Your Annex 1 Strategy is Set.
Now, Make it Smarter.
Two years post-Annex 1, operational drag is the real challenge. Cleamix vH2O2 technology moves you beyond basic compliance to true efficiency, pairing the total coverage of True Vapor with the absolute control of Vaisala sensor technology.
Is Your Contamination Control Strategy Holding You Back?
While your facility achieved Annex 1 compliance, many first-generation processes introduce hidden operational inefficiencies and risks that compound over time. What seemed adequate for initial compliance validation now creates bottlenecks that impact productivity, increase costs, and introduce unnecessary audit anxiety.
Wasted Time & Energy
The Pre-Drying Drain:
Lengthy pre-conditioning steps and slow manual processes consume valuable cleanroom time. Your facility spends hours achieving “optimal” humidity conditions before even beginning decontamination, creating scheduling constraints and reducing operational flexibility.
Risk of Equipment Damage
The Condensation Fear Factor:
Uncontrolled “wet” processes create constant anxiety about moisture damage to sensitive electronics and instrumentation. The risk of condensation formation forces conservative approaches that compromise decontamination efficacy to protect equipment.
Inconsistent Results & Audit Anxiety
The Coverage Question Mark:
Methods like aerosols, manual wiping, or UV-only approaches make it difficult to prove total surface coverage. Shadow areas, complex geometries, and gravity-dependent distribution patterns create validation challenges that keep quality teams awake at night during audit preparations.
The Science of Certainty: Why True Vapor Outperforms Aerosol Mist
For Annex 1 compliance, repeatable and total coverage is non-negotiable. The difference between a true gas and an aerosolized mist is the difference between validated certainty and operational risk.
| Decontamination Factor | Cleamix vH2O2 (True Vapor) | Conventional Aerosol / ‘Dry Mist’ Systems |
|---|---|---|
| Physical State | True gaseous state – molecular distribution follows gas laws | Liquid micro-droplets suspended in air – subject to gravity and air currents |
| Penetration & Coverage | Uniform distribution reaches all surfaces including shadow areas, crevices, and complex geometries | Gravity-dependent droplets with poor penetration into shadowed areas and vertical surfaces |
| Process Control | Precise control via RS monitoring enables maximum efficacy without condensation risk | Limited control over droplet distribution and settling patterns |
| Condensation Risk | Active condensation prevention through Vaisala RS measurement – zero risk to electronics | Uncontrolled condensation potential requires conservative approaches |
| Validation Reliability | Consistent, repeatable coverage patterns enable robust validation protocols | Challenging validation due to variable distribution and settling patterns |
Aligned with Annex 1 Principles
Annex 1 (Clause 4.22) specifically calls for “gaseous or vaporized” agents for critical applications like isolators, validating the scientific superiority of the true vapor approach. This regulatory preference is based on physics: gases provide uniform distribution that liquid droplets simply cannot achieve.
The Cleamix Difference: True Vapor, Total Control
Total Coverage, Guaranteed by Physics
Cleamix generates authentic hydrogen peroxide vapor in a true gaseous state, not aerosolized droplets. This fundamental difference means the decontaminant follows gas laws for uniform distribution, reaching every surface regardless of orientation, geometry, or accessibility. Unlike gravity-dependent methods, true vapor penetrates into shadow areas, under equipment, and into complex spaces where contamination typically persists. The result is comprehensive coverage that can be validated with confidence.
Powered by Vaisala HPP272 for decontamination
without risk of condensation
Cleamix integrates the industry-leading Vaisala HPP272 sensor to measure Relative Saturation (RS), not just relative humidity (RH). This critical distinction enables precise control at the molecular level. While RH sensors can be “fooled” by the presence of hydrogen peroxide vapor, RS measurement provides the only accurate prediction of condensation potential. This advanced control allows Cleamix to operate at maximum decontamination efficacy while maintaining absolute safety for sensitive electronics and instrumentation. No pre-drying. No equipment risk. No compromise.
Industry-Leading Technology
Vaisala’s own technical publications emphasize the critical importance of RS measurement for vH2O2 processes, stating that traditional RH sensors can provide misleading readings in hydrogen peroxide environments. The HPP272’s RS capability represents the gold standard for condensation prevention in critical decontamination applications.
Beyond Compliance: Annex 1 Excellence Made Practical
The Requirement
Annex 1 mandates that sporicidal disinfectants be used routinely in Grade A and B areas, with particular emphasis on validated effectiveness against the most resistant microorganisms.
The Cleamix Advantage
Cleamix vH2O2 achieves validated 6-log reduction against bacterial spores (including Geobacillus stearothermophilus), representing the gold standard for sporicidal efficacy. The true vapor approach ensures spores in all locations—including those hidden under equipment or in crevices—are exposed to lethal concentrations. Automated data logging provides complete audit trails documenting both the treatment parameters and environmental conditions throughout each cycle.
The Requirement
Clause 4.22 specifically requires that isolators and RABS be decontaminated using “gaseous or vaporized” disinfection methods, acknowledging the superior distribution properties of gaseous agents.
The Cleamix Advantage
Cleamix directly fulfills this regulatory preference by generating true hydrogen peroxide vapor, not aerosol droplets. The gaseous state ensures uniform distribution throughout complex isolator geometries, including around glove ports, material transfer chambers, and intricate equipment arrangements. Vaisala sensor monitoring provides real-time verification that target concentrations are achieved and maintained throughout the enclosed space.
The Requirement
All materials and equipment entering Grade A and B areas must be appropriately disinfected, with particular attention to surfaces that may harbor contamination in hard-to-reach areas.
The Cleamix Advantage
The penetrative power of true vapor makes Cleamix ideal for material transfer decontamination. Complex equipment surfaces, packaging crevices, and intricate geometries receive uniform treatment without the shadow effects common to directional methods. The no-condensation approach protects sensitive materials and electronics during transfer, while comprehensive documentation supports material release protocols and validates the transfer process for regulatory review.
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“The precise sensor data and automated PDF reports have transformed our audit preparations. We now have complete confidence in our decontamination validation, with real-time RS monitoring that proves we’re operating safely below condensation limits while achieving maximum efficacy.”
— QA Manager, BioPharma Manufacturing
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“Eliminating the pre-drying step alone saves us 3-4 hours per decontamination cycle. The portable system gives us flexibility to treat multiple areas without major infrastructure changes, and the precise sensor-based control means we never worry about damaging our sensitive analytical equipment. Our turnaround times have improved dramatically.”
— Operations Manager, Sterile Manufacturing Facility
Ready to Optimize Your Decontamination Process?
Get a personalized quotation for Cleamix vH2O2 technology and discover how our True Vapor approach with Vaisala sensor control can reduce your operational costs while enhancing compliance confidence.
ISO13485 certified
Our quality system is compliant with the highest international standards
EN17272 certified
One of the very few decontamination systems to be certified by this standard.
Cleamix provides advanced, certified hydrogen peroxide vapor decontamination solutions that ensure hygiene, safety, and regulatory compliance across industries, from pharmaceuticals and food production to hospitals and defense.
Cleamix Ltd
Mekaanikonkuja 6
70900 Toivala, Finland
+358 40 500 5031
info@cleamix.com
