CURIS® Hybrid Hydrogen Peroxide™ (HHP™) technology, an innovative low-concentration VPHP (aka vapor phase hydrogen peroxide) solution, delivers proven sporicidal efficacy, low-residue performance, and regulatory confidence—helping pharmaceutical manufacturers meet and exceed EU GMP Annex 1 contamination control requirements.
Why Annex 1 Matters
In August 2023, the updated EU GMP Annex 1: Manufacture of Sterile Medicinal Products went into effect, placing greater emphasis on proactive contamination control, risk assessment, and validated decontamination methods.
For pharmaceutical cleanrooms, isolators, and RABS, meeting Annex 1 requires:
- Validated sporicidal efficacy using regulatory-approved data
- Complete spatial coverage, including challenging areas
- Material compatibility to protect critical assets
- Detailed documentation for audit readiness
CURIS® VPHP Solutions
CURIS System offers portable, integrated, and fully customized biodecontamination systems—engineered to support cGMP compliance and Annex 1 requirements.
Key Features
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Validated >6-log Sporicidal Reduction
Biological indicator validation to meet Annex 1 efficacy standards.
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Full Spatial Coverage
Reaches gloves, under‑deck spaces, and hard‑to‑access surfaces.
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Smart Automation
Pre‑programmed cycles, remote activation, real‑time reporting.
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Low‑Concentration, High‑Impact Chemistry
7% HHP™ vapor minimizes residue, corrosion, and off‑gassing.
Product Options
Portable Systems — CURIS 3 and TRINITY™ deliver mobility and precision, ideal for multiple suites or shared facilities.
Integrated Systems — CURIS 7000ei and fixed-nozzle installations for pass boxes, airlocks, and closed-loop equipment coverage, including stand-alone decontamination chambers.
Service Solutions — Full-service biodecontamination for fast turnaround, effective even for challenging equipment (e.g., lyophilizers, IVC racks, under-deck spaces).
Explore our complete Pharmaceutical Manufacturing Solutions.
Compliance & Documentation
Annex 1 readiness goes beyond achieving a disinfected surface—it requires proof.
CURIS® systems generate detailed cycle reports including:
- Cycle parameters
- Dwell times
- Operator credentials
- Pass/fail biological indicator results
This supports internal QA, cGMP records, and external regulatory inspections.
Benefits at a Glance
✅ Annex 1-compliant sporicidal efficacy
✅ Faster re-entry times (4.8x quicker than 35% VPHP)
✅ Safer for sensitive materials and electronics
✅ Minimized audit risk with complete documentation
✅ Scalable for small isolators to full facilities
Ready to align your facility with Annex 1?
Let our contamination control experts design a VPHP solution for your cleanroom, isolator, or production line.