Vincent F. Pizzi

RFID sensors as the common sensing platform for single-use biopharmaceutical manufacturing

The lack of reliable single-use sensors prevents the biopharmaceutical industry from fully embracing single-use biomanufacturing processes. Sensors based on the same detection platform for all critical parameters in single-use bioprocess components would be highly desirable to significantly simplify their installation, calibration and operation. We review here our approach for passive radio-frequency identification (RFID)-based sensing that does not rely on costly proprietary RFID memory chips with an analog input but rather implements ubiquitous passive 13.56 MHz RFID tags as inductively coupled sensors with at least 16 bit resolution provided by a sensor reader. The developed RFID sensors combine several measured parameters from the resonant sensor antenna with multivariate data analysis and deliver unique capability of multiparameter sensing and rejection of environmental interferences with a single sensor. This general sensing approach provides an elegant solution for both analytical measurement and identification and documentation of the measured location.

Passive multivariable temperature and conductivity RFID sensors for single‐use biopharmaceutical manufacturing components

Single‐use biopharmaceutical manufacturing requires monitoring of critical manufacturing parameters. We have developed an approach for passive radio‐frequency identification (RFID)‐based sensing that converts ubiquitous passive 13.56 MHz RFID tags into inductively coupled sensors. We combine several measured parameters from the resonant sensor antenna with multivariate data analysis and deliver unique capability of multiparameter sensing and rejection of environmental interferences with a single sensor. We demonstrate here the integration of these RFID sensors into single‐use biopharmaceutical manufacturing components. We have tested these sensors for over 500 h for measurements of temperature and solution conductivity with the accuracy of 0.1°C (32–48°C range) and accuracy of 0.3–2.9 mS/cm (0.5–230 mS/cm range). We further demonstrate simultaneous temperature and conductivity measurements with an individual RFID sensor with the accuracy of 0.2°C (5–60°C range) and accuracy of 0.9 mS/cm (0.5–183 mS/cm range). Developed RFID sensors provide several important features previously unavailable from other single‐use sensing technologies such as the same sensor platform for measurements of physical, chemical, and biological parameters; multi‐parameter monitoring with individual sensors; and simultaneous digital identification.

Integration of passive multivariable RFID sensors into single-use biopharmaceutical manufacturing components

Single-use biopharmaceutical manufacturing requires monitoring of critical manufacturing parameters. However, the lack of reliable single-use sensors prevents the biopharmaceutical industry from fully embracing single-use biomanufacturing processes. We report here an approach for passive radio-frequency identification (RFID)-based sensing that does not rely on costly proprietary RFID memory chips with an analog input but rather implement ubiquitous passive 13.56 MHz RFID tags as inductively coupled sensors with 16-bit resolution provided by a sensor reader. Developed RFID sensors combine several measured parameters from the resonant sensor antenna with multivariate data analysis and deliver unique capability of multiparameter sensing and rejection of environmental interferences with a single sensor. In this study we are integrating these RFID sensors into single-use biopharmaceutical manufacturing components such as buffer bags. Performance of these sensors for simultaneous solution conductivity and temperature sensing is discussed.

Temperature-independent passive RFID pressure sensors for single-use bioprocess components

Single-use biopharmaceutical manufacturing requires monitoring of critical manufacturing parameters. However, the lack of reliable single-use sensors prevents the biopharmaceutical industry from fully embracing single-use biomanufacturing processes. We report an approach for temperature-independent pressure sensing in single-use bioprocess components using passive radio-frequency identification (RFID) sensors. An RFID pressure sensor is fabricated by applying a pressure sensitive flexible membrane to an RFID-tag-based transducer and a layer that modulates the electromagnetic field (EMF) generated in the RFID sensor antenna. The sensor signal is modulated upon pressure-induced flexing of the membrane, providing a desired quantitative response of pressure of the fluid during the operation of the single-use component. We demonstrate a temperature-independent RFID pressure sensor that was tested to measure pressures from −5 to 33 psi with the ± 0.25 psi accuracy after gamma irradiation. Temperature-independent pressure response is provided from the multivariate analysis of the measured impedance of the sensor.

Passive gamma-resistant RFID tags integrated into gamma-sterilizable pharmaceutical components

The single-use bioprocessing is an attractive new approach of biopharmaceutical manufacturing. Digital identification of single-use bioprocess components is critical to facilitate their asset management, to document electronic pedigree, and to provide authentication. This identification can be achieved using radio frequency identification (RFID) tags. In this study, we critically analyze the challenges for the gamma-sterilizable RFID tag technology to retain the reliable read/write ability of the tags after their gamma irradiation. In RFID tags, the gamma radiation induced loss of device performance (i.e. the ability to reliably write and read data from an integrated circuit (IC) memory chip) originates from two independent sources such as (1) radiation effects on the non-charge-based storage memory material and (2) radiation effects on the performance of analog and digital circuit components of an IC memory chip device. Our interdisciplinary knowledge of product design, analytical instrumentation, RF engineering, and Six Sigma statistics has resulted in the design and implementation of the tag interrogation concept that insures the high reliability of tag read/write after the gamma irradiation.

Lab-scale long-term operation of passive multivariable RFID temperature sensors integrated into single-use bioprocess components

We address the significant need for the monitoring of critical manufacturing parameters in single-use biopharmaceutical manufacturing by developing passive radio-frequency identification (RFID)-based sensors and their integration into single use bioprocess components. Our sensor development approach converts ubiquitous passive 13.56 MHz RFID tags into inductively coupled sensors. In this work, we integrated RFID sensors into single-use bioprocess bags and have tested these sensors for over 570 h for measurements of temperature. The achieved performance accuracy was 0.1 °C when measurements were performed over the 32 – 48 °C temperature range. Developed RFID sensors provide several important features previously unavailable from other single-use sensing technologies such as the same sensor platform for measurements of physical, chemical, and biological parameters; multi-parameter monitoring with individual sensors; and simultaneous digital identification.