Are your metrology systems 21 CFR Part 11 compliant?

According to the US Food and Drug Administration (FDA), 7,252 medical products were recalled in 2020 — 41 per cent of these products were medical devices. Recalls are costly, both financially and to a business’ reputation, but also can pose a risk to patient safety, something all medical device businesses want to avoid. Here Jason McGlynn, commercial manager for Ireland at industrial metrology specialist The Sempre Group, explains how quality engineers can maintain data integrity — and stay 21 CFR Part 11 compliant — to prevent recalls.

Traceability is vital when manufacturing medical devices. Manufacturers must be able to provide information about every step of the process — including when each operation was completed, why, how and by who — to ensure product quality and safety.

What is 21 CFR Part 11?

Audit trails chronologically catalogue every process to provide records of operational activity during manufacturing. Auditors of devices that will be sold in the US market will check this trail to ensure that the process is fully traceable and there are no gaps where human error could cause issues, in accordance with 21 CFR Part 11.

This FDA regulation refers to how medical device companies use electronic documentation and signatures in their quality management systems. 21 CFR Part 11 was first published in 1997 to help companies in the medical device industry know how to use computers and software, maintain data safely and securely to ensure it is not corrupted or lost and trace changes to data to prevent and/or detect falsified records. It has been updated since, to reflect how technology use has changed in medical device manufacturing.

Full traceability

Not all 21 CFR Part 11 compliant equipment and software will provide a fully traceable audit trail. For example, a validated measurement system can take hundreds of measurements of a device and generate large reports of raw data so manufacturers can monitor quality. However, if quality engineers export that data and import it into another data analysis system, it leaves a gap. If there are no clear security controls when moving data manually between systems, there are multiple opportunities for human error to introduce faults that cannot be traced.

Moving data between systems can compromise data integrity — which the FDA defines as the completeness, consistency and accuracy of data and how it is recorded. Using an electronic quality management system (EQMS) can both ensure data integrity and reduce the risk of issues occurring. Information is automatically time stamped, alterations are recorded and information is stored in one central location.

Compliant equipment

When choosing data collection software, opting for one that is 21 CFR Part 11 compliant will help ensure security and authenticity. Automated, real-time data collection software, such as the Prolink SPC Data Collection Software, otherwise known as QC-CALC, can extract real-time data from any device to enable full analysis and reporting. An easy-to-use system can provide total visibility and control of data across the entire manufacturing process. Another benefit is the ability to automatically generate password protected reports, which makes it easy to spot any changes during production, identify where they happened and why and take steps to investigate and fix the issue.

Effective quality management and reporting processes can help prevent expensive recalls that can damage a manufacturer’s reputation. A compliant electronic system also means that, if a recall does occur, medical device companies have the ability to refer to transparent and authentic data so that they can correct the issue quickly and effectively.

Meteor Communications wins Scottish Water monitoring contract

Meteor Communications has been awarded a multi-year shared framework agreement by Scottish Water for the provision of multi-parameter wastewater quality final effluent monitoring. The contract has an estimated value of £2 million and follows a competitive tendering process which began in November 2020.

Bidders were invited to tender for the supply of monitoring systems that are well suited to continuous remote monitoring of final effluent. Flexibility was required in terms of the monitoring parameters; the systems should be able to operate on low (ideally solar) power in a turbulent final effluent discharge. Secure access to cloud-based data was a key requirement, in addition to minimal levels of maintenance.

The data provided by the systems will allow operators to better understand plant performance and resilience, and provide further insights into performance trends, events and pollution incidents.

Following the contract award, Meteor Communications will supply ESNET (Environmental Sensor NETwork) portable and kiosk systems in conjunction with Xylem EXO multiparameter sondes to measure final effluent water quality. The ESNET systems met the tender requirements and are ideal for this application. Meteor’s MD Matt Dibbs explains: “Historically, the installation cost and on-site maintenance requirements of final effluent monitors at smaller wastewater plants have been preclusive, but the development of ESNET systems has meant that water companies can now equip smaller rural plants with a comprehensive monitoring capability.

“There are hundreds of ESNET systems delivering water quality data from all over the UK, providing customers with high-resolution, real-time, accurate data to manage their resources with greater confidence.

“In addition to fixed applications, portable ESNETs can also be deployed in minutes; providing users with the opportunity to easily move the monitors from site to site in order to conduct short-term investigations and assessments.”

