Permission to change and develop in the Life Sciences!

20/06/2017
• Enjoy a unique environment to meet and gain input from all stake holders on industry direction, challenges and solutions.
• Shape your strategy on the way solutions should be developed and applied in your facility
• Understand how partnering can take you further, faster and with reduced risk
• Experience hands on demonstrations of automation equipment and packages.

The invitation was interesting, and challenging. “Future.Now – Developing the Life Sciences Landscape Together” was an arresting title. It was a co-operative event between National Institute for Bioprocessing Research and Training (NIBRT) and Emerson. We were invited to “Boost your knowledge, gain from the experience of others and increase your professional network at NIBRT state of the art facility in Dublin!”

Mike Train, Executive President with Emerson explains their focus under the attentive eye of European President Roel Van Doren.

This correspondent was aware of the NIBRT facility but had very little idea of what it was real function or its relevance to Irish industry. This was an opportunity find out. Further looking through the programme two things became apparent. One was the calibre of personnel speaking from the Emerson organisation and then the application rather than product orientation of the various sessions.

It proved to be a very interesting two days.

Day 1: Working together towards a common future.
Presentations from NIBRT, Industrial Development Authority (IDA), GSK, Alexion, Zeton, Novo Nordisk and Emerson Automation Solutions.

Pharma v Biopharma

After a short welcome fro Emerson Europe President, Roel Van Doren, the CEO of NIBRT, Dominic Carolan, outlined the foundation and raison d’etre of the organisation. It is a training and research in the area of bioprocessing. It is located in a new, world class facility in Dublin (IRL). As medical science advances “simple” chemistry, while still essential, is not fully capable of solving all health issues – Pharma versus Biopharma. Bioprocessing is a specific process that uses complete living cells or their components (e.g., bacteria, enzymes, chloroplasts) to obtain desired products.

Thus this facility exists to support the growth and development of all aspects of the biopharmaceutical industry in Ireland. It is purpose built to closely replicate a modern bioprocessing plant with state of the art equipment.

Making Ireland ready – a good news story.
Dr Chantelle Keirnan, Scientific Advisor with the Industrial Development Authority (IDA), described the far-seeing intuitive initiative to look at bioprocessing “before it was profitable or popular!” This state body is responsible for the attraction and development of foreign investment in Ireland and had been extraordinarily successful in attracting nine of the top ten pharma companies to set up manufacturing processing plants in Ireland. They considered at the turn of the century that bioprocessing was the way that life science was going and took steps to ensure that Ireland was ready. One of those steps was the provision of Government funding of NIBRT.

Togged out for the tour

Many of the delegates – in excess of one hundred attended some from other countries – donned white coats and took the opportunity to tour the impressive facility during the event. It includes a purpose-built, multi-functional building which replicates the most modern industrial bioprocessing facility. Some idea of this facility may be gleaned from their website here.

This is a good news story. How often are decisions of state organisations regarded, not entirely without justification, with a jaundiced eye? Those that are good are “oft interréd with their bones!” The vision that saw this development in industry and the individuals who having caught the ball ran with it and brought it so successfully to fruition is worthy of equal attention and praise.

The rest of the day was an examination of the industry, processes and looking into the future. Mike Train, Executive President of Emerson spoke on the changes that are influencing industry and his company’s focus. We are facing “an evolution not a revolution” he stated, a point emphasised by other speakers throughout the day. He also stressed the importance for giving permission to change. (See full list of speakers at below.)

Pictures from the event!

We then had a series of speakers from the industry, people who get their hands dirty so to speak in actual processing speaking of their experiences and challenges. Speakers from GSK and Novo Nordisk explored areas like partnership, legacy issues, building on or expanding existing plants, saving energy, wireless. There was some discussion on the cloud and its advantages and just how vulnerable it might be to security breaches.

The discussion on handling all this data and identifying and retrieving those pieces of data which are really useful to the process brought to mind the prophetic words of the American media theorist, Neil Postman years ago, “…a central thesis of computer technology – that the principal difficulty we have in solving problems stems from insufficient data – will go unexamined. Until, years from now, when it will be noticed that the massive collection and speed of light retrieval of data have been of great value to large scale organisations but have solved very little of importance to most people and have created at least as many problems for them as they have solved…” (Neil Postman: “Amusing ourselves to death:” 1985)

Peter Zornio, Chief Technology Officer with Emerson gave their philosophy in meeting the demands of “Life Science Visions.” He lauded the various discussion groups such as the Biopharma Operations Group in helping how to keep up to date with technology and fostering new ideas.

We are on a digitizing journey. Moving from manual and paper to digital recording and control.

Day 2: “New Technology, New Processes, New solutions!”
Presentations from BioPharmaChem, GSK, Infinity Automation and Emerson.

The day started with a presentation on modular flexible manufacturing – introducing the PK Controller and a little later in the day there was an exposition on DeltaV Discovery/DeltaV 14 in maintaining data and transferning and easing technology transfer through the life cycle of drug development.

