Quality assurance for medical device manufacturers.

The maXYmos TL ML, from Kistler, is the first process monitoring system to meet the strict FDA and MDR regulatory requirements for quality assurance in the medtech sector. The new monitoring system can deliver 100 per cent testing; a critical requirement for manufacturers operating in environments where pharmaceutical goods and medtech equipment are produced.

The new maXYmos TL ML, based on the tried-and-tested maXYmos system, can be easily qualified and validated for integration into existing quality management systems.

Process monitoring systems play an increasingly important part in quality assurance on automated production lines. Medical device manufacturers must demonstrate that their products meet the requirements for safety and quality and provide proof of the reliability and precision of quality assurance monitoring not only throughout their own manufacturing process but also that of their suppliers.

In extreme cases, inadequate quality assurance, during the production of medical devices, can cause injury or even loss of life. Companies that place medical devices on the market are fully liable in the event that their products fail to function accurately and consistently. This is partly why the industry is subject to such strict regulation. Producers of medical devices as well as plant and machinery manufacturers operating in the medtech and pharmaceutical sectors are confronted with huge challenges, especially when it comes to integrating process monitoring systems into automated production and packing processes.


Kistler has developed this new solution on the basis of its maXYmos TL (Top Level) well proven system. Like all the systems in the maXYmos family, maXYmos TL visualizes process profiles and offers an extensive range of interfaces for connecting sensors. The system is integrated directly into the production line to monitor and evaluate the quality of every step in the manufacturing process on the basis of a curve. With the help of evaluation objects (EOs), users can adapt the curve evaluation to the specific monitoring task. For instance, the tolerances defined in the process validation can be used for this purpose. Based on this specification, the system then decides whether each workpiece is good or bad.

The functions integrated in maXYmos TL ML comply with the regulatory requirements for applications in the medtech industry. The system hardware also meets the specific requirements for measurement equipment that apply in the medtech industry, including:

• Designed to accommodate exceptionally small measuring ranges (force-displacement monitoring, torque sensor technology) • Integrated user management compliant with FDA regulatory requirements • Audit trail of all changes to testing processes, with time and user indexing for end-to-end traceability of each individual product • Optional blocking of ports for secure integration into the customer's data structure • Direct printer connection so that test records can be documented as hard copies

The new maXYmos TL ML process monitoring system from Kistler gives producers of medical devices, as well as machinery and plant manufacturers operating in the medtech and pharmaceutical sectors, a much easier solution to the validation of their production processes. With 100 percent inspection of each step in the manufacturing process, the need for mandatory process validation in production can be completely eliminated.

Qualification of the production equipment is the first requirement for proof of the system's safety. For this purpose, Kistler supplies ready-to-use checklists for Installation Qualification (IQ) and Operational Qualification (OQ). An in-plant calibration can then be performed to validate the measurement system at any time – a service that Kistler offers for its customers throughout the world. This also makes requalification of assembly plants much simpler, because the entire measuring chain is calibrated. The key benefit to manufacturers is that they can bring their product developments and innovations to market much more quickly giving them the competitive edge that is such a critical factor in this industry.

The maXYmos TL ML system supports OPC UA, so that it can be easily connected to machine controls and communicate with higher-level control and management systems.

#Kistler #Medical 

Top supplier announced!

Bechtel, one of the most respected global engineering, construction, and project management companies and the largest construction firm in the U.S. has announced ABB as a top supplier and subcontractor in its annual Supply Chain Awards.

ABB has been awarded as a top supplier and subcontractor for exceptional contributions to one of Bechtel’s major projects and relating to mining and metals. The prestigious award was presented at an annual ceremony held this month in Reston, Virginia and recognizes supplier excellence in supporting Bechtel's landmark projects across the globe. ABB local units in the U.S., Brazil, Chile, Colombia, Switzerland and Germany have worked with Bechtel on numerous equipment deliveries over the years, which are essential to the success of their projects.

The 2019 award honors technology leader ABB for excellent contractor and supplier performance in delivering Gearless Mill Drives (GMD), 245kV Gas Insulated Switchgear (GIS), 24kV Gas Insulated Switchgear (GIS), Main Power Transformers, Distribution Transformers, Harmonic Filters, as well as other equipment for the Bechtel project.

