Information Unlimited Magazine – Special PHARMACEUTICAL by COPA-DATA

S P EC I A L I S S U E 2020

T HE COPA-DATA M AGA ZIN E

SPECIAL PHARMA

produc t s & serv ices

S ERVI C E G R I D

FAQs

Everything you ever wanted to know about the zenon Service Grid Now it’s easier than ever to use the Internet of Things in industry

The zenon Service Grid is the perfect addition to the Software Platform, particularly for distributed applications. Here, we’ll consider the particular benefits of this software expansion. Why is it ideal for equipment distributed across a country or around the globe? How does it establish the connection between a company’s OT and IT networks? How is it installed and what license models are available? The answers to all these questions and more can be found here. Is the zenon Service Grid intended to replace zenon Runtime, zenon Logic, and the zenon Analyzer? No. The zenon Service Grid expands the platform in the direction of the Internet of Things (IoT). It is not a standalone product. Rather, it is an IoT upgrade for the zenon Software Platform that enables completely new applications. The zenon Service Grid was designed in line with current best practices and state-of-the-art approaches to software development. It uses architecture concepts such as microservices, bringing together several individual software components to form a large, scalable application. The distribution of the components allows you to make efficient use of the existing hardware resources. What are the key benefits compared to other IoT solutions? The zenon Service Grid allows you to monitor data from distributed locations in an integrated solution. In conjunction with the Service Grid, the zenon Software

Platform makes it possible to transfer data continuously from the fieldbus level to the cloud within a single system. The central development environment makes engineering easier and reduces the amount of work required overall. Thanks to the backward compatibility, existing projects can also be easily integrated into the overall system. How does the Service Grid help to protect the OT network? The zenon Service Grid works exclusively with unidirectional connections. All nodes use outgoing connections to communicate with the Service Hub – this includes zenon Runtime. Communication is encrypted via Transport Layer Security (TLS) and the participants’ identities are verified by means of digital certificates.

produc t s & serv ices

What kind of applications is the Service Grid best suited to? The main purpose of the zenon Service Grid is to provide a simple connection between geographically distributed zenon installations – in the case of international production sites, for example, or in the field of power generation. The collected production data can be visualized in a central location, such as a control center, with the aid of zenon Runtime or the HTML Web Engine. The Service Grid can also be used as a security gateway between OT and IT networks to transfer data from the field level to third-party systems in the IT landscape. For more information on this subject, please refer to the previous article, which contains further concrete examples. Is the Service Grid intended to replace the zenon network? No, the zenon Service Grid and the zenon network can and should exist in parallel and each should be used appropriately, as the situation demands. When does it make sense to continue using the zenon network? The zenon network is used in the context of OT within one plant to synchronize runtimes with each other. The zenon Service Grid, on the other hand, is generally used in conjunction with WAN connections over large distances to process selected data from zenon Runtime or zenon Analyzer in a cloud application or a local data center. Which systems can be integrated for the purposes of exchanging data? The zenon Service Grid is primarily used to exchange data between the software components of the zenon Software Platform: i.e. between zenon Runtime, zenon Analyzer, zenon Logic, and the HTML Web Engine. To guarantee the security of the data and the data exchange process, external systems cannot be integrated with the Service Grid’s internal communication layer. Third-party systems can obtain data for further processing via the Service Grid API’s REST interface. What kind of data can be exchanged via the Service Grid? The Service Grid supports various types of data. Process data such as variables, alarms, and events can be exchanged in large volumes. As well as distributing real-time values, the system can also access historical archived values. Furthermore, you can set whether each individual data point should be available as read-only, available for read and write access, or not available at all in the Service Grid. Alarms can be confirmed and linked with comments as well as causes. The Service Grid also has an interface

with zenon Analyzer, which can be used to generate and retrieve reports. zenon Analyzer also allows you to use all existing SQL-stored procedures to carry out data analysis. Engineering data can be synchronized between zenon Editor and zenon Analyzer, ensuring that zenon Analyzer metadata is always up to date. Is the zenon Service Grid scalable? A stable, high-performance system essential, particularly in the case of large distributed systems with numerous plants. For years, zenon Runtime has served as a stable foundation for data acquisition and analysis, as well as process control in such environments. The zenon Service Grid responds dynamically to high load peaks. A higherlevel management system records the utilization of individual services and can implement scaling measures. Through a generic approach with container-based applications, you can scale each service independently within the zenon Service Grid. You have free choice when it comes to the container platform and the management system. However, COPA-DATA recommends using Docker and Kubernetes. Instructions for operation on the basis of these platforms can be found in the help documents. Why is the REST interface provided in the zenon Service Grid? REST interfaces are widely used and are a popular way of exchanging data between software systems via HTTPS. Further benefits include the fact that they are not dependent on any particular programming languages or platforms, they are optimized for large data volumes, and they enable the connection of mobile applications. REST interfaces are not standardized and are always configured for the specific application in question. They support various data exchange formats, including JSON, XML, and any type of text format. What does the Service Grid do in the event of a network failure? zenon allows you to evacuate historical data from zenon Runtime into zenon Service Grid. If the network connection fails, the entries are buffered until communication is reestablished. Following successful synchronization, the local memory is enabled again, thus preventing data loss. How are user authorizations implemented? The authentication and authorization mechanism is based on a two-stage concept. In the first stage, the user is authenticated by means of the Identity Service, thereby answering the question “Who am I?”. The Policy Service is then used to decide what rights the user has, thus answering

produc t s & serv ices

the question “What am I allowed to do?”. This system makes it possible to implement complex access rights. Do staff need specialized IT knowledge to install and operate the zenon Service Grid? Your IT staff will need some in-depth knowledge; for example, to tailor the required parameters of the individual services to the installation platform. This is carried out directly via configuration files during installation. If you want to benefit from advanced functionalities, such as dynamic scaling and failsafe performance, you will need to use technologies such as Docker and Kubernetes. Specialized knowledge and experience are required in this case, as the IT staff will be responsible for operating and maintaining the installation in the long term, including taking care of troubleshooting and software updates. Does the Service Grid only run in a particular cloud environment? The zenon Service Grid is platform-independent and cloudindependent. You can choose any cloud provider or opt for operation within a private data center. Why are new technologies such as Docker used? It is particularly advantageous to use new technologies when running web applications in the cloud environment. Application requirements such as scalability, platform independence, and easy installation can be achieved more easily and efficiently with these technologies. Where are the installation packages and how do I install the zenon Service Grid? The process varies depending on the type of installation. A Windows setup program is available for classic installation, which should be carried out on the server hardware and server operating system. For installation in a cloud environment or a local data center, Docker images are available in the COPA-DATA registry. These images should be installed on an existing Kubernetes cluster. How are the Service Grid’s individual components updated? In the case of classic installation, the individual components are updated with the ISO installation package. If the Service Grid is operated with Kubernetes, you can easily update the components by using the latest Docker images. In both cases, only the components’ binary files are updated. The configuration of the Service Grid installation remains the same. This means that you can continue using the system immediately after the update.

Do I need an SLA for the Service Grid? You will need a valid service level agreement (SLA) to purchase and operate the zenon Service Grid. This will give you access to the latest security updates and functional enhancements at all times. Improvements are implemented in the zenon Service Grid on an ongoing basis and are provided via the COPA-DATA registry. What license models are available? You can purchase the zenon Service Grid as a monthly subscription with billing on an annual basis. The Service Hub, Data Storage, Identity Service, and Egress Connector components are included. The Ingress Connector can also be licensed, if necessary. In this case, the price is dictated by the number of variables in the existing zenon Runtime. The connection between the Web Engine and the Service Grid can be configured either as a read-only connection or a read-and-write connection, whereby licensing is based on the number of users. Any further components connected via the API Gateway can have either a read-only or a readand-write connection. Furthermore, a connection from zenon Analyzer to the zenon Service Grid can be licensed to output reports via the Web Engine or the API Gateway. How does the release cycle for the Service Grid compare to zenon Supervisor and zenon Analyzer? We have been systematically developing and refining the zenon Software Platform over the last few years. With the next version – zenon 10 – zenon Software Platform components will be released simultaneously for the first time, including the zenon Service Grid. An annual release cycle is regarded as appropriate in the OT world, but is not fast enough for cloud scenarios. COPA-DATA will, therefore, offer the zenon Service Grid in two different versions. The version with long-term support will be released annually with the other zenon Software Platform components. To enable timely updates and enhancements, there will also be three further releases: one at the end of each quarter. You are free to choose the option that best suits your needs.