In his second presentation Peter Zornio gave the business case behing IIoT. IoT is usually referring to domestic, building environment and other civil applications. But it is also useful in the industrial environment where it is referred to as IIoT. Initially it was a link up at the instrument and control area but of late it is spreading to the portfolio of sensors. Their emphasis is on “the first mile!” (This is a backward reference to the perennial problem in many, especially rural, areas of “the last mile” – the internet connection directly into the home! – a heart felt sigh from your correspondent!)

The Real Challenges!

Ian Allen of Infinity Automation spoke on challenges to the life science automation world. “Don’t go backward to go forward” he said. We must use things like data integrity, cyber security, Microsoft dependencies and Industrie 4.0 as “gifts to leverage the opportunity and change!” The real challenge is not so much the technology but our use of it. We were coming back to “permission for change!”

We might perhaps use the words of the Bard of Avon, “The fault, dear Brutus, is not in our stars. But in ourselves….”  The “gifts” are there. The Technology is there or on the way.

Let’s own these gifts and make them our own.

 

Pic: Travis Hesketh


The Speakers:

Day 1
Dominic Carolan
CEO – NIBRT
Dominic Carolan was appointed CEO of NIBRT in April 2015. Mr. Carolan previously held senior roles in Mallinckrodt (Dublin), Genzyme (Waterford), also Genzyme (Corporate) where he was Senior Vice President of Manufacturing, and in Sanofi, where he headed their global network of Sterile Injectable Lyophilisation sites. He has successfully lead the startup of two significant Pharma & BioPharma facilities in Ireland and has a proven track record in operations leadership and in attracting and developing the talent required to deliver long term success. A graduate of UCD in Chemical Engineering, Mr. Carolan was Chairman of BioPharmaChemical Ireland from 2008-2010.
Dr Chantelle Kiernan
Scientific Advisor – IDA

Dr. Chantelle Kiernan joined IDA in September of 2009 and is responsible for attracting research related foreign direct investment for Ireland. Chantelle has responsibility for the Multinational research portfolio – spanning Pharmaceutical, Biotechnology, Medical Device, Engineering Food services industries. Chantelle has spent her career equally dispersed between academia and industry. She holds a PhD in Immunology from Trinity College Dublin in the area of immunomodulation and continued her academic career with a Post-Doctoral fellowship in Harvard University, Boston. Chantelle is currently undertaking an MSc in International Business law. She has spent almost fifteen years in industry. In her current role as Scientific Advisor for the IDA, she has been integrally involved in attracting and securing large scale R&D foreign direct investments for Ireland.

Mike Train
Executive President – Emerson Automation Solutions
Michael H. Train leads the Automation Solutions business of Emerson, which posted sales of $10.2 billion in fiscal 2015. Train began his career with Emerson in 1991 as an international planner, then took on additional responsibilities in a number of executive posts that included serving as President of Emerson Japan and Korea, VP of Corporate Planning, President of Emerson Process Management Asia Pacific, and President of Emerson’s Rosemount business. He was most recently President of Global Sales for Emerson Process Management, responsible for sales, service, support, and customer satisfaction for all products and services across five world-area organizations. In that role he was also part of the leadership team that drove strategic initiatives and investments for the entire business group. Train earned a bachelor’s degree in electrical engineering from General Motors Institute and an MBA from the Johnson Graduate School of Management at Cornell University. He currently serves on the management school’s advisory council and was a 2008 Eisenhower Fellowship recipient.
Dave Tudor
Vice President, Head of GMS Strategy – GSK
Dave joined GSK in 1992 at Worthing as a PhD Chemist from Glasgow University. He has over 20 years’ experience with the company carrying out a number of Technical, Compliance and Manufacturing leadership roles. In 1997 he moved to Irvine to take up a lead chemist role before coming Quality Control Manager in 1998. He joined the site leadership team in 2001 to run Technical Development before moving to manufacturing as Actives Production Director in 2005. During this time he completed a Masters degree in Manufacturing Leadership at Cambridge University. In 2007 he moved to GSK House to work on a central network re-structuring project before becoming Site Director at Montrose in October 2008. At Montrose, he led the transformation of the site to manufacture over 12 products for GSK including a major investment programme. In 2011 he was appointed VP Primary Supply Chain with responsibility for global Active Pharmaceutical Ingredients (API) manufacture and supply, a network of GMS sites across the world including facilities in Asia and Europe. In 2017 he was appointed VP Head of GMS Strategy with responsibility for manufacturing strategy, deployment of strategic programmes, performance management and advocacy. He plays an active role with a number of Governments and is currently co-chair of the Life Sciences Scotland Industry Leadership Group. Dave is also a member of UK Chemicals Industry Association Council and Board. Dave is married with 4 children and lives in Troon, Ayrshire. He enjoys all sports, particularly football, is a keen reader of Scottish history and does cooking to relax.
Peter Zornio
Chief Strategic Officer – Emerson Automation Solutions
As Chief Strategic Officer for Emerson Automation Solutions, Peter has responsibility for overall coordination of technology programs, product and portfolio direction, and industry standards across the Automation Solutions group. He has direct responsibility for the product definition and development organizations for control systems and software products. He has been at Emerson for 10 years. Prior to Emerson, he spent over 20 years at Honeywell in a variety of technology and marking roles, most recently as overall product management leader. Peter holds a degree in Chemical Engineering from the University of New Hampshire.
Herman Bottenberg
Marketing Director,, Zeton

