Piovan, S. Maria di Sala, Italy, launched its supervisory software for the Smart Factory, Winfactory 4.0, as a world premiere at K 2016. Winfactory 4.0 is fully compliant to "Industrie 4.0", the set of protocols and technologies to be industrially implemented by the year 2020, that forms the core of the fourth industrial revolution: the digital manufacturing. 

Supervision Software for the Digital Factory 

Industrie 4.0

Workflow- / Prozessmanagement

Winfactory 4.0 

HKS-Systems GmbH of Weiden, Germany, has expanded its portfolio further and, for the first time at the Fakuma 2017, is presenting a complete IT solution for plastics injection molding companies. The central software is their ERP system PPS::Plus Kunststoff that has already been introduced to the market. The extension is their MDE/MDS system MDE::Plus. With it, injection molding machines will be included via the OPC-UA- or a serial/parallel interface. 

HKS 

Spritzgießen

Qualitätssicherung

Digitalizing Injection Molding  

In live applications of clamping forces ranging from 500 to 2000 kN, KraussMaffei Technologies GmbH of Munich, Germany, will feature all-electric PX and hydraulic CX series injection molding machines. Liquid silicone rubbers will also be processed on all-electric machines. In addition to innovations in machine technology – all machines are equipped with the new, expanded APC plus (Adaptive Process Control) – KraussMaffei is focusing on glossy finishes that can be achieved by inductive mold temperature control. 

KraussMaffei 

Prozessregler

Spritzgießmaschinen

Freedom of Design due to Inductive Mold Temperature Control 

At a time of increasing complexity in production, efficient and rapid production and decision-making processes are essential in order to remain competitive. A fundamental requirement for this is complete transparency throughout the entire process chain ¿ including in tool and mold making. One option for creating the necessary infrastructure and transparency for rapid and improved decision-making is to use apps. 

Towards Agility and the Internet of Production with Mobile Applications 

CAD Werkzeug-, Formenbau

ERP-Systeme

Spritzgießwerkzeuge

Werkzeug- und Formenbau

Apps in Individual and  Small-Series Production 

Managing the use of injection molding equipment and associated operating costs throughout the equipment life cycle is vital to maintaining profitability. Implementing appropriate upgrades can significantly lower a manufacturer’s part costs and help ensure a competitive advantage. In special cases even replacing existing injection molding equipment with new systems is recommended. 

Spritzgieß-Zubehör und Einzelteile

Qualitätsmanagement

Profitability Study: Upgrading or Replacing? 

Contemporary 3-D measurement methods open up new ways for processors to optimize and monitor injection molding processes economically and efficiently. A benchmark helps them select and decide which optical 3-D measurement system is right for their operations. 

Optische 3D-Messsysteme

Injection Molding Production: Parts Geometry at a Grasp 

In the October issue, we investigated the most important developments in toolmaking during the past decades. The subject not only provides material for a nostalgic review, but also gives answers to burning questions – particularly if one views past history under the aspect of current and future challenges. So what could be more natural than having a round table discussion with representatives from the high-tech business to debate the two facets of “then and now”? 

Analysetools, FEM

A Round Table: No-Hassle Tooling for the Premier League 

Electro-Physik Dr.Steingroever GmbH & Co. KG, Cologne, Germany, has extended its portfolio to include the CTM-S in-line thickness measuring system. This system is suitable for continuous thickness measurement,as well as monitoring and documentation of non-metallic materials in web form.Monoor multi-layer polymer films, latex, rubber, textile or paper webs can be measured at material feed rates of up to 100 m/min and thicknesses of 20 µm to 15 mm during production. For the measurement, which can be integrated into the production process, the material (film or other webshaped material) is fed continuously over the ferromagnetic sensing roller. Flutterfree contact of the web or sheet on the roll is guaranteed by a suitable angle of wrap of the material. The measurement consists in pneumatically lowering the active-sensing, magneto- inductive roller probe onto the surface line of the material, where it records the thickness readings. 