BUILDING A HEALTHIER FUTURE – FOR ALL! The results of an analysis of trends in the global pharmaceutical market were presented during the Pharmintech Exhibition 2019, held in Bologna over April 10–12. Together with the IQVIA “The global use of medicine in 2019 and outlook to 2023” report, the “Pharmintech Monitor” research offers interesting insights into the changes underway in the life sciences sector.

Published in

information unlimited the copa-data magazine No. 35, November 2019 © Ing. Punzenberger COPA-DATA GmbH www.copadata.com/iu

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In 1978, human insulin was created in Herbert Boyer’s laboratory in San Francisco by inserting DNA into Escherichia coli bacteria, signaling the birth of biotechnology and the start of a new future for the pharmaceutical industry. Today, the life sciences sector is a clear example of where knowledge sharing and exchange between different fields such as genomics, big data, robotics, and nanotechnology is delivering improved patient outcomes. Personalized medicine and digital medicines are becoming a reality and are positioned to totally restyle the approach to many illnesses. They offer an improvement in therapies that seemed unthinkable until only recently. Medicines are now not just for treating an illness, but for treating the illness based on genetic characteristics. This is a highly innovative sector that calls for close collaboration between the academic world, companies, and institutions. At the same time, the expiration of patent coverage for many medicines and the resultant growth in generic medicines has reduced the entry barriers for treatments in developing countries. Governments around the world are looking to increase patient access to low-cost medicines, thus increasing demand and creating the conditions for a gradual improvement in quality of life for an ever-growing number of people. A M A R K E T I N CO N S TA NT G ROW TH What are the expectations for the global pharmaceutical market? According to IQVIA,(1) by 2023 the total value of the market should reach 1.5 trillion US dollars, with an

average annual growth of between 3 and 6 percent. This is a decrease compared to the 6.3 percent seen in the last five years. The USA continues to have more marked growth (4-7 percent) compared to the main European countries (1-4 percent), while China proves to be the biggest “pharmemerging” market. It is expected to reach 140-170 billion dollars by 2023. Turkey, Egypt, and Pakistan stand out among the emerging countries, with average growth between 5 and 8 percent. The sector is growing, although not as intensely as in previous years. This slowdown in growth is essentially due to three factors: – Price pressure, especially in the USA and Europe, due to the policies of the national health services, the actions of insurers, new distribution channels, and large-scale distribution. – The continued growth of generic medicines and biosimilars against “patent” (originator) medicines. – Euro-dollar currency effects (Europe vs. USA). The impact of the loss of exclusivity in developed markets is forecasted to be around 121 billion dollars between 2019 and 2023, a period in which 18 of the 20 biggest branded medicines will lose their patents, opening the way to generics or biosimilars. Figure 2 shows Pharmintech Monitor’s(2) evaluation of the global pharmaceutical market and the trend for the period 2018-2021.

10%

1,600

1,400

Spending US$Bn

7% 1,000

800

5% 4%

600

400

2% 200

2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 Spending Figure 1: Globa l Me d ic i ne Sp e nd i n g a nd G r ow t h 2 0 0 9 -2 0 23. Source: IQV I A Ma rket P r og nos i s , S ept. 2 018; IQV I A I n s t it ute, De c. 2 018

Growth

Forecast

Growth Rate Constant US$

8% 1,200

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671

+2.8%

+3.1% +4.8% +3.3% Accelerating Constantly growing Slowing down

+1.3% +4.9%

WORLD

+3.6%

Figure 2: Ph a r m ac eut ic a l m a rket t r e nd s du r i n g t he p e r io d 2 018 -2 0 21 d iv ide d i nto m ac r o a r ea s. Source: Ph a r m i nte c h Mon itor.

WH AT A B O U T TH E B I G G E S T D R U G M A N U FAC T U R E R S ? Another common trend in big pharma is an increase in R&D costs, equivalent to around 18.3 percent of sales value. This accounts for a slight reduction in gross operating margins (EBITDA), which fell from 34.7 percent in 2016 to 32.3 percent in 2018. Moreover, there is the added strain of an increase in the costs associated with the discovery and the route to market for new drugs and a drop in turnover due to the gradual expiration of patents. TH E R E LE NTLE S S A DVA N C E O F G E N E R I C M E D I CI N E S The spread of generic medicines is more evident in emerging countries: the market share of generics is 88.9 percent in China and 74.8 percent in India. However, this phenomenon is also present in developed countries. In Germany and England, the utilization rate is around 60 percent, while in Italy the share for generics grew from 9.8 percent in 2008 to 22 percent in 2018. We are therefore seeing a gradual specialization by companies dedicated to this sector, with the most important company specializing in the manufacture of generic medicines being Mylan. It has a turnover in excess of 10 billion dollars. It is followed closely by Teva Pharmaceuticals and Sandoz (Novartis group) and then companies with a lower turnover such as Sun Pharmaceuticals, Fresenius, Lupin, Cipla, and many others.

CO NTR AC T D E V E LO P M E NT A N D M A N U FAC T U R I N G O RGA N I Z ATI O N S (C D M O) Manufacturing within the pharmaceutical industry also takes place through companies working on the basis of Contract Development and Manufacturing, an internationally established organizational model whereby companies holding market authorizations for medicinal products outsource their manufacturing and pharmaceutical development activities. The activity of these companies has been on the rise in recent years, in terms of both staff and turnover as well as investment, and the sector continues to grow. According to Farmindustria,(3) in Italy, the top EU country for pharmaceutical production, the value of CDMO production grew 41 percent between 2010 and 2016, driven by exports in particular. Contract development and manufacturing is worth â&#x201A;Ź7.9 billion in the European Union. The sole aim of CDMOs is to manufacture quality medicines at the lowest possible price. The distinctive characteristics of CDMO activity leads companies to allocate significant resources to investment in manufacturing aimed at supporting efficiency and quality. Over three-quarters of investments relate to production lines (53 percent to new lines and 25 percent to the modernization of existing lines). This figure demonstrates the importance of partnerships with equipment suppliers, hardware and software technologies, and capital goods in general.

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VALUE OF CDMO MANUFACTURING MILLIONS OF EUROS

% OUT OF EU TOTAL

Europe total ............................ 7,900

19%

Italy............................................... 1,872

Other EU countries*

24% Italy

Germany ..................................... 1,747 France........................................... 1,519

16%

United Kingdom ........................ 784

United Kingdom & Spain

Spain .............................................. 496

22%

Other EU countries* ...............1,483

Germany

19%

* Austria, Belgium, Greece, Croatia, Ireland, Portugal, Czech Republic, Romania, Sweden

France

Figure 3: Ma i n E U cou nt r ie s by pr o duc t ion t h r ou g h C DMO s. Source: Fa r m i ndu s t r ia

P H A R M AC E U TI C A L M A R K E T I N TH E E U Italy is th e Europ ea n U nion’s top pha rma ce utic al ma n ufa c ture r, surpassing G e rma ny in 2017 with pro duc tion totaling ¤ 3 1 . 2 billion compa re d to G e rma ny ’s ¤ 3 0 billion . This success is down to a boom in expor t s , which a ccount for a ro un d ¤ 2 5 billion . Th ese co untries a re followe d by th e U K (¤ 2 1 .7 billion), Fra n ce (¤ 20. 2 billion), a n d S pain (¤ 1 5 . 5 billion). O ut sid e th e EU, Swiss prod uc tion has a value of a roun d ¤ 4 6 billion . (5 )

