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PDT® Proprietario - Prodotto

Certificazione Digitale PDT® in Blockchain

Rilasciata a:

Newster System S.r.l.

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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.

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Newster System S.r.l.

Cerasolo 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.

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Rilasciato in data

06/09/2021

Rilasciato in data: 06/09/2021

Valido fino a

06/09/2022

Valido fino a: 06/09/2022

Data del primo rilascio

06/09/2021

Data del primo rilascio: 06/09/2021

Revocato in data

08/09/2022

Revocato in data: 08/09/2022

Descrizione

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.

Obiettivi

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.

Standard di riferimento

• UNI 10384:1994 • DPR 254/03 – Attachment I (art. 2, subparagraph 1 letter to)) “Types of sanitary waste and their classification (sample list)” for treatable materials, Attachment III (art. 2, subparagraph 1, tetter m)) “Validation and verification of plant efficiency and sterilization process”; • Technical Assistance Manual: State Regulatory Oversight of Medical Waste Treatment Technologies A Report of the State and Territorial Association on Alternative Treatment Technologies (STAATT) – 1998 • 2006/42/CE Machinery Directive • 2014/30/CE Electromagnetic compatibility directive • UNI EN 12100: 2010 • CEI EN 604339-1 :2000 • CEI EN 60204-1 :2006 • UNI EN ISO 13849-1: 2008 • UNI EN ISO 13849-2: 2008 • Newster management process validation protocol for potentially infectious health waste streams – Rev. 00 of the 04/08/2021 • Specific process performance/Installation service and assistance of sterilization machines for potentially infectious waste and sanitization of dedicated containers – Rev. 00 of the 04/08/2021

Campo di applicazione

Technological solution of Newster System S.r.l. for on-site sterilization of potentially infectious dangerous healthcare waste

Principali processi coinvolti

• Supply of the sterilization plant • Training and acknowledgement of the Newster Accademy (E-learning platform + Reserved Area) • After-sales assistance (diversification of use, software update, remote control, and assistance)

Gestione della conoscenza

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.

Competenze del personale

Ruolo	Conoscenze	Abilità	Competenze trasversali	Competenze
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

Caratteristiche misurabili e tracciate digitalmente

Fase	Caratteristica	Indicatore	Risultato
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
		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	2021_02_10_AIR_EMISSION_ANALYSIS.pdf
		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	2021_02_10_WATER_EMISSION_ANALYSIS.pdf
		Sterilized residue quality check	No characterization of HP1-HP15 risk for microbiological and physic-chemical analysis	2021_02_00_URBAN_MIXED_WASTE_ANALYSIS.pdf
		Sanitization of waste containers	Colony count at 30° C on sanitized infectious waste containers	< 1 cfu/ cm² or 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

Evidenze

- Test reports carried out by Laboratorio Accreditato Gruppo CSA S.P.A. - IQC reports related to audit activities at the Ospedale Privato Accreditato Sol Et Salus in Viale San Salvador, 204, 47922 Torre Pedrera RN