In-Line Thickness Measurement 

CTM-S in-line thickness measuring system 

Hans Hagelstein, President EMEIA at Mold-Masters, has been with the Canada-based hot-runner manufacturer for 24 years, and so knows the company like the back of his hand. In an interview with Kunststoffe, he talks about the radical changes following the change of ownership eighteen months ago, building up capacity in global engineering, newly installed spokespersons for the markets, and de-cored molds for maximizing profits. 

Mold-Masters’ Head of Europe and India, Hans Hagelstein, in an Exclusive Interview with Kunststoffe 

Heißkanaltechnik

"We Want to Be Seen as a Solution Provider" 

Mettler Toledo introduces Sensors That Learn - learning sensors for process analytics. Advanced algorithms allow sensors to learn process conditions within one day. 

Sensors for Process Analytics 

Sensors That Learn 

During this year’s pandemic, maintaining supply capability has become a key necessity among processors. Closer involvement of suppliers is only logical in these circumstances. In toolmaking, new challenges are emerging for services related to molds.

Tool qualification in the test center in Bahlingen, Germany. After that, the tool is ready for the “site acceptance test”, i . e. for the acceptance on site directly at the customer

The Advantages of a Network for Global Qualification for Injection Molding

Kunststoffverarbeitung: Verfahren

Erstbemusterung, Erstmusterprüfbericht

Dienstleistungen

Werkzeug-, Formen- und Modellbau

Werkzeugbau

Inline- / Online-Messsysteme

Qualitätssicherung Kunststoff

Fast and Effective Start of Production

Digital transformation presents concrete challenges in a dynamic way. Continually mastering them, time and again, requires a workforce with a high degree of expertise and know-how. The plastics processor framas therefore not only regards training and ongoing education as essential, they usually begin directly on recruitment. It is now three years since the SME re-prioritized the issue of qualification as a strategically important competitive factor and began to promote it.

Advanced training is continually required and fostered – whether for new recruits or seasoned employees

At framas, Advanced Training of All Employees Is a Cornerstone of the Company’s Strategy

Soft Skills

Wissensmanagement

Wirtschaft

Strategie und Organisation

Digitale Transformation

Innovationen und neue Technologie

Weiterbildung, allgemeine

Seminare, Schulungen, Kongresse

Fertigungsautomation

Continuously Investing in  Expertise and Skills

In order to certify its products for the required cleanroom class for food, pharmaceutical, and medical industries, the plastics processing company Pöppelmann relies on software by CAQ AG.

The product portfolio of Pöppelmann includes laboratory supplies that meet highest quality requirements

16:9

Quality Management Software

Software Qualitätsmanagement

Software

Measurable and Reproducible Processes in the Cleanroom

In production and research, process data and previously defined quality values are tracked to determine optimization models and pursue consistent quality management. In contrast, data that is not relevant to the specific application is rarely recorded.

Structure and interconnection along the information-pyramid subsequently generate knowledge from sensorsignals.

Part 9: Consistent Data Structures for Sustainable Access to Secure Knowledge

Messdatenerfassung und -verarbeitung

Machine Learning

Datenanalyse

Datenbanken

Industrie 4.0 für die Kunststoffverarbeitung

Big Data für die Qualitätssicherung

Industrie 4.0 für die Qualitätssicherung

IoT-Plattformen für die Kunststoffverarbeitung

Complete Data without Ifs and Buts

Making Converters Fit for the Manufacture of Medical Devices

VDI ProValiMed Guideline Project Launched

In particular, for component manufacturers, also called converters, the validation of processes under the new Medical Device Regulation is a challenge – whereas the product manufacturers of medical devices already have ways of approach worked out for that. The ProValiMed 2023 initiative sets guardrails with the help of a new VDI guideline. The aim is to use the guideline to create a generally agreed consensus in the sense of “good practice”. As a guideline for action, it defines framework conditions for processes of manufacturing plastic components for medical devices.

Safety of users and patients are indispensable requirements for medical devices. In addition to clinical evaluation and testing of usability, the validation of product properties and manufacturing process in the development is therefore of particular importance (Fig. 1).

