By Ken Baker Hoses, tubing, valves, and other critical components demand precise usage records to ensure product safety. See why pharmaceutical, food, chemical, and other process industries are turning to RFID tags to stay on track.
| | Assigning a hose assembly with a unique serial number through an RFID tag allows it to be identified, logged, and tracked.
'Companies that establish replacement dates based upon a uniform calendar projection method open themselves to operating inefficiencies.' Pharmaceutical companies and other industries that deal with high-purity products, such as foods and cosmetics, are adopting process equipment tracking programs in response to Title 21, Section 211.67 of FDA's Code of Federal Regulations. Accurate records on equipment cleaning and maintenance, as well as the ability to provide an audit trail, are important parts of compliance and product safety. Automation can help to ensure the reliability and consistency of record keeping, and radio frequency identification tags, more commonly called RFID tags, are emerging as the technology to meet this need. A common challenge for manufacturers is the implementation of a simple, effective program to evaluate the frequency of process equipment use and to determine maintenance and replacement schedules. Process equipment includes hose and hose assemblies, tubing, pumps, bio-bags, diaphragm valves, filters, UV lamps, and other critical components. Precise, detailed records must be kept regarding the usage of these components to ensure product safety and avoid contamination of, for example, an expensive pharmaceutical batch due to overused, misapplied, or improperly prepar Timely access to a complete biographical history of any processing equipment in a production facility provides a comprehensive tool for equipment management and the required information for reordering. Such information could include manufacture date, batch number, lot number, material specifications, material lot number, certificates of compliance, size specifications, and equipment description. What happens to a particular piece of equipment from the time it is installed to the time it needs replacement will have a direct impact on its life expectancy. These wear-related events include the date and number of cleaning cycles (clean-in-place, steam-in-place, and autoclaving) and the actual number of batches processed. Companies that establish replacement dates based upon a uniform calendar projection method open themselves to operating inefficiencies by increasing costs. They may be replacing process equipment before it is necessary. By switching to a replacement method based upon actual usage, replacement decisions are based solely on the actual wear and condition of each individual part, thus providing a higher return on investment. If you toured five different processing facilities, there is a good chance you would find five different methods for tracking events that are critical to process equipment degradation and ultimately lead to equipment replacement. Hand-written charts requiring correct and timely human entry are not uncommon, but they offer the possibility of errors such as transposed numbers, incorrect dates, illegible handwriting, misread data, and misfiled documents. Requirements for automating this procedure have been requested, and in some cases demanded, in order to provide concrete evidence of having standard operating procedures in place to determine equipment replacement schedules and create an audit trail for validation processes. Benefits of such automated systems include the substantial risk reduction of contaminating a batch of product, actual equipment failure, and the costly repercussions associated with waste and production stoppages. Automation provides an increased degree of safety for the final product. RFID tags are now being used for hose assembly identification and tracking and specifically address process equipment used in pharmaceutical, biotech, biomedical, food, beverage, chemical, and cosmetic applications. The RFID tags are attached to individual components, such as filters, hoses, and pumps, for identification and tracking purposes. Assigning a hose assembly or another process equipment part with a unique serial number through an RFID tag allows it to be identified, logged, and tracked with ongoing wear-related events and then updated with event information as events are completed. Updated information can be downloaded to a tracking database and used to analyze the equipment's lifecycle, calculate its life expectancy, and even generate a reorder based upon biographical data. When implemented as part of an overall maintenance program, the use of RFID tags can simplify record keeping for FDA compliance. Summary of Advantages
RFID tags offer other benefits including the following advantages. The elimination of an inefficient calendar method for replacing used parts, resulting in a reduction of wasted production life and under-utilized equipment The reduction of equipment failure due to overuse A more accurate life expectancy using actual event data The allowance of embedded production protocols such as disassembly and reassembly instructions and photographs, training aids, and damaged part examples Safe use with various cleaning methods Applicability with predictive maintenance systems Space-saving record storage since computerized data is stored much more easily than file cabinets full of traditional paper records Reliability External attachment for cleanliness, which means no contact with the material flow How Tags Are Attached RFID tags are attached to equipment by various methods, depending on which one best suits a particular application. They are used in conjunction with a handheld reader/writer that recognizes each tag by its unique serial number. The reader/writer is able to record and access the complete biographical history of a part, which may include its date of manufacture and/or installation, cleaning cycle information, number of batches processed, and other user-defined events. Conclusion Identification and tracking systems that ensure the dedication of equipment for specific applications, processes, and products are important to the compliance of FDA’s Title 21 CFR 211.67. Maintaining records on process equipment’s age and consistency of application provides assurances against biological contamination and cross-contamination of product lines or product matrix components. RFID solutions greatly help to simplify record keeping, improve accuracy, provide an audit trail, and most important, increase product safety. FDA's Title 21 CFR 211.67 The Code of Federal Regulations Title 21 CFR 211.67 states that equipment and utensils shall be cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. In addition, written procedures shall be established and followed for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product. Important Data to Track The biographical history of your processing equipment should include: Manufacture date Batch number Lot number Material specifications Material lot number Certificates of compliance Size specifications Equipment description Key Events to Track What happens to equipment from the time it's installed has a direct impact on its life expectancy. Important wear-related events include: Date of cleaning cycles Number of cleaning cycles Number of batches processed About the Author: Ken Baker is the CEO of AdvantaPure, the high purity products division of tubing and hose manufacturer NewAge Industries Inc., 145 James Way, Southampton, PA 18966. Baker has more than 20 years of experience in the plastic tubing and hose industry and developed the AdvantaPure sanitary products division in 2001. Questions about this article can be addressed to Baker at firstname.lastname@example.org or 215-526-2151. Additional information is available at www.advantapure.com.