Why Cleanroom Decontamination is Critical
Cleanrooms are built to safeguard the most sensitive operations—from aseptic fill-finish lines and cell and gene therapy labs to vaccine manufacturing and medical device assembly. Yet no matter how controlled the environment, microbial threats persist.
Whether contamination originates from personnel, incoming supplies, or even from cleaning chemicals themselves, it can jeopardize more than just product quality. In GMP-regulated spaces, a single contamination event can undermine Safety, Identity, Strength, Purity, and Quality (SISPQ), trigger a costly recall, or escalate into an FDA Form 483 observation or warning letter.
Effective cleanroom decontamination must:
- Achieve consistent, validated >6-log sporicidal reduction
- Treat hard-to-reach and high-touch surfaces uniformly
- Be safe for sensitive materials, electronics, and equipment
- Align with GMP, ISO, and Annex 1 expectations
That’s where CURIS® comes in.
Vaporized Hydrogen Peroxide (VHP/VPHP) vs. Traditional Cleanroom Sterilization
Legacy methods like formaldehyde and ethylene oxide may once have been standard, but today, they fall short of cleanroom safety and compliance needs. These chemicals are carcinogenic, corrosive, and require extensive aeration.
Chlorine dioxide (ClO₂) offers high-level efficacy, but its material degradation risks, acute toxicity, and post-treatment neutralization make it impractical for most GMP environments.
CURIS' patented Hybrid Hydrogen Peroxide™ (HHP™) technology delivers:
- Faster return-to-service than high-concentration peroxide systems
- Safer chemistry (7% H₂O₂), minimizing corrosion risks with no harmful residue
- Proven efficacy across isolators, MALs, pass-throughs, and entire cleanroom zones
📍 Learn how Hybrid Hydrogen Peroxide™ vapor biodecontamination outperforms formaldehyde fumigation (see our study with Boehringer Ingelheim).
CURIS Validated Cleanroom Cycles
CURIS offers scalable, automated cleanroom decontamination systems that provide:
- Pre-programmed, validated disinfection cycles
- Robust data reporting including dwell time, concentration, operator input
- Consistent, repeatable results across transfer spaces and critical zones
CURIS technologies treat:
- BSCs and isolators
- Material airlocks (MALs) and pass-throughs
- Full cleanroom environments, including underdeck zones, walls, and ceilings
These capabilities support the principles of Pharma 4.0, helping facilities advance toward fully autonomous decontamination. CURIS’ integrated systems feature onboard sensors, real-time cycle feedback, and seamless facility integration—enabling automated, data-driven performance with full traceability in line with ALCOA+ standards for data integrity.
GMP & ISO Compliance
CURIS cleanroom solutions align with:
- EU GMP Annex 1 requirements for validated sporicidal disinfection
- ISO standards for material compatibility and contamination control
- FDA expectations for cGMP documentation and consistent high-level efficacy
Rapid Turnaround
CURIS systems provide rapid aeration—reducing room re-entry and closed-loop equipment return to use delays compared to 35% peroxide-based vapor systems. This enables shorter turnaround between production runs or shift changes, maximizing facility uptime.
Industries Served
CURIS cleanroom decontamination solutions are trusted by leaders across:
- Pharmaceutical manufacturing (aseptic fill-finish, isolators, MALs)
- Biotech and gene therapy labs
- CDMOs and CMOs
- Vivarium, bioscience, and academic research
- Compounding pharmacies
From portable systems like the CURIS 3 to fully integrated biodecontamination suites, CURIS delivers solutions tailored to your space and compliance profile.
📍 Learn more about our Regulatory Compliance solutions
Cleanrooms Demand More Than Clean Surfaces—They Demand Certainty
Whether you're preparing to meet Annex 1 updates, planning a facility expansion, or simply upgrading your decontamination workflow, CURIS provides peace of mind through:
- Validated >6-log sporicidal reduction
- Material-safe, low-concentration HHP™ and Rapid Vapor™ technologies
- Turnkey systems, mobile units, and customized integrations
- Full traceability and audit-ready reports
Ready to eliminate contamination guesswork?
Talk to a CURIS expert today to build the ideal solution for your cleanroom.
More on this topic: 5 Benefits of Hydrogen Peroxide Decontamination for Cleanrooms.