Posts Tagged ‘ISA 88’

The Pharma Challenges – Focus on Improvements

Thursday, December 11th, 2014

reporting quality alarmszenon’s ergonomic automation solutions are about bringing systems together to provide transparency across your facility, with a user-centric interface to the processes around them. This platform provides knowledge of the processes throughout the facility, at all management and operation levels, even direct at the machine level live KPI’s, such as OEE, can be presented for example. With high usability graphics, real-time data access, trending, reports, are all available through different interfaces such as workstation, server, tablet, machine HMI, SCADA terminal, web access. The operator is well informed, as is the manager, engineer, production management, senior management, etc. With transparent systems you can remove the requirement where operators need to continually walk up and down the machine – they can see all activity for a particular production line from each machine HMI terminal.

The zenon Product Family is configurable in nature with a significant library of functionality, providing a platform where entire solutions can be implemented in a configured environment, which reduces complexity, novelty, and risk, whilst increasing quality. Bespoke code can be accommodated, then encapsulated into this parameterization culture, whereby the code is validated once, then reused in a configurable fashion. Under the GAMP 5 guidelines, a software category 4 (configured product) significantly reduces risk and compliance requirements when compared to a programmed alternative. The zenon Product Family significantly reduces the validation and compliance efforts that need to be carried out. It also reduces the level of engineering required to design and support such a system.

We have a strong communication platform, which not only links into industrial networks, PLC’s and devices; but this continues up to the business and management layers to MES and ERP, with native interfaces to SAP, Microsoft Dynamics, and SQL; where bilateral transfer of information can take place in real-time. Our dynamic reporting server ‘zenon Analyzer’ brings information from the production environment and presents the information focused to the user’s need, i.e. with production batch reports, quality reports such as RBE, or engineering reports e.g. analyze alarm demographics. High visibility and transparency has positive influences on productivity and driving business goals. Giving real-time accurate data allows for closed loop control on business objectives, production initiatives, and engineering opportunities.

All of this increases the technical and communication capabilities of your facility, which can be integrated to your existing infrastructure without changing anything on a running system. Providing holistic knowledge and control of your processes which improve consistency to increase productivity.

The Pharma Challenges – The demands and difficulties in pharmaceutical automation

Wednesday, December 3rd, 2014

Challenge: About 15 years ago, the emphasis in pharma production was all on validation. Because of that, automation engineers in pharma were really good at paperwork and change procedures. In a lot of cases they never learned how to be true engineers to make their processes run better and find improvement opportunities.

In the past, Engineering has had significant focus on compliance and validation issues, in a ‘validate all’ culture which instilled fear for all people concerned. But the world keeps turning, things evolve; zenon Process Overview in Pharmaceutical Productionhas a lot of integral functionality which is brought to life through parameterization, which brings the product to a GAMP software category 4. With this you have complete solutions created in a validation efficient environment. The FDA is also evolving from this ‘validate all’ culture, in-line with the ISPE GAMP 5 guidelines, applying risk analysis to find and focus the validation activities on the regions of the automation which affect product quality and security. The zenon Pharma Edition looks to aid this design stage with automated documentation tools, project versioning, and project comparison, which highlight which changes have been made to a project, clearly stating what has been affected by the change, and so focus the attention of validation to only critical areas, thus reducing the uncertainty and bringing higher quality as a whole.

Challenge: More than one fourth of the errors could probably be avoided by implementing automation.

Following the GAMP 5 risk assessment, non-conformity or risk of quality failure is assessed through a risk matrix, where Severity and Probability of failure determine a risk class, which is assessed with Detectability to determine the probability of failure. The task of the automation system in concept and operation is to make aware Severity, Probability, and Detectability. Through highly visible processes these three markers can be determined and qualified through clear understanding and identified as Critical Quality Attributes. High levels of visibility and reporting bring certainty to detecting determinable errors. COPA-DATA has a strict Quality Control structure, with procedures and documentation tracing development of each module in our product range. This library of functionality is enabled through parameterization. This means projects built on zenon technology, have a high level of quality and reliability, all pushing down the risk of non-compliance.

Challenge: Automation engineers should start thinking about a holistic change that will eliminate problems and issues.

Regulations in the recent past have segregated automation, in order to put boundaries on processes. The lack of simple communication mechanisms created isolated non-deterministic production environments. zenon offers simple to configure networks, and simple to configure automation solutions, which can control, acquire, communicate, and present information. Individual machines can now be lifted in to processes, and process-wide assessment carried out, with process audit-trail, alarm, and reporting. Holistic solutions for holistic operation.