PDEng. Ir. Herman Bottenberg is a chemical engineer with 15+ years of industrial experience, along with two years of Post academic work on Plant Design. He worked for 17 years at Zeton B.V. in The Netherlands, with five years of experience in project engineering and project management. The last 12 years he has been active in business development, sales and marketing. Since 2016 Herman is also responsible for the Marketing and Sales group at Zeton B.V. Herman has specialised in transformation of processes from batch to continuous, process intensification and modular processing plants for pharma and chemical industry.

Day 2
 Matt Moran
Director – BioPharmaChem Ireland
Matthew Moran is Director of BioPharmaChem Ireland. He graduated in Chemistry at Trinity College Dublin in 1980 and in Chemical Engineering at University College Dublin in 1981; he holds an MBA also from University College Dublin (Smurfit School of Business). He worked for over ten years in the pharmaceutical industry where he held a number of management positions both in active ingredient and dosage form manufacture. He is a member the European Chemical Industry Council (CEFIC). Matthew Moran is a Board member of the Active Pharmaceuticals Ingredients (API) Committee of CEFIC (CEFIC/APIC) and The European Association for Bioindustries (Europabio) BioPharmaChem Ireland represents the interests of the biopharmachem sector in Ireland. CEFIC/APIC represents the European API Industry. Europabio represents the European Biotech Sector.
Ian Allan
Automation Consultant – Infinity Automation
Currently the Managing Director of Infinity Automation, a relatively new company carrying out Automation & MES Consultancy, Strategic Planning and Major Program/Project Health checks, with blue chip Global Life Science companies and Strategic vendors that support that Industry. Formerly Ian was the Global Head of Automation & MES with Novartis, where he was responsible for the Manufacturing Automation Strategy and MES Program within Technical Operations in the Vaccines division.  Prior to that he worked for GSK as Global Automation Director responsible for Automation, Process Control and MES across 73 sites worldwide. There he led a team that developed a library of Emerson DeltaV modules to be deployed in multiple Bulk API sites across the world, as well as developing a blueprint for MES integration and Network delivery of Electronic Batch Records. Prior to that he held several roles in GSK within the Engineering and Automation departments. Ian started his career with IBM as a junior engineer when computers were a little bigger than they are today and holds a BSc in Electrical & Control Engineering from Strathclyde University. He is currently facilitating GSK’s Global Automation Steering Team and is leading the Digital Factory Automation workstream for a new Hybrid Manufacturing platform with the first instance being delivered in GSK Singapore Jurong site.
Colin Chapman
Director of Manufacturing IT – GSK
Colin Chapman is a Chemical Engineer with nearly 20 years experience in Life Sciences with GSK. Colin’s career has spanned across process engineering & automation, operations and new product introduction in both commercial manufacturing and clinical supply chains. In his current role as Director of Manufacturing IT Colin has successfully led the introduction of Manufacturing Operations Management across the clinical supply chain driving business process re-engineering and global workflow automation using technologies such as Syncade. GSK’s continuing program focuses on three value drivers, Compliance, Business Intelligence and Productivity.
Klaus Erni
Product Manager & Namur 148 Board Member – Emerson Automation Solutions
Klaus started his Emerson career in 2003 in Germany, where he was working as a Technical Manager for Key Accounts before he transferred to Austin, TX to become the DeltaV Hardware Product Marketing Manager. In 2015, he went back to Europe and took over another Global Role, being now the Technical Consultant to some major Strategic Accounts. While in Germany with Emerson, he was responsible for the technical aspects of the DeltaV Systems during the Sales and Implementation Phase, as well utilizing the latest Hardware and Software features while upgrading and expanding Systems on Key Customer sites. Prior to Emerson, Klaus was with the Hoechst AG, he did several Engineering projects with various PLC and DCS and SIS Systems and was as well a RS3 System User.
Danny Vandeput
Director Pervasive Sensing Strategies – Emerson Automation Solutions
The (Industrial) Internet of Things (IIoT) is revolutionizing the way we live but it also provides many new challenges to the industry. This can create confusion, uncertainty – combined with fuzzy statements – and different opinions. My great passion is to bring clarity in the Industrial Internet of Things and what benefits it can bring for you. I help industries to find the right perception of IIoT, how sensors can maximize profit, reduce downtime and bring the ROI into the IoT. Being already 23 years with Emerson I have assisted many types of industries on their way to Top Quartile Performance. This includes amongst other trainings, workshops, audits and implementing solutions.
#PAuto @EMR_Automation @NIBRT_ #IIoT @HHC_Lewis
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Interesting facts emerge from financial report.