G O O D N E WS FO R EQ U I P M E NT M A N U FAC T U R E R S Our many clients that specialize in equipment manufacturing for the pharmaceutical industry can enjoy a positive outlook over the next three years. Figure on Page 63 shows the sales forecasts for packaging equipment for the pharmaceutical industry. It appears to be more dynamic than the forecasts for the industry's own growth (+4.4 percent overall for equipment vs. +3.6 percent for the pharmaceutical industry). This is down to a high volume of technology and investments for renewal and replacement of production equipment, the majority of which are compatible with the new standards defined by Industry 4.0 and capable of complying with the requirements of Data Integrity guidelines. A CO M B I N ATI O N O F E F F I CI E N C Y & CO M P LIA N C E The brief overview outlined here provides a snapshot of the transformation underway in the pharmaceutical industry. For a more in-depth look, please refer to the reports cited in the notes at the end of this article. We have seen how the development of a new generation of drugs will make extensive use of technologies related to ICT, big data, and artificial intelligence. The gradual opening of markets through the introduction of generic medicines and biosimilars intensifies competition between companies that are increasingly focused on mass production. For these companies, the fundamental objectives will be production efficiency, flexibility, and overall cost reduction thanks to the digitalization of production processes. Unlike other industry sectors, the world of life sciences must continue to get to grips with the good manufacturing practices (GMP) required by the regulatory authorities of different countries. In this context, compliance with Data Integrity can be an opportunity to digitize processes related to the regulatory framework. For example: human

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69 3

210 mln¤ -0.8%

1.058 mln¤ +4.1%

1.631 mln¤ +4.1% 1,743 mln¤ +5.4% 270 mln¤ +3.2%

WORLD

354 mln¤ +4.8%

5.264 mln¤ +4.4%

Figure 4: Ph a r m ac eut ic a l pac k a g i n g e qu ipme nt for e c a s t 2 018 -2 0 2 0. M a rket va lue a nd e x p e c te d g r ow t h . Source: Ph a r m i nte c h Mon itor – It a l ia n Pac k a g i n g Mac h i ne r y Ma nu fac t u r e r s’ A s soc iat ion ( UC I M A) Re s ea r c h C e nte r.

error avoidance due to paper-based procedures, manual data entry reduction, electronic batch record, batch review by exception. This is one reason why the International Society for Pharmaceutical Engineering (IPSE) has set up a working group on the issue of “Pharma 4.0.” It will look at how to implement Industry 4.0-based manufacturing concepts in a sector as highly regulated as the pharmaceutical industry.(4) zenon’s extensive presence in the pharmaceutical industry has in part been made possible through COPA-DATA’s collaboration with leading international equipment and installation manufacturers. Furthermore, the knowledge sharing and exchange of ideas between sectors traditionally focused on issues such as OEE and energy efficiency have enabled COPA-DATA to be involved in tackling the challenge of combining efficiency and GMP compliance for some time.

Te x t Sourc e s: (1) IQV I A – T he Glob al Us e of Medic ine in 2019 and O utlook to 2023 ht t p s://w w w.iqv ia.c om/in s t it ute/rep or t s/the- glob al- u s e- of-medic ine-in-2019 - and- outlook-to -2023 ( 2) UC I M A Re s earch Center, Phar mintech Monitor (s p ec ial thank s to D r. Luc a B araldi) ht t p://w w w.phar mintech .c om/phar mintech/phar mintech _ monitor/ Phar mintech Monitor_ 2019.p df UC I M A web s ite: ht t p://w w w.uc ima.it/uc -it/s er v i z i- a s s oc iat iv i/c ent ro - s t udi/ ( 3) Far mindu s t r ia: 2018 Phar mac e ut ic al Indic ator s – https://www.farmindustria.it/app/uploads/2017/12/Farmindustria_IndicatoriFarmaceutici_WEB2018.pdf (4) I SPE Phar ma 4.0 web s ite: ht t p s://i s p e.org/init iat ive s/phar ma- 4.0 (5) Far mindu s t r ia, u s ing data f rom E uro s tat, I s tat, E F PI A , IQV I A. Far mindu s t r ia-Web s ite: ht t p s://w w w.far mindu s t r ia.it/

GIUSEPPE MENIN Industry Manager Pharmaceutical Giuseppe Menin began his career in the mechatronic engineering at the end of the 1980s, covering different technical roles in automation and software development. In 2004, he joined COPA-DATA Italy as an area manager. Since 2014, he has been a member of the International Society for Pharmaceutical Engineering (ISPE). As member of the Connected Machines working group within GAMP Italy, he is regularly in contact with professionals involved in the life sciences sector. He is currently covering the role of Industry Manager Pharmaceutical at COPADATA HQ.

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ZE NON SUCCE SS STORY P ER FEC T C LE A N RO O M TEC H N O LO GY FO R TH E P H A R M AC EU TI C A L I N D U S TRY

Sterile and safe production with SKAN and zenon If the tiniest dust particle can falsify results, if toxic substances endanger health, if active ingredients need to be precisely handled, then isolators can ensure perfect safety and sterile working conditions. For many companies, one of the pioneers in cleanroom technology comes into play here: Swiss SKAN AG.

Published in

information unlimited the copa-data magazine No. 34, June 2019 ÂŠ Ing. Punzenberger COPA-DATA GmbH www.copadata.com/iu

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51 1

Figure 1: E ve r y t h i n g u nde r cont r ol: T he i nte r n a l ze non va r iable s c lea rly d i s play i mp or t a nt i n for m at ion , s uc h a s w atc hdog or ava i lable me mor y s pace.

Whether for the pharmaceutical industry, biotechnologies or colleges, special equipment is required in all laboratories and production sites where work is carried out with sensitive or dangerous substances. The basic requirements include cleanrooms and isolators. Isolators protect with strict physical separation of products and people in both sterile or toxic applications in production, quality control and sterile working, as well as for active ingredient processing. SKAN AG has been a partner of many well-known corporations since 1968. As an expert in cleanrooms and isolators, it provides many laboratories with special technology. The required control technology and visualization is made to order by an on-site engineering team. For its isolators for filling process equipment, SKAN AG builds on the expertise of Swiss SATOMEC AG and the HMI/SCADA software zenon from COPA-DATA. As the supplier of many customers, SKAN utilizes the advantages of zenon in order to create a uniform and modern interface as standard, which can then be rapidly and simply adapted to customer-specific requirements. T WO P ROS I N TH E P H A R M AC E U TI C A L I N D U S TRY With zenon, SKAN AG has specifically chosen a software that is on the one hand highly deployable and on the other hand, with its specialized functions, is innately able to fulfill many of the mandatory requirements in the pharmaceutical industry. Heinz Leutwyler, Head of Automation at

SKAN AG: â&#x20AC;&#x153;For us, a high level of availability in production and ergonomic and rapid diagnosis is particularly important for the user. Compliance with FDA/GMP guidelines is mandatory. Furthermore, we lay great importance on contemporary usability, for example, through Multi-Touch operation, and visualization that can be handled without much extra coding in complicated language or software from other manufacturers.â&#x20AC;? This is why a high level of importance has been given to user guidance. The clear equipment screens ease orientation and help with fault locating. Important information is prominently displayed. And for necessary entries the rest of the monitor is dimmed and the operator's attention is directed to the element which requires action. zenon can satisfy these demands very well. The FDA and GMP guidelines are fulfilled out of the box. And when it comes to Multi-Touch, its manufacturer, COPA-DATA, is a pioneer. The user administration could also convince immediately, confirms Elger Gledhill, zenon Sales Manager at SATOMEC AG. zenon is deployed on isolators for filling process equipment and is responsible for the sensor to the MES connection, such as to Osisoft PI, or to the ERP level, with SAP for example. The audit trail for compliance with FDA and GMP guidelines is simply parameterized with a few mouse clicks. Many predefined functions and modules keep programming efforts for special requirements to a minimum, such as the native integration of Multi-Touch.