This contract award builds on the existing ESNET network in place with Scottish Water which is already providing data that can be viewed securely using the MeteorCloud portal on a tablet, PC or smartphone. The Meteor Data Centre is integrated with Scottish Water SCADA as well as upcoming platforms to deliver a futureproof solution.

As part of the framework, Meteor will provide training to Scottish Water personnel to build a comprehensive knowledge base around water quality monitoring to enhance understanding of works performance.

D-Sub demand drives connector specialist’s expansion

PEI-Genesis, a leading provider of custom-engineered connector and cable interconnect solutions, has extended its partnership with global connector manufacturer Positronic across Europe and Africa. The expansion comes after considerable demand from customers in these regions. As of June 25, 2021, enginee­rs in Africa and Europe can benefit from PEI-Genesis’s value-add service of Positronic connectors. This service involves custom configuring the vast range of standard Positronic D-Subminiature connectors from component stock, meaning greater choice with shorter lead times.

Positronic, an Amphenol company, is known for the reliability of its connectors and offers customers a range of power and signal connectors for several critical sectors, including industrial and military. PEI-Genesis offers many products from Positronic’s full portfolio of power and hybrid, rectangular and circular connectors, but it is the D-Sub product line in particular that has attracted demand from customers worldwide.

The previous franchise agreement covered the Americas, China, Southeast Asia, Oceania, and a few countries in Europe. After seeing success and demand for Positronic connectors in these regions, PEI-Genesis believes this expansion will help meet the growing needs of industrial businesses in the European and African markets, several of which have already expressed interest in the range.

“Our European and African customers have been keen for us to introduce the Positronic range, including connectors such as the D-Sub, to these markets for some time now,” said Jonathan Parry, Senior Vice President, and MD Europe for PEI-Genesis. “The D-Sub is well known for its versatility as it is used in a range of sectors for transmitting data, power, and radio frequency signals. Additionally, its reliability and relatively low cost make it a popular choice for engineers.”

Anita Warner, Director of Inside Sales and Distribution at Positronic, added: “PEI-Genesis has a strong reputation in the interconnect market for providing quick and easy access to electrical components. We are pleased to expand our relationship with them in Europe and Africa. This partnership will provide customers with an additional resource for sourcing world-class connector products.”

As part of the new franchise agreement, PEI-Genesis will assemble components at its South Bend facility in Indiana, USA. By assembling connectors from component parts, instead of holding inventory of finished goods, the company can offer greater choice with over 88 million interconnect parts in stock.

Off to a flying start

Can enclosures be machined and fitted out even faster? This article explores how the AX compact enclosure from Rittal speeds things up.

The Perforex cuts all necessary holes using data from the digital twin. Faster assembly: Interior fit-out is around 30 per cent quicker with the AX than with the predecessor model, the AE.

Meurer-etechnik is looking to the new AX compact enclosure from Rittal to improve its production efficiency. How does the new model differ from its predecessor, the AE? A day spent with enclosure production staff reveals all.

A new working day dawns at Murer-etechnik in Germany’s Westerwald region. In the incoming goods section, a young man wearing a black T-shirt with the company logo on the front and the sleeve is taking delivery of a pallet with eight AX compact enclosures from Rittal. Production Manager Steven Lauer is al- ready waiting for their arrival. In just a week’s time, the UL-compliant enclosures are set to be delivered to a special-purpose machinery manufacturer based in the Cologne area. Lauer, can’t wait to see how the new AX enclosures differ from the predecessor model, the AE.

Let’s get started,” he says. Lauer has assigned the task of fitting out the AX enclosures to three of the plant electricians. One of them is already clamping the first enclosure door into the Perforex CNC machining centre. The mounting plates are next. Progress is rapid, because the doors and mounting plates are simply added to the delivery package and staff don’t have the hassle of first detaching them from the enclosure, as is normally the case. Using the digital twin’s manufacturing data from Eplan Pro Panel, the machine cuts all the necessary holes in double-quick time. “That part is the most fun,” says Lauer, who is standing casually at the machine’s operator terminal.

“There are hardly any questions to deal with and you can see the results straight away,” he adds. t’s now time for pre-assembly, configuration and wiring. A fully automatic wire processing machine has already produced the necessary cable harnesses – also using data from the design engineering department. In this way, Meurer-etechnik is gradually implementing “enclosure manufacturing 4.0”.