Challenge: People in automation need to improve their way of translating their work into business value for Managers.

The zenon Product Family aims to touch on all operations in the control pyramid, linking layers, accessing all areas of production and automation, bringing systems and people together. Real time information can be processed and focused to a specific person’s usage. This puts automation into all operations within the production environment, translating production operations into: Business measurable data, Operation management efficiency, Operator productivity and motivation. All from the automation and engineering backbone.

(Source: Management’s View of Automation – Impressions of Automation Performance)

The Pharma Challenges – Investment value and pharmaceutical automation demands

Thursday, November 27th, 2014

Challenge: Automation in the pharmaceutical industry has more requirements than other manufacturing. Especially requirements concerning safety, quality, and regulatory compliance increase production costs.

Indeed, the pharmaceutical industry requires that many key elements come together in each automation action, with strict quality and compliance measures adhered to. Quality isn’t finally designed in to a solution, it must be there from the core. This why COPA-DATA has strict Quality Control within its company culture, with a dedicated product for the life-science industries, embracing these unique challenges and demands head-on.

Automation in PharmaChallenge: People believe that there is a huge gap between the technologoy they use at home and the technology in automation at the plants.

One of the biggest revolutions in personal technology has been the intuitive interface on our smart phones. This type of user centric operating system has been dynamic and opened the way to bring technology to everybody. In this regard, zenon has pioneered with the first multi-touch HMI/SCADA technology, which is a window to our ergonomic user-centric environment. It embraces all our technology benefits to any user, directly through intuitive multi-touch interfaces.

Challenge: There are a number of projects initiated to maintain systems rather than adding new functions.

A significant advantage of having one product family for the entire scope of automation functionality for a facility which easily integrates to others systems, it that expansion of that project or adding other projects is performed in easy stages. Existing functionality can be easily expanded with integral functionality, simple configuration affords an efficient validation of added functionality; and communication brings the systems together. Design once and used many times, allows efficient reused and modular construction using pre-validated blocks.

Challenge: Very often, automation people are disconnected from the process. If automation is a separate function in organizations, most of the time it is not part of the decision process. This makes the problem even more complicated.

Employing high levels of technology brings people together – as technology advances the traditional boundaries are getting blurred. For example with the zenon Product Family you can access all production equipment and facility management processes, bringing these into the business domain through the zenon Analyzer and ERP interfaces. Link production operations to business measurable data, of cost, productivity, efficiency, energy usage, media usage. All of this through configuration, all of this in real time.
In this way, engineering affects operation efficiency. An integrated system can reduce the need for engineering interventions. The two become aligned and efficient through a common goal, with interfaces focused to their individual needs originating from the same data.

Challenge: A major problem is that operations very often does not talk to Automation.

Through my experience in LEAN and Quality Circles, progressive evolution is only possible through a task force of multi-discipline personnel. In my experience the problem was always getting the accurate data – to create measurable milestones they collectively must hit. zenon has a high level of connectivity to natively communicate with industrial networks, PLC’s, and devices, thus bringing systems together, providing real-time accurate data.

(Source: Management’s View of Automation – Impressions of Automation Performance)

The Pharma Challenges – Level of Automation and Automation Value

Monday, November 17th, 2014

Pharma_AutomationAutomation has a very good opinion in the eyes of the Operations Manager in the Pharmaceutical Industry. They believe automation contributes positively to achieving key performance goals such as improving safety, improving quality, improving regulatory compliance, and improving production capacity.

This is the motivation to use new technology. Then comes the challenge and reality to implement the solution. And this is not easy!

zenon is a configurable system, making it very efficient on validation effort. The zenon product family touches on all production operations, embracing People-Process-Equipment-Management.

Level of automation and Automation value


Challenge: A big barrier to adding automation in a pharmaceutical production facility is the need for plant shutdown.

Having an environment which aids commissioning would reduce the plant inactivity during shutdown. As a progressive, scalable and modular concept zenon can realize projects stage by stage to massage evolution around retro-fit evolution. zenon hot-reload is efficient when commissioning to keep the project updated with the needs of the process, not waiting until the end of the day to make changes, other software may be inflexible to online commissioning – but not zenon. Repeatable modules promote the concept of ‘design once and reuse’, in the pharmaceutical industry this has the distinct advantage that risk is reduced, and with that validation is reduced. Either use the same project and apply it to different areas, or use the individual modules in unique arrangements. Design once and reuse.