15/05/2017
E+H reports sales flat, but sees growth in Ireland, reports Processingtalk.info‘s  Nick Denbow from Basel.

This year, Endress+Hauser expanded the presentation of their annual financial results, inviting journalists from not only Germany and Switzerland, but including others from Belgium, the Netherlands and Great Britain. In all 70+ attendees heard Klaus Endress and Matthias Altendorf say that the consolidated Group sales fell slightly between 2015 and 2016, by 0.2%, achieving Euro2.1Bn. This fall was actually only because of currency fluctuations. “Currencies created a headwind for us last year,” said Altendorf. Working from the value of sales in local currencies, sales in total actually increased by 2.1%. Whilst the Group is family owned, their annual report is published and audited to the standards expected of any other international business.

CEO Matthias Altendorf emphasised that “When compared to overall industry growth, we held our own”. E+H performed well in Europe, but sales in America declined. Africa and the Middle East experienced solid growth, but in the Asia-Pacific region business stagnated.

Within Europe, the best performances for E+H came from Ireland, Italy and Finland. The best performing sectors in all countries were food & beverage, life sciences, and water & waste water. Overall business declined in oil & gas, chemicals and primary industries like metals. The power and energy industry sectors showed good performance outside Germany, where E+H also felt the effect of weak German exports and some internal restructuring. The oil & gas decline badly affected sales in USA, UK and Norway, although the UK sales centre gave a good performance by aligning efforts with other active market sectors.

Investment continues.

Production

E+H plans for investment and growth continue for the current year. Earlier in the week a new factory extension was opened in Reinach, where flow products are manufactured. (see Read-out Signpost – “Flowmeter output growth requires new facilities” – 5 May 2017).  The journalists were given a tour of the manufacturing facility in Maulberg (D), where a new extension to the production area is in operation, and a new NMi level measurement system calibration facility for radar based systems has just been completed. This is certified suitable for calibration of the Micropilot NMR81 radar system, working at 80GHz, which achieves a +/-0.5mm accuracy over a 30m range, for use in oil storage tanks and oil terminals. There are plans now to extend this calibration facility to allow such calibration out to 40metres, as well as to extend the factory yet further: 1912 people work at E+H Maulburg, and 5200 people in the Basel region, out of the total E+H staff of 13,000.

Analytical measurements
The biggest growth area in E+H is actually in the analytical instruments that use Raman spectroscopy to analyse liquid and gas streams on-line. The major industries now applying this technique are within the life sciences sector, where immediate analysis of input and both gaseous and liquid effluent streams enables much closer control of biochemical and fermentation processes. Indeed the 2017 issue of the E+H corporate magazine “Changes” features a major focus on new applications in the Life Sciences industries.

Other new analytical techniques are developed for monitoring water treatment processing, for example in the new Swiss plants which by law have to have a fourth stage of purification, to remove hormones, phosphorus and other drug residues. The strength of E+H here derives from their strategic decision a few years ago to invest in the process analytical area, particularly in the field of spectroscopy, acquiring Kaiser Optical, Analytik Jena and SpectraSensors. “Our analytics strategy has been validated by the market,” said Matthias Altendorf.

Bundling IIoT activities

Digitization

The acquisition of German SensAction AG in early 2017 also ties in with Strategy 2020+ which was rolled out last year. The company, headquartered in Coburg (D), manufactures innovative systems for measuring concentrations in liquids. Endress+Hauser is tackling the challenges of digitalization by bundling a number of activities. A new subsidiary in Freiburg in Breisgau,(D), is working exclusively on products, solutions and services related to the Industrial Internet of Things (IIoT).

The significance of digitalization can also be seen in the growing number of patent registrations. There were 273 first filings in 2016. The intellectual property rights portfolio thus boasts more than 7,000 active patents. R&D spending rose to 7.8 percent of sales. Endress+Hauser introduced 64 new products to the market. “We are investing in innovation for our customers,” underlined the CEO.

Trends in automation.
The focus for E+H sales and their customer base is broadly on automation engineers, so it was interesting to hear Matthias Altendorf comment that the statistics for industrial output show that the Britain has now dropped out of the top 10 countries in terms of automation business activity, whereas they had held a prominent position there some years ago.

The other aspect of interest was that there are distinct differences between countries, in terms of the sex of the engineers involved in the major projects served by E+H. In Germany they are mostly male, whereas the majority of engineers in Turkey are female. In South Korea and India there are high percentages of female engineers (and engineering journalists). Also, by industry, it is noticeable that in the biochemical and life science sectors the engineers are predominantly female.

 @Endress_Hauser #PAuto #IoT

Continuous compliance with PLM.

27/07/2016
Adam Bannaghan, technical director of Design Rule, discusses the growing role of PLM in managing quality and compliance.

The advantages of product lifecycle management (PLM) software are widely understood; improved product quality, lower development costs, valuable design data and a significant reduction in waste. However, one benefit that does not get as much attention is PLM’s support of regulatory compliance.

