Cutting the Cost of Compliance

When questioned, Magnus Hermansson, general manager for GE Healthcare’s Life Sciences in Uppsala, Sweden, notes his facility doesn’t fall under direct FDA (U.S. Food and Drug Administration), scrutiny. What the plant produces, after all, is the chromatography media used in protein separation and purification.


2009: Measure, monitor falling mercury

When questioned, Magnus Hermansson, general manager for GE Healthcare’s Life Sciences in Uppsala, Sweden, notes his facility doesn’t fall under direct FDA (U.S. Food and Drug Administration), scrutiny. What the plant produces, after all, is the chromatography media used in protein separation and purification. Those purified proteins are what eventually end up in biopharmaceutical drug offerings, while the media never does.

However, in many ways the absence of formal regulation doesn’t matter, explains Hermansson. “We are continuously being audited by our clients, the biopharmaceutical industry.”

A look at operations in Uppsala and elsewhere shows how companies are meeting regulatory requirements and what hardware and software strategies are being used to lower the cost of compliance. Discussions also reveal some problems and trends.

Purifying proteins for less

The Uppsala site’s customers are subject to a set of methodologies and procedures known as good manufacturing practices, or GMP, with the most current definition found in the FDA’s 21 CFR 210 and 211. GMPs mandate training, include instructions on how to build and maintain clean manufacturing facilities, provide strict policies for compliance, and cover other aspects of production.

Not surprisingly, biopharmaceutical companies use GMP as a guideline when auditing plants, even those the FDA never inspects. “We are very close to GMP without having a formal requirement on a regulatory basis,” says Hermansson.

The Uppsala site supplies protein separation media worldwide, with hundreds of products, because different types of molecules of interest require different media. Manufacturing is done in a batch process, similar to that used for bulk production of pharmaceuticals themselves. Thus, the plant faces a large-product-mix, multiple-recipe situation, with growing volumes. There are extensive in-line process controls and evaluations, along with a bevy of tests done on the finished products for certification prior to shipping to customers.

Hermansson notes that the plant has automated and manual process lines, but that all new investments are in automated production. This isn’t being done as a way to achieve compliance, but the switch will help in that regard, with automation potentially cutting compliance costs.

The latest automated installation is an ABB System 800xA, which will control and monitor 4,000 input and output (I/O) signals from tanks, reactors, valves, stirrers, and other process equipment. In addition to integrated batch control and management, the system will also handle record protection and retrieval. The two production units controlled by the software will increase the media manufacturing capacity of the Uppsala site by 50%. The new production units are expected to be up and running by early 2009, after going through validation and testing.

Hermansson won’t give any figures that detail what the cost savings of automating the process are, in part because new equipment is also part of the mix. Hence, comparisons to older manual lines are not entirely valid. However, he does point out that the savings from automation show up in several areas. One, obviously, is lower personnel-related costs. Another is a more repeatable manufacturing process. This boosts product quality by eliminating defects due to manual processing. It also reduces the amount of material that must be scrapped or reworked.

There is another benefit of automation, one that directly impacts process trouble shooting and proof of compliance. “There is better documentation,” says Hermansson of the automated line.

Not up in smoke

For power plants, the applicable regulations come out of the Clean Air Act as interpreted by the U.S. Environmental Protection Agency (EPA). Greg Banchiere, president of system integrator Control Analytics of Greensburg, PA, notes that the regulations and requirements for coal and other fossil fuel burning facilities come in two parts. One deals with pollution reduction and involves cutting the emission of such pollutants as nitrogen oxides (NOx). The other part of the regulations deals with pollution reporting, which has to be done in a strict format and is covered by EPA’s CFR 40 part 75.

In addition to NOx, other controlled pollutants involve sulfur oxides (SOx). For coal-burning plants, there are also impending regulations involving mercury emissions (see sidebar). In tracking these pollutants, the industry employs continuous emissions monitoring systems from such companies as Environmental Systems Corp. of Knoxville, TN. System integrators like Control Analytics play a role in installation and maintenance.

Many pollutants are regulated under a flexible government cap-and-trade program that can decrease total emissions for less cost as long as regional emissions requirements are met. In this approach a plant above the target limit can buy credits from one below the target. The total amount of emissions is reduced over time, with plants trading credits. That puts a premium on accurately measuring and reporting pollutant emissions all the time, because a failure to do so catapults the site into a default category where emissions are defined to be much higher. Even a short time in such a state can be costly.