“ABB has been a vital partner to Bechtel, working with us to achieve outstanding results for our customers,” said Al Hankins, Corporate Manager Procurement & Contracts. “The performance of key suppliers continues to be critical to delivering superior service to our customers and advancing innovation for the industry.”

Companies were evaluated on multiple factors including: overall performance, ability to deliver quality services/supplies on time, ability to work collaboratively to meet milestones, and meeting or exceeding project expectations in aspects of safety, performance, technical expertise, and environmental compliance. Nominations were reviewed and approved by Bechtel procurement and project managers with final approval from senior leadership.

"This prestigious award underscores ABB's ability to deliver innovation, quality and dedication to customer success and we are truly honored to be recognized by Bechtel as one of their top suppliers." said Brandon Spencer, Managing Director for ABB’s Process Industries business. “Helping our customers to succeed and take their business forward is a key priority for ABB; our ongoing work with Bechtel exemplifies this commitment.”

#PAuto @ABBgroupnews @Bechtel

Mobile diagnostics for fieldbus network control valves

ValveLink™ Mobile 4.0 provides greater plant-wide access to control valve status for improved reliability, increased uptime

Emerson Process Management’s ValveLink™ Mobile software version 4.0 introduces mobile management of control valves on a FOUNDATION fieldbus network. Available on 475 Field Communicators, ValveLink Mobile 4.0 offers an intuitive interface featuring large touch screen icons which allow operators to configure, calibrate, validate, diagnose and troubleshoot valves in the field.

The intrinsically safe Field Communicators extend ValveLink Mobile 4.0 advantages to hazardous areas where FIELDVUE™ digital valve controllers are located. Greater plant-wide access to control valve status means operating reliability is improved, while overall plant uptime is increased using troubleshooting guides embedded in ValveLink Mobile.

Designed to meet modern work practices, ValveLink Mobile 4.0 enhances worker productivity and improves asset management with its seamless integration of field diagnostics of HART and fieldbus instruments into the ValveLink software.

ValveLink Mobile 4.0 is pre-installed on new 475 Field Communicators and can be added to existing 475 and 375 Field Communicators using the Easy Upgrade utility from Emerson

Package aids pain therapeutics process plant

Software product ensures transparent management of starting materials in pharmaceuticals development at Grünenthal (D).

Grünenthal bundles all research
and development activities at 
its campus in Aachen (D).

The research-based international pharmaceutical company Grünenthal will deploy the PAS-X process development package. The group is leading in the field of pain therapies and invests more than a quarter of its revenues in research and development. Operating Werum's PAS-X process development, pharmaceutical and biotech companies can simplify and accelerate the modeling of manufacturing processes for pre-clinical and clinical studies. Grünenthal will initially install the package for substance tracking of clinical batches at its plant in Aachen, Germany.

"With PAS-X process development we are capable of tracking the use and consumption of all raw materials in pharmaceutical development," says Dr. Martin Lueck, Vice President Head of Pharmaceutical Development & Drug Delivery at Grünenthal. "This enables us to further increase the efficiency of our development activities."

In addition to PAS-X process development, Grünenthal will also deploy the PAS-X business functions master batch records, warehouse management and weighing & dispensing.

Process automation system upgrade!

Latest release offers increased integration and easy upgrade for process, machinery and drives automation

Honeywell has upgraded Experion^® PMD, boosting the range and functionality of its comprehensive automation solution for controlling processes, machinery and drives through a single system.

The new release of Experion’s integrated Process, Machinery and Drive control, (PMD) widens the scope of the solution further, integrating Experion Alarm Management, Experion Integrated Historian,  OneWireless™ and Digital Video Manager solutions for the first time. Release 800 also adds a new Field Controller Express (FCE) controller with over 60 percent more controller point capacity, integrated Profibus and TotalPlant Alcont UPLINE/IOLINE highway interface, native peer-to-peer connectivity with Experion MX and the Experion PKS controller family through parameter connection and a single point of data entry. 

“With Experion PMD the result is better quality, more efficient production, and reduced maintenance and project lead times,” said Brad Garnett, business director, Pulp, Paper & Continuous Web Solutions at Honeywell Process Solutions. “The updates in Release 800 make it a truly all-encompassing automation solution for pulp and paper manufacturers, as well as others in the chemicals, metals, pharmaceuticals and food and beverage industries.”