Compliance-PLMNobody would dispute the necessity of regulatory compliance, but in the product development realm it certainly isn’t the most interesting topic. Regardless of its lack of glamour, failure to comply with industry regulations can render the more exciting advantages of PLM redundant.

From a product designer’s perspective, compliance through PLM delivers notable strategic advantages. Achieving compliance in the initial design stage can save time and reduce engineering changes in the long run. What is more, this design-for-compliance approach sets the bar for quality product development, creating a unified standard to which the entire workforce can adhere. What is more, the support of a PLM platform significantly simplifies the compliance process, especially for businesses operating in sectors with fast-changing or complicated regulations.

For example, AS/EN 9100, is a series of quality management guidelines for the aerospace sector, which are globally recognised, but set to change later this year. December 2016 is the target date for companies to achieve these new standards – a fast transition for those managing compliance without the help of dedicated software.

Similarly, the defence industry has its own standards to follow. ITAR (International Traffic in Arms Regulations) and EAR (Export Administration Regulations) are notoriously strict exporting standards, delivering both civil and criminal penalties to companies that fail to comply.

“Fines for ITAR violations in recent years have ranged from several hundred thousand to $100 million,” explained Kay Georgi, an import/export compliance attorney and partner at law firm Arent Fox LLP in Washington. “Wilful violations can be penalised by criminal fines, debarment, both of the export and government contracting varieties, and jail time for individuals.”

PLM across sectors
The strict nature of all these regulations is not limited to aerospace and defence however. Electrical, food and beverage, pharmaceutical and consumer goods are also subject to different, but equally stern, compliance rules.

Despite varying requirements across industries, there are a number of PLM options that support compliance on an industry-specific basis. Dassault Systèmes ENOVIA platform, for example, allows businesses to input compliance definition directly into the program. This ensures that, depending on the industry, the product is able to meet the necessary standards. As an intelligent PLM platform, ENOVIA delivers full traceability of the product development process, from conception right through to manufacturing.

For those in charge of managing compliance, access to this data is incredibly valuable, for both auditing and providing evidence to regulatory panels. By acquiring industry-specific modules, businesses can rest assured that their compliance is being managed appropriately for their sector – avoiding nasty surprises or unsuccessful compliance.

For some industry sectors, failure to comply can cause momentous damage, beyond the obvious financial difficulties and time-to-market delays you might expect. For sensitive markets, like pharmaceutical or food and beverage, regulatory failure can wreak havoc on a brand’s reputation. What’s more, if the uncompliant product is subject to a recall, or the company is issued with a newsworthy penalty charge, the reputational damage can be irreparable.

PLM software is widely regarded as an effective tool to simplify product design. However, by providing a single source of truth for the entire development process, the potential of PLM surpasses this basic function. Using PLM for compliance equips manufacturers with complete data traceability, from the initial stages of design, right through to product launch. What’s more, industry-specific applications are dramatically simplifying the entire compliance process by guaranteeing businesses can meet particular regulations from the very outset.

Meeting regulatory standards is an undisputed obligation for product designers. However, as the strategic and product quality benefits of design-for-compliance become more apparent, it is likely that complying through PLM will become standard practice in the near future.

#PLM @designruleltd #PAuto #Pharma #Food @StoneJunctionPR

Compliance – more than just red tape.

03/07/2016

A growing customer demand for regulatory compliance combined with increased competition amongst manufacturers has made SCADA software a minimum requirement for the pharmaceutical industry. Here, Lee Sullivan, Regional Manager at COPA-DATA UK discusses why today, more than ever before, regulatory compliance is crucial for the pharmaceutical industry.

copabatchstdFDA statistics are forcing the industry to identify and implement improvements to its manufacturing processes. In its latest reports (published in Automation World), the FDA identified a significant increase in the number of drug shortages reported globally. With 65% of these drug shortage instances directly caused by issues in product quality, it’s clear that if more pharma manufacturers aimed to meet the criteria outlined in FDA and other industry standards, drug shortages and quality issues would certainly become less frequent.

The compulsion to become compliant obviously differs from company to company and standard to standard but one thing is certain: development starts with batch software. The range and capabilities of batch software vary immensely, but there are three factors to consider before making a choice: flexibility, connectivity and ergonomics.

Flexibility
To assist the complex processes of pharmaceutical manufacturing, batch software needs to be flexible. The software should manage traceability of raw materials through to the finished product and communicate fluently with other equipment in the facility. To ensure it provides a consistent procedure and terminology for batch production, the software should also be in line with the ISA-88 standard.

To meet increasing demand for personalised medication, manufacturers are seeking out batch software that is capable of creating flexible recipes, which are consistently repeatable. Traditional batch control creates one sequence of each process-specific recipe. While this model may be ideal for high volume manufacturing where the recipe does not change, today’s pharmaceutical production requires more flexibility.

To remain competitive, manufacturers need to provide compliance in a quick and cost-effective manner. Modern batch control software ensures flexibility by separating the equipment and recipe control. This allows the operator to make changes in batch recipes without any modifications to the equipment or additional engineering, thus saving the manufacturer time and money.