Challenge: Managers are positive about the value automation brings to their plants. They believe that automation contributes to achieving the goals of improving safety, product quality, production capacity, and regulatory compliance. Still, there are lacks in implementing.

zenon is a one stop product providing all functionality within one integrated product family. The education on how to overcome current problems or risk in pharmaceutical automation is well documented on our Pharmaceutical section on our website. This is just the first stage, because zenon is more than just survive and succeed. It allows transformation, and opens the way to put your vision of the future into reality. This reality can be Optimization, Quality, Performance OEE, Operational Excellence, Energy Management & Optimization, including for example the ISO 50001 certification.

Ergonomic automation engineering believes in achieving goals in all areas. Ergonomics – particularly with zenon – is making information transparent. Production affects more than just production personnel. Its figures and progress touch directly on business and management needs, quality has a clear need for actual and historic data, and it goes without saying that Operations management and Engineering departments require direct knowledge of production status. All of this requires the same information, but focused and aligned with the specific needs of the user. Putting the user centric to the processes operating around him or her, bring clear and instant understanding.

Challenge: Top Managers such as Site managers and Vice presidents don’t think that automation contributes to lower manufacturing costs.

Lowering manufacturing costs has many flavors. It requires a combination of exercises to be carried out to realize the full potential. For example, operational excellence looks to i) People, ii) Process, iii) Equipment, iv) Management. In most people’s eyes automation only attacks the third element ‘Equipment’, but this alone is not enough. Ergonomics focuses the automation and brings the four together, with holistic improvement that brings management initiatives into production processes, and forces the marriage between equipment and people. Then results are passed back up the line to management efficiently, where change can be acted upon. Process improvements can be incremental, or as clean as turning a page. zenon has many philosophies that fit here, scalable and modular technology applies solutions to the needs and possibilities of now. We never lose the focus that well managed technology gives positive results in reducing production cost, regulation compliance, product quality and safety.


(Source: Management’s View of Automation – Impressions of Automation Performance)

“Life is Time, and Time is Gold” (Part 3): Paper on Glass

Thursday, June 26th, 2014

Paper on Glass’ transforms a paper-based production system into something quite remarkable. Without change to any production equipment, automating the operator and production reporting means post-batch analysis is reduced to an absolute minimum; releasing stock to market weeks in advance of older paper-based systems. Quality is optimized and risk is mitigated as production flows are consistent between batches, execution is strict, no information is missing from the record, and errors in recording information are as far as humanly possible eliminated. Business management is happy on many fronts as costs are avoided, no paper needs to be generated, and there are no mountains of paper to store in secure locations. Instant batch analysis means instant revenue, production activities are aligned in real time to the gravity of business.

Visibility is more than knowing what is happening now. At all levels, across functions, people know what the processes are doing, they know the choices they can make when it matters, they know what is next in the OPEX initiative and, importantly, they know how they have made a difference.

The wind of change is now to your advantage: leverage technology to gain strength, remove the blindfold and realize optimum performance. Sail your own destiny!

“Life is Time, and Time is Gold” (Part 2): OPEX in Pharmaceutical Manufacturing

Wednesday, June 18th, 2014

Operational Excellence (OPEX) has at its core: Organization, Communication, Visibility, People, Process, and Equipment. It touches on all aspects of an organization, requiring strong commitment from higher management and business leaders. OPEX in a company has many subsystems: each subsystem is critical, with each element reinforcing the other.

Toyota, with its pioneering work on organizing production to obtain brilliance, employed technical toolkits such as Just In Time (JIT), Total Productive Maintenance (TPM), and Total Quality Management (TQM). Toyota found that success needed something deeper than a technical toolkit. TPS (Toyota Production System) embraces the social and cultural management of quality and work organization. Support, encourage, continually improve processes and people is its focus.

OPEX, therefore, is not a one-size-fits-all shopping trip. Sometimes the mission and focus of the manufacturing facility has to be on management practices rather than technical procedures.

In pharmaceutical manufacturing you can’t go very far without addressing regulation. Regulations do provide constraint, but there is more than enough room for life science manufacturing to improve on all four key business processes. Remember OPEX is about organization, visibility and communication. Ergonomics swings data around; focusing knowledge on specific driven needs.

zenon Analyzer is a gift to production agility, supplying much more than vision alone. From production, a single version of the truth is presented individually to different focus groups. Engineering needs information on plant running conditions, early indicators of equipment wear out, root cause analysis.

