

Key Takeaway

Performance Qualification (PQ)is the ultimate validation phase, proving that UV Smart UV-C devices not only meet standards, but sustain performance in daily use.
Through PQ, UV Smart helps hospitals move from validation to verified clinical trust, reinforcing safety, reliability, and infection prevention excellence.

The Complete UV Smart Validation Series

Together, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) form the foundation of UV Smart’s validated UV-C disinfection process, ensuring every device is installed correctly, performs safely, and delivers consistent results in daily hospital workflows.

• Installation Qualification (IQ): The Foundation of Safe and Validated UV-C Disinfection
      Establishes that every UV Smart device is properly installed, documented, and ready for validation in compliance with MDR and ISO 13485 standards.
• Operational Qualification (OQ):  Proving the Power and Safety of UV Smart Technology
      Confirms that each system operates exactly as designed, verifying UV-C dosage, cycle performance, and safety interlocks under controlled conditions.
• Performance Qualification (PQ): Proven Results in Real Clinical Workflows
      Demonstrates consistent, validated UV-C disinfection in real hospital environments, ensuring traceable, reliable results across everyday clinical use.

Together, these three phases ensure UV Smart partners and hospitals can adopt UV-C disinfection with complete confidence, backed by data, documentation, and engineering expertise.

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