The mosT effecTivebio-deconTaminaTionequipmenT

Innovative solutions for life sciences

WHYCHOOSE

The control of microbiological contamination is necessary to ensure that production and research meet the requested quality and safety parameters. Periodically VPHP bio-decontamination cycles should be carried out to maintain the required conditions and manage the risks that microbial contaminants are present to these environments.

BioReset is a bio-decontamination system that uses Vapour-Phase Hydrogen Peroxide as a cold sterilising agent. It is lethal to all known microorganisms, chemically active against spores with proven kill rates, easy to handle and safer to use than other gaseous agents.

This makes Bioreset the most suitable solution for bio-decontamination.

Proved efficiencyIndicated for a wide range of micro-organisms and viruses, Bioreset uses the H2O2 in vapour phase to guarantee a uniform distribution able to reach the most difficult areas of the environment.It guarantees a microbiological 6 log reduction on all exposed surfaces, and here is a list of microorganisms removed with this technology.

Excellent compatibility Hydrogen Peroxide has chemical-physical characteristics that give very good compatibility with many materials such as metals, plastics, elastomers and all electronic devices.The vapour-phase H2O2 limits the formation of potentially corrosive liquid.

Unbeatable speedThe low working temperature and the efficiency of the vapour-phase H2O2 allow a cycle time that is attractive to a wide range of applications, and offer a rapid recovery of the production activity.

Perfectly harmlessIt is not dangerous for staff and is safe for the environment. In fact at the end of each bio-decontamination cycle it catalyses into water and oxygen, with no pollution risk.

THE MOST SUITABLE SOLUTION

Vapour-phase Hydrogen Peroxide advantages

Applications Cycle times (aeration phase included)*

Suggested model

Pass-through box 1 hBioreset Pro Bioreset PlusFilling line 2 h

Isolator 2 hMicrobiological safety cabinet 4 h

Bioreset SmartLaboratory 4 hClean Room 4/8 hAnimal care lab 4/8 h

* Cycle times have been acheived in real specific customer application

BioReset is mainly used to remove the airborne and surface microbiological contamination in controlled or classified environments for pharmaceutical, biomedical, biotechnological, animal care fields and in all those environments sensitive to microbiological contamination. BioReset works with efficiency and speed, no pre-conditioning of the environment is needed, uses Hydrogen Peroxide (H2O2), and requires little maintenance. Cost savings due to speed of cycles and less need of costly consumables makes BioReset the most convenient solution on the market.

Removable microorganisms

Bacteria Bacillus, Clostridium, Mycobacterium, Listeria, Lactobacillus, Enterococcus, Staphylococcus, Enterobacter, Escherichia, Klebsiella, Serratia, Salmonella,Yersinia, LegionellaAcietobacter, Pseudomonas, Acholeplasma.

Viruses Herpesviridae, Iridoviridae,Poxviridae, Adenoviridae,Orthomyxoviridae,Paramyxoviridae, Parvoviridae, Rhabdoviridae,Flaviviridae, Arenaviridae, Caliciviridae, Picornaviridae,Reoviridae.

Fungi Alternaria, Aspergillus, Candida, Coccidioides, Blastomyces, Histoplasma, Penicillium.

The Environmental Protection Agency (EPA) identifies it like a sterilant able to destroy all microbiological life form, including all spores, fungi and viruses.

In the USP (Chapter 10325 USP 32-2008) Vapour-Phase Hydrogen Peroxide is described as a surface sterilant.

The Food & Drug Administration (FDA) approved it as a very powerful and efficient sterilizer.

Hydrogen Peroxide efficiency

DESIGNED FOR EVERY NEED

Treatable volume: max 500 m3

Injection rate: 0-10 g/min Air flow: up to 200 m3/h (adjustable) Dimensions: 315 x 603 x 300 mm (L x D x H) Weight: 25 kg

BioReset is available in 3 models: - The Smart - stand-alone unit for any manual application, can be remotely controlled.- The Pro - built-in unit, for integration into filling lines, pass-through boxes, isolators, microbiological safety cabinets and others. - The Plus - automated and mobile unit, with touch screen display, recipe storage and secure data register. Incorporates print functionality for cycle reporting.

Treatable volume: max 500 m3

Injection rate: 0-10 g/minAir flow: up to 200 m3/h (adjustable) Dimensions: 400 x 802 x 620 mm (L x D x H) Weight: 85 kg

Treatable volume: max 500 m3

Injection rate: 0-10 g/min Air flow: 90 m3/h Dimensions: 350 x 450 x 240 mm (L x D x H) Weight: 10 kg

“Built-In” version, designed to be integrated with process equipment or facilities. This version is suitable for customers manufacturing isolators, pass boxes, RABS, filling line machines, washing machines and who want to

have an integrated bio-decontamination solution.It is controlled through the OEM PLC ofthe customer’s equipment.An integrated HEPA ensures no particles are introduced with gas-enriched air.

Compact, user friendly, with the bestquality-price ratio. Thanks to its small dimensions it is easy to transport and can be used inside safety cabinets, RABS, isolators and rooms.

Placed directly inside the environment, it works in a stand-alone mode with manual activation. Cycle setting through a simple timer.Connected to a SCADA or PLC it can be controlled for remote operation.

Automatic and mobile version with printer, designed to be used outside the treated environment.

The instrument is fully controlled through a touch screen, with recipes and report printout. A T/RH% probe can be used to further control the cycle as an option.

In order to give a complete range of qualified solutions, Amira offers to its customers Bioreset Service, a complete service package including sales, rental and technical support.

- On-site bio-decontamination service, to reset the environmental sterility or prove the efficiency of the instrument if the customer is interested in purchasing.- The validation service, executed with chemical indicator map

to verify the correct distribution and microbiological map with biological indicators charged with Bacillus Stearothermophilus spores to prove the cycle efficacy. Biological indicators are

incubated at 55 °C as described in the international guidelines. - The monitoring service, executed with appropriate instrumentation, to check the residual Hydrogen Peroxide

based on international guidelines of < 1 ppm.- Supply of consumables.

In addition all Bioreset models are accompanied with documentation and execution of IQ/OQ protocols with development of bio-decontamination cycles with chemical and microbiological map. Also PQ is available on request.

Consumables

All consumables used during validation activity such as chemical indicators, biological indicators, culture media are available.Hydrogen Peroxide is available in different quantities from 500 ml up to 5 l, accompanied with MSDS and certificate of analysis with lot traceability.

TOTAL CUSTOMER SERVICE

Amira SrlVia Vecchia Milanese 1220844 Triuggio (MB) ItalyPh. +39 0362.5281.78Fax +39 0362.9195.96info@amirasrl.comwww.amirasrl.com

For more informationsvisit www.bioreset.it

Bioreset® is a registered trademark of Amira srl

Innovative solutions for life sciences