RBE Alarms and TrendsQuality needs real-time CQA (Critical Quality Attributes) to be communicated before violations are compromised, process variation analyzed, for fast and accurate automated batch analysis, and succinct post-production analysis, as for example, with Report By Exception (RBE) reports.

Operations need availability, batch reports, information focused on daily improvement. Dime and Dollar figures are the underlining motivation for higher Management to show processes on these terms. People need the confirmation that their actions are beneficial; live accurate information keeps a strong heartbeat running through the organization.

New Process Development and New Product Development have a hard time in regulated environments without Batch Control. Flexibility and agility require an ability to perform process changes quickly. Batch Control manages these processes and equipment structures through recipes, thus allowing for easy process flow modifications and equipment usage. A batch recipe cannot violate predefined equipment performance, therefore each recipe is deterministic, and with no change to the compliant production equipment new process flows can be validated efficiently.

“Life is Time, and Time is Gold” (Part 1): Manufacturing and OPEX in Pharma

Thursday, June 12th, 2014

The perfect process overview - with zenon Pharma EditionUltimate performance is not guesswork. It takes science, culture, and technology.


If you were driving down a perfectly straight six lane highway at 100 km/h, a long road with no other vehicles, would you drive blindfolded? The answer without doubt is “No!”.

So why are there so many examples of production in pharmaceuticals (and related industries) operating in the dark? This is not a blindfolded walk through life: we have science providing answers, in a community of different intelligent people. Increased use of technology is the solution that brings it all together.

Let’s get straight to the point. What role does manufacturing have? Well, manufacturing finds itself at the junction of four key business processes:

1. Manufacturing supply chain

The manufacturing supply chain includes the entire execution of current business. Information is shared along the length of its chain, individual elements and goals must consider the whole chain.

2. Operation strategy and deployment

This area concerns initiatives that achieve the priorities and business targets. Here, we develop manufacturing capabilities in the equipment, people and process.

3. New product development

This comprises activities which improve the company’s current catalogue of products and services. Competitive markets demand new products and upgrades of existing ones.

4. New process development

This area focuses on the improvement of current production processes and activities. Industry best practices age over time, continuous improvement retains the competitive edge.

The high revenue ‘Blockbuster’ drug era is in its twilight and pharmaceutical companies find themselves in a transition period to the next era of ‘Flexible & Agile’ facilities and increased global competition.

The perfect storm has hit! The global financial crisis, competition, and pharma’s specific patent cliff, have ignited interest in the manufacturing part of the business supply chain. It must be ‘faster’, ‘less cost’, and meet ‘increasing quality requirements’. The next five years will determine the winners and losers; now production costs count and manufacturing efficiency is being calculated.

Validation efficiency.

Thursday, January 23rd, 2014

Regulated industries require all processes and equipment to be validated. The validation process is far reaching, for example this would include: equipment operation, how equipment interfaces with other equipment, how people interface and the procedures they need to follow, with events and alarms defined. And in most cases a human readable report needs to be generated for each batch.

When a change to the equipment is needed, a risk assessment is usually carried out to show how the change would fulfill the requirement, highlighting which processes are affected, and the overall risk exposure to product and business.

With a direct change to equipment the production line is wide open to full validation on all connected systems. Not only the actual change, but all the line processes, procedures, interfaces, communication, archiving and reporting are potentially influenced by the change and need to be tested.

Batch separates the process engineering from the equipment engineering. The equipment is designed to operate within its own limits, the interfaces, archiving, reporting, etc. are designed and validated only once in this maximal configuration. The batch engine designs the process engineering through recipes, which define the process flow and operating parameters. This divide between what is process flow, and what is equipment logic has severe advantages, a change to the process flow or parameter is defined in the batch recipe, the recipe is allowed to use the equipment to maximum functionality, but not further.

With a change to the process flow the equipment logic or connected systems are not changed or affected. The validation exercise is limited therefore to the process change only, the equipment remains untouched ensuring fast, efficient and continued secure operation. Below is a table showing the differences to validation and risk exposure.

Changes - Validation Impacts


With Batch Control new process flows or new products are easy to design. Process change is executed in one location not on several machines. Validation is as efficient as it possibly can be. Production is robust and sustainable. Simple!