International regulations, such as the recently revised Medical Device Regulation MDR 2017/745 [MDR17] of the European Union with regard to increased requirements for patient safety, call for validation of the manufacturing processes as part of the development process. The MDR defines safety as an essential performance requirement for the medical device. The requirements for the validation of the process are not explicitly defined. However, for technical documentation, specifically for the design and manufacturing information, the regulation requires „complete information and specifications, including the manufacturing processes and their validation, their adjuvants, the continuous monitoring and the final product testing.“ (MDR 2017/745, Annex II, pt. 3b). Further explanations for validation are still open. Standards describing quality management systems for medical devices, such as ISO 13485 [ISO16], on the other hand, elaborate on the concept of validation in more depth: „The organization shall validate any processes for production and service provision where the resulting output cannot be or is not verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered.“ (ISO 13485, 7.5.6 Validation of processes for production and service provision).

This assessment is also made by the Experience Exchange Group of the Bodies Notified under the Medical Devices Regulation (EK-Med), a national body of the Central Authority of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices. Sterilization processes, cleaning processes, aseptic filling, packaging processes for sterile products, coating processes, injection molding, soldering, gluing, welding are named as processes to be validated [EKM07].

AiF Project “ValiData“ Delivers First Solutions for Injection Molding

It is clear that validation of the process is required, but the regulations deliberately do not include explicit requirements for validation and place this in the hands of the manufacturers placing the product on the market. The AiF project “ValiData“ aims to provide an initial approach to validation specifically for the injection molding process. The Institute for Plastics Processing (IKV) Aachen, Germany, is currently investigating methods for validating injection molding processes for medical technology through process control strategies as part of a joint industrial research project [AIF20].

The product manufacturers of medical devices have meanwhile developed their own strategies and approaches to validation, adapted to their products and manufacturing processes aligned with the Notified Bodies. This marks an individual approach that is customary in the industry, but also results from the fact that standards and guidelines for orientation have not yet been available for this topic.

In particular, small and medium-sized converters respectively producers of components who act as suppliers for various product manufacturers are faced with major challenges against the background of the growing requirements for process validation. After all, they have to organize their own manufacturing processes accordingly and establish a validation process that conforms to the regulations. Process validation requires both time and capacity resources. It must be planned and taken into account at the right time. The documentary effort involved in validation should not be underestimated. Different views on the contents and procedures within the scope of a validation between customers and suppliers sometimes not only cause friction and discord in the project process, they can even lead to a considerable delay.

The need for a framework guideline for plastics processing was recognized by the VDI technical working group “Plastics in Medical Technology“. In April 2021, the VDI guideline project 2023 “Validation of plastics processing for medical – ProValiMed“ was launched. The aim is to develop a guideline that provides guarding rails and framework for the validation of manufacturing processes for plastic components. This should enable converters, i.e. component manufacturers, in particular to design their own validation processes based on it. The guideline focuses on the injection molding process, although it can also be applied to other plastics processing methods such as extrusion, film production and welding processes. In this way, it should also be possible for manufacturers previously unfamiliar with the sector to align their own processes accordingly with the requirements of medical technology in order to gain a foothold in the industry. Another important aspect is that customers can refer to these guardrails. Often the product manufacturer who brings the final product into the market is not an expert in plastics processing. He does not have to be. For both sides, it is therefore important to avoid unnecessarily overshooting the mark due to lack of knowledge.

25 Experts Structure the Guideline Piece by Piece

The working group consists of about 25 representatives of product manufacturers, producers (converters) of plastic components, universities and machine manufacturers as well as experts from statistical data analysis. Together, they started last year to design the structure of the guideline and to fill it bit by bit with content. The guideline addresses the various aspects of validation for component producers and manufacturers (Fig. 2).

In a first step, the roles and responsibilities of the actors are to be defined. The section “Regulatory requirements“ describes the context of the topic of validation in relation to the legal requirements. The concept of validation is based on a risk-based approach with regard to the use of the medical device, which is presented in a separate chapter. The methods of statistics and test specifications form the statistical toolbox of validation, terms such as sample analysis, AQL values or process capability are thereby explained. The procedure for determining process limits and validation strategies, for example for similarity consideration and analogy conclusions for the validation of comparable processes up to recommendations for action for revalidation or the procedure for changes to the process (Change Management) also mark up an important part of the guideline. Further topics are the handling of process data and the documentation for validation.

