In pharmaceutical and hospital settings, compliance with a bio-decontamination cycle is not based on a mere manufacturer’s declaration. It is underpinned by standardised test methods, biological indicators and traceable documentation. The EN 17272:2020 standard is now the benchmark for automated airborne surface disinfection systems.
Solidfog develops its VHP and VH₂O₂ systems in accordance with this standard. Every product in the range is designed to meet the requirements it sets out, from the uniform distribution of the biocide to the full traceability of cycles.
What the EN 17272:2020 standard says
The EN 17272 standard sets out test methods for determining the disinfectant efficacy of automated airborne disinfection processes. It applies to the medical, veterinary, food and industrial sectors. Its aim is to standardise the conditions under which a manufacturer may claim a defined antimicrobial efficacy.
It covers the disinfection of non-porous surfaces throughout the entire treated area, including the external surfaces of equipment located within the premises. Air treatment is explicitly excluded.
Micro-organisms covered by the standard
The EN 17272 standard applies to processes claimed to be effective against the following groups of micro-organisms: vegetative bacteria, mycobacteria, bacterial spores, yeasts, fungal spores, viruses and bacteriophages. Bacterial spores are the most resistant micro-organisms on this list. The ability to eliminate them with a 6-log reduction represents the highest requirement of the standard.
Uniformity of distribution: a key requirement
The EN 17272 standard includes a distribution test. This test assesses the uniformity of disinfection at every point within the chamber, on all surfaces, including areas far from the generator, corners and horizontal surfaces facing the floor. This is a requirement that did not exist in the former French standard NFT 72-281, on which EN 17272 is based. Solidfog nebulisation technology ensures uniform and reproducible distribution of VH₂O₂ throughout the treated volume, thereby directly meeting this requirement.
Compliance with EN 17272 and in situ validation: two distinct stages
A system’s compliance with the EN 17272 standard does not exempt it from on-site validation. These two stages are complementary and both are necessary.
Compliance with EN 17272 certifies that the system has been tested in accordance with a standardised method under defined conditions. This is carried out by an independent laboratory. On-site validation, on the other hand, demonstrates that the system actually achieves the required performance in the customer’s real-world environment, with its own constraints in terms of volume, geometry and configuration.
In situ validation using biological indicators
In situ validation is based on biological indicators placed within the enclosure to be decontaminated. It must demonstrate a 6-log reduction under actual operating conditions. Each decontaminated volume is subject to a specific validation procedure. Solidfog systems are designed to produce reproducible cycles, which facilitates this validation stage and enhances its reliability.
How VHP Solidfog systems meet the requirements of the standard
VHP Solidfog systems are developed, manufactured and validated in-house. This complete control over the development process ensures consistency between the advertised performance and the results achieved in the field.
Performance validated at a reduction of 6 log
All systems in the Solidfog range, from the DosyMist® to the DosyMist CS®, deliver a validated efficacy of 6 log reduction. This level corresponds to the elimination of 99.9999 per cent of microorganisms, including spores. This is the standard required in pharmaceutical environments subject to GMP.
Data traceability and integrity in accordance with 21 CFR Part 11
The EN 17272 standard requires that cycles be documented and results traceable. Solidfog systems generate an automatic report at the end of each cycle. These reports are time-stamped and can be exported. The systems’ architecture complies with 21 CFR Part 11, which sets out the requirements for electronic data integrity in the pharmaceutical industry.
Reproducible cycles for long-term compliance
Compliance is not a one-off check. It must be maintained throughout each cycle, over the long term. Solidfog systems continuously monitor critical parameters: the dose of biocide injected, pressure and exposure time. The DosyMist XL® features a high-precision weighing sensor that automatically stops the injection as soon as the target dose is reached. The DosyMist CS® locks in recipes and checks safety prerequisites before each cycle.
EN 17272, GMP and Annex 1: a coherent regulatory framework
The EN 17272 standard forms part of a broader regulatory framework. Annex 1 of the European GMP guidelines, revised in August 2022, strengthens the requirements for controlling microbiological contamination in aseptic manufacturing areas. It explicitly refers to bio-decontamination using hydrogen peroxide in the context of isolators and barrier technologies. It also requires a validated pre-cleaning procedure prior to any hydrogen peroxide bio-decontamination cycle.
Solidfog systems are designed to remain compliant with these regulatory developments. The DosyMist® has undergone successive technological updates since its launch in 2012 to remain aligned with the requirements of Annex 1 of the GMP.
Bringing your installation into compliance with VHP requirements
Compliance with the EN 17272 standard depends not only on the system chosen, but also on how it is integrated and validated within your environment. Solidfog supports its clients in defining critical parameters, drafting the User Requirements Specification (URS) and carrying out the qualification stages.
Would you like to assess whether your installation complies with the requirements of EN 17272 and GMP?