The most effective bio-decontamination equipment. Innovative solutions for life sciences

Transcription

1 The most effective bio-decontamination equipment Innovative solutions for life sciences

2 WHY CHOOSE 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.

3 THE MOST SUITABLE SOLUTION 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 (H 2 ), 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. Hydrogen Peroxide efficiency 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 USP ) Vapour-Phase Hydrogen Peroxide is described as a surface sterilant. The Food & Drug Administration (FDA) approved it as a very powerful and efficient sterilizer. Applications Cycle times (aeration phase included)* Pass-through box 1 h Filling line 2 h Isolator 2 h Microbiological safety cabinet 4 h Laboratory 4 h Clean Room 4/8 h Animal care lab 4/8 h * Cycle times have been acheived in real specific customer application Suggested model Bioreset Pro Bioreset Plus Bioreset Smart Removable microorganisms Bacteria Bacillus, Clostridium, Mycobacterium, Listeria, Lactobacillus, Enterococcus, Staphylococcus, Enterobacter, Escherichia, Klebsiella, Serratia, Salmonella, Yersinia, Legionella Acietobacter, Pseudomonas, Acholeplasma. Viruses Fungi Herpesviridae, Iridoviridae, Poxviridae, Adenoviridae, Orthomyxoviridae, Paramyxoviridae, Parvoviridae, Rhabdoviridae, Flaviviridae, Arenaviridae, Caliciviridae, Picornaviridae, Reoviridae. Alternaria, Aspergillus, Candida, Coccidioides, Blastomyces, Histoplasma, Penicillium. Vapour-phase Hydrogen Peroxide advantages Proved efficiency Indicated for a wide range of microorganisms and viruses, Bioreset uses the H 2 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 H 2 limits the formation of potentially corrosive liquid. Unbeatable speed The low working temperature and the efficiency of the vapour-phase H 2 allow a cycle time that is attractive to a wide range of applications, and offer a rapid recovery of the production activity. Perfectly harmless It 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.

4 DESIGNED FOR EVERY NEED 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. Compact, user friendly, with the best quality-price ratio. Thanks to its small dimensions it is easy to transport and can be used inside safety cabinets, RABS, isolators and rooms. 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 Automatic and mobile version with printer, designed to be used outside the treated environment. 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. have an integrated bio-decontamination solution. It is controlled through the OEM PLC of the customer s equipment. An integrated HEPA ensures no particles are introduced with gas-enriched air. 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. Treatable volume: max 500 m 3 Injection rate: 0-10 g/min Air flow: 90 m 3 /h Dimensions: 350 x 450 x 240 mm (L x D x H) Weight: 10 kg Treatable volume: max 500 m 3 Injection rate: 0-10 g/min Air flow: up to 200 m 3 /h (adjustable) Dimensions: 315 x 603 x 300 mm (L x D x H) Weight: 25 kg Treatable volume: max 500 m 3 Injection rate: 0-10 g/min Air flow: up to 200 m 3 /h (adjustable) Dimensions: 400 x 802 x 620 mm (L x D x H) Weight: 85 kg

5 TOTAL CUSTOMER SERVICE 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.

6 For more informations visit Bioreset is a registered trademark of Amira srl Amira Srl Via Vecchia Milanese Triuggio (MB) Italy Ph Fax info@amirasrl.com Innovative solutions for life sciences