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Comments on the Pharmaceutical Automation Roundtable (Part 2)

Part 3: Focus on Improvements

Part 1: Level of Automation and Automation Value

Investment value and pharmaceutical automation demands

Pharmaceutical Automation Roundtable:
“Automation in the pharmaceutical industry has more requirements than other manufacturing that increase cost particularly safety, quality, and regulatory compliance functions.”*

zenon: 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.

Pharmaceutical Automation Roundtable:
“I think people see what technology is delivering to the world at home on their computers, and then they contrast the automation in their plants. They see the gap.”*

zenon: 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.

Pharmaceutical Automation Roundtable:
“There are a number of projects initiated to maintain systems rather than adding new functions and these have minimal ROI.”*

zenon: 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.

Pharmaceutical Automation Roundtable:
“Organizations in which automation is a separate function and not part of the decision process are further compounding the problem.”*

zenon: 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.

Pharmaceutical Automation Roundtable:
“The automation group reports into the maintenance manager at many of our sites, disconnecting automation people from the process.”*

zenon: Following on from the previous answer, see how engineering affects operation efficiency. See how 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.

Pharmaceutical Automation Roundtable:
“I asked the operations manager from one particular site if they bring in the automation people when brainstorming continuous improvement activities and he responded, ‘No, we don’t really talk to the automation people.’ The problem is Operations does not talk to Automation and that breaks the chain.”*

zenon: 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.

Pharmaceutical Automation Roundtable:

“I think we got here in the early 2000’s when the emphasis was all on validation and ended up with a generation of automation engineers who were really good at the paperwork and change procedures. In a lot of cases they never learned how to be true engineers to make their processes run better. They are not on the floor like years ago finding significant improvement opportunities. I have no problem contracting out the people to do paperwork and have in-house engineers that are constantly looking to make us better.”*

zenon: 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 has 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.

Pharmaceutical Automation Roundtable:
“If you went through all the non-conformance issues, 25-30% of them could probably be avoided by implementing some automation”*


zenon: 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.

Pharmaceutical Automation Roundtable:
“They (automation practitioners) should be stepping back and thinking about a holistic change that will eliminate problems and issues. In the 1990’s we used to do these things, but we were usually in front of our process engineering peers.”*

zenon: 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.

Pharmaceutical Automation Roundtable:
“People in automation do an awful job of translating their work into business value for management.”*

zenon: 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.

Pharmaceutical Automation Roundtable:
“We have a facility which is fully automated and we had a lot of debate on the value of it until the fully automated facility pulled way ahead of other facilities. We proved that automation is significantly better.”*

zenon: Our philosophy entirely, we “Aim to be the heartbeat of the automation industry”.

 

Part 3: Focus on Improvements

Part 1: Level of Automation and Automation Value

 

 

 

*quotes from automation.com – Management’s view of automation – Impressions of automation performance: http://www.automation.com/automation-news/article/managements-view-of-automation-impressions-of-automation-performance [21.05.2013]