Food & Pharmaceutical Futures

‘Food & Pharmaceutical Futures’ was the title of an ISA Symposium held in Cork, Ireland in March 2016, the first ISA Food and Pharmaceutical Symposium to be held outside North America. Eoin O’Riain reported on the event, which was a major success, in his magazine Read-out.net, and also on-line: his webpage reference is bit.ly/1odd6cZ

Most of his report is re-presented here, as follows:

From the time it was first mooted for Ireland in 2015 the planning for the 3rd ISA Food & Pharmaceutical Symposium was embraced with enthusiasm by the local Ireland Section. This was in Philadelphia early in 2015  and since then the ISA’s Food & Pharma Division under the able directorship of Canadian Andre Michel has ploughed forward, overcoming setbacks and the not inconsiderable distances between North America and the capital of Munster. Chair of the symposium and former Ireland Section President, Dave O’Brien directed a strong committee charged with ensuring that this – the first such international symposium organised by the ISA outside North America – would be a resounding success.

And it was.

Venues were assessed, speakers recruited and the various minutiae associated with organising an international event were discussed, duties assigned and problems solved over many late night transatlantic telephone conferences. Using the experience of the ISA staff in North Carolina and the many years of experience in organising table-top events and conferences in Ireland by the Ireland Section a very creditable event was staged at the Rochestown Park Hotel. With some justification the Symposium Chair could state before the event started “We have assembled a truly outstanding program this year, featuring some of the world’s most accomplished experts in serialization, process optimization, cyber security and alarm management to name a few. These experts will speak on the vital issues affecting food and drug manufacturers and distributors. We are delighted to have the opportunity to bring this event to Ireland for its first time outside of the United States!”

Indeed upwards of 200 registrands agreed with this view and attended the two day event: a turnout that nearly doubled the attendance at last year’s event in Philadelphia USA. Plus it was noticeable that the bulk of the delegates stayed right up to the completion of the final sessions.

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Technology and Innovation for 2020 Global Demands

Two fluent keynote speakersPaul McKenzie, Senior Vice President, Global Biologics Manufacturing & Technical Operations at Biogen (who addressed “Driving Change Thru Innovation & Standards”) and Dr Peter Martin, VP and Edison Master, Schneider Electric Company (Innovation and a Future Perspective on Automation and Control) may be said to have set the tone. The event was also graced with the presence of ISA International President for 2016 Mr Jim Keaveney.

The technical programme featured 40 presentations, delivered by 33 experts in their fields: a few of the session highlights were as follows:

Serialization

The important subject of serialization which affects all level of the pharmaceutical business especially in view of deadlines in the USA and the EU. From an overview of the need and the technology to a deep dive into the user requirements, this session provided the latest information on the world requirements and helping provide the solution needed in each facility. Speakers, as in most sessions, were drawn from standard, vendor and user organisations as well as state enforcement agencies.

Track & Trace

In the parallel Food thread of the symposium the rôle of track and trace technologies were examined. Product safety, output quality, variability and uniqueness of customer requirements manufacturers are facing increasing demands on the traceability of raw materials, real-time status of manufactured goods and tracking genealogy of products throughout the value chain from single line to the multiple sites of global manufacturers. The evolution of data systems and technologies being offered means greater benefits for Industry and presenters Vision ID and Crest will show these solutions and the advantage of modernization.

116Both conference threads came together for much of the event mirroring the similarity of many of the technologies and requirements of each sector.

Digitalization

Digitalization in industry shows what bringing the worlds of automation and digitalization together provides true and advanced paperless manufacturing with more complex devices and interconnected data systems. This is an enabler to integrated operations within industry. Using MES as a core concept to create a Digital Plant and optimized solutions with data driven services was explained. And a practical example of a plant was discussed showing the journey to paperless manufacturing and a real pharmaceutical strategy of integrating automated and manual operations.