The AX’s doors and mounting plates are simply added to the delivery package and are quick to machine using the Rittal Perforex BC

Lauer indicates an area in the rear part of the light-filled factory building to three members of staff, who lift the compact enclosures onto small metal trestles. Next to each of the plant electricians is a trolley with tools and a number of boxes containing electronic components. The enclosures are now lying on their backs with the doors fitted. Beside them are the mounting plates, to which the men next attach the mounting rails and cable ducts. Contactors, terminals, inverters and similar components are then installed.

During this configuration process, the electricians regularly consult their tablets to compare their work with the 3D model. Next comes the wiring. Last but not least, the fully wired mounting plate is fitted into the enclosures.

Lauer has been with Meurer-etechnik for ten years. Back when he was an apprentice, he still had to learn how to position each hole manually. “The technology has come a long way since then,” he says before asking his colleagues the following question: “So, what’s different about the AX?” The answer: “It feels like there’s more room on the gland plate.” And there is indeed 30 per cent more space for inserting cables. “That’s a huge advantage,” insists Lauer, because digitalisation is continuously increasing the number of components in the enclosure and thus also the number of cables that need to be routed inside via the gland plate.

30 per cent faster assembly thanks to tool-free installation of the handle system

He also takes a closer look at the interior wall of the compact enclosure. “There always used to be problems with the interior fit-out, because there weren’t enough options for fitting the depth stays. That has now changed,” he notes. Being able to install the rails at a variety of heights makes the process of designing the levels more flexible. Lauer points to a grey box on one of the trolleys. There are now only three cable harnesses left in it. “Once the box with the cables starts looking empty, I know we’re on the finishing straight,” he says.

There were no errors during testing, and the enclosures for the special-purpose machinery manufacturer were even ready half a day ahead of schedule. “You’re happy if, when you get to the end of the day, there’s no danger of failing to meet the delivery deadline and the quality is as it should be,” says a delighted Lauer.


Better Together: Co-Located Trade Shows for the manufacturing and engineering sector

Messe Frankfurt UK, Nineteen Group, and Rapid News Group are pleased to announce a 3-year partnership to collocate their UK manufacturing and engineering events.

The new collaboration will see Automechanika Birmingham, Design Engineering Expo, Engineering Expo, Manufacturing Expo, Med-Tech Innovation Expo, and TCT 3Sixty come together at the NEC Birmingham. The launch edition will take place for the first time from 8-9 June 2022.

Within this 3-year period all 6 events will take place alongside each other at the NEC in Birmingham creating a phenomenal offering for the manufacturing and engineering community from all vertical sectors. The partnership brings huge added value to attendees and exhibitors, with a visitor registering for one event gaining access across all shows, providing a united approach to encourage market innovation and trade.

Simon Albert, Managing Director at Messe Frankfurt UK who organise Automechanika the UK’s leading trade exhibition for the automotive aftermarket and supply chain sector comments: We have an exciting new proposition for the UK automotive supply chain and this partnership in June 2023 strengthens this opportunity further. These events naturally complement each other and by working together we can deliver the strongest platform for our customers to do business. Collocating gives the market the best possible reason to take time out of their busy schedules to visit for the duration of the shows.”

Ed Tranter, Event Director at Nineteen Group and behind the launch of the Manufacturing Expo, Engineering Expo and Design Engineering Expo explains: “Collaboration and continuous improvement is at the heart of manufacturing & engineering and the Nineteen Group. We are thrilled to be working closely with other organisations at the forefront of the sector.

As companies begin their recovery from a year of disruption, there has never been a more important time for our industry to pull together to help promote and encourage innovation and see our sectors grow. The shows provide the perfect platform for connections between suppliers and buyers with conference programmes to give a clear roadmap for a successful future. Collocating these 6 shows is an exciting opportunity and ultimately provides more value to the communities we serve. We are stronger together.”