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Figure 2: Pe r fe c t ove r v ie w : T he w ide a r ray of e qu ipme nt comp one nt s a r e v i s ible at a g la nce for fa s t , s i mple fau lt loc at i n g.

The shift between languages and measuring units for international use is also achieved in a mouse click. SKAN AG engineers simply define the wording and the measuring units for all required languages. These are tailored in the Runtime with the click of a button, or automatically during log in. The capability of zenon to connect to the customers' Active Directory offers notable simplicity for the engineering team. It makes the user administration very simple and clear. And especially: the regular license renewal of passwords required by the FDA can be carried out in a sub-network in the zenon Runtime. Perfect for use in the pharmaceutical industry: All operations are logged and listed in the Audit Trail. Should an action require special rights or a signature, this can be easily configured. P E R F E C TLY I NTE G R ATE D SKAN AG is often involved in very heterogeneous environments. Its customers utilize various control systems. Furthermore, the plants differ greatly in size. The systems can range from small equipment with a zenon Runtime to large redundant systems with zenon Supervisor and numerous clients. Easily scalable systems such as zenon are obviously at an advantage. Secure and simple integration is especially important.

SKAN engineers particularly need to be able to equally reliably control Siemens or Allen-Bradley PLCs or a Box PC with Windows 8.1, or a broadband monitor with Multi-Touch from B&R. As zenon can directly control all these systems and many more, the connection, selection and configuration of the corresponding driver is rapidly achieved. The network configuration of zenon is particularly valued: “Activate the network project properties, enter server. Done.” Heinz Leutwyler happily states. He adds: “The competent support by SATOMEC and the quick realization of any additional requirements we had of zenon were implemented in conjunction with COPA-DATA in a professional collaboration.” A B O U T S K A N AG With over 200 employees, the SKAN organization provides the pharmaceutical industry and colleges with high-quality cleanroom equipment and isolators. SKAN was founded in 1968 in Allschwil, Switzerland, and has built on many years of partnerships with longstanding customers. An inhouse engineering department sees to modern and tailored visualization and control. Further information: www.skan.ch

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51 3

Figure 3: S oph i s t ic ate d u s abi l it y: T he d i m me d s c r e e n a l low s t he at te nt ion a nd foc u s to b e t ra n s fe r r e d to t he i mp or t a nt i n for m at ion a nd d ia log s.

A B O U T SATO M E C AG SATOMEC AG is a commercial company with dealers for automation systems. The partner, based in Cham, supports its customers in Switzerland and Liechtenstein with highlyqualified support, consulting, instruction, training and a comprehensive warehouse in Switzerland. Control systems, visualization, HMI or IPC and network technology are some of the areas of expertise of the Swiss company with 15 employees. SATOMEC AG was founded in 1976 and has been privately owned by the Studhalter family since 2005. Further information: www.satomec.ch.

S K A N A N D Z E N O N – TE A M WO R K I N C LU D I N G : –

Dire c t drive rs for custom e r-sp e cif ic control , e .g . Sie me ns a n d Alle n B ra dley

–

Con n e c tion to O siS of t PI (M E S) or SA P (ER P)

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Use r a dministration via M icrosof t Ac tive Dire c tor y with a ccess f rom sub - n et works

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E x te n de d Tre n d m odule for historic al data display

–

Re por ting

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N ative M ulti-To uch for Win dows 8 .1

CO NTAC T: E lg er G led hill S ales M a nag e r Control Syste ms SATO M EC AG elge r.gle dhill @ satom e c .ch

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O FF TH E R ECO R D:

THE TRUTH ABOUT DATA INTEGRIT Y IN PHARMA

The Food and Drug Administration (FDA) has long emphasized the importance of reliable data in pharmaceutical manufacturing. Despite this clear recommendation, recent FDA reports have highlighted an increase in data integrity violations during several recent current Good Manufacturing Practice (cGMP) inspections.

In simple terms, cGMP states that pharmaceutical manufacturers should follow instructions and document actions correctly. This way, if any deviation occurs in the product, the company can investigate it and put measures in place so that the same error does not happen again. This guarantees the repeatability and safety of the product being manufactured and protects the brand. Data integrity refers to the completeness, consistency, and accuracy of data, which needs to be attributable and legible. Data integrity violations can lead to warning letters Published in

information unlimited the copa-data magazine No. 33, November 2018 ÂŠ Ing. Punzenberger COPA-DATA GmbH www.copadata.com/iu

and even fines. More importantly, drugs approved on the back of inaccurate data could pose a threat to patientsâ&#x20AC;&#x2122; lives. For all these reasons and more, data integrity is at the heart of the pharmaceutical records discussion. AU D IT TR AI L S The pharmaceutical industry has been slowly transitioning from manual paper records to automated, electronic records. Batch records predominantly take an electronic form today, but other systems, including production processes

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such as start-ups, changeovers, running documentation, and sampling, are not always digitalized. Although paper records can work well for some companies, they leave more room for human error and data manipulation than their electronic counterparts. The true benefits of digital records become obvious when companies use reliable automation software to automatically record the actions each user carries out. The software also makes data manipulation impossible; once a user inputs data, the action is saved automatically. If the input is outside acceptable parameters, the system records the error and the user is required to leave a comment in order to continue with production. Another advantage of using HMI software for electronic recordkeeping is that it can be set to ensure the user canâ&#x20AC;&#x2122;t start or finish a batch without completing a required set of information. This means there will be no more gaps in the records, which in turn improves data accuracy. Finally, automation software can automatically log any critical event and allows users to set alarms or notifications should any of the predefined values be outside set parameters. This ensures that any deviation in the process is identified in real time, automatically shared with relevant members of staff, and recorded for the audit trails. TH E LO G I N D I LE M M A The best way to ensure precise data integrity is to assign individual logins on a per-user basis. There are several ways of achieving this. One common method is to assign each operator an individual username and password. Other secure, reliable methods could be using Active Directory logins or personal fob cards with a scannable bar code. With individual user login enabled, the system can record any action or change made by an operator, thus offering a clear picture of the overall process. Individual logins also increase a system's security, potentially at no additional cost, because they allow a company to attribute different authorization levels to users. DATA SA F E T Y Another common concern of pharma companies is data safety: how does a manufacturer know its production data is safe and complete? By using reliable automation software, companies can help eliminate this issue. When exporting archives to an external database, for example, the software uses its internal mechanisms to check whether the data has been correctly and completely transferred. If the transfer fails for some reason, the software will automatically resend the transfer next time it starts a cycle, so data is never lost or corrupted. The software will also log the incident chronologically in the events list.

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To ensure data safety, the software stores critical data such as audit trails and alarm lists in binary files â&#x20AC;&#x201C; which are illegible to the human eye â&#x20AC;&#x201C; in a proprietary format. Authorized users can modify data within the software, but the modification will always be logged in the audit trail. This practice ensures the archive is accessible, easy to read, and accurate for authorized users, while also adding an additional layer of protection against unauthorized access. The benefits of using electronic records in pharmaceutical manufacturing go beyond regulatory compliance. Looking to the future, companies who strive for continuous improvement can use electronic records to achieve this business goal. Digital records that guarantee data integrity and safety allow companies to breeze through regulatory compliance and focus on improving and growing their business, comfortably complying with the FDA CFR 21 part 11, annex 11 and cGMP.

lee sulli va n, r egiona l m a nager sou th uk

industr ies & solu tions

Can you Hear? Can you See? Can you Imagine? YO U R P L A NT I S TA LK I N G , A N D TA LK I N G I N C E S SA NTLY A B O U T E V ERY TH I N G . D O YO U H E A R W H AT IT I S SAY I N G?

zenon continues to develop, engulfing new technologies and embracing each new industrial era without hesitation. However, future success is built upon the strong pillars of history. One of those fundamental pillars is the zenon Historian. In the Life Science industries, recording process information is fundamental to any production activity; data acquisition and a historian are therefore a primary focus. In this article, I would like to turn the tables on the traditional automation hierarchy and give the zenon Historian prime importance (see figure 1), and position the other zenon features as its supporting modules.