Cybersecurity

Of course this is one of the key topics in automation in this day and age. Without implementing the proper preventative measures, an industrial cyber-attack can contribute to equipment failure, production loss or regulatory violations, with possible negative impacts on the environment or public welfare. Incidents of attacks on these critical network infrastructure and control systems highlight vulnerabilities in the essential infrastructure of society, such as the smart grid, which may become more of a focus for cybercriminals in the future. As well as threats from external sources steps ought to be taken to protect control and automation systems from internal threats which can cripple a company for days or months. This session highlighted the nature of these threats, how systems and infrastructure can be protected, and methods to minimize attacks on businesses.

Automation Challenges for a Greenfield Biotech Facility

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Networking in the coffee break

These were outlined in this session in the pharmaceutical thread. Recent advances in biotechnology are helping prepare for society’s most pressing challenges. As a result, the biotech industry has seen extensive growth and considerable investment over the last number of years. Automation of Biotech plants has become increasingly important and is seen as a key differentiator for modern biotech facilities. Repeatable, data rich and reliable operations are an expectation in bringing products to market faster, monitor and predict performance and ensure right first time delivery. This session provided the most topical trends in automation of biotech facilities and demonstrated how current best practices make the difference and deliver greater value to businesses.

Process Optimization and Rationalization

Meanwhile in the Food & Beverage thread incremental automation improvement keeps competitiveness strong. Corporate control system standardization leads to constant demand for increases in production and quality.

Industry 4.0 (Digital Factory: Automate to Survive)

The fourth industrial revolution is happening! This session asked how Global Industry and Ireland are positioned. What did this mean to Manufacturer’s and Industry as a whole? The use of data-driven technologies, the Internet of things (IoT) and Cyber-Physical Systems all integrate intelligently in a modern manufacturing facility. Enterprise Ireland and the IDA headlined this topic along with the ICMR (Irish Centre for Manufacturing Research) and vendors Rockwell and Siemens.

OEE and Automation Life-cycle

Worldwide today many of the over 60 Billion Euro spend in installed control systems are reaching the end of their useful life. However, some of these controls, operational since the 80’s and 90’s, invested significantly in developing their intellectual property and much of what was good then is still good now. Of course some aspects still need to evolve with the times. This requires funding, time and talent. For quite some time now there has been a skilled automation shortage at many companies leading organizations to outsourcing, partnerships and collaboration with SME’s to help manage the institutional knowledge of their installed control systems.

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Further networking

With corporate leadership sensitive to return to shareholders, plant renovation approval hurdle rates are usually high when it comes to refreshing these control systems. In many manufacturing facilities, engineers and production managers have been asked to cut costs and yet still advance productivity. To solve this dilemma, many world class facilities continue to focus on driving improvements through the use of automation and information technology. Some are finding that using existing assets in conjunction with focused enhancement efforts can take advantage of both worlds. Here we were shown great examples of where innovation and such experiences are helping to create real value for automation modernization.

Alarm management

And of course no matter how sophisticated systems are Alarms are always require and necessary. DCSs, SCADA systems, PLCs, or Safety Systems use alarms. Ineffective alarm management systems are contributing factors to many major process accidents and so this was an important session to end the symposium.

The social aspect of this event was not forgotten, and following a wine reception there was an evening of networking, with music, at the end of the first day.

Training Courses

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Eric Cosman in full flow

On the Wednesday, although the symposium itself was finished there were two formal all day training courses.

  1. Introduction to Industrial Automation Security and the ANSI/ISA-62443 Standards (IC32C – Leader Eric Cosman, OIT Concepts ).
  2. Introduction to the Management of Alarm Systems (IC39C – Leader Nick Sands, DuP0nt).

These, and other, ISA courses are regularly held in North America and the Ireland Section occasionally arranges for them in Ireland.

In Summary

Andre Michel, ISA FPID Director, and President of Efficient Plant Inc, summed up the impressions left by this first such ISA conference outside North America: “This was truly an internationally focused event because it tackled the significant issues and trends in automation affecting the food and pharmaceutical industries on a global scale.”

All in all the Ireland Section and its members may feel very proud in looking back on a very well organised and informative event which in an email from one of the attendees, “Thank you all, It was the best symposium I attended in the last 10 years!”

