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PDT® Machine 4.0 Ready

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.

Clicca qui per maggiori informazioni sul modello di certificazione PDT® Machine 4.0 Ready

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

03/05/2021

Rilasciato in data: 03/05/2021

Valido fino a

03/05/2025

Valido fino a: 03/05/2025

Data del primo rilascio

03/05/2021

Data del primo rilascio: 03/05/2021

Revocato in data

03/11/2022

Revocato in data: 03/11/2022

Descrizione

Obtains this PDT® digital certificate the organization that manufactures and markets goods used for the technological and digital transformation of enterprises, according to the “Industry 4.0” model, now known as “Transition 4.0”. These assets are prepared to interconnect with the company system in which it comes into operation and provides for periodic monitoring to ensure the achievement and maintenance of the declared performance standards. This PDT certificate does not certify a possible interconnection between the Certified Asset and the company’s management system and logistics or the company’s supply network, which shall be assessed following the commissioning of the asset

Obiettivi

To highlight to its costumers the attention that the company has placed in correlating information management of its own products according to the characteristics declared in the PDT® certificate. 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

Standard IQC srl “Machine 4.0 – M 4.0 rev 01” with reference to: • Law December 11th, 2016, n. 232 • Law December 27th ,2017, n. 205 • Law December 27th, 2019, n. 160 • Law December 30th, 2020, n. 178 • Circular Agency of Revenue n. 4/E, 30/03/2017 • Guideline UNI/TR 11749 Enabling technologies for Industry 4.0 – Integration and interconnection: main aspects and examples

Campo di applicazione

Plants called “NEWSTER® NW5 – NEWSTER® NW15 – NEWSTER® NW50” intended for on-site sterilization of potentially infectious healthcare waste, integrate under a single control interface: - Machine for sterilization and conversion of hospital waste - Cleaning and Sanitizing System of Containers for Infectious Waste - Weighing system consisting of an industrial scale - Webapp software Cloud IN-Sight 4.0

Principali processi coinvolti

Newster System S.r.l. provides plants for the conversion and sterilization of infectious healthcare waste, prepared for integration and interconnection with the company system that meet the wider needs of the customer, through the following processes: • Feasibility analysis, technical support, specific consultancy on available/implementable technological solutions • Training and knowledge transfer (E-learning platform + Reserved area) • After-sales assistance (diversification of use, software update, remote control and assistance)