Duncan Wood, Chief Executive at Rapid News Group, organisers of TCT 3Sixty, the event for 3D printing and additive intelligence and Med-Tech innovation Expo, the UK’s leading medical device design and manufacturing technology event adds: “The synergy between our group of shows delivers two clear benefits to the market and underpins the rationale for aligning our dates and access protocols. For the visitor the breadth of solutions under one roof at one time is unprecedented, time is precious, and these co-locations enable a prospective attendee to optimise their time out of the office. Equally the free flow of visitors across all the shows means that the return on investment for exhibitors is hugely enhanced versus each of us operating alone on different datelines. We are hugely excited to be working with a group of organisations who view the visitor experience and exhibitor ROI as importantly as we do, and we look forward to next June in anticipation.”

Hylec increases headcount, appoints Chris Shore as South Western Area Sales Manager

Hylec-APL, the specialist supplier of electrical components and enclosures, has appointed Chris Shore as South Western Area Sales Manager from July 1, 2021.  Chris joins an expanding team at Hylec as the company reports robust sales across its entire product portfolio. 

Shore is responsible for UK sales from Cornwall in the South-West across to Hampshire in the South, North and South Wales and up to Cheshire and the West Midlands.  He joins Ed Lightfoot, Northern Area Sales Manager and Jake Pitcher, Southern Area Sales Manager in the Hylec sales team headed by Sales Director Steve Robbins. 

Comments Shore: “I’m delighted to be joining Hylec at the beginning of this exciting period of growth. We are stocking high levels of product across our entire portfolio to assist customers during the present phase of high demand and to help offset production delays due to material shortages.  Across the next 12 – 18 months, we forecast strong sales as the industry emerges from the pandemic and I look forward to meeting with existing and new customers at contract manufacturers, OEMs, multi-nationals, lighting companies and designers.”

Shore joins following twenty years with a leading electronic components distributor, where his experience included worldwide purchasing and sales. 

ABB wins prestigious Red Dot Award for the product design of its new ultrasonic level transmitter

ABB’s LST200 ultrasonic level transmitter was awarded best in category for physical, as well as technical, design. The winning ABB transmitter is particularly notable for solving the surface condensation challenge often faced by plant owners, where a buildup of water has historically affected accuracy of essential plant readings. The LST200 uses new generation, active surface technology known as a “Lotus Effect” whereby surface condensate will fall off before it pools into larger droplets that could then cause problems, offering an efficient and cost-effective solution.

ABB team in Shanghai receiving the award

The Red Dot Award is a highly regarded international design prize which began in 1955. More than 15,000 admissions are submitted annually from over 70 countries around the world.

The Red Dot Awards jury said “This robust level gauge impresses with a simplicity that has been thought through down to the last detail. It presents itself as a proven means of ensuring efficiency and reliability.”

Jacques Mulbert, President of ABB’s Measurement & Analytics Division added: “To win a product design award of this magnitude is an honour. When developing the LST200 we focused on building in design and technical excellence throughout to create a product that features an intuitive user experience and powerful industrial capabilities with the overall aim of making measurement easy.”

LST200 for water applications

The smart ultrasonic level transmitter is used to measure distance between one object and another by establishing the time between emission and reception. It can be used in various industrial environments but has been designed especially for the water and wastewater treatment applications. Its design focuses on simple operation and reliability. It is modular which lends itself towards ease of installation, maintenance and upgrading. A built-in interference filter ensures that information obtained from the sensor can be used and analysed easily.

Innovative features include the adaptive intelligent algorithms based on long-term experience data and the inclusion of the ABB Ability™ Field Information Manager software for the PC which improves customer configuration efficiency.

Using an ultra-stable algorithm, the device can detect environmental changes including temperature, disturbance, measuring distance and signal strength. It then automatically compensates the variations to keep the device performing at its best.

Contrinex photoelectrics detect blood vials orientation

A manufacturer of automated laboratory equipment for in-vitro diagnostics trusts the long operating distance and high resolution of Contrinex’s reflex photoelectric sensors, available from PLUS Automation, to detect which end a cap is fitted on a blood testing vial which is a small glass test tube.

Customer application

To automate the placement of the small test tubes into carrier racks, a machine picks test tubes from a conveyor. The vials must be pushed into the carrier racks the right way up, with the cap uppermost. The challenge is that whilst the test tubes are aligned parallel to each other on the feed conveyor, they can be positioned with the orientation of the tube having the cap to the right, or the left.

The shape and material of the test tubes make measuring them difficult because they are round, transparent and filled with liquid in varying quantities, with indistinct contours and a lack of planar surfaces. Camera-based identification systems or profile scanners were considered to be too expensive. Additionally, the customer needed a quick solution that was reliable as well as economic.

