The pharmaceutical, biotechnology and hospital sectors require bio-decontamination processes that are reliable, reproducible and compliant with current regulations. These requirements have profoundly transformed practices within the sector over the years. Vaporised hydrogen peroxide has gradually established itself as the gold standard for meeting these requirements. This is no coincidence: it is the result of a convergence between robust technical properties and an increasingly stringent regulatory framework.
The limitations of traditional decontamination methods
Before the rise of VHP, other methods were used in critical environments. Each had its own limitations, which led the sector to seek safer and more effective alternatives.
Formaldehyde: effective but phased out
Formaldehyde has long been used for the decontamination of critical environments. Its antimicrobial efficacy was well recognised. However, it is classified as a CMR substance – that is, carcinogenic, mutagenic and toxic to reproduction. Regulations governing its use have gradually become stricter in Europe, leading to a ban on its use in many industrial contexts. The safety constraints associated with its handling, its residual toxicity and the need for neutralisation have rendered it incompatible with current standards. It was precisely in this context that Solidfog co-developed its first VH₂O₂ technologies with GSK Vaccines, which was seeking a reliable alternative to formaldehyde.
Liquid disinfectants: structural limitations
Liquid disinfectants remain effective on directly accessible surfaces. However, they do not allow for the uniform treatment of all surfaces within a given space. Inaccessible areas, downward-facing surfaces, corners and crevices cannot be reached by manual application or spraying. This limitation is a major drawback in environments where total control of microbiological contamination is a regulatory requirement.
The features that have made VHP a benchmark
VHP did not become the standard simply because previous methods were inadequate. It has intrinsic characteristics that make it a suitable solution for the most demanding conditions in critical environments.
A proven broad-spectrum antimicrobial effect
VHP is effective against all groups of micro-organisms defined by the EN 17272 standard: vegetative bacteria, mycobacteria, bacterial spores, yeasts, fungal spores and viruses. Bacterial spores are the most resistant microorganisms on this list. The ability to eliminate them with a 6-log reduction represents the highest standard. This is the standard that Solidfog systems achieve across their entire range.
Non-toxic residues
VHP breaks down into water and oxygen after neutralisation. It leaves no hazardous residues on surfaces or in the ambient air. This property is crucial in aseptic manufacturing environments, where any residual chemical contamination poses a risk to both the product and staff. This is one of the inherent advantages of VHP over formaldehyde.
Material compatibility suited to critical environments
VHP is compatible with the majority of materials found in cleanrooms, isolators and RABS, provided that the cycle parameters defined during validation are adhered to. This compatibility makes it a suitable solution for sensitive pharmaceutical equipment and surfaces that come into contact with sterile products.
The VHP and current regulatory requirements
The adoption of VHP as a standard is not solely due to its technical properties. It is also because it complies with the regulatory requirements in force in the pharmaceutical and hospital sectors.
A method governed by the EN 17272 standard
The EN 17272:2020 standard sets out the test methods for assessing the disinfectant activity of automated airborne disinfection processes. It is now the benchmark regulatory framework for validating the performance of a VHP system. In particular, it sets out the requirements for distribution uniformity and logarithmic reduction. Solidfog systems are developed in accordance with this standard.
A process recognised in Annex 1 of the European GMP guidelines
Annex 1 of the European Good Manufacturing Practice guidelines was revised in August 2022. This revision strengthens the requirements for controlling microbiological contamination in aseptic manufacturing areas. It explicitly refers to bio-decontamination using VHP in the context of isolators and barrier technologies. This regulatory recognition confirms VHP’s status as the benchmark process for the most critical environments.
How Solidfog embodies these standards in its VHP range
The Solidfog range has been developed to provide a practical solution to the requirements that have made VHP an industry standard. Each system is designed, manufactured and validated in-house at Solidfog’s workshops in Belgium.
A 6-log validation across the entire range
The DosyMist®, DosyMist XL® and DosyMist CS® all deliver a validated efficacy of 6 log reduction. This level corresponds to the elimination of 99.9999 per cent of microorganisms, including spores. It complies with the requirements of standard EN 17272:2020 and GMP.
Traceability in accordance with 21 CFR Part 11
Each cycle generates an automatic, time-stamped report that can be exported. The architecture of Solidfog systems complies with 21 CFR Part 11, which sets out the requirements for electronic data integrity in the pharmaceutical industry. This traceability is an essential requirement in environments subject to regulatory inspections.
Technology developed in-house over the past 20 years
Solidfog has been developing its VHP systems for over 20 years. The company manages the entire process: design, manufacture and validation. This ensures complete consistency between the advertised performance and the results achieved in the field, regardless of the installation environment.
Choosing a VHP system suited to your environment
VHP simultaneously meets the technical, regulatory and operational requirements of critical environments. Its adoption as an industry standard is based on solid foundations: a validated broad spectrum of activity, non-toxic residues, a recognised regulatory framework and compatibility with current GMP regulations. Each installation has its own constraints. The choice of the appropriate VHP system depends on the volume to be treated, the level of integration required and the project-specific traceability requirements.
Are you looking to implement a VHP solution in your critical environment?