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CleanSPOT Humidifiers

GMP STANDARD. VDI 6022. EU CE CERTIFIED.

Humidity and Disinfection Systems for Pharmaceutical Production

Low humidity increases static charge and product handling risk, and standalone equipment creates monitoring gaps in your compliance data.

CleanSPOT holds RH in spec and integrates with your BMS for continuous, auditable compliance, backed by real clean room installation experience.

Humidity control system installed in pharmaceutical clean room facility
PHARMACEUTICAL FACILITIES AT A GLANCE

What We Build For

Every system we ship into a pharmaceutical facility is engineered against the same baseline: the clean room classifications, air hygiene standards, and control integration your compliance program actually requires, not a generic HVAC accessory adapted after the fact.

Clean room class
B & C
Air hygiene standard
VDI 6022
Manufacturing standard
GMP
Control integration
Direct BMS
Documented Installation Qualification (IQ) and Operational Qualification (OQ) provided with every installation, so your humidity control equipment is audit-ready from day one, not something you have to chase down paperwork for after the fact. Every unit is also EU CE certified and built to withstand continuous industrial operation, not intermittent commercial use.

Why Humidity Control Matters in Pharmaceutical Production

Humidity in a pharmaceutical facility isn't a comfort setting, it's a process variable that affects product quality, equipment reliability, and whether your compliance documentation actually reflects what happened on the production floor. Four things go wrong when it isn't controlled properly.

Static charge and powder handling

Below roughly 40% RH, dry powders and granulates build up triboelectric charge during transfer and mixing. This affects flow consistency, tablet coating uniformity, and can create dust adhesion issues on packaging lines. Operators sometimes work around this manually, adjusting line speed or handling procedures, but that's a symptom fix. Controlling humidity at the source removes the problem rather than compensating for it downstream.

Continuous compliance, not a snapshot

VDI 6022 compliance is assessed on ongoing air hygiene performance, not a single inspection reading. A standalone humidifier with no BMS integration creates a monitoring gap, your compliance data has a hole in it exactly where an auditor will look. What matters isn't whether the humidifier was running when someone checked, it's whether you can show it was running correctly the entire time.

Class B and C clean room tolerances

Clean room classification tightens the acceptable range for both particulate and environmental drift. Humidification systems in these spaces need to hold spec tightly and predictably, not just on average across a shift. A system that swings within a wide band and averages out to the right number on paper still creates real risk during the periods it's out of range.

Documentation you can hand to an auditor

Equipment that works isn't enough on its own. You need Installation Qualification (IQ) and Operational Qualification (OQ) documentation proving it was installed correctly and performs as specified, that's what actually closes out an audit finding, not just a working humidifier with no paper trail behind it.

HVAC ultrasonic humidification project for Alkaloid pharmaceutical clean rooms
CASE STUDY

Alkaloid AD, Skopje

Alkaloid AD is one of the largest drug production companies in Europe. Their project required humidity control integrated directly into existing air handling units serving Class "C" clean rooms, spaces where environmental tolerance is tight and downtime for retrofitting isn't a realistic option.

CleanSPOT supplied two HVAC ultrasonic humidification devices, sized at 84 L/h and 50 L/h, matched to the specific air volume and clean room requirements of each AHU. The project was completed successfully and remains in operation.

84 L/h + 50 L/h Class C clean rooms AHU integration
Read the full case study
WHY CLEANSPOT

A Specialist in Regulated Production, Not a Generalist Supplier

Real Clean Room Experience

Completed Class C clean room installations for pharmaceutical manufacturers, including a two-unit AHU project for Alkaloid AD in Skopje
We're not a generalist HVAC vendor learning pharmaceutical requirements on your project, this is our core specialization
Our engineers understand triboelectric charging, powder handling, and cleanroom classification tolerances, not just HVAC basics

Audit-Ready by Default

Installation Qualification (IQ) and Operational Qualification (OQ) documentation provided with every installation
You get proof the equipment was installed correctly and performs to spec, not just a working humidifier and no paperwork
Documentation is included as standard, not an add-on you have to specifically request or pay extra for

Full BMS Integration

Every system connects directly to your building management system, monitored continuously, not spot-checked
No standalone units creating a monitoring blind spot in exactly the data an auditor will ask to see
VDI 6022 compliance is assessed on continuous performance, our integration is built around that reality
COMPLIANCE

Meeting Your GMP Storage Requirements

Three standards, one integrated system, so you're not managing compliance for humidity control separately from everything else in your facility.

GMP standard

Systems built to GMP standards from the start, not retrofitted after the fact to meet requirements they weren't originally designed around.

VDI 6022

The German air hygiene standard for HVAC and humidification systems, covering hygienic design, maintenance, and inspection requirements for the equipment itself.

EU CE certified

Certified to essential EU requirements and standards, documented and available for your own regulatory file.
FAQ

Frequently Asked Questions

What clean room classifications have you worked with?
We've completed projects for Class C clean rooms, including a two-unit installation for Alkaloid AD in Skopje at 84 L/h and 50 L/h capacity.
Do your systems integrate with our existing BMS? +
Yes. Our Duct & AHU and BMS-controlled humidifiers connect directly to your building management system, no standalone units creating monitoring blind spots.
Are your systems GMP standard? +
Yes, built to GMP standards and EU CE certified.
What is VDI 6022 and why does it matter? +
VDI 6022 is a German air hygiene standard for HVAC and humidification systems, relevant to pharmaceutical production environments where air quality is audited.
Ready to Spec Your Pharmaceutical Facility?

Tell us your clean room classification and target RH, we'll recommend the right system.

Request a quote