Customer solution

Test tubes lying on the conveyor pass under a lightweight lever that traces the contour of the test tube, rising or falling accordingly. The side of the lever facing the photoelectric sensor provides a planer surface, guaranteeing reliable measurement.

The sensor can detect the fitted cap because it has a 2mm larger diameter than the test tube. Therefore, the machine’s controller polls the sensor every 20 ms and uses its analogue value to determine the position of the larger cap mathematically. According to this measurement, the machine then turns the test tube the right way up and pushes it into the rack. A test tube without a cap is identified by the sensor as an error since no significant difference can be detected and the machine stops running. The automation enables one test tube to be inserted every second and ensures its correct orientation.

Benefits for test and measurement market from Using LabVIEW with Sentinel 3

In the test and measurement market, Laboratory Virtual Instrument Engineering Workbench (LabVIEW), is an important tool which is used by many. LabVIEW provides users with visualisations for every aspect of an application, which makes it easier to identify problems and make adjustments where necessary in a system.

In order to use LabVIEW with PPM Test’s world-leading EMP/EMC ruggedised and shielded RF over fibre Sentinel 3 system, the team at PPM Test created a driver that is compatible with LabVIEW based systems. The driver has been approved by National Instruments and provides a high level of accuracy at +/- 1⁄4 dB across the Sentinel 3 link gain.

The Sentinel 3 driver uses the standard LabVIEW architecture and provides users with the ability to easily create an application to control Sentinel 3 and run repeatable and consistent tests that improve data accuracy. The on-screen display on the Sentinel 3 unit helps to show users the graphical programming from LabVIEW, allowing for instant test results to be displayed. As a result, manual processing is removed, saving time by a factor of four.

Within the system, users can use LabVIEW to set the transmitter and receiver gain mode, including Automatic Gain Control (AGC). It can be used to adjust the display on the Sentinel 3 to show different panel information including Tx and Rx gain, power mode, stability, status, remaining battery charge and system information, depending on what the users need.

Richard Jacklin, Global Sales Director of PPM Test, comments: “It’s critical that intelligent RF over fibre products like Sentinel 3 can work and interoperate with test & measurement graphical environments like LabVIEW. A great milestone in the Sentinel 3 development; and now working with more EMC test users.”

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Endress+Hauser and Hahn-Schickard create joint venture

Increased safety in food production and other process applications is the declared aim of the joint venture between Endress+Hauser and Hahn-Schickard. To this end, both partners have established Endress+Hauser BioSense GmbH based in Freiburg, Germany. Its aim is to enable rapid, on-site molecular analyses for the detection of bacterial or viral contamination in water and beverages, genetic modifications in food or contaminated milk.

The research and development service provider Hahn-Schickard has been working closely for many years with the Department of Microsystems Engineering at the University of Freiburg to develop rapid diagnostic tests that can detect extremely small concentrations of infectious pathogens with portable instruments. The joint venture is now aiming to transfer this technology from the field of medical diagnostics to industrial process and laboratory automation applications.

Innovative cluster

During the first few months, Endress+Hauser BioSense will operate in spaces located at the university and Hahn-Schickard. Next year the company will move into the university’s innovation center, FRIZ, currently under construction on the campus of the Faculty of Engineering. The start-up will thus expand Endress+Hauser’s activities in Freiburg, where developers are already working on new sensor technologies, biosensors and Industry 4.0 solutions.

In the development of equipment and methods for molecular analyses for process and laboratory environments, Endress+Hauser BioSense will be working closely with IST Innuscreen GmbH in Berlin, which is also part of the Endress+Hauser Group. IST Innuscreen offers a broad portfolio of nucleic acid isolation and molecular diagnostics products and among other things supplies kits and assays for PCR diagnostics.

Experienced leadership team

The joint venture is 75 percent owned by Endress+Hauser, with the remaining 25 percent held by Hahn-Schickard. Dr Nicholas Krohn, who has in-depth knowledge and experience in the field of food analysis, will serve as managing director of the new company. Dr Stefan Burger and Dr Martin Schulz, two long-time employees of Hahn-Schickard who obtained their doctorates in the field of molecular diagnostics at the University of Freiburg, will round out the management team.