PMD controllers can be used on all control levels for implementing advanced controls, fast machine controls and process controls. A single, consistent set of engineering tools across these levels means lower capital costs and enables cost effective execution of production line and plant- wide control. Benefits include reduced database maintenance, easier training, increased access to diagnostic information, single alarm and event logging, and faster control responses.

The new release is fully scalable and also continues to support migration from Honeywell’s TotalPlant Alcont (TPA) systems. Customers migrating to Experion PMD are able to reuse many existing TotalPlant Alcont assets to minimize costs, and commissioning and start-up times. Existing TotalPlant Alcont application solutions are converted to Experion using existing cabinets, I/O and wiring so the costs of implementation can be minimized while significantly extending the life of assets.

Accelerating results!

On-line Process for Supplier Selection

ARC STAR (Solutions That Accelerate Results), a domain-specific supplier selection service has been launched by ARC Advisory. This on-line, cloud-based, hosted solution provides easy-to-use tools that define a process and selection criteria for making strategic supplier selections. ARC clients can now make use of ARC’s proven supplier selection process, in an on-line, hosted, and guided environment. ARC STAR will be available for most key enterprise, automation, and manufacturing software application areas. At this release, ARC STAR is available for Advanced Process Control (APC), Analytics for Operational Excellence, Batch Control Systems, Collaborative Production Management/MES (for Discrete and Process Industries), and Distributed Control Systems (DCS).

ARC STAR – Supplier Selection Service guides users through a step-by-step process selecting and evaluating suppliers and their products against specific application and cultural requirements. The process guides the user through the project and team definition, reviewing and editing ARC-provided selection criteria and supplier questions, weighing selection criteria, developing a supplier Request for Information (RFI) list, evaluating supplier responses, and developing a final ranking of RFI results. ARC STAR then fully documents the process and results for management review and approval. ARC STAR helps ensure inclusive, fact-based, impartial supplier evaluations and selections, free of the user bias issues that typically hamper these activities. In addition, ARC estimates that ARC STAR can reduce the cost and effort of a supplier selection process by well over 50 percent.

“ARC STAR is a new area of value for ARC end user clients. We have been involved in many custom supplier selection processes over the past 25 years and have used this expertise to create a simple, cost-effective service, for others to use,” says ARC President Andy Chatha. “The ARC STAR offering will expand from the current six domains to over a dozen in the coming months.”

A complete measuring chain

The latest version of the Kistler maXYmos BL process monitoring and product testing system is the basis of a complete XY measuring chain costing less than €2400, including sensors. Since its launch, the maXYmos BL system has proved to be a cost-effective method of monitoring a wide range of manufacturing processes, especially joining, assembly, and product testing. Monitoring the relationship between force, measured by piezoelectric or strain gauge sensors, and distance, measured by potentiometric displacement sensors provides an accurate evaluation of any variation in a production process or product performance compared with a known optimum.

The new version adds envelope curve evaluation as standard to further enhance the performance of this versatile and compact monitor. During setup, the band of the envelope curve automatically wraps around the outside contour of a previously measured bundle of curves evaluated as “Good”. Automatic trend tracking, which can be activated for the band of the envelope curve, tracks the set-point limits, for example with progressive tool wear, and adjusts the evaluation function to suit the actual process in real time. One or two separate envelope curves, in addition to other evaluation objects, may be defined for each measurement curve.

In addition, new PC software allows direct transfer of the test data from the maXYmos BL to a PC and provides an easy to use method for displaying, measuring and analysing measurement curves and process values, and for evaluating process capability.

Finds root cause of upsets automatically

ExperTune’s PlantTriage software now automatically finds the root cause of process upsets.  The latest advance, “Root Cause Finder™”, automates the in-depth analysis that was previously performed by an experienced engineer.

The new technology works by evaluating correlations between instrument readings throughout an entire manufacturing facility.  Upsets that start in one part of the plant are reflected in the data patterns from other parts of the plant.  By evaluating the correlations between these patterns, and the time-shift from one to the other, PlantTriage is able to determine the most likely sources of process variation.

George Buckbee, Vice President of ExperTune, comments “Process plants can be very complex, and root cause can be difficult to find.  Our clients have been able to uncover the root cause of many difficult problems, often within minutes.  This is a real ‘needle in a haystack’ type of tool.”

Using advanced mathematical techniques, the Root Cause Finder™ works without requiring any process models or other prior knowledge of the process. 