Connectivity
To avoid complications, manufacturers should choose independent software that supports a wide range of communication protocols. COPA-DATA’s zenon, for example, offers more than 300 high-performance interfaces that function in accordance with the ‘plug-and-play principle’. This makes it easy to implement and the user can start to collect, process and monitor production data straight away.

The communication model of the batch software extends upwards to fully integrate into manufacturing execution systems (MES) and business enterprise resource planning (ERP) systems. This links the raw material from goods-in through to the finished product at the customer’s site. The strong communication platform includes all layers of a production environment and extends to these systems.

Having no association with specific hardware providers ensures that regardless of the make and age of equipment, the batch software will be fully compatible and integrate seamlessly. Using this high level of connectivity minimises disruptions and quality problems, while also allowing pharmaceutical companies to collect data from the entire factory to archive digital records and ensure compliance across the processing line – allowing manufacturers to establish a fully connected smart factory.

Ergonomics
Lastly, understanding and using batch software should be stress free. As the pharmaceutical industry becomes more complex and more manufacturers begin exploring the realms of smart manufacturing, factory operators should be able to control and change batch production without complications.

By using software fitted with clear parameters and access levels, operators gain the ability to create and validate recipes, monitor the execution of production and review the performance of industrial machinery – without accidently altering or changing existing recipes and data. Reducing the amount of software engineering makes the operator’s life easier and minimises potential problems that could arise.

The benefits of complying with various industry regulations and standards do not stop with an enhanced Quality Management System (QMS). More customers will buy from you because you appear more reliable and your supply chain will see improved production indicators, such as increased OEE, reduced wastage, reduced recalls. On top of all of these benefits, you also improve product and thus patient safety.

To comply with industry standards, pharmaceutical companies should take steps to modernise their manufacturing processes, beginning with upgrading their batch control software. Anything else would be like putting the cart before the horse.

 

@copadata  @COPADATAUK #PAuto #SCADA

#EmrEX: All change at Brussell Centraal.

18/04/2016
Emerson User Group EMEA in Brussels, Belgium – 12th – 14th April 2016

“Seems to me that #EMrex is focusing not so much on new technologies, though important, but looking closer at how we do things.”  our tweet on day one.
Cfrpq9-UUAE8qVi

Brussels looked lovely on the morning that the Emerson User Group meeting opened. There was little to suggest the trauma that the city had faced just a few short weeks previously as delegates strolled through the sun-lit streets to the conference centre. The security however was markedly tighter as we entered the building however with strict adherence to the best security practices. However once inside the building things were as normal.

 Emerson Exchange Brussels – The Videos!

Other Reports (as they appear)
• Operational Excellence at Emerson Exchange Brussels (Emerson’s Stuart Turner – 20/4/2016).
• Nick Denbow ‘s travel travails: My worst week as an air traveller!  (30/4/2016)

Speaking with the organisers it promised to be a bumper event, stretched as it was over three days examining all aspects of automation, experiences, applications and of course exciting new products and concepts. The attendance was slightly down on the last time in Stuttgart, some were reluctant to travel, others were unable to make it due to the inability of the severely damaged to adhere to a normal service. Those who attended were in part in broad agreement with the message penned by Emerson’s Travis Hesketh – Standing up for Brussels. Indeed the User Group very quickly confirmed after these terrible events that they were going ahead with #EMrex. At several of the social events at the periphery, like the evening reception for publishers and journalists the people who suffered were remembered.

The venue was a modern conference and the one hundred or so presentations and industry forums were stretched over about six floors including an exhibition floor and at the very top of the building was a cyber café and a wonderful panoramic hall with the breathtaking view (featured at the top of this page from a tweet by Emerson’s social media guru – Jim Cahill)

But on to the the meeting!

Peter Iles-Smith of GlaxoSmithKline opened proceedings as chair of the Users Exchange Board. He welcomed the over two thousand delegates from so many countries through out the EMEA who travelled for the event.

Steve_SonnenbergSteve Sonnenberg, President Emerson Process Management (pictured right) and Roel VanDoren, their President in Europe, in a joint presentation entitled “New Reality, New Opportunity” addressed the changes and challenges facing companies in the 21st Century. They did not talk about products or applications but on ways of doing things. Indeed during the presentation we tweeted: “Emerson’s approach – yes equipment, but more importantly perhaps is attitude or culture.”

Nobody does business the way they it was done even twenty years ago, when the internet was a baby and nobody imagined never mind thought possible social media platforms like twitter,  yet in many cases industry is way behind in adapting to change. Possibilities are there which were inconceivable a short time ago and these need to be harnessed for the good of humanity.

Research into these possibilities, new technologies are leading to changes especially the importance of planning including all stakeholders at the earliest opportunity. This thinking is leading to an innovative technology and engineering-based approach for improved capital efficiency such as their Project Certainty approach  which aims to tackle complexity by decoupling the dependencies suppliers have on each other, eliminating bottlenecks and allowing concurrent work streams. In a word it aims to transform capital investment and releasing the frightening amounts of money currently being lost in big and not so big projects.