The validation of the medical device itself is not the subject of the guideline work described, as this is the responsibility of the manufacturer. The focus of the guideline work is rather to be placed on the development of validation concepts for the manufacturing process of the components with regard to the aforementioned procedures and thus to address in particular the manufacturers of plastic components such as medium-sized processors respectively converters but also manufacturers of medical devices.

What is the roadmap for the future? Now that the structure of the guideline is in place, the various topics are currently being worked out in a joint dialogue. The working group does not see itself as a closed circle; other interested parties who would like to contribute their expertise on the topics are highly welcome to contact the working group via the authors of this article. A draft, the so-called “greenprint“, which will be presented to the public for discussion, is expected in early 2023.

Ultimately, the resulting guideline should contribute to the standardization of the procedure in process validation for plastic components in order to save cost and time in the validation process through coordinated validation concepts and the associated documentation, thus contributing to safe products.

[AIF20] AiF Arbeitsgemeinschaft industrieller Forschungsvereinigungen ‚Otto von Guericke‘ e. V.: Entwicklung einer effizienten Methodik zur Validierung von Spritzgießprozessen am Beispiel der Medizintechnik durch Integration neuer Regelungs- und Qualitätssicherungsstrategien – ValiData, Vorhaben Nr. 21127 N, Laufzeit 01.05.20 – 30.04.22

[EKM07] Erfahrungsaustauschkreises der nach dem Medizinproduktegesetz benannten Stellen (EK-Med): Validierung von Prozessen der Produktion und der Dienstleistungserbringung (einschließlich Software), Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, Dokument 3.9 B 18, Juni 2007

[ISO16] DIN EN ISO 13485: 2016–08: Medizinprodukte – Qualitätsmanagementsysteme – Anforderungen für regulatorische Zwecke

[MDR17] Verordnung (EU) 2017/745 des Europäischen Parlaments und des Rates vom 5. April 2017 über Medizinprodukte

Hochschule Schmalkalden FB Maschinenbau 

Ausgabenartikel

Fig 1. Validation as an integral part of the medical device development process.

  Source: B. Braun Melsungen AG; graphic: © Hanser

Fig 2. Thematic fields of the VDI Guideline 2023 “ProValiMed“.  

Illustration: VDI/Ulrich Overländer; graphic: © Hanser

Name - Hauptartikel

Prof. Dr.-Ing. Stefan Roth is Professor of Product Development and Design at Schmalkalden University of Applied Sciences and Chairman of the VDI Technical Committee “Plastics in Medical Technology“; <a href="mailto:s.roth@hs-sm.de">s.roth@hs-sm.de</a>

Prof. Dr.-Ing. Thomas Seul is Professor of Production Engineering and Tool Design at Schmalkalden University of Applied Sciences and President of the Association of German Tool and Mould Makers (VDWF e. V.), he chairs the VDI Guideline Committee 2023 “ProValiMed“; <a href="mailto:t.seul@hs-sm.de">t.seul@hs-sm.de</a>

Technical Regulations: from the “Greenprint“ to the Guideline

VDI guidelines are technical regulations that set quality standards in a wide range of technical fields. For this purpose, technical experts meet in guideline committees and develop guidelines on technologies, processes, materials and procedures on a voluntary basis. The Association of German Engineers (VDI) e.V. is responsible for coordination and publication. The bilingual German/English guidelines are considered to be particularly practical. A guideline is first published in draft form as a so-called “greenprint“. This is followed by a commentary phase in which everyone has the opportunity to address comments and notes to the technical committee. After evaluation and, if necessary, consideration by the expert committee, the final version is published as a “white paper“. In the meantime, more than 2200 guidelines have been produced, which are widely used in the industry.

Medizintechnik (KU)

Kunststoffverarbeitung

Prozessgestaltung

Prozessmanagement

issue 07/2022

issue 06/2022

issue 05/2022

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