“The risks are… high if you do have data loss or have inaccuracy in your system,” says Banchiere.

There are different styles in how compliance for power plants is approached. Some companies take a minimalist tack, while others mount multiple analyzers, utilize fiber optics for communications to avoid problems associated with running wiring up a stack, and otherwise go well above the minimum. Success in either case, though, comes from sound engineering and not focusing on the installed costs.

As Banchiere says, the really big expenses come from remediation, not measurement and control. On the other hand, measurement and reporting can’t be neglected. “Our data is critical for providing compliance information and keeping plants operational and in the good graces of the EPA,” he says.

The relative cheapness of measurement compared to remediation efforts does have an impact, though. “We don’t have people worried about cost per se. They’re much more worried about accuracy and doing sound engineering.”

Adding value in the supply chain

Yves Dufort, director of Invensys Wonderware’s production and performance management manufacturing execution systems business unit, says the need for reporting results and logging records is common in regulatory compliance systems. So, too, is the need to track and document changes in processing recipes. “When something gets changed, who changed it? What was the former value? What’s the new value?” he says in describing what is logged.

In complying with regulations, companies also try to satisfy other business needs and thereby produce cost savings. Dufort cites the case of a cosmetics company operating in New Jersey, where local laws require workers be informed of substances being used and what protective equipment should be worn. The company set up the compliance software to document that workers have been informed of the presence of such ingredients, thereby improving efficiency while meeting regulations.

Enhance quality at the same time

Companies also may tweak a system so that it stays in compliance while enhancing product quality and consistency. Certain products, such as paper or cheese, contain water, and the percentage of that inexpensive component in the final product can be adjusted by humidity control. Hence a capable control system can satisfy regulations and optimize water content.

Likewise, those involved in freezing food can use the control system to assure product quality, comply with regulations, and save money. By carefully adjusting the timing of refrigeration, it’s possible to shift demand to the local electric utility’s off-load times and thereby save substantial sums on electric bills. A more aggressive and networked implementation of the same idea involves lowering the temperature of a cold store at night and allowing it to rise during the day. Such an approach is currently being investigated by the Netherlands Organization for Applied Scientific Research, with the hope of putting it into practice on a national scale. If successful, the scheme will effectively store tens of thousands of megawatthours of energy.

Such a smart use of control systems may become more necessary, in part because compliance requirements are becoming more widespread. Drug manufacturers, for instance, now often require temperature control from the time the drug leaves the production facility until it is delivered to the patient. Thus, the entire supply chain has to achieve what amounts to regulatory compliance, says Dufort. “That’s something that certainly wasn’t there 20 years ago but is becoming more and more present.”

Author Information

Hank Hogan is a contributing writer for Control Engineering.

2009: Measure, monitor falling mercury

Starting in January 2009, U.S. power companies will have to monitor and report on the amount of mercury emitted from coal-burning plants. Mandatory reductions will kick in, and utilities will enter a new world.

“Being in compliance with mercury is all new,” says Control Analytics’ Greg Banchiere. What emerges from the stack of such a plant can be elemental mercury, a mercuric compound, or even mercury laden particles. The regulatory scheme will vary from state to state, which means utilities will have to do some homework to ensure compliance.

Because mercury is part of the coal that plants use and not a result of combustion, industry has a limited number of options in dealing with it. Some reduction can be achieved by cutting other pollutants produced, which has the effect of reducing mercury emissions. Additional reductions could arise from burning low mercury coal, but that could run into problems of cost. It also could conflict with the desire to burn low sulfur coal, since low mercury coal isn’t necessarily also low-sulfur. Another possible solution would be to capture the mercury and sequester it.

Modern control systems may actually help in this mercury reduction effort because they allow much finer regulation of the furnace than was possible with older, pneumatic controls. Adjusting the conditions in the combustion chamber might help reduce overall emissions. But first the industry has to settle on some basic technology solutions for such issues as in-situ measurement and control. Even current measurement technology, which isn’t in-situ, hasn’t been widely deployed before, notes Banchiere: “Nobody’s tried to measure mercury before. They’re brand new systems.”

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