Sensors, transmitters, regulators, valves and myriad other equipment required for pharmaceutical manufacturing can combine to create a minefield of surprises for process engineers and operators. Fortunately, technology advances now allow this equipment to provide intelligent data that can be tracked, analyzed, reported and archived electronically.
The availability of equipment and device information related to electrical connection, status (clean, dirty, in repair, etc.) and usage ," in real-time and online ," enables production planners and schedulers to maximize production while running the process and equipment at an optimal level.
In today's heavily regulated Good Manufacturing Practice (GMP) production environment, facilities that run their processes and equipment at an optimal level reduce:
Loss of revenue resulting from prod-uct unavailability. Manufacturers could lose thousands of dollars each day the product is not available.
Loss of expensive raw materials and supplies. If production is shut down because of equipment-related issues, raw material degradation or expira-tion could become an issue.
Customer dissatisfaction. If a manu-facturer consistently misses delivery dates, customers are sure to become disenchanted.
The possibility of losing business to competitors. If a product is not available, some customers will be forced to seek an alternative.
Shortened product shelf life. The shelf life of drugs is critical. If a product is delayed as a result of equipment-related deviations or out-of-specification situations, then shelf life is condensed even further.
Many pharmaceutical manufacturers wish to accelerate drug production, but find it difficult. The companies still must adhere to regulations issued by the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture, the U.S. Environmental Protection Agency and many other government agencies. The Code of Federal Regulations that governs many aspects of pharmaceutical production requires companies to keep equipment maintenance-related data records, activity logs and reports with respect to maintenance activities performed, equipment condition status before and after use, dates for events performed and equipment control parameters.
Noncompliance with regulations has become an increasingly costly proposition. In 2001, FDA collected approximately $500 million under consent decrees with manufacturing companies, up from just $100 million in 1999. Many of FDA's actions related to GMP violations. In 2003, the total fines could approach a billion dollars.
Manufacturers, therefore, need information and solutions that address their need for fast production-cycle time and sustained regulatory compliance. A proactive preventive maintenance and asset management program ," one that is linked closely to and integrated with production schedules and recipe execution ," can help.
The key to creating this link is Extensible Mark-Up Language (XML). XML is a specification originating from the World Wide Web Consortium. It was developed to provide programmers and Web application designers with a common format to describe and facilitate the exchange of data between application software programs.
XML "explains" the way data are formatted and communicated between software applications and the computers running the applications. When data are formatted in XML, the applications requiring those data do not require the creation and maintenance of standardized application programming interfaces (APIs) over the lifecycle of use. In addition, XML allows facilities to use more programming tags to format, structure and search for information within an application. For example, "text" is one of the few data formats universally supported on computer platforms even when the character sets on the platforms vary with special characters.
XML also promotes data simplicity. It organizes data while keeping it in a user-readable form.
Using XML, facilities can access, combine and reuse data without re-entering them, and can tag or label data elements in formats that different application software programs can recognize. Facilities then can exchange data among equipment, controller and software more easily.
XML promotes data simplicity
When data are formatted in XML, the applications requiring those data do not require the creation and maintenance of standardized application programming interfaces (APIs).
Pharmaceutical manufacturers can speed their time to market by eliminating as many process stoppages as possible. Information technology can be an important tool.
Typically, preventive maintenance programs monitor equipment continuously and produce work orders in real-time or on an as-needed basis. For example, if a piece of equipment begins to operate at an unacceptable level, a predictive maintenance program will issue an alert, and a technician will respond before an out-of-specification occurrence causes an equipment stoppage. The equipment stoppage can be even more serious if a lack of available spare parts delays the repair, adjustment or calibration.
By linking predictive and preventive maintenance programs to recipe execution, pharmaceutical plants can avoid equipment problems and process stoppages. Instead of reacting to equipment failures as they occur, operators, process engineers and production planners would be able to predict when equipment will begin to develop a problem and could take proactive measures to bring the equipment or device back to specification ," without being forced to scrap the current production batch.
Predictive maintenance programs involve many elements, but device and equipment data are essential. Plants can collect equipment performance data using a variety of devices.