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Emerson Enardo relief valves get WirelessHART communications

Emerson acquired Enardo, a manufacturer of pressure and vacuum relief valves based in Tulsa, Oklahoma, in late 2013. This week saw the launch of a new wireless enabled version of the Enardo pressure and vacuum relief and safety valve used on storage tanks in the oil and gas, petrochemical and pharmaceutical industries.

Enardo_950_w-bracket

By adding the Smart Wireless monitoring system operating over the Emerson WirelessHART network, the safety valves, normally located on the top of large storage tanks, can easily signal to operators in the control room that they have been triggered to either relieve a pressure or vacuum condition. Such situations can arise as a result of changes in temperature, liquid level, or both, and relief valves are essential to prevent tank over or under-pressure conditions that could lead to structural failure. Enardo pipe-away, vent-to-atmosphere, in-line and end-of-line relief valves are typically installed on storage tanks to control evaporation and fugitive emission losses that result from flammable and hazardous petroleum vapour-producing products. Knowledge of the actuation of such a safety valve enables an immediate response, where needed, to prevent problems which can be related to safety, emissions, and the quality of a tank’s content.

Steve Attri, product manager at Emerson for the Enardo valves, commented: “Until now, PVRVs have remained un-monitored, with none of the feedback loops commonly seen in other pressure control devices. As the tank’s primary pressure control device, this wirelessly-monitored solution can be invaluable.”

Enardo manufactures tank and terminal safety equipment, including hatches, vent, pressure and vacuum relief valves and flame arrestors used in the oil and gas, petrochemical, chemical and other industries. Enardo in-line and stack vent valves have been the oilfield industry standard for more than 80 years.

Prior to the acquisition by Emerson, Enardo had sales of $65m a year, and employed 140 people. It now operates within the Regulator Technologies business, previously known as Fisher Regulators, within Emerson Process Management.

© Nick Denbow ProcessingTalk.info

@ProcessingTalk

Ireland moves ahead in PAT for biopharmaceuticals

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Dr Karen Twomey, holding a PATsule

Ireland has established pharmaceuticals as one of their major production industries, and this has led to a major concentration of expertise, particularly around Cork. The Tyndall National Institute there, with others, have developed a smart sensor capsule for use in bioreactors, to provide process analytical information – a true PAT sensor. Given the name of a ‘PATsule’, the sensor is designed to float freely about in the process liquids, to transmit in-situ process monitoring even from within the active biofluid: it communicates with the rest of the world using wireless. The PATsule “uses a multi-disciplinary approach of micro- and nano-sensor technology, miniaturised instrumentation, data analytics and wireless communications” according to Dr Karen Twomey, at Tyndall. The PATsule has been specifically used in the production of protein therapies.

In March even more pharma expertise will visit Cork, as the ISA from America recognizes Ireland’s status as the place to review modern pharmaceutical production by bringing the Food and Pharma Division symposium to Cork. This is the first time ever that this symposium will be held outside North America.  Special attention will be paid in the meeting to the rôle of automation technology and innovation in the industry, particularly relating to regulatory requirements and manufacturing costs. The dates to be in Cork are 14-15 March.

New paperless recorder

Yokogawa has announced the launch of their new SmartDAC+ GX and GP series paperless recorders, which comply with the FDA 21 CFR Part 11 guidelines, and accommodate an increased number of inputs. The FDA 21 CFR Part 11 guidelines were issued in 1997, and stipulate what is required for electronic records and electronic signatures to have the same validity as paper-based records and signatures. With release 2, the GX and GP series recorders now comply with these guidelines for use in production operations.

In addition the new units can be used with up to six expansion units, each of which can accommodate up to 60 inputs. Including direct inputs, this gives each recorder the ability to handle a combined total of up to 450 inputs. The expansion units can be located at up to 100m from the recorder, so enabling reduced cabling costs for satellite operations.

The recorder also is available with an optional graphic display, enabling the unit to operate as a process display unit or console panel, in addition to its main data recording function.