Paper on glass

Thursday, September 26th, 2013

Batch Control Recipe

Batch processes are very varied, across different industries and within a specific industry. My work takes me mainly into the pharmaceutical sector where a whole suite of production methods exists. But what is on my mind today is the extensive use of paper based operations for both executing the work order and recording critical data. I would like to open your eyes to using some key pillars of zenon Ergonomics together, coupling good user interfaces with the Batch Module and the strong reporting capabilities within zenon Analyzer or zenon Supervisor.

Electronic Batch Records

Using an operator to execute commands from a sheet of paper and asking him or her to record events and critical data manually on paper, is prone to so many openings to errors and missing data. The fun doesn’t stop there, several Standard Operating Procedures (SOP’s) and Batch Records (BR) are needed for each batch, which all need to be collated, analysed, documented and reported on. This is an extensive manual activity costing a significant percentage of the revenue, which is heavy on errors, personnel motivation, and limits the future dimension of the company’s possibilities.

The reason why these practices are present is clear, as the SOP’s and batch records are established within the Quality Management System. To change this is a mountain of hassle and significant cost.
But we can change this…

Outside the world of zenon, other reporting systems do exist; these are mainly positioned to business reporting with their links to the process being arbitrary, and understandably they have no process understanding. On the other side of the field are the batch system producers, now these do know process, but reporting is either not a feature or a very weak function.

Cutting to the chase, the roots of zenon are grounded from the beginning in process knowledge and control. Our reporting system zenon Analyzer competes one-to-one as a business reporting agent. These environments are homogeneous, focused here with an ISA 88 Batch Module, strong user interfaces, archiving, and reporting.
Now we have talked previously about intelligent connectivity to industrial systems, networks, etc. This is not the only possibility. What I am talking about today is intelligent connectivity to the operator and business systems.
The batch engine, has phases and operations which promote the user to execute certain tasks and record data, in the correct sequence, at the right time. When the batch is complete, the individual SOP’s and batch records have been recorded and stored electronically, the reports can be generated automatically without a person in sight, and no data is missing, deviations are zero, the process has been encapsulated by the batch engine, with only the fingers and eyes of the operator needed to complete the execution.
The initial advantage here are that paper is eliminated, the established SOP’s don’t change, and there has been no modification or addition to the control structure of the processes. The original quality mechanisms remain untouched. But with better results, strong reports, confident production, and increased quality. The operator is motivated, with access to all information via a tablet. And finally the production is released with increased speed, and with less dollars consumed by the manufacturing chain.


The advantages don’t stop at the initial operations, reviews of Electronic Batch Records (EBR’s) in the pharmaceutical industry reveal a wider benefit of quality and significant cost reduction.

  • Shorter release times, collation of data is reduced, review is a simpler process with all information present
  • Right first time is increased from 47% to 90%
  • Records with errors reduced from 38% to 18%
  • Missing entries reduced from 22% to 8%
  • Corrections down from 66% to 18%

In addition to the hard figures, my feeling on EBR systems is the confidence such a production environment creates, opening the avenue for more flexibility in production, the ability to widen the portfolio of products, with the difference on profit margins being night and day from the antiquated paper heavy days.

Batch Control integrates with SCADA and reporting

Wednesday, July 3rd, 2013

Production is getting more complex, with greater demands on its practices. High levels of technology increase flexibility, enabling any facility to be more reactive to demands and initiatives, whether from business, quality, or engineering.

Integral functionality opens doors

We have talked previously about how zenon Batch Control separates the machine logic control and the high level process control; this releases the ultimate in flexibility when coupled with zenon’s native communication and vertical integration.

There is one other piece to this puzzle – zenon’s integral functionality allows such high levels of technology to be used in any facility as an integrated solution, with all the control structure needed: Process control, Equipment logic, Communication, Historian, SQL, Reporting, User Administration, SAP connectivity. To those who are in the know, this is clearly our Product Family, where the batch module fits in seamlessly.

And this is where we can grow another thread. Batch control is seen as a high level process function, relying on a top heavy infrastructure; and with zenon this can be true. But what can also be true is to use the batch as a standalone system, bring the ultimate in automation flexibility to all levels of control; machines, production lines, and skids can benefit with a fully equipped control structure set at the relevant process level – including Reporting, Historian, Audit-trail, Alarm analysis, Trend analysis, SQL, User Administration, SAP connectivity in one system.


Optimal process structures put the control where the decisions need to be made, batch control introduces flexibility, and ergonomics marries zenon to unique environments.