Product category:
Plantwide control
News Release from: Emerson Process Management - Systems and Industry | Subject: Batch process control systems
Edited by the Engineeringtalk Editorial
Team on 07 September 2000
Hot topics in batch control
Batch Control faces close scrutiny: process control must allow production versatility whilst collecting the production records needed to maintain regulatory compliance, as Nick Taylor explains
The fine chemicals and pharmaceuticals industries have changed their approach to manufacturing, moving away from dedicated production facilities to smaller, more flexible process areas that can be linked in various configurations, or switched from one product to another The pace of product development is accelerating, especially illustrated by efforts to target specific diseases with tailored products derived from biosynthetic reactions
This article was originally published on Engineeringtalk on 12 Mar 2001 at 8.00am (UK)
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At the same time, regulatory requirements to ensure product quality, traceability, and production records are increasing.
In process plant control systems, the Batch Control features face close scrutiny: they must allow the manufacturer flexibility to achieve the required production versatility whilst collecting production records needed to maintain regulatory compliance.
Many control systems offer a 'Batch Engine', a piece of software which co-ordinates the development and maintenance of recipes, manages the production of the batch according to the recipe and collects data against a unique batch ID.
The ISA's S88.01 standard (IEC 61512-1) defines models and terminology that have enabled the batch community to talk in the same language as each other; most Batch Engines adhere to this model.
S88.01 does identify 'Production Planning and Scheduling' as a key activity, but most systems offer only a simple queue of batches, to be put through the plant in turn.
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Most users need to be able to alter this list; modifying it in light of new orders, raw material availability, equipment failure, etc.
To cater for this need, vendors are now supplying packages allowing the creation of a series, or campaign, of batches.
All batches in the campaign can be manipulated as one; processed in a different train, use alternative raw materials, made in a different order, etc.
In conjunction with finite capacity scheduling techniques, these packages will be able to add the value of an experienced plant manager who knows how to get the best out of the plant.
The next step along this line will enable campaigns to be remotely created or modified from ERP production scheduling systems.
We have a long way to go before all process plants have their control system integrated with the business management application layer.
It is clear that the manufacturer who is able to respond quickly to changes in the business world by altering the manufacturing process will be in the best shape to compete in the e-future.
Most modern control systems are 'open', i.e they can be linked to other information systems more easily than in the past, so technology is not now the limiting factor.
In a demonstration recently, a FOUNDATION fieldbus pressure transmitter sent out a diagnostic alarm up through the control system, onto the ERP layer, which, via e-commerce, ordered a replacement transmitter from the instrument manufacturer.
Such integration is uncommon, but it proves a point.
Today's technology allows very close integration between the process and business layers, but there is a huge amount of work required to define exactly what is shared between the two and how the data is used.
The focus has shifted from "How can we make these system communicate?" to "What information shall we share and why?" FDA validation continues to be a topic that dominates any discussion between pharmaceutical end user and vendor.
Briefly put; validation of the control system is the ''Procedure of establishing documented evidence which provides a high degree of assurance that a specific Computer-Related System will consistently operate in accordance with predetermined specifications" (PDA '96) There may be no new requirements in validation, but technology is changing and more functions are carried out within the control system than ever before.
A recent article by Ian Allan at SmithKline Beecham explains how their PlantWeb field-based architecture, from Fisher-Rosemount, causes all process valve and instrumentation calibration and maintenance records to be automatically updated, without any manual reporting, so forming a key part of their compliance procedures.
Another Fisher-Rosemount DeltaV installation integrates plant floor bar code readers into the batch production records, so identifying the actual shipment and identity of raw materials used in the process.
In regulated industries, the manufactured product is worthless without the accompanying record of correct production, the batch record.
Although this is especially true for the pharmaceutical industry, the culture is spreading.
In 1997, US Government 21 CFR Part 11 became law.
Part 11, as it is commonly known, covers the use of electronic records with particular regard to security of data.
The regulation was developed at the request of the pharmaceutical industry to allow it to make use of the benefits of computers to store batch records electronically.
The intention was to ensure that electronic records are trustworthy, reliable and compatible with FDA work.
Up until recently, the FDA inspections have not applied the regulations rigorously, but the trend is to train new inspectors on Part 11 and there will be increasing vigilance in its regulation.
With electronic, rather than paper records, it is crucial that the control system provides adequate security of interface between man and machine.
Network security, user names, passwords etc, must ensure that the inclusion of an 'electronic signature' in an electronic production record carries weight equal to that of a handwritten signature on a traditional paper report.
The DeltaV system provides this security and allows the user to require operator and/or supervisor confirmation (re-login) at key process stages, as required by Part 11.
Batch records are stored by DeltaV, protected as required.
The DeltaV Batch Historian allows graphical comparison of a series of batches, as well as open features allowing FDA visibility of data.
Security was a major factor in the Cedarburg Labs (Wisconsin) choice of the DeltaV scaleable process system for their batch control.
Cedarburg are a contract producer of active pharmaceutical ingredients and intermediates, having four "suites" of fully instrumented glass lined reactors.
The DeltaV control equipment has to accommodate frequent product and process changes, with customer confidentiality maintained between suites, when four different clients are using the facility, but a single customer might need to occupy the entire facility, so then the four suites must seamlessly interact and integrate.
The whole had also to provide Cedarburg's client with the batch records, event data, and signatures and control strategy confirmation, for his own records.
The plant could not have functioned as flexibly without the ease of use of the DeltaV and PlantWeb field based architecture, according to Cedarburg's President, Dr James Yarger.
They also found the small footprint associated with the DeltaV operators systems invaluable in positioning each controller within the relevant suite of process vessels, without requiring a separate control room.
S88.01 flavoured batch control solutions have done a great job providing flexible implementations at many sites worldwide.
Master Recipes are tailored to equipment trains and parameterised to become Control Recipes dedicated to a single batch ID.
S88.01 recognises that enterprises may make a product in slightly different ways at different sites and that the product identity or brand characteristics are ultimately defined by a "higher level" recipe.
The gap between this higher-level recipe and the Master Recipe is often vast; the former comes from chemists in process development, the latter produced by process engineers with intimate knowledge of the equipment and raw materials at a specific site.
A great deal of value must be added to get from the high to the low level.
The concept of a General Recipe has often been discussed, particularly by larger enterprises with multiple sites.
Control system vendors are keen to develop solutions to help bridge this gap: S88.02, i.e Part 2, is due out this year and will contain guidelines for development of General Recipes.
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