Début for Azbil Corp at the ARC World Industry Forum

Last month most of the news flow seems to have emerged around the ARC World Industry Forum, which took place in Orlando, Florida from February 11-14.With around 24 companies acting as sponsors at the conference, and attending as exhibitors in the ‘Innovations Showcase’ area, there were even more magazines and websites present to report on the event – 29 listed as sponsors, and 40 media companies in total!

Just like last year the major name noticeably missing from the exhibition, out of the main process automation suppliers, was that of Honeywell. But this provided a major opportunity for Azbil, the former Yamatake – who had a license agreement with Honeywell until 2002 – to make an impressive entrance to the ARC Forum scene, perhaps building on their recent acquisitions and initiating further expansion plans.

Azbil business profile
Based on nine months of their current financial year Azbil is a $2.2Bn sales turnover company, of which 90% is in the home Japanese market. The major proportion of exports go to China, followed by the rest of Asia: North American sales are fairly insignificant in group terms, but are around $1.5m.

The name Azbil*
The word Azbil was introduced on the 100th anniversary of the founding of the company, to signify “human-centered automation” as the new direction for the business. The group philosophy is to “realize safety, comfort and fulfillment in people’s lives and contribute to global environmental preservation through human centered automation”. The management – Seiji Onoki, chairman, and Hirozumi Sone, president and ceo – are striving to extend it both inside and outside Japan, in a drive for global growth.

Three new acquisitions
The management method adopted to achieve the global growth is seen to be by strengthening ties with global partners, and so over the last three months Azbil has announced three acquisitions: Telstar of Spain in the Life Automation business; Taco of Japan, a specialist in pneumatic technology and oil mist lubrication systems; and VorTek Instruments of USA, a vortex flowmeter manufacturer.

The background to the company and these three acquisitions is the topic for a major article in the March issue of the Industrial Automation Insider Newsletter, http://www.iainsider.com

*Azbil, I now discover, represents, or is short for – ‘Automation Zone Builder’ !

New biopharma plant in Switzerland chooses Emerson automation

Belgium-based UCB has awarded Emerson Process Management a Euro4.7m contract to provide integrated process automation and operations management systems for a new biopharmaceutical production centre in Bulle, Switzerland. Emerson’s technologies and engineering services will be crucial in meeting the very high standards expected by the UCB project team.

UCB is investing Euro175m to construct the first phase of a new plant, its first biopharmaceutical project in Switzerland. The 20,000-square-metre facility, which will be one of the largest in Europe, will be the main production centre for Cimzia (certolizumab pegol), which is used to treat rheumatoid arthritis and Crohn’s disease.

“The state-of-the-art and largely automated facility at Bulle will be a model for the industry when it opens in 2015,” said Michele Antonelli, UCB executive vice president. “To ensure the project meets its tight build-out schedule, we selected Emerson Process Management for its demonstrated ability to engineer and coordinate fast-track automation projects of this type.”

Emerson’s integrated solution includes its Syncade Smart Operations Management Suite, DeltaV digital automation system, and AMS Suite predictive maintenance software. Emerson will also provide related engineering services, including design, installation, testing and commissioning.

The Syncade Suite software integrates real-time plant floor data with business processes, decisions, and asset management – a key advantage in managing complex operations and extensive documentation required in pharmaceutical production. Syncade Suite manages workflow processes, including electronic work instructions, equipment status and material tracking, recipe-driven operations, automated weigh and dispense operations, and exception reporting.

“Typical biotech manufacturing can involve thousands of pieces of paper that can affect the ability to produce ‘right-first-time’ batches,” said Lorenzo Zampini, automation project manager. “With Emerson’s integrated operations management and control systems, we can automate the reporting process as well as gain tighter process control for increased productivity and smoother regulatory compliance.”

The Syncade software integrates with Emerson’s DeltaV automation system to facilitate operational activities and information flow from the plant floor up to UCB’s SAP system. In the UCB plant, the DeltaV system will control 163 process units including fermentation, purification, filtration, and bottling.  Emerson’s new electronic marshalling technology with CHARMs (characterization modules) will help minimise installation time by eliminating up to two-thirds of the wiring and connections needed with traditional control systems.