Published in

information unlimited the copa-data magazine No. 32, October 2017 ÂŠ Ing. Punzenberger COPA-DATA GmbH www.copadata.com/iu

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industr ies & solu tions

Collect Data

Structure

Historicize

Export

Communicate with plant processes, equipment, networks, and infrastructure

Flexible architecture, multiple historian structures, integration projects

Record data as time-series, cyclic, on event, manually

Integrate to other databases, OPC-UA, CSV, XML, PDF

Long-term Storage  zenon proprietary binary files  SQL, any ODBC connected database  PDF or hard copy printout

Figure 1: C on s i s te nt i nteg rat ion f r om d at a col le c t ion to s tora ge.

Z E N O N H I S TO R IA N F RO NT A N D C E NTE R The zenon Historian is a process data highway. Data can enter the system at any point within the infrastructure from its connected PLC processes, IT-layer systems such as MES or ERP, or mid-level HMI & SCADA systems. Data can also leave the highway at any point, at the equipment level, production process level, or globally across plants. Starting at the zenon Historian itself, flexibility and the ability to adapt to individual processes are key qualities. Historians can be placed at the top of the IT structure, capturing the entire plant's activity. Or historians can be placed at the equipment or production line level, to have stand-alone functionality. If desired, these smaller historians can then be tied into larger process historians and multi-site global historian systems. With native communication drivers, including standard industry protocols, zenon Historian can connect with any industrial system. This powerful connectivity brings together different systems from different process equipment, including systems such as MES, ERP, and other databases. Data can enter and exit the zenon Historian freely from the different layers and systems in a bidirectional sense. No existing infrastructure needs to be changed to connect with it – native drivers connect without modification to the third party system. The big plus here is that validated processes remain unaffected. The diagram above displays how the zenon platform connects to the different processes that collate data. The raw data entering the system is then structured with meta-data so archives can be defined with independent processes of variable scope and independent data logging.

Finally, data can be stored long-term, with the possibility of exporting it in different forms to suit the desired outcome. F LE XI B LY CO LLE C T DATA zenon is independent and flexible; connecting natively with different industrial systems, PLCs, devices, industrial networks, databases, and other IT systems. This is a powerful advantage in any industry, but its benefit is magnified in the pharmaceutical sector because connecting natively minimizes additions or changes to validated systems – leaving qualified processes untouched. This environment brings multiple systems together while reducing engineering design effort and risk to the process, and resulting in significant positive effects on quality and the level of validation a historian system needs. The ergonomics of zenon benefit the final historian solution, allowing manual data to be entered easily alongside automated data. Using a desktop PC or workstation, mobile tablet, or smartphone, manual tasks can be requested. User events, results, and comments are then recorded in the same historian. This data has a time stamp and meta-data, which is archived like any other element of process data. Wider systems such as building management and energy systems can also be included in the scope of an application. Any data from a sensor, device, industrial network, or manual entry can be archived in a site-wide, global, or cloud-based zenon Historian. VI S UA LI Z E E V E N CO M P LE X I N FO R M ATI O N I NT U ITIV E LY Now the data is in the system, there is no need to keep it hidden away. We can now touch on powerful knowledge

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cloud

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Q U I C K FAC T S : CO L L E C T DATA

Audit Trail Batch Production Report

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N ative communic ation drive rs

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O P C- DA , O P C- UA , M o db us , C A N , BACn et, I EC 6 0 870, I EC 6 1 8 5 0, I EC 6 14 0 0, I EC 6 149 9, I EC 620 5 6 , SQ L , D N P3 , VD M A , M - B us , Prof ib us , Prof in et

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clo ud , A zure drive r

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Figure 2: F le x ible a nd i nt u it ive v i s u a l i z at ion e n able s acc u rate a nd qu ic k de c i s ion m a k i n g.

V I S UA LI Z E

generated from within the production environment; visualizing this knowledge with plant overview dashboards and detailed process screens with, for example, alarm and event information. Process variables can be displayed in trends, KPIs are generated from live or historical production runs, and equipment GANTT charts provide a detailed view of active processes and production losses. Valuable production information is close at hand. You are able to deal with complexity and abnormality, and make the right decision quickly.

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Process scre e ns , dashboa rds

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Ala rm & eve nt n otif ic ation

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K PI , tre n ds , GA NT T

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AG I LE S TR U C T U R E S E N H A N C E E F F I CI E N C Y Reading your process data and storing it requires structure. This structure needs to be agile in order to be matched to the process, then the outcome of the data is focused and a true representation of real-world events. “Time-series data” creates a very accurate and storage-efficient way to archive processes. Reading data and only storing this data “On change” records events spontaneously – therefore you can be certain no event is missed. “Cyclic” data records processes at a certain frequency, e.g. every minute the variables will be recorded, thus recording a predicable snapshot of the process. “Event triggered” allows zenon Historian to synchronize with external systems or process events. All data coming into zenon is structured before reaching the historian; adding richer knowledge and grouping to reflect the actual processes being recorded. Variables can be defined in an ISA 95 Equipment Modelling structure, and alarms can be defined by group, class, or area. The historian archives can be placed where the data is most relevant for the processes. For example, a traditional top-heavy structure can be applied, with a central historian system at the top of the IT tree. Alternatively, the archives can be generated and reside where the data is generated, directly at the individual piece of equipment or production line. Historians and archives can overlap each other. For example, when process data is being logged as time-series, certain critical process values within this data can additionally be being logged cyclically at a defined frequency. Therefore, no data is lost and all representations of the data can be displayed. In a distributed

H I S TO R I C I Z E –

Time -se ries data; store data on cha ng e

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Eve nt trigge r ; syn chronize data write with process eve nt(s)

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Cyclic al data; f ixe d f re que n cy data a cquisitio n

STRUCTURE –

Flexible a rchive scop e a n d loc ation , H M I , SC A DA , top laye r produc tion IT.

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Equipm e nt m odelling: I SA 9 5 , I SA 8 8

EXPORT –

SQ L , a ny O D B C- conn e c te d data base

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O P C- UA , sta n da rd in dustrial inte r fa ce

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C SV, h uma n rea da ble f iles , E xcel compatible

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XM L , struc ture d comm on f ile format

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Azure Websites

Cloud-based

zenon Analyzer Historic Analysis Data Analytics

...

zenon Runtime Real-time Dashboard

Azure ML

Everywhere Server

Azure Table Storage

Users / Clients

Azure SQL

Site A

Site B

On premise

Azure Event Hub/ IoT Hub

Site C

Figure 3: Mu lt i-s ite a n a ly s i s a nd ef f ic ie nt lon g-te r m s tora ge w it h c loud te c h nolog y.

system, local archives at the equipment or production line level can also be included with archives at the top-level IT layer. E F F I CI E NT LO N G -TE R M DATA S TO R AG E zenon's proprietary storage files have the distinct benefit of acquisition speed, especially for large volumes of data. Using proprietary binary files increases security for longterm storage. Open to have the choice of integration possibilities, you are also able to use an external SQL or any ODBC-connected database. Keeping your data over the long term may also include exporting data to other databases, or printing it to PDF or as a hard copy. D E LIV E R E N H A N C E D A N A LYS I S Now we start to accelerate the possibilities: with strong reporting and analytical tools releasing the potential of your production data. Production reporting, such as batch reports, are a common reason for implementing a historian, proving quality and regulation compliance. Once you have this installed, we can start to release additional potential with zenon. On the same platform, it is a simple matter to provide deep analysis. Practical examples of this include: alarm analysis highlighting where losses are holding you back; KPIs such as OEE to increase efficiency; including energy consumption in your analysis; or using RBE (Review by Exception) reports to increase quality.