And these figures are frightening. If the type of approach spoken of here is adopted savings of up to €400 Billion (yes BILLION) would be released to invest in, for instance,  production, reliability, safety, energy, training, security and innovation.

So what is involved?

Xavier_MarchantXavier Marchant, (right), Emerson’s Vice President Process Systems and Solutions in Europe, gave dramatic examples of the possible savings in labour and materials. For instance the decision to use smart junction boxes in a large project could save both money and space (95% in control room space). Spare parts are another area where there is phenomenal waste. He quoted a spokesman from a International Energy and Chemical Company, “On our last construction project we overspent on maintenance spares to the tune of €50,000,000…we just wrote it off….because we did not have a robust spares analysis process.” Reduce the complexity by the involvement of stake holders at the start of planning for a project and allowing them to develop it side by side. One simple idea is to separate software from hardware in the development. The “old way” is to tie them together from the start whereas this way the software can be developed using virtual systems and then later on when the actual operation is seen to work in the virtual world (he called it virtual FAT – Factory Acceptance Test) it may be introduced to the real or concrete world – or “late binding” as he called it.

vFAT
Virtual FAT has far less chance of harming one than the real thing?

He quoted  François Davin of Sanofi “Emerson’s Remote Virtual Office allowed us to collaborate with experts and resources from multiple sites to conduct our Factory Acceptance Test (FAT). The result was less travel and site disturbance to our operations. Also, more operators could participate remotely which improved the new automation system adoption.”

We were introduced to the concept of  quartile performance and their site Top Quartile Performance is a exposé of how they view this as a concept and how it is influencing their thinking as a group.

Peter_Zornio

Of course all these changes would be impossible without the availability and enthusiastic embracing of the so-called “new” technologies. Peter Zornio (right), Emerson’s irrepressible Chief Strategic Officer, gave us an insight into these and how the company is using these and its co-operative involvement with the pioneers in these , the Internet of Everything(CISCO),  Industrial Internet (GE), Smart Planet (IBM) and The Internet of Things (Microsoft). These technologies, and others embryonic or not even conceived of are guiding  the current and future development of technology used in the manufacturing and processing sectors.

Keynotes: The Emerson User Exchanges whether in the USA or EMEA always have exciting and inspirational keynote speakers each day. This event was no exception. Jack Uldrich, a futurist spoke about future-proofing business. The majority of businesses are not ready for what is happening in the real world or for the speed at which it is happening.

Another of these speakers Prof Jan Rotmans who spoke about change. He maintains that we are not living through an “era of change” as a “change of era!” Many of us are in the old era, our mobile phone is just that, we read newspapers, buy books in bookshops. Our kids live on their mobile phones, they are their liveline. We are “old-fashioned” our kids are “cool!” Change is disruptive and the old ways are totally unable to cope. The old top-down certainties are dissolving and the “common man” is taking charge, sometimes violently. Chaos is the name of the game.

Finally a veteran at EmrEX, David Beckman, brought all the thoughts and ideas of New Reality, New Opportunity together. In view of Rotmans’ talk earlier the title he chose was more than relevant as he introduced delegates to the “Worst Case Scenario Survival Handbook.” Although he prepared us for worst case scenarios he described real opportunities for industrial automation.

Presentations. The various threads were divided into five headings or sectors, Business & Projects; Operate Safely, Securely and Legally; Process Optimisation; Maintenance & Reliabilitym and, Control System Applications & Migrations and were held through each of the days.

Forums: There were also Industry Forums with panels and general discussions on the various specialities e.g. Life Sciences or Refining & Petrochemicals. These were opportunities for participants to learn and exchange information and experiences with each other.

Training: There were also training  sessions and other sessions (called Roadmaps) on Emerson products and possible future developments.

projcertExpo

ExpoEmrEx16274Solutions EXPO: Of course no event is complete without actually seeing product and EmrEX is no exception. The floor was divided under the same zone headings as the threads of presentations above. (See sketch on left).

There were several unique exhibits. One was the Operations Centre of the Future. This was an imaginative presentation of a plant with a H.A.L. like computer responding (or not) to commands or requests from the operatives. It featured a drone delivery of spare parts and a really effective alarm situation which featured a realistic vibration of the floor. Of course the real message is that though it is the future most of the technology used is possible today.

Of course the Project Certainty concept featured prominently in the Business & Projects area and we were show possible scenarios. They had also rather bravely set up a wall where delegates could post what they consider are the features that should be addressed in projects. This should help “to focus ruthlessly on what’s directly relevent to a company strategy.”

Of course there were actual instruments on display to examine and handle.