Emerson’s AMS Suite predictive maintenance software that will be supporting HART instrumentation will make it easy for technicians to calibrate critical instruments, check their status, and even detects potential problems before they affect operations.

“Emerson is delighted that UCB has chosen us to automate this ground-breaking facility,” said Steve Sonnenberg, president of Emerson Process Management. “Our proven ability to provide a single source for both plant automation and operations management systems will help UCB seamlessly manage operations from the plant floor to the head office.  We look forward to working with them as they bring the Bulle facility to life.”

Optimal Automation celebrates 25 years

Optimal Automation, a world leader in data management for PAT (Process Analytical Technology), and one of the UK’s premier designers, builders, programmers and installers of PLC, SCADA, DCS, MES and vision systems, has just celebrated it 25th anniversary, on January 1st 2012.

Founded in 1987 by Martin Gadsby and David Richards – both ex-KRAFT research employees, Optimal Automation is now one of the leading developers and integrators of process analytical technology (PAT) solutions for the Life Sciences and Chemical sectors using its own in-house developed synTQ data management software. The software is now used all around the world, following the conclusion of a Global Marketing Alliance with Emerson Process Management in Feb 2009.

Optimal is also a leader in vision systems – manufacturing its own 21 CFR Part 11 compliant packages – and is in the first rank of UK systems integrators, evidenced by its appointments as a Tier 1 Solutions Provider for Siemens, an Approved Systems Integrator for ABB, and a Software Solutions Provider for Rockwell Automation. In addition, Optimal has for some years been an approved Siemens WinCC Professional and PCS7 Integrator. This comprises a very select number of companies that have been audited, examined, and through displaying extensive experience, have been approved as high level integrators for the Simatic WinCC and PCS7 product ranges including FDA 21 CFR Part II compliant projects in the pharmaceutical industry.

“We are a well kept secret at Optimal, due to so many of the high level projects we undertake being covered by non-disclosure agreements”, said Martin Gadsby. “We have worked with most of the top tier Life Sciences suppliers on Automation and PAT projects, and have designed and implemented automation projects across many sectors – Automotive, Food and Drink, Chemical, Power Generation, Aerospace – that improve quality, throughput and time to market. But the nature of these projects means that we are never allowed to go public with them.

However, industry insiders talk to each other, and our success in one project has resulted in many more, simply via word of mouth – third party recommendation, which is very gratifying and shows that we are delivering exactly what our customers are demanding.”

Over 25 years Optimal has grown from a UK only developer of special purpose machinery into a truly international organisation, handling projects globally. “We now work all over the world: this first started by clients taking us abroad to replicate projects that we had executed for them in the UK and Europe,” said Mr Gadsby. “The expansion of our technology base that accompanied our growing international outreach also resulted in a growth of skilled personnel. One consequence of this was our first project in Machine Vision technology undertaken about 8 years ago. This took us full circle, in that clients often require the complete machine as well as the vision system, and so we now once again design and build special purpose machines.”

Evidence of Optimal’s continuing growth is provided by the company’s modern purpose built factory, strategically located on the Westerleigh Business Park, at Yate near Bristol – close to the motorway network. Built early in the new millennium, the facility represented a considerable investment by Optimal in its future. It offers some 12,000 square feet of offices and workshops, providing excellent facilities for the company’s employees and clients. The new factory enables Optimal to provide a complete in-house design and build capability covering all automation aspects. These include an extremely broad ranging software capability for its projects and products; electrical design & build; special purpose machinery design & assembly; complete unit operation assembly and test in our factory; documentation and validation services; international installation and commissioning; and a range of training and post-sale support offerings.

“Our employees are the key to our success”, said Martin Gadsby: “some have been with the company for over 20 years, and many more have over 15 years service. This ensures real continuity of our operations and preserves our skills base.

In addition, despite the company having grown through the years, it still retains its core beliefs and ethos, providing our clients with first class automation solutions designed to suit their needs. Our customers and their requirements come first: the technology is just the enabler.”