E XPA N D SCO P E I N TH E C LO U D Adding the Microsoft Azure platform effectively places the zenon Historian into the cloud. On premise zenon systems transfer local process information with high security and fast data acquisition to the cloud. In so doing, zenon Historian becomes an ergonomic Big Data solution, using its conventional native archiving technology in a highly accessible global historian system. The Azure cloud platform adds a different dimension to what data is available and where. The use of a global cloud solution is becoming very popular with equipment suppliers where their equipment is deployed at end-customer sites throughout the world. The cloud is used to obtain and store equipment performance, where no record is made of actual production results â&#x20AC;&#x201C; only equipment performance. This helps the equipment supplier become closer to the customer â&#x20AC;&#x201C; enabling it to suggest preventative maintenance based on real data and facilitating the possibility of providing different services, such as pay-per-use machines. For end customers, the cloud offers global connectivity. Data security is a major question in this choice. Which is answered using a combination of Azure encryption, Azure security certificates, and zenon network security. From the on-premise system to the cloud, the Azure mechanism only transfers raw data. This raw data has no context until the zenon Historian operating in the cloud receives it â&#x20AC;&#x201C; at which point it becomes information and knowledge.

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Figure 4: A n a ly t ic s a nd r ep or t i n g.

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ze n on proprieta r y bina r y f iles

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SQ L , a ny O D B C- conn e c te d data base

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p df or ha rdcopy printo ut

Sankey Diagram 12.08.2014 00:00:00

12.08.2014 22:00:00

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A N A LYS I S

Air Flow Sankey Diagram

From node

To node

Values Relative Values

To node

Compressor A

Air Accumulator

Compressor B

Line 1

Compressor C

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Air Accumulator

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Ala rm a nalysis , stoppag es , brea kdown

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En e rgy ef f icie n cy, I SO 5 0 0 01

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Custom formula

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zenon Analyzer | www.copadata.com

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D E LI V E R

P E R FO R M AT YO U R B E S T WITH Z E N O N zenon has the ability to connect with any industrial system, wherever it is located, and is easily scalable – from a single equipment unit to multi-site global operations. This means you can hear what your plant is saying, wherever your plant is. zenon helps you to futureproof your processes, release your imagination, and continue to perform at your best.

robert h a r r ison

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P D F, HTM L , E xcel , Word , Powe r Point, TI FF

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Process eve nt trigg e r, e .g . e n d of batch , ala rm eve nt

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Time -sch e dule d eve nt

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C LO U D –

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I n dustr y, process a n d ha rdwa re in d e p e n d e nt

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Archive , visualization , re por ting

THE FABRIC OF COMPLIANCE Data Integrity the FDA Makes its Move

Published in

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As automation engineers, we often focus on speed, with fast control and resolution being paramount. After all, mechanical and chemical processes do operate in real time and so highly available automation is required to gain instantaneous control. Global regulations demand that pharmaceutical manufacturers prove their methods and while the drug is in circulation, a history of this proof is needed. For example, under cGMP (current Good Manufacturing Practices), production batch records are generally stored for at least seven years, with records of adverse events being stored for 10 years. This adds the dimension of a lifecycle to good data management and data integrity. Effective architectures and algorithms ensure that data is captured and controlled at a frequency determined by process risk. For historical data, however, it doesn't matter whether an inspection looks at processes which were executed this morning or at production records from years ago; GMP records need to be available and to stand robustly on their own.

The FDA released a new guidance document on “Data Integrity” in April of last year, which describes data integrity as the completeness, consistency, and accuracy of data. It is currently reported that the number one enforcement priority of the FDA is Data Integrity, indicating the FDA see it as an important component of the industry’s responsibility to ensure the safety and the quality of drugs and, with that, the FDA's ability to protect public health. The FDA's Part 11 regulation emerged in the 1990s because increasing levels of automation were being deployed into pharmaceutical production environments. Its focus was to embrace the new technology and set out rules for its acceptance in line with the established paper methods and paper recording procedures. Part 11 facilitates the use of electronic systems if they are capable of creating the same – or better – levels of quality and validation than the paper equivalent. The automation and computing power available today stands in sharp contrast to what was possible when Part 11 was released in 1997. The smartphone in your pocket has more power than the most advanced supercomputers of the early 1990s. Introducing or amending regulations can be a long and arduous process, and to facilitate their correct adoption, guidance documents are created. The FDA's Data Integrity guidance is essential to the Part 11 regulation, widening the focus of Part 11 to include the current thinking of the FDA in response to a large number of recently cited violations.

After the event, the facts do come very easily. Today, twenty years on, we can see that the FDA Part 11 regulation not only demonstrates that electronic systems are equivalent to or better than paper-based systems, but that the essence of Part 11 is data integrity. The new guidance focuses the attention from the technology to the secure, long-term accuracy and management of data. Data integrity is critical to compliance and managing data holds centre stage in pharma's most high-profile challenges. Building on the Part 11 regulation, the Data Integrity guidance document is formed as a question-and-answer format, which aims to clarify the fundamental role data integrity has in good manufacturing practices (cGMP). Thus, it provides valuable insight for the manufacturer as to what the FDA inspector is looking for during a plant inspection. Of course, not every issue that might be faced by a company is answered. However, as we noted earlier, this topic is currently the top enforcement priority of the FDA. The MHRA (Medicines & Healthcare products Regulatory Agency) in the UK has released its own guidance and definition of data integrity. Moving along the same lines as the FDA, the MHRA is allowing paper-based and hybrid systems to be acceptable until an automated integral audit-trail system is available, with a clause stipulating that GMP facilities should upgrade to an automated system by the end of 2017.

industr ies & solu tions

contemporaneous

Data Integrity

legible

attributable

The FDA expectations for electronic data can be distilled into the acronym ALCOA: A Attributable, the person and process is intrinsically linked to the record. L Legible, the event details are clearly readable and permanent. C Contemporaneous, time-stamped and recorded immediately as the event occurred. O Original, a true representation of the process. A Accurate, in measurement, time, and context of the process, equipment and person. SO M E K E Y FAC T S – Metadata is the context of the data required to understand the event, e.g. date/time, user ID, variable, units, location. – Data should be maintained throughout the lifecycle retention period with all the associated metadata required to reconstruct the process activity.

original

accurate

–

The audit trail is the chronological list of the who/what/ where/when/why of the process, with the aim to track the record creation, modification or deletion with date/ time, user ID, parameters, values, and location, etc. Appropriate user access controls must be in force to comply with the Part 11 regulations. The Data Integrity guideline goes further to address how the authorizations are used. For example, the rights to change settings (system administrator rights) should be assigned to personnel who are independent from the individuals responsible for recording the event (production users). These additions support best practice, which aims to limit the range of fraudulent activities. Electronic copies can be used as true copies of paper copies, provided the electronic copy preserves the content and meaning of the original data, including the associated metadata.

Simply having Part 11 compliance is not enough to ensure that good levels of quality are in place. Good Manufacturing Practice covers many aspects of production

industr ies & solu tions

and, in this context, data integrity is key to maintaining accurate and complete records which lead to superior production processes. The outcome of data integrity relies on the company's organization as much as the technology capabilities. Organizational transparency is required: with flowcharts, workflows and organigrams to track the process and its data and record the knowledge of who is accountable for it. Effective strategies to manage data and process control lead the manufacturer through different iterations of process understanding and knowledge management. Based on their own processes, risk is assessed and technology can be understood in the context of their own business culture. For an engineer using zenon, these requirements are of little challenge. Part 11 requirements are a base feature in zenon. It has integral user authorization, access restriction, audit trail, alarm management, and a high-performance historian enabling you to take the requirements in your stride. All activity from the process, system and user are recorded in the audit trail. Adverse events are additionally recorded in the alarm management, and stored long-term in the historian structure, either as proprietary zenon formats, or in SQL. Any data change, addition, or deletion is recorded in the audit trail, and is seen in the historianâ&#x20AC;&#x2122;s event log. When all the data is housed in a central zenon system, the resulting validated solution ensures the records are original and a permanent archive is in place, and the original record keeps the raw data intact with its associated metadata. No matter the duration of the data lifecycle, regulated reports and analysis are easily accessible. Thus, zenon welcomes the new FDA guidance. Through configurable functionality, zenon can implement these guidelines on brownfield or greenfield installations, connecting to processes, even when running, without the need to make changes to the validated equipment, bringing data out of the process and on board zenon. Tie together the historian, audit trail, alarms and the Report Viewer, and you have an out-of-the-box configurable solution that fits to your individual GMP production environment.

robert h a r r ison, industry m a nager ph a r m aceu tic a l

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industr ies & solu tions

ACG, Innovation for India’s Pharmaceutical Powerhouse FLE XI B LE , SA FE , A N D I N CO NTRO L

India has emerged as a powerhouse of pharmaceutical manufacturing and is now one of the largest providers of generic drugs globally. Enjoying this very important position in the global pharmaceutical market, India’s scientists and engineers are shaping the industry and raising standards.

