P•E•T Process Equipment Tracking® offers a new degree of safety and reduced risk for the pharmaceutical processing industry, as well as other high purity applications in the food and beverage, cosmetic, chemical, and biomedical sectors. Using RFID (radio frequency identification) technology, all process equipment involved with a particular batch of product is monitored from start to finish. Track usage and cleaning cycles to ensure timely maintenance and replacement . . . before parts begin to fail, risk product integrity, and waste time and labor. Briefly stated, you can track who did what to each batch and when. It’s a logical approach to tracking all critical process components.

• PROCESS EQUIPMENT APPLICATIONS
• TYPICAL CONFIGURATION
• POSSIBLE ATTACHMENT METHODS

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P•E•T ADVANTAGES

• Identifies individual process equipment devices such as pumps, bio-bags, diaphragm valves, filters, UV lamps, and hoses using RFID tags
• Tracks key wear-related events such as cleaning cycles/dates and batches of material processed or other user-defined events
• Ensures timely maintenance and replacement before parts begin to fail, risk product integrity, and waste time and labor
• Provides an audit trail to assist in validation processes; helps accelerate data collection procedures and lower costs
• Reduces errors on the production floor
• Consolidates documents by electronically linking to notes, cleaning schedules, files, certifications, photos and illustrations, installation instructions, warning notices, and other protocols
• Safe for use with CIP, SIP, and autoclave processes
• Various tags address applications involving high temperatures, gamma irradiation, and mounting to metal
• Gamma-radiation-resistant RFID tag – GammaTag® – now available
• Different tag sizes and shapes available
• Field installation methods available
  to immediately start tracking existing equipment
• U.S. Patents 7,195,149 and 7,259,675

 

ADVANTAGES

Minimizes Risk

• Tags are encoded with serial numbers and other information and are externally attached to each piece of process equipment – no contact with material flow
• An administrative level access, known as Kiosk mode, prevents changes to the system – restricts usage to help enforce 21 CFR Part 11 validation
• Identifies individual process equipment parts such as hoses, pumps, bio-bags, diaphragm valves, filters, and UV lamps using RFID tags
• A fast, efficient, and precise identification system for critical process equipment
• Eliminates dependence on manual log book record keeping, its inefficiencies and inaccuracies, and the books' contribution as a contamination source

Reduces Costs

• Accesses and records the current status of any tagged component on the spot
• Reduces errors on the production floor
• Limits failures and helps calculate equipment life expectancy using actual data
• Eliminates the inefficient calendar method of swapping out used parts – reduces wasted production life and underutilized equipment
• Field installation methods available to immediately start tracking existing process equipment
• Applicable to predictive maintenance systems (PdM)

Consolidates Documents

• Eliminates inefficient paper labels and hang tags
• Reduces dependency on paper records and their inherent problems, such as transposed numbers, incorrect dates, handwriting legibility, misread data, and misfiled documents
• Electronically links to notes, cleaning and maintenance schedules, files, certifications, photos and illustrations, installation instructions, warning notices, and other protocols
• Allows recording and storage of all critical information
• Links to a database that contains the complete biographical history of parts
• Allows information access from any networked computer running the P•E•T program

Provides an FDA Audit Trail

• Third-party validated for 21 CFR Part 11
• Speeds audits and lowers their costs by eliminating the time and labor of locating, retrieving, and gathering paper records and traditional log books
• Tracks key wear-related events such as cleaning cycles/dates, batches of material processed, calibration, and other user-defined events
• Provides a secure, tamper-proof record to track time, date, and operator data

Provides an FDA Audit Trail

• Unlike bar code labels, tags do not require a clear sight line for reading/writing
• Safe for use with CIP, SIP, and autoclave processes
• Integrates with existing workflows
• Custom engineered to best meet individual needs
  
• Select the tag attachment method best suited for each particular item – choose from a molded pouch, lamination, watchband style encasement, silicone fusible tape, or any customized design

 

RFID Tracking Used In Process Equipment Applications Calendar & Manual Log Methods For Replacing Critical Process Components Can Be Unreliable, Increasing Risk Of Product Contamination & Wear Related Failure RFID Tags Attached To Process Equipment Are Scanned By Reader/Writer To Track Wear Related Events & Update Computer Database Process Equipment Identification and Lifecycle Analysis System Provides An Audit Trail To Assist In The Validation Process

 

TYPICAL CONFIGURATION RF Identification Attachment Methods   Portable Handheld Reader/Writer   Lifecycle Analysis Tool The RFID tag is attached to each device and encoded with a unique serial number. Several attachment methods are available and include a molded pouch, lamination, stainless steel strap, silicone fusible tape, complete silicone encasement, etc. Many of these methods allow tag attachment to process equipment currently installed in facilities. Tag encoding can be customized to meet specific needs.   The handheld reader/ writer identifies each device by its serial number for reference in a database. The reader/ writer logs and tracks ongoing wear-related events such as the number of cleaning cycles and dates performed (CIP, SIP, autoclave), and the number of batches of material processed. Data is programmed back onto the RFID tag and later downloaded to a database for analysis.   Specific data is transferred to a local computer using the Lifecycle Analysis Tool (software) to catalog process equipment, maintain wear-related events, and store application data associated to a particular location. Personnel can perform lifecycle analysis for individual locations for an accurate, application specific replacement schedule prior to excessive degradation or failure.

 

POSSIBLE ATTACHMENT METHODS A wide variety of process components exist in various shapes and sizes creating a need for different attachment methods. The AdvantaPure engineers are up to the challenge of attaching RFID tags to your components and are ready to work with you to design something that fits your specific requirements. Our development of the Hose Track System has given us extensive experience with hose attachment methods. For example: ...silicone injection molded to the O.D. of a hose assembly ...wrapped silicone fusible tape for use with existing hoses ...plastic tie-wrap for use with existing hoses Using a diaphram valve as an example, different means could be employed to place an RFID tag onto the component such as: ...a plastic pouch and wire tie ...integrated into bonnet design Many more applications exist and other solutions can be further developed. What works for you? ...a tag holder could be attached to a filter housing using a stainless steel strap ...a pouch can be affixed to the exterior of a biobag ...a mounting block could be fastened to the exterior of a mixing vessel

 

 

 

Click the link to download a printable version of our P•E•T Process Equipment Tracking brochure. PET_Process_Equipment_Tracking.pdf (1.2MB)