Posts Tagged ‘PFC’

Video: Paper on Glass and Electronic Batch Reports

Wednesday, June 10th, 2015

Paper on Glass’ is a very simple concept, with one main aim – to replace paper batch records with a mobile device. Pharma production is getting more and more complex. Watch this video to see how mobile devices powered with zenon reduce post batch analysis time and increase Right First Time (RFT).

The problem with paper

Paper is used a lot in pharmaceutical production environments; it drives the operator through the production sequence and records critical processes. It forms the base to prove each batch is of high quality and compliant to the regulations. But today’s Pharma production is becoming more and more complex, and in parallel the international regulations are increasing their demands.  Paper also needs to be printed and stored in secure environments for long periods of time. Using paper to drive production in Pharma, is like standing outside in a storm ripping up $100 bills:

  • Paper is manually intensive and RFT is less than 50% when using paper to drive production.
  • ⅔ of rejects are down to simple human failings: Missing entries and incorrect entries.
  • Collation of production data and analysis takes 15 to 40 days post batch

Paper on Glass: Putting automation in the hands of the operator

Using a batch engine gives you a consistent sequence in production, with clear instructions and safety information. Information is recorded from the operator directly into the historian. Missing entries are eliminated, and incorrect entries are also eliminated as far as possible. The collation of data is automatic and complete, batch recording and analysis documentation is instantly available.

Validation efficiency

No change to equipment or processes is needed. Production is being produced on exactly the same equipment, using the same workflow, with the same documentation.

Video: Paper on Glass and Electronic Batch Reports with zenon

Take a look at this Video to increase RFT, quality, and production efficiency with ‘Paper on Glass’.

In this video, you will see:

  • How to change your workflow without changing equipment or processes
  • Example applications in zenon
  • Batch Reporting possibilities

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

Conclusion

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.

Benefits

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.

Conclusion

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

 

Batch Control – Communicate and Control

Wednesday, June 26th, 2013

Moving on from the last Batch Control blog entry, we now put this powerful control into commission. Previously we stated that Batch Control separates out the equipment control and the process control. This is a powerful structure, continuously evolving, and the ultimate in flexibility.

But this power is only released through communication.

Hardware integration through native drivers

Competitor products achieve this level of control only using their own hardware and software; Batch Control in zenon connects different systems, basically any PLC or control device can be lifted into a batch control environment through our connectivity. Once you have this effective communication, in such a flexible and powerful structure, evolution can really take hold. Remove manual processes, integrate isolated equipment, remove paper-based operating procedures and paper-based reporting. All can be commanded, controlled, monitored, and reported through this integrated automation environment. From start to finish, production orders are managed, produced and reported on in one automation environment, which has been achieved on your existing processes and current control equipment.

Vertical integration

Effective communication doesn’t stop at the process equipment – connectivity into business and manufacturing execution systems is of extreme importance. Removing manual steps from a production process removes the risk of error. Batch Control recipes can be created and controlled by functions which can be called up by other higher level systems. This integrates the physical batch production into the supply chain commanded by the business ERP or MES systems.

Conclusion

As multiple batch recipes can be executed concurrently, this connectivity to different machines, and different generations of machines, can bring any facility to the latest level of production control architecture and control.

All processes are different; we understand this difference in both the communication and its control.

 

zenon Batch Control – let’s go!

Monday, May 6th, 2013

Batch_Control_ScreenWelcome to the first blog entry on zenon’s ‘Batch Control’ module. Let us get the feeling of the next generation of automation, and see how batch control fits in zenon, and where zenon fits in batch control.

Flexible process control

One principal entity of the ISA 88 compliant batch control is that the process engineering and the equipment automation is kept separate. Having equipment control blocks (called phases) which can be flexibly placed, moved and modified in the process flow; opens up the equipment to a multitude of process combinations and thereby enables a wide selection of product possibilities.

The equipment control links the hardware together and controls this collection of hardware to obtain a certain state. For example, in a reactor there are temperature, pressure, and agitation control loops. The PLC knows which hardware is used and how to control the equipment to obtain a certain temperature, pressure or agitation speed.

The Batch Control module then uses ‘Recipes’ to describe the production control, and choose where in relation with other equipment in the process, these control loops are used. Each phase includes parameters which defines how the equipment will control this loop, and when the phase has completed with the ‘Phase done condition’

The Batch Control module is fully integrated into the zenon Supervisor SCADA software; here the full complement of functionality, flexibility and possibilities are available. More importantly it makes use of the extensive communication possibilities, where any equipment hardware can be connected and tightly controlled – whether standalone or distributed solutions are needed, from ERP to sensor.

Conclusion –
Continuous improvement in compliance with ISA 88

The Batch Control module and zenon’s mature functionality bring process automation to life, adding the dimension of flexibility and continuous improvement to distributed or standalone solutions.

My next entry will be about communication and connectivity in zenon’s Batch Control module.