Erschienen in

information unlimited das magazin von copa-data Nr. 29, April 2016 © Ing. Punzenberger COPA-DATA GmbH www.copadata.com/iu

Figure 1: ACG Worldw ide, ACG Ph a r m a Te c h nolog ie s , S at a ra fac i l it y.

industr ies & solu tions

Even with a constant drive for success, pharmaceutical producers cannot go it alone. The agile flexibility of OEMs specializing in the pharmaceutical industries has harnessed their decades of experience and leveraged “blue sky thinking” to introduce the latest technologies. Collectively, this is their competitive edge: high-end process solutions to advantage India’s pharmaceutical manufacturing. In this article, I would like to introduce you to one of the pillars of this sector. Since the 1960s, ACG Worldwide has had its finger on the pulse of global pharmaceutical manufacturing. Originally producing hard capsules used in final drug manufacturing, ACG realized there was a huge international potential for its product. It heavily invested in upgrading its plants and processes to become a world-

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Having accomplished this, ACG is now being recognized globally for its capsule filling, solid dose and packaging equipment. ACG enlarged its scope of talent quickly; moving further upstream in the manufacturing process in response to industry demands for its expertise of solutions in chemical process technologies. This is how ACG Pharma Technologies was born. It now produces a wide range of fluid-bed solutions for granulation, drying, and pellet coating. This transition into fluid-bed process equipment also required a transition in automation technology. The previous technology was more suited to the requirements of discrete control, but this new process environment needed automation especially designed to meet the needs of process control.

“The zenon software and the batch control software products from COPA-DATA have proven to be the perfect platform for our new configurable X-ONE COMMAND control system. The new X-ONE COMMAND control system from APT fulfills all the requirements of batch control machines in the pharma industry by following the GAMP 5 guidelines, the modular S-88 standards as well as the GMP and the FDA 21 CFR Part 11 requirements in a master product development lifecycle. With X-ONE COMMAND and zenon Batch Control, including its MES or ERP interfaces, our pharma customers receive a highquality control platform for any new batch control machine equipment. It is also the perfect way to upgrade and qualify any existing batch control machine by following the pharma GMP requirements for control systems.” KLAUS FEUCHTMANN, PROJECT LEADER AUTOMATION, XERTECS GMBH, GERMANY

class provider for the global pharmaceutical industry. The phenomenal success that ACG generated and the knowledge gained during this optimization led to a wealth of expertise which would go on to shape a group of worldclass companies dedicated to the pharmaceutical industry. ACG’s expertise generated opportunities to support and optimize its customers’ production facilities. Valuable knowledge which embraced wider process elements beyond capsule manufacturing evolved a few decades ago when ACG began to develop new machines for the innovationhungry Indian pharmaceutical producers. ACG led the way: producing machines for filling powders, liquids, pastes, and combinations in capsules, plus equipment for the solid dose stages of tableting, inspection, and soft gel manufacture.

ACG was already well acquainted with COPA-DATA, using zenon as standard on some of its machines’ equipment automation. During this collaboration, an understanding developed between ACG and COPA-DATA India – and more specifically with ACG Pharma Technologies – where we were privileged to be involved in the concept discussion for the new process fluid-bed systems for drying, spray granulation and spray coating. It was natural to evolve in this way, building on ACG’s successfully proven automation technology. zenon provided the desired flexibility, especially with GAMP 5 adherence and FDA 21 CFR Part 11 compliance; a global product on the global stage of international regulations and industry best practice.

industr ies & solu tions

Figure 2: I n t he f le sh , ACG Ph a r m a Te c h nolog ie s s te e l work con s t r uc t ion of f lu id-b e d s y s te m s.

To secure global expertise in this new field, ACG partnered with Xertecs GmbH, which operates internationally from its European and US offices. Xertecs specializes in the implementation of technology, processes and services for the pharmaceutical industry. Specifically, for ACG Pharma Technologies, Xertecs’s direct experience of excellence in fluid-bed systems, and their adroitness in key international regulations and certifications, provided a powerful partnership – combining the highest levels of innovation with maximum flexibility. ACG’s fluid-bed solutions needed process control at a machine level, in a self-contained system. The initial sketches described the following requirements: – – – –

Process control Scalable technology Part 11 compliance, audit trail, alarm management, user administration, Historian, reporting Integration to higher level system, ERP, MES, SQL

– – – – –

GAMP 5 guideline best practices, software category 4 (configurable system) Process modifications by the end customer, not automation engineers Flexible and agile processes Reduce risk exposure as far as possible Efficient validation

For the team at COPA-DATA, these requirements echoed the initial use cases we developed for zenon’s Batch module, the backbone on which the module was designed. The zenon Batch Control module is scalable – from entire plant control with multiple concurrent batches and Historian, through to single use on individual production lines or, as in this case, individual machines. It integrates seamlessly into the zenon environment, where zenon supports Part 11 compliance and GAMP 5 adherence, to create a very flexible end product for ACG. A solution resulted that combines the process knowledge and control in an environment that allows for new process

industr ies & solu tions

Figure 3: ACG X- ON E COM M A N D s y s te m : P r oce s s ove r v ie w.

recipes to be created without the need for an automation engineer to be involved: a living example of “you innovate and we take care of the compliance”. Adhering to the GAMP 5 guidelines positively impacts the validation necessary to qualify equipment for its intended purpose: reducing effort, time and cost at the end customer’s site. zenon’s connectivity allows for a smooth integration into a facility’s supply chain, MES, ERP and user management system, and is flexible to accommodate the end customers’ QMS. In pharmaceutical production equipment, the user interface is a critical element. This is the window where the end customer sees the benefits of the machine solution, and where the regulatory data is controlled and generated. The system needs to comply with international regulations (e.g. FDA Part 11), it needs to be robust with very long uptimes, and have a variety of functional roles depending on who uses it. The automation solution needs to integrate

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Figure 4: ACG X- ON E COM M A N D s y s te m : Batc h r e c ip e.

seamlessly into each customer’s unique production and quality system, as this is the junction between the effective equipment technology and the customer’s operational procedures. The connectivity and functionality of zenon create a robust and competent control environment to fulfil the process needs, the flexibility of configuration allows for a smooth interface into the wider production systems, and all this is achieved under the watchful eye of the strict regulations and industry best practices. The principles of Batch Control defined in the ISA-88 standard has some very desirable features, especially in the regulated industries of pharmaceutical production. Batch Control separates the direct physical control of the equipment in the PLC logic, with its real-world variables and many control elements, from the process control arena, with its process control loops and process parameters.