Root Cause Finder™ results are displayed graphically, at the top of PlantTriage’s “Process Interaction Map”.  This display also shows other affected process areas.  The color-coded results show the extent and the time-lag of the cause.

John Gerry, President and Founder of ExperTune, adds “Our clients have seen literally millions of dollars in savings from people using PlantTriage Interaction Analysis.  With Root Cause Finder™, the average plant engineer can look like a genius.”

System of systems in lube plant!

InFusion ECS implementation at  lubes plant unifies existing systems to help achieve operational excellence

Invensys Operations Management has successfully implemented an InFusion™ Enterprise Control System (ECS) for ExxonMobil Lubricants & Specialties Company. Through a joint Invensys and ExxonMobil team effort, the installation was successfully completed and the plant was back to full production on schedule with no safety incidents.

Installed at ExxonMobil’s lubricants plant in Beaumont (TX US), the InFusion ECS will help manage the operating facility, controlling major processes and integrating the existing SAP enterprise resource planning, batch process and final packaging and shipping systems. By making extensive use of Invensys’ open, industry-standards-based ArchestrA® architecture framework and other advanced technologies, the ECS will apply the principles of real-time process automation across the manufacturing enterprise to improve production flexibility and workflow, as well as address end-of-life issues within the existing control systems.

“In 2004, ExxonMobil embarked on a global modernisation plan to realise the lubricant plant of the future, selecting Invensys as their preferred production and integration partner,” said Eric Moorehead, vice president, strategic accounts, Invensys Operations Management. “The InFusion ECS installation at Beaumont continues that modernisation effort. Operating as a ‘system of systems,’ the InFusion ECS holistically integrates our open technology with legacy applications and third-party solutions to improve the plant’s operations and performance in real time. This unique ability is what sets the InFusion ECS apart from anything on the market today.”

As part of its ongoing relationship with ExxonMobil, Invensys is also using its Houston (TX US), Engineering Center of Excellence to incorporate best practices for ExxonMobil in Beaumont and Port Allen, (LA US). This approach is helping ExxonMobil continually improve its control system strategies and achieve its goal of developing the lube plant of the future.

Meeting environmental and operational challenges.

Proficy® Software Platform Named GE ecomagination sm Product 

GE Intelligent Platforms has announced that its industry-leading software platform, Proficy®, has been named an ecomagination ^sm product its parent company, GE. ecomagination is GE’s corporate-wide commitment to help customers meet their environmental and operational challenges.

About ecomagination! GE is driving a global energy transformation with a focus on innovation and R&D investment to accelerate the development and deployment of clean energy technology. Since its inception in 2005, more than 90 ecomagination-approved products have been brought to market with revenues reaching $18 billion in 2009. With $5 billion invested in R&D its first five years, GE committed to doubling its ecomagination investment and collaborate with partners to accelerate a new era of energy innovation. The company will invest $10 billion in R&D over five years and double operational energy efficiency while reducing greenhouse gas emissions and water consumption. As part of the initiative, GE launched the “GE ecomagination Challenge: Powering the Grid”, a $200 million financial commitment challenging innovators to join in building the next-generation power grid.

The ecomagination program, which now has 98 approved products in the portfolio, is based on GE’s belief that solving environmental problems is good business around the world. It represents a pledge by the company to continually improve operations and invest in research and development that will produce more innovative ecomagination products. ecomagination is GE's business strategy to address global energy issues through technology and innovation. Through ecomagination, GE is driving a global energy transformation with a focus on innovation and R&D investment to accelerate the development and deployment of clean energy technology.

The Proficy Software Platform is used worldwide for industrial and commercial applications to provide deep insight into process/asset performance and identify ways to reduce costs and take corrective actions, enabling companies to increase productivity and efficiency, optimize production and decrease energy consumption and associated CO² emissions.

“The ecomagination designation is an affirmation of our commitment to providing products that meet both the ecomagination environmental performance standards, as well as the business needs of customers around the world,” said Maryrose Sylvester, President and CEO of GE Intelligent Platforms. “GE is delivering innovative products that help customers gain a sustainable competitive advantage in both operating performance and environmental performance.”

