Emerson Process Management has stepped up its efforts to sell its engineering, process control and digital automation technologies into the life sciences sector with the launch of a new programme, called OpX, at the Interphex exhibition in New York, reports Phil Taylor.
The company has a 30-year history in supplying the services and components underlying OpX to companies in the refining, chemical and other process industries- including pharma - but it is only recently that changes in the regulatory environment have opened up opportunities in the life science sector.
Emerson executives told an Interphex press conference that the time has come for the drug industry to embrace technologies that enhance its control over production and reduce costs.
"The life sciences industry is facing a 'perfect storm' of business conditions, including growing competition, quality and safety concerns and new price pressures," said Bob Lenich, business director of the new OpX (Operational Excellence) project.
The pharma industry's traditional reliance on the blockbuster model has held back investments in plant architecture, and this has been exacerbated by a regulatory compliance constraints that hitherto have made changing a process time-consuming, cumbersome and expensive.
Now, the introduction by the US Food and Drug Administration (FDA) of its new current Good Manufacturing Practice (cGMP) and Process Analytical Technologies (PAT) initiative has changed all that. Pharma companies are now being encouraged to use on-line, at-line and real-time measurements in the processes to reduce cycle times, prevent rejects, allow real-time release of products and reduce energy use.
Despite this, "PAT has not yet moved out of the lab and into the plant," according to Jerry Brown, vice president of life science industry sales and marketing at Emerson.
OpX has at its heart Emerson's Plantweb digital architecture, a system of monitoring devices and control software that gather and monitor data on conditions in the facility and addresses the fundamental requirements of PAT, he added.
Plantweb has already been applied in a number of life science companies - including Genzyme, Amersham, Indena, Lonza, Novo Nordisk Engineering and IDEC (now Biogen IDEC) - but on the whole the drug industry is only just adopting principles the chemical and food industries have used for decades.
Compared to its earlier offering, OpX adds in service programmes and project management functions and the expertise Emerson can bring in life science plants.
However, one of the main obstacles to the broader adoption of Plantweb in the pharma industry has been technological, according to Lenich.
He told In-PharmaTechnologist.com that one of the keys to OpX extension into pharma is the introduction of a new component that, for the first time, can be used to monitor the performance of rotating machinery such as pumps and mixers, used in three quarters of all life sciences process facilities.
The CSI 9210, as it is known, monitors vibration, temperature, motor flux and machine speed to gauge machinery health, and plugs one of the few remaining gaps in the Plantweb control architecture. The other main gap is in real-time control of the laboratory/analytical function, and Emerson is working on this as well as seeking out technologies to partner or acquire, said Lenich.
The savings achieved by implementing OpX are enormous, according to Emerson. For example, in a plant with $250m in assets to maintain, full implementation of the system can cut operating costs by $10 million for each facility, claims the company, largely through reductions in shorter cycle times, reduced operational and maintenance costs, reduced calibration times, fewer machinery shutdowns and improving the efficiency of batch record reviews.
"Independent studies suggest that while manufacturing automation accounts for only 5 to 8 per cent of total plant costs, proper application f automation technology to plant floor business practices has enormous impact on production efficiency and product quality," said Brown.
He also noted that while other process control systems based on SAP are available, these lack the automated device components of Plantweb, so still rely on operators feeding in data, which in turns raises the risk of human error.
The OpX programme consists of a one- to two-day initial assessment, followed by a more detailed study, the issuing of a report detailing the firm's recommendations for equipment, changes in work practice etc. Once the project is implemented, the results are analysed and compared to baseline objectives.
"We can guarantee improvement," said Lenich. "Its that simple."