EMPQ Without Delays: Same-Day Results That Keep Your Cleanroom On Schedule

Co-Authored by: Nicolle Gill, Microbiology Laboratory Manager, Quantus, Inc. & Jared Eberly, Field Service Department Manager, Quantus, Inc.

If you’ve lived through a paper-heavy EMPQ, you know the feeling: crews finish, reports are pending, QA waits, and small issues grow teeth. Suddenly, you’re staring at a bigger punch list and a slipping date. It doesn’t have to go that way.

When teams leave with same-day non-viable data in hand - and QA gets electronic reports and preliminary notifications quickly - you can make decisions in real time. Less waiting. Fewer surprises. A cleaner path to qualification.

At Quantus, our Environmental Monitoring Performance Qualification (EMPQ) services elevate cleanroom standards by blending preparation, compliance, and speed. An EMPQ validates your Environmental Monitoring Plan - proving your cleanroom meets stringent requirements day in and day out - while aligning with FDA, ISO 14644, and global regulatory expectations to keep your operations audit-ready.

What EMPQ Covers

EMPQ is a critical step in demonstrating that a controlled environment meets defined cleanliness and performance standards that protect your product and patient. It provides the first insights into how people and processes impact the space.

Viable vs. Non-Viable Monitoring

• Non-viable (particle counts): A fast, same-day read on particle load and airflow behavior.
  
  
• Viable (microbial growth): Samples are incubated, colonies counted, and grouped into morphology classifications.

Digital Sample Maps: Each sample point is mapped, traceable, and verified across operating states—room by room, state by state—ensuring nothing is overlooked.

The Quantus Difference

Same-Day On-Site Snapshot

You don’t wait for the first signal. We share non-viable results before our team leaves, plus a clear summary of what was sampled, where, and with which equipment. If something needs attention, you can address it immediately while the right people and tools are still on-site.

Electronic Reporting + Preliminary Notifications

No clipboards. No retyping. You receive electronic reporting and preliminary action/alert excursion notifications so QA can review, escalate, or close items quickly. It’s the early nudge that keeps small issues small and projects on track.

Hands-On Onboarding

This isn’t a one-size-fits-all template. Our microbiology experts collaborate with your team to align sampling points, limits, documentation, and communication cadence with your SOPs—so what we deliver integrates seamlessly into your quality system and satisfies auditors.

Laboratory Precision

Every EMPQ is backed by our state-of-the-art Microbiology Lab in Blue Bell, PA, equipped with HEPA-filtered air supply, dedicated sample-receipt airlocks, and high-efficiency incubators. This infrastructure ensures continuity, reliability, and results you can trust—whether we’re on-site or analyzing samples from across the country.

Why Digital Over Paper

• Digital Mapping: Room-referenced, time-stamped, and tied to operating state.
• Traceability: Instrument → Operator → Result, fully connected.
• Fewer Errors: Data flows electronically; no transcription mistakes.
• Faster Fixes: Same-day snapshots let engineering adjust airflow or procedures immediately.
• Cleaner Audits: Structured records mean faster answers and shorter audit meetings.

When to Engage EMPQ in a Build or Expansion

The earlier we talk, the smoother it goes.

• Good Times to Call: At design phase, pre-commissioning, before PQ windows, or any time you add rooms or change classifications.
• Sterile Injectable Expansions: Complex builds benefit from an early sampling strategy which, reduces discussions before crunch time.
• Hospital Pharmacy: New rooms, upgrades, or repurposed spaces all need clear maps and expectations upfront.

What You’ll Get: Day 0 to Final Report

Day Of (On-Site):

• Non-viable snapshot with particle counts and key observations.
• Equipment & method list tied to each location and operating state.

After Incubation:

• Final viable results are captured along with colony morphology classifications.
• Rapid electronic report that includes all viable results, non-viable results, and sample location maps in an all-inclusive package.

Communication Cadence:

• Preliminary notifications so QA stays ahead of issues.
• Direct access to Microbiologists for technical discussion and Laboratory Management for documentation support.

At Quantus, we go beyond basic compliance—setting a new standard in environmental monitoring by ensuring sterility, safety, and audit readiness at every step. Every data point supports one goal: protecting product quality and patient health.