Rilasciato in data
06/09/2021
Rilasciato in data: 06/09/2021
Valido fino a
13/12/2023
Valido fino a: 13/12/2023
Data del primo rilascio
06/09/2021
Data del primo rilascio: 06/09/2021
Revocato in data
25/03/2024
Revocato in data: 25/03/2024
Certificazione Digitale PDT® in Blockchain
Rilasciata a:
Newster System S.r.l.PDT® - È un marchio registrato di proprietà IQC srl. La certificazione PDT è un procedimento di analisi, rilevazione e successiva rappresentazione digitale delle risultanze, riferite ad organizzazioni, processi, prodotti e persone. La certificazione PDT® con tecnologia Blockchain, rende visibili, ove possibile con rilevazione digitale, lo stato delle cose a sostegno di dichiarazioni inerenti le performance.
Clicca qui per maggiori informazioni sul modello di certificazione PDT® Proprietario - ProdottoCerasolo di Coriano
Newster Group è uno dei leader europei nella produzione e commercializzazione di apparecchiature certificate e brevettate che offrono risposte ecologiche per risolvere i problemi legati all'igiene ospedaliera con una gamma di prodotti in grado di soddisfare tutte le esigenze sanitarie per lo smaltimento dei rifiuti. Newster prepara progetti in partnership con organizzazioni internazionali, Università e strutture ospedaliere al fine di risolvere i problemi legati al trattamento dei rifiuti sanitari infettivi nelle strutture sanitarie legate alle emergenze umanitarie.
06/09/2021
Rilasciato in data: 06/09/2021
13/12/2023
Valido fino a: 13/12/2023
06/09/2021
Data del primo rilascio: 06/09/2021
25/03/2024
Revocato in data: 25/03/2024
Newster System S.r.l. obtains this PDT® certificate as it has defined in written and manifest way the qualifying characteristics of its own products and provide a periodic surveillance to guarantee the attainment and maintenance of the performances standards declared in the IQC Srl PDT.
To highlight to its costumers the attention that the Company has placed in correlating information management of its own processes according to the characteristics declared in the PDT®. The discreet and continuous digital detection of important information makes it possible to trace and monitor the evolution and guarantee the characteristics declared in the PDT® certificate.
Technological solution of Newster System S.r.l. for on-site sterilization of potentially infectious dangerous healthcare waste
Newster System S.r.l. guarantees a professional training and a continuous updating of its own designers, researchers, and technicians due to the organization of periodic scientific and legislative training courses and the participation in national and international comparison circuits, in order to provide the most qualified technical, scientific, commercial and legal support to its customers.
3rd Level Operator | - What is the potentially infectious waste – Best practices in the collection and management of the potentially infectious waste – Difference between the incineration and sterilization – Newster sterilization models: components and accessories – Frictional heat sterilization principles – How the Frictional Heat Treatment (FHT) sterilizer works– Safety rules: safety rules to follow about the workplace, precautions for use and individual protection devices – Treatable materials in the sterilizer NW – Machine loading instructions – Sterilizer work cycle procedures – Control panel: service and error messages – Sterilization process validation: how to conduct physical and biological tests. Periodic monitoring program – Instructions of how to operate the container sanitization and how to verify the sanitization efficacy – Procedures to resolve the most common problems or the most frequent error messages – Cleaning and preventive maintenance operations: how to achieve them and how frequently – Mechanical’s maintenances and procedures of installation – Dismantling and maintenance of the main mechanical components: motor, cell, dinghy, blades – Dismantling and maintenance of solenoid valves and sensors – Filters and heat exchangers maintenance – Troubleshooting – Ordinary and extraordinary maintenance of the electrical part and the programming – How to operate on the Siemens software – Procedures to dismantle, to repair and/or to substitute complete group of components – Procedures to uninstall and to substitute the complete plant | - DPI correct use – Apply the safety rules for the prevention, the containment and the contrast of infections spread – Be able to accurately and safely load and unload the material,and keep accurate record of cycles – Be able to run the plant efficiently – Be able to maintain the plant in good condition, providing the necessary cleaning and preventive maintenance – Be able to use biological indicators to verify the sterilization – Be able to perform routine installation operations – Ability to recognize the malfunctions of the plant, identify the causes and the relative possibilities of action aimed at their resolution – Ability to perform ordinary and extraordinary maintenance, both mechanical and electrical – Ability to disassemble, maintain, repair and replace any part of the sterilizer, its accessories and the connections that make up the system | Work independently, problem solving, energy saving and environmental sustainability | Know how to carry out your work effectively and efficiently, in compliance with safety measures to ensure the sterilization of health waste, and the abatement of the risks associated with it |
Plant supply |
Technological characteristics of the plant | PDT Newster “Machine 4.0 Ready” | |
Environmental characteristics of the plant | PDT Newster LCA | ||
Technical characteristics of the waste | Weigh reduction | 20-25 % | |
Volume reduction | 70-75 % | ||
Low degree of humidity | 15-20 % | ||
Reduction of the microbial load to ensure a degree of sterilization in accordance with STAAT Level IV for 28 days |
2019_07_26_ENG_NW_MICROBIOLOGICAL_VALIDATION.pdf
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Air emission quality check | The quality of airborne emissions from equipment is within the limits imposed by Legislative Decree 152/2006 – Part V – Annex I |
2022_ENG_Air_Emission_NW.pdf
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Wastewater quality check | The quality of the water produced by the equipment is within the limits imposed by Legislative Decree 152/2006 – Part III – Annex V |
2022_ENG_Waste-Water_NW+BWS.pdf
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Sanitization of waste containers | Colony count at 30° C on sanitized infectious waste containers |
2022_ENG_Flocs_Characterization_NW.pdf
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Colony count at 30° C on sanitized infectious waste containers | < 1 cfu/ cm² or abatement retes > 1 log | ||
Washing of containers cart | Colony count at 30° C on washed containers cart |
Abatement retes > 1 log | |
Training |
Training process | Technical and commercial training for the distributors | 100 % |
Training of operators specialized for the use of the sterilizer (1st level operators) | 100 % | ||
Training of operators specialized for the use and ordinary maintenance (2nd level operators) | 100 % | ||
Assistance |
Remote maintenance and/or remote diagnosis | Availability of specialized technicians for the extraordinary maintenance (3rd level operators/maintainers) | 100 % |
Response times to the request for intervention for extraordinary maintenance | Immediate | ||
Timing of intervention on site | ≤ 48 hours | ||
Installation of the webAPP In-Sight | 100 % | ||
System during in-use operation quality check |
Quality assurance of the plant | Regular verification of the plant performance in conditions of use delegated to third part | Annual |