The ZHEROX® mobile Airborne Surface Disinfection (ASD) system

STERIGENE offers a new Airborne Surface Disinfection (ASD) solution featuring innovative Industry 4.0 technology: the mobile Zherox® system by AM Instruments.

What is ASD?

Airborne Surface Disinfection (ASD) is a process of dispersing a product in the form of a gas, vapour and/or aerosol (excluding water vapour) from a device, without the need for human intervention, targeting surfaces rather than air. (Definition per EN 17 272:2020)

It can be carried out:​

• In different forms: fogging (wet mist, droplet size > 10 µm) or nebulisation (dry mist < 10 µm)
• Using different dispersion systems: ultrasound, high pressure, compressed air nozzles or ultracentrifugation
• With different products, which must have the following characteristics: safe, controllable, molecular stability, material compatibility, rapid action and quick re-occupancy of premises, permeability and diffusion, and minimal environmental emissions

 

Why ASD?

The new text of Annex 1 of the EU GMP guidelines has been published. It has become more structured, logical and demands a robust scientific approach. The main changes are:

— An extended scope: the requirements of Annex 1 now also apply to non-sterile manufacturing.

— A principle to be implemented robustly: the Contamination Control Strategy (CCS)

Chapter 4 on premises stipulates in particular, under the section on disinfection, that:

• The disinfection process must be validated
• Where fumigation or vapour disinfection (e.g. vaporised hydrogen peroxide) of cleanrooms and associated surfaces is used, the efficacy of any fumigant and dispersion system must be understood and validated

To meet these requirements, two standards must be complied with: NF T 72-281 and EN 17272.

The NF T 72-281 standard certifies the efficacy of the disperser/product combination and determines bactericidal, yeasticidal, fungicidal and sporicidal activity.

The EN 17272 standard aims to:

• Verify, under standardised conditions close to real-world practice, that the ASD processes proposed achieve the objective for which they were designed
• Compare different processes under reproducible conditions
• Provide an experimental design framework

It is divided into two parts: efficacy testing (minimum requirements) and distribution testing (room coverage).

 

Why the Zherox® system?

As a specialist in process equipment for the pharmaceutical, biotechnology, animal facility and healthcare laboratory industries, STERIGENE selected the Zherox® system because it fully meets the regulatory requirements of its clients, and is also one of the few products to offer such innovation combined with Industry 4.0 technology.

Its Italian manufacturer, AM Instruments, specialises in the design and manufacture of contamination control equipment. It offers 3 systems for performing airborne surface disinfection using the same innovative technology on the market: HPE technology.​ AM Instruments​

 

HPE technology: a market innovation

A hydrogen peroxide solution at a concentration of less than 8% is vaporised through a nozzle, creating a mist of microdroplets that then pass through a high-voltage electromagnetic field and undergo ionisation.

The resulting solution has a high concentration of hydroxyl radicals capable of destroying micro-organisms through oxidation, guaranteeing a 6-log reduction on spores.

The electromagnetic field imparts an electrostatic charge to the dry mist, ensuring homogeneous dispersion across all surfaces of the treated area, leaving no residue or traces — only oxygen and water. There is therefore no corrosion of equipment.

This technology offers the advantage of a short diffusion time with rapid contact time (> 3 hours), enabling minimal downtime in the disinfected space.

Compliance

• Machine/Product: NFT 72 281:2015 & EN 17 272:2020
• Product: BPR No. 528/2012
• CE compliant and FDA CFR21 Part 11 directive compliant

 

The mobile Zherox® system

This is a standalone machine capable of disinfecting a volume of 300 m³. No additional ventilation system is required for proper dispersion distribution. Multiple units can be linked together to treat a larger volume. Zherox® systems are connected in real time to AM Cloud®. Via a smartphone, PC or tablet relay, you can programme and monitor your ASD cycles, check the status of your devices, collect traceability data… When using multiple Zherox® systems, the units connect to one another and synchronise to launch simultaneous ASD cycles (data saved in each Zherox® system).

 ADVANTAGES:

• HPE technology
• Short cycles
• Real-time monitoring
• Cycle traceability
• Predictive maintenance via app
• GMP report generation
• Simple user interface via the integrated screen or remotely via smartphone

 

SYNEXIN support services

STERIGENE is a company within the SYNEXIN Group, a specialist in controlled environments. We can therefore be present at every stage of your project to provide you with 360° support.​ SYNEXIN​

IMPLEMENTING ASD IN YOUR PREMISES

Our engineering department will develop the disinfection strategy to be implemented based on your recommendations, the safety of your operators, your equipment and the volume of your premises. Once validated, our technicians — equipped with the latest Zherox® models — will intervene on site. The entire disinfection process is tracked via the real-time connection system of the Zherox® units and will be delivered to you in the form of documented reports at the end of our intervention.

• Rapid and scheduled interventions
• In accordance with applicable standards and your HSE prerequisites
• Tailored contracts
• Qualified operators and specialist Zherox® equipment
• Quality documentation provided

QUALIFICATION & VALIDATION OF THE SYSTEM

Our Qualification & Validation service provides the services required to qualify and validate the ASD system in accordance with your reference frameworks and applicable standards:

• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Metrology
• Metrological verification

We can also provide, upon request, reports on biological indicators collected by our intervention teams and analysed by an accredited independent laboratory.

TRAINING YOUR PERSONNEL

Our training service offers technical and applied training modules delivered by a specialist trainer:

• Principles of bio-decontamination and ASD
• Use of ASD systems and machine interface

In-house, at your site, you will be trained in the use of the Zherox® system, integrating ASD into your bio-decontamination processes in compliance with GMP guidelines.

 

AND MORE

We can also provide maintenance services throughout the entire lifecycle of your ASD system:

• Corrective maintenance
• Preventive maintenance
• Predictive maintenance

Thanks to our specialist technical support service, we are able to intervene rapidly and effectively at your premises in accordance with your internal regulations.

If you are interested in our Zherox® system or would like to discuss any specific requirements, please contact Denis SCHRILIN by email at denis.schirlin@sterigene.com or by telephone on +33 (0)7 76 11 35 86.​denis.schirlin@sterigene.com ou par téléphone au +33 (0)7 76 11 35 86.