Fisher-Rosemount and Bristol-Myers Squibb have announced a contract for a new greenfield pharmaceutical plant in Ireland, which will include the application of intrinsically safe Foundation fieldbus technology in PlantWeb field-based architecture.
The project will use intrinsically safe equipment and digital communications via Hart and Foundation fieldbus to provide a process automation solution for this major new pharmaceutical plant to be constructed near Dublin, Ireland. The project is being engineered by Kvaerner of Portsmouth, and will be installed from early 2001.
The project, known as the Cruiserath Bulk Manufacturing Facility, is for multi-purpose batch manufacture of health care products, and will involve the DeltaV automation system — a key control platform in the PlantWeb architecture — with over 1000 instrumentation and control points.
In particular, Rosemount pressure, temperature and flow instrumentation will be supplied as part of the initial order, which exceeds £1.7 million. All equipment will be intrinsically safe or flameproof, and the key networked intelligent field components will transmit information, especially plant equipment diagnostics, using Hart and Foundation fieldbus communications.
The PlantWeb architecture will include Asset Management Solutions (AMS) as a key modular software platform, enabling PlantWeb to use information from field devices to manage plant assets.
The company claims that PlantWeb architecture reduces commissioning costs, including field labour costs for checking wire connections, attaching devices, verifying communications, and troubleshooting such as device installation and wiring checks. With the polarity-insensitive connections on Foundation fieldbus devices, time is not wasted checking and re-checking polarity for each termination.
It is no longer necessary to send a technician into the field with a walkie-talkie as every device is manually ‘rung out’ to verify its identity. Instead, devices are auto-sensed and auto-addressed in the DeltaV system as they are connected to the control network. The AMS tools allow the engineer to diagnose process and instrumentation problems remotely, allowing one person in one location to quickly detect and track down possible problems for an entire project.
Bristol-Myers Squibb’s Worldwide Medicines Group is expanding in order to increase production and meet increasing consumer demand for its products. Construction of a 100-acre bulk manufacturing facility in Cruiserath began in January of 2000 and is scheduled for completion by 2002.
The US Food and Drug Administration (FDA) has announced federal regulations ensuring that companies comply with standards for electronic record keeping and the use of electronic signatures. Known as 21 CFR Part 11, the regulations have been in effect for three years but have not been enforced until now because of the investment being made to sort out the Y2K problem. The regulations will have a major effect on manufacturers not just in the USA but across the World.
The regulations went into effect in August 1997 and establish standard methods of electronic record keeping and submissions to the FDA. Among those records are biologics license, product license, and new drug applications. The regulations also provide the criteria for the use of so-called ‘hand written’ electronic signatures – the computer-generated equivalent of an individual’s unique signature.
The agency has recently become more diligent about enforcing the regulations by issuing inspection observation documents and, in some instances, warning letters. FDA has the power to shut down operations that are not in compliance. Naturally this can only happen in the USA but FDA also has powers to prevent the import of non-compliant products into the USA.