Caratteristiche misurabili e tracciate digitalmente

Fase	Caratteristica	Indicatore	Risultato
Industry 4.0	PLC/CNC	The transformation and sterilization NEWSTER® system for healthcare waste of the series NW5, NW15 and NW50. These are equipped with a Siemens S7-1200 PLC	Compliant
		Interconnection	The NEWSTER® systems can be connected to the internal network or to the web via a router connected to the Ethernet port of the Siemens S7 PLC. These are uniquely identified through the IP address assigned by the network. Once connected to the network, the plants are credited to the Cloud In-Sight Newster that allows to communicate to the customer’s management or to third parties via SMTP, transferring CSV files	Compliant
		Predisposition to Integration with logistic systems	The machines can be integrated through two solutions. 1) Side supply: via In-Sight, through the shipment (directed or through the business managerial) of the orders of consumables supply restoration. 2) Logistic System Side: processing the data of the In-Sight production automatically prepares the data for the environmental declaration of the customer by exporting it via SMPT in CSV format. The files can be sent directly to the customer’s environmental management system	Compliant
		Human-machine interface	NEWSTER System are equipped with a SIEMENS HMI interface which is operating on a 9” backlit touch screen operator panel. The interface is simple and intuitive and thanks to the HMI operators can control and monitor production	Compliant
		Safety requirements	NEWSTER® systems of the series NW5, NW15 and NW50 comply with 2006/42/EC (Machinery Directive), 2014/30/EC (Electromagnetic Compatibility Directive) and the applicable parts of the harmonised standards UNI EN 12100:2010, CEI EN 60439-1:2000, CEI EN 60204-1:2006, ISO 13849-1:2008 and ISO 13849-2 2008	Compliant
		Remote maintenance and/or remote diagnosis	In-Sight web interface allows a full access to the machine diagnostic data. The adoption of the Secomea gateway allows the Newster service to access the PLC taking safely a full remote control even to update the firmware	Compliant
		Continuous monitoring of process conditions and parameters	The machine continuously monitors the minimum sterilization time. In case of obvious drift of this time the machine is automatically blocked at the end of the current cycle and a malfunction communication is sent. The machine block remains until the malfunction is verified. The sensor network that equips the NEWSTER® plants of the series NW5, NW15 and NW50 measure the duration of the exposure to the heat and the parameters related to the working cycle temperature are monitored and recorded. A check on the engine’s absorption is implemented to correct any “jamming” and/or stop the machine	Compliant
		Cyberphysical System	Functionalities are not implemented	Not present
Ecological Transition	Sustainability and environmental impact	The plants named “NEWSTER® NW5 – NEWSTER® NW15 – NEWSTER® NW50” designed for the on-site sterilization of potentially infectious solid waste reduces the environmental impact of disposal by reducing the volume of waste and reclassifying it and providing it as urban solid waste
Supply distinctive features	Integration in the production management	The Plants named “NEWSTER® NW5 – NEWSTER® NW15 – NEWSTER® NW50” designed for the sterilization of potentially infectious waste integrate the management software In-Sight 4.0. This is a webAPP with cloud web pages dedicated to the collection of administrative/environmental data related to hospital waste that will be subjected to the sterilization process. The management software ensures a real-time control of the sterilization plant and allows an on-site storage in units of kg and packages of non-infectious hospital waste that must be disposed by authorised operators that have to be regularly registered to the Environmental Managers Register	License and user manual Software Webapp Cloud In-Sight 4.0 .pdf
		Integration with Cleaning and Sanitizing System for Infectious Waste Containers	The group of sterilizers “NEWSTER® NW5 – NEWSTER® NW15 - NEWSTER® NW50” is equipped with a certified system for washing and sanitizing by means of Medical Devices “MD” of plastic containers for handling potentially infectious waste. The traceability of the container washing cycle is guaranteed by a special (automatic) labelling	User manual of the Washing and Sanitizing System Containers for Infectious Risk Waste.pdf
		Integration with the integrated weighing system	The group of sterilizers “NEWSTER® NW5 – NEWSTER® NW15 - NEWSTER® NW50” is equipped with integrated weighing systems for the digital compilation of the machine register and of the loading/uploading system register for other hospital EWL (European Waste List) not subjected to the sterilization process. The integrated weighing system allows the monitoring of the input and output of kg for every treatment cycle together with the other characteristic data	User manual of the Integrated Weighing System .pdf
Performance characteristics	Newster FHT Sterilization Process Validation	The sterilization process of potentially infectious waste via the plants named “NEWSTER NW5 – NEWSTER NW15 – NEWSTER NW50” it has been validated through laboratory tests conducted by the ACCREDIA accredited third-party laboratory	Evidence Validation of the Sterilization Process .pdf
Training	Training process	The group of sterilizers Newster NW5 - NW15 – NW50 is further enhanced by the “DOCEBO” e-learning platform combined with the access to the “RESERVED AREA” that provides on-line courses designed for operators and service technician and the possibility of direct access from the website www.newstergroup.com. The courses prepared allow a remote training of the personnel dedicated to the management of the machines and their maintenance	Evidence Training Process.pdf

Evidenze

• Technical compliance file i4.0 of the Plants named “NEWSTER® NW5 – NEWSTER® NW15 – NEWSTER® NW50” of the 02/05/2021 • The i4.0 certificate of the named plants “NEWSTER® NW5 - NEWSTER® NW15 - NEWSTER® NW50” of the 03/05/2021 • EC declaration of conformity of the machine named “NEWSTER® NW5” • EC declaration of conformity of the machine named “NEWSTER® NW15” • EC declaration of conformity of the machine named “NEWSTER® NW50” • User manual of the machine named “NEWSTER® NW5” • User manual of the machine named “NEWSTER® NW15” • User manual of the machine named “NEWSTER® NW50” • Data Sheet of Plants named “NEWSTER® NW5 - NEWSTER® NW15 - NEWSTER® NW50” • Brochure of the Plants named “NEWSTER® NW5 - NEWSTER® NW15 - NEWSTER® NW50” • Data Sheet PLC • Evidence Sustainability and Environmental Impact • License and user manual Software Webapp Cloud In-Sight 4.0 • User manual of the Washing and Sanitizing System Containers for Infectious Risk Waste • User manual of the Integrated Weighing System • Evidence Validation of the Sterilization Process • Evidence Training Process