Ind1stNotable was this industry first, the Rosemount X-well system, a wireless transmitter, accurately measuring process temperature without need for thermowell. Accurate process temperature measurement is possible without requiring any intrusions or penetrations into the process, allowing for quicker and easier installation along with simplified long-term maintenance. Users do not have to design, size or maintain thermowells. Wake Frequency Calculations are eliminated, as well as time spent determining material compatibility, the right insertion length and the necessary profile.

pressure_gaugeAlso the new Emerson Wireless Pressure Gauge created quite buzz among delgates. Th“This new gauge design fundamentally will change how customers use pressure gauges by helping them make better business decisions!”  It is another industry first. Does this signal the end of the Bourdon Tube?

Energy management is of course critical in all processes. It is effected not only by cost factors but also by legislation driven by concerns on pollution and global warming. Here Emerson demonstrated some prototypes of monitoring and control equipment not yet available. They emphasised savings on space occupied and of course ease of use by operatives.

Jim_CahillAnother very popular item was on the Maintenance & Reliability Zone. Here was an opportunity to experience the immersive training simulator. A goggle like apparatus was placed on the head and using a game-like hand piece the engineer is able to travel through a plant and see where various problems may be without any danger to him or her. It is a fascinating experience and one really feels that one is travelling through the plant rather than sitting or standing in a control room or office.  In this picture we see Emerson’s Chief Blogger, Surface Dweller, Head of Social Media enter the virtual world for real! We can confirm that he returned to real reality afterwards.

Around the periphery of the EXPO were the booths of companies which compliment the Emerson offering – what they call their complementary and strategic partners.

history-passageThere was also a section dedicated to history featuring milestones in science and automation over the years. It was a demonstration of change in the past. What will feature in future shows? The new opportunities taking advantage of the new realities of the past.

Always a major highlight of the Emerson User Group events is waht the call the “Networking Event.” This year was rather unique in that it was a visit to the Museum of Fine Arts and the Magritte Museum. This was an unique opportunity to see the best of Belgian painters – creativity of a different type than that extolled during the day sessions. Artists such as the Brueghels, Rubens, Jordaens and Magritte were enjoyed during this evening. Food and beverages were served – Belgium is famous for its beers of course but it also has its own cuisine and of course it’s chocolate is to die for.

This years event, despite the unexpected difficulties, was on a par, indeed because of these difficulties had perhaps more user participation than previous ones. There were many exciting things to see, concepts to understands and friends with which to share experiences.  And of course fun with a capital F.

Look at this and tell me people weren’t enjoying themselves! (Twitter pic ‏@Julian_Annison)

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Emerson’s Travis Hesketh and Nick Taylor appreciating (?) art.


Our unedited photos from the conferenceon the Read-out Facebook page.

Follow on twitter #EmrEX

The videos here give an impression of each day:
Day One


Day Two


Day Three

• We have written about our travelling experiences to and from Brussels in our personnel blog (Sa Bhaile: (“Home” in Irish). These were relatively smooth if labourious but there is indeed no comparison to the experiences of Nick Denbow of ProcessingTalk which he outlines on their blog: My worst week as an air traveller! 


Previous EmrEX EMEA Events.
2014: Stuttgart: Revving up in Stuttgart!
2012: Duesseldorf: Automation returns to Düsseldorf!

All our reports on EmrEX Events (including North America).


#EMrex #PAuto @EmersonExchange @EmersonProcess #PAuto #IoT

Food & Pharmaceutical Futures.

21/03/2016

ISA’s first international symposium outside of North America is adjudged a success.

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From the time it was firsted 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 the this, the first such international symposium organised by the ISA outside of 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 asigned and problems solved over many late night transatlantic telephone conferences. Using the experience of the ISA staff in North Carolina and the many years experience of 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 attended the two day event and it was notable that the bulk of these stayed until the final sessions were completed.

• All through the event highlights were tweeted (and retweeted on the Ireland Section’s own twitter account) with the hashtag #FPID16. See also the ISA official release after the event: Food & Pharma symposium almost doubles in size!

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ISA President Jim Keaveney (3rd from right) with some of the speakers ath the FPID Symposium

Technology and Innovation for 2020 Global Demands
Two fluent keynote speakers, Paul 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 Internationa President for 2016 Mr Jim Keaveney.

We will highlight a few of the sessions here!

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 role 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.

 

day1a2Both 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 practicale example of a plant was discussed showing the journey to paperless manufacturing and a real pharmaceutical strategy of integrating automated and manual operations.

 

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Eric Cosman makes a point!

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:
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):

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Networking between sessions

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 Lifecycle: Plant lifecycle and Operational Equipment Effectiveness

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More networking

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. 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 automatio modernization.

 

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Alarm management:
And of course no matter how sophisticated systems are Alarms are always require and neccessary. 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 importan session to end the symposium.

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

Training Courses:
On the Wednesday, although the symposium itself was finished there were two formal all day training courses. These covered, Introduction to Industrial Automation Security and the ANSI/ISA-62443 Standards (IC32C – Leader Eric Cosman, OIT Concepts ), and 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.

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!”

Well done!

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#FPID16 #PAuto #PHarma #Food

The 2017 FPID Conference is scheduled for Boston (MA USA) for 16-17 May 2017.