To earn ecomagination approval, Proficy was evaluated for its ability to significantly and measurably improve customers’ environmental and operating performance. The rigorous, multi-tiered review process concluded with a third-party audit to ensure accuracy and thorough documentation of technological performance. The extensive nature of this process reflects GE’s commitment to the accuracy and rigor of ecomagination, which has brought global recognition of the company’s environmentally advanced products. ecomagination products are re-qualified regularly to help ensure that claims remain accurate.

The Proficy Software Platform is ecomagination approved for improving overall process efficiency, reducing waste and defects, and reducing energy usage. “Proficy Software layered on top of our existing plant infrastructure has provided the tools to manage quality, efficiency, inventory levels, consumption and delivery information,” said Stefan Malmsten, Industrial IT Manager for Eka Chemicals, a business unit in AkzoNobel. The company’s strategy has paid off. Its sustainable business practices have earned AkzoNobel the global leader in the chemical industry ranking from The Dow Jones Sustainability World Indexes (DJSI).

Proficy Software’s integrated capability to collect, organize, analyze, and drive work processes around massive volumes of real-time data provides companies with a sustainable competitive advantage into the future. This was proven by numerous customer proof points including:

• A wine bottler in the U.S. saved $5 million annually through improved quality; increased production by 5 percent and reduced defects by 25 percent and reduced plant downtime by 25 percent. In addition, the company protected the environment by significantly lowering energy needs to run the glass furnaces, decreasing emissions by 80 percent.
• A producer of cooling lubricants in Switzerland realized up to 45% reduction in energy costs and reduced CO2 emissions with its Proficy Software solution.
• A U.S. manufacturer in the steel industry reduced scrap by more than 1,000 tons per year and improved machine uptime by approximately 1%.
• A water treatment plant in Italy realized a 28% energy efficiency improvement and significantly improved its water improvement process.
• Polish brewing company decreased the total number of mechanical and electrical downtime events by 39% and increased the availability of resources.

The Proficy Software Platform can improve overall process efficiency by approximately 3% to 15%, and can reduce waste and defects in manufacturing and infrastructure applications by approximately 1% to 10% on average. Many companies may see an even greater reduction. In addition, Proficy can significantly reduce the average energy usage associated with operations.

Proficy is the latest example of how GE’s $4 billion-a-year software and solutions services businesses are helping customers improve productivity.

Enterprise-wide collaboration made easier

Invensys Operations Management has announced the release of Skelta™ BPM 2011, a robust  business process management solution.

Skelta, a brand offering of Invensys Operations Management, provides business process management (BPM) and advanced workflow solutions for enterprises worldwide. Its flagship product, Skelta BPM software, provides a strong and collaborative platform that automates the sequence of human and system activities that are required to complete specific business goals.

A next-generation business application platform, Skelta BPM software provides users with the ability to create new BPM-enabled applications rapidly by making use of powerful features such as an embeddable, web-based process designer; forms designer; process monitoring and optimisation capabilities; multi-tenancy; multiple communication channels; and strong integration with Microsoft®  technologies. In addition, the software offers online access to the operating environment, thus enabling a SaaS or cloud version that reduces barriers to access and use.

This new release of the Skelta BPM software has many new productivity enhancements, including the ability to collaborate from within web-based forms, extending advanced BPM functionality to Microsoft SharePoint® 2010; document management enhancements; customisable user-friendly business dashboards and web parts; and support for custom controls.

Skelta BPM software is used by approximately 700 customers across many industry verticals. It is used by financial institutions, government organisations, educational institutions, business process outsourcers and other organisations to build horizontal solutions such as accounts payable, document management, compliance management, HRIS and other business processes.

Sanjay Shah

Sanjay Shah, Skelta managing director for Invensys, said, “The Skelta BPM 2011 software has matured and evolved. We strongly believe it will provide businesses across the world a better platform for enterprise-wide collaboration, while at the same time leverage existing systems to achieve operational excellence and high returns on our clients’ BPM investments. We also thank our customers and partners for giving us their valuable suggestions to help us evolve this product over the time."

To mark the launch of the Skelta BPM 2011 software, Sandy Kemsley, a leading independent BPM analyst and systems architect specialising in business process management and Enterprise 2.0, will deliver a webinar titled BPM and Application Composition. The webinar will be hosted on Tuesday, February 1, 2011, explaining how BPM-enabled composite applications ensure rapid ROI. Attendees will also have free access to a complementary whitepaper on the topic.