“The batch control module from COPA-DATA has given us a perfect base on which to provide a value solution to our customers for recipe management. Various permutations and combinations of process parameters at different process stages are simple to achieve with the help of pre-validated modules. In this way, zenon supports flawless configuration in our project development. We greatly appreciate zenon – and the efforts of COPA-DATA and Maestro Technologies, who have supported us in adopting this technology and integrating it in our projects.” SUDHIR KALKAR, GM TECHNICAL, ACG PHARMA TECHNOLOGIES, INDIA

A B O U T ACG P H A R M A TE C H N O LO G I E S : ACG Pharma Technologies is a member of ACG Worldwide. With over fifty years of industry experience, ACG Worldwide is an integrated processing, manufacturing and packaging solutions provider for the global pharmaceutical industry. The Group synergistically integrates businesses right from granulation and tablet coating equipment to hard capsules and capsule-filling machines; barrier packaging films to blister packing and cartoning machines; tablet compression systems to tablet tooling; vision inspection systems to end-ofline packaging solutions. With the backing of a dedicated R&D facility - SciTech Center - in Mumbai, India, ACG has been committed towards continuous investment in innovative products and technologies that serve the pharmaceutical industry. Recognized as ‘Best Vendor’ by OPPI, ACG has also bagged awards for several innovative products from IIP & Pharmexcil. ACG serves customers in more than 100 countries and has its subsidiaries in Brazil, China, Indonesia, the US and the UK. Find out more at www.acg-world.com or www.acgpharmatechnologies.com.

Lea rn , h ow you too, c a n e n ha n ce your batch pro duc tion with ze n on B atch Control . Fa c t S h e et, vid e os a n d more at your f ing e r tips! ht tp: // kay wa . me/ UsZ 7 T

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Effectively, the zenon Batch Control module lifts the process control out of the intricate world of automation engineering. It allows process engineers the vision to see the fluid and chemical chains, and have a tool at their fingertips to put this into action. They don't need to know anything about automation or individual variables. They simply drag and drop pre-validated phases to define the process, then zenon effectively executes the process control. A process environment, for process engineers: design the automation once and reuse it for many different products. ACG’s vision is to be globally recognized for pioneering new technology and nurturing talent to attain successful products and services in a demandingly complex industry. It is a pleasure to have zenon operating within this sphere of expert knowledge, and to be a part of making the “blue sky thinking” a reality at ACG.

robert h a r r ison, industry m a nager ph a r m aceu tic a l

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H A R RO H Ö FLI G ER I N V E S TS I N U S ER- FR I EN D LI N E S S

Visibly Better What does a human-machine interface need to do in order for operators, service staff and maintenance staff to be able to work efficiently and productively? Harro Höfliger has created a modern user interface for all types of machines on the basis of zenon from COPA-DATA. It is characterized by intuitive design which allows for quick learning and by functional operation, thanks to familiar Multi-Touch gestures.

Capsules, tablets, inhalation products, liquid products, aseptic products, diagnosis products, batteries, machines for product assembly and packaging – Harro Höfliger Verpackungsmaschinen GmbH, a company founded in 1975, now offers a broad range of machine types for the production and packaging of pharmaceutical goods, medicine, consumer goods, cosmetics and chemical technology. The large number of machines means that complexity also increases – the complexity of machines Erschienen in

information unlimited das magazin von copa-data Nr. 29, April 2016 © Ing. Punzenberger COPA-DATA GmbH www.copadata.com/iu

and thus also the complexity of operation. “A station, i.e. a functional component of a machine, previously only had a few parameters. Now, individual stations have up to twenty screens, each with 20 parameters that can be set”, explains Fabian Elsässer, HMI/SCADA Systems Group Leader at Harro Höfliger Verpackungsmaschinen GmbH. “Only ergonomically-designed user interfaces allow the user to overcome this complexity.”

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E r gonom ic s doe s n't ju s t i nc r ea s e pr o duc t iv it y. It m a ke s work ea s ie r, r e duce s s t r e s s , a nd a l low s qu ic k a nd we l l-g r ou nde d de c i s ion-m a k i n g.

U SA B I LIT Y I N FO CU S In order to cater to the greater scope of functions and performance of the machines, and to guarantee targetorientated, efficient and error-free work, Harro Höfliger decided to implement a new human-machine interface (HMI) on the basis of zenon. The company has already been using the HMI/SCADA solution from COPA-DATA for more than ten years. Harro Höfliger conceived and developed the new HMI together with CaderaDesign. The company specializes in industry and user interface design, usability and user experience. CaderaDesign provides support for the complete process of developing HMIs and user interfaces – from the idea through to user interface programming and implementation. Complete operating concepts, software ergonomics and clear navigation structures, screen/control and icon design are the building blocks that the company offers. A CO M P R E H E N S IV E A N A LYS I S A S A BA S I S Before Harro Höfliger took the step of introducing a new, comprehensive user interface, Fabian Elsässer and CaderaDesign collected customer feedback during the analysis phase and analysis workshops, compiled the requests and wishes of the users and also spoke to employees at the company. The people involved in the project then evaluated the tasks of the users, took a close look at the different types of machines and evaluated the functionality and its benefits, together with specialists from the company. The next thing was to sketch out the ideas and to develop and evaluate layout concepts. “We were quick

“ Fa s te r, h ig he r, w ide r ” i s not t he mot to for s ucce s s f u l autom at ion ; it i s “r ea son able, compr e he n s ive, s u s t a i n able – e r gonom ic ”.

to develop first wireframes, that means simple, structural representations of the user interface, and gradually defined the structures in various workshops”, explained Florian Fuchs, Qualified Designer and Certified Usability Engineer at CaderaDesign. O B J E C TIV E : A F U T U R E - O R I E NTATE D CO N C E P T FO R A LL M AC H I N E S The new HMI should be based on a future-orientated concept, covering both touch and Multi-Touch applications and can be implemented with existing components of the HMI/SCADA solution zenon from COPA-DATA. Furthermore, it should have a design that is both individual and timeless. Due to the complexity of the machines, Harro Höfliger and CaderaDesign decided to have a clear task orientation as principles for the user and interaction in the new HMI. Thanks to the task orientation in the HMI, the user is now clearly shown which tasks they must fulfill and how the operation process works, such as setting up a machine or loading a recipe. The user gets these tasks depending on the production mode (prepare for production, production, end production) and depending on their user role. Who triggers which action and allocation of machine functions that employees may use are saved in the user profiles – and thus in the user administration. A clear information concept guarantees that the user gets only the information needed during production. Here, information and figures, such as the speed of the machine, for example, are shown in widgets on the main screen. A widget is a component or an operating element of a graphic

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user interface. Harro Höfliger has created a standard library of widgets for the different machines. The widgets perform certain functions or display certain parameters and data (such as counter values for example). Users can create their individual home screen from the widgets that are relevant to their task.

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as they need. Thanks to the online language switching integrated into zenon, the country-specific language selection is very easy.

“zenon is an HMI/SCADA solution that offers an extremely large range of functions out of the box, and also has the flexibility, thanks to the programming interface, to design the application in such a precise way that a company's complete customer requirements can be fully met.” FABIAN ELSÄSSER, GROUP LEADER OF HMI/SCADA SYSTEMS, HARRO HÖFLIGER VERPACKUNGSMASCHINEN GMBH

A smartly-created, abstract and modular machine display makes it possible for the user to navigate using the centrally-placed machine screen and to change parameter settings or make corrections at the individual stations of the machine. In doing so, the machine screen is shown in an abstract form with the individual stations as navigation elements. A machine can consist of up to 100 stations. To be able to keep an overview, the users can use the Worldview control in the station overview. This zoom and navigation tool allows a clear display of large and complex process screens – regardless of the display size. Users can focus on individual stations, zoom and navigate in these. C LE V E R M E N U S TR U C T U R E FO R E F F I CI E NT A N D S E CU R E WO R K The main menu now consists of six menu items: Management, Stations, Diagnosis, Statistics, Service and Help. Recipe administration, lot and batch management, audit trails and alarm administration are under the “Management” item. The user administration is also integrated there, so that users only execute the tasks and operate the functions that are saved in their user profile. In the “Stations” menu item, the user can select, set parameters for, and configure individual stations of a machine. “Diagnosis” delivers error messages from the controllers, and provides assistance with troubleshooting and error detection. The “Statistics” menu item provides counter screens, lists, production counters, error counters, extended trends, production statistics etc. In order to be able to work with ease, the user can state whether they are left handed or right handed and position the menu bars on the left-hand side or right-hand side

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