TruFluor® pH Single-Use
Optical pH Sensors

The TruFluor® pH and temperature single-use sensor consists of a disposable sheath, an optical reader, and a transmitter (blade or external).

The single-use sheath can be pre-inserted in a single-use bioreactor bag port and irradiated with the bag, in order to preserve the sterile barrier. All wetted materials of the sheath are USP class VI compliant.

The optical reader utilizes a patented optical design that minimizes photodegradation of the active sensing element. The design has been optimized to provide accurate in-situ measurement of pH using phase fluorometric detection in real time.

The temperature measurement leverages a 316L stainless steel thermal window embedded in the sheath, and provides accurate results that can be used as a process variable, or for temperature compensation.

Benefits

  • Minimize contamination, maximize vessel integrity
  • Obtain real-time pH and temperature
  • Collect drift-free data from pre-calibrated sheaths
  • Meet cGMP regulations with lot traceability and loop validators
  • Rely on USP Class VI / gamma radiation resistant wetted materials

Smart Calibration

SmartChips  All Finesse SmartSensors contain embedded SmartChips that hold factory calibration data and are gamma radiation resistant. The SmartChip also holds manufacturing lot and serial numbers that can be part of the batch record if used with the blade transmitter.

SmartReaders  Each optical SmartReader is normalized to a traceable standard at the factory. The validator loop can be used to verify the performance of the measurement loop prior to each batch run for cGMP operation. For the best measurement results, the user can always perform 1-point standardization or a 2-point calibration using an off-line reference analyzer.

SmartReaders minimize drift and photo-degradation

TruFluor® pH and TruFluor® DO optical smart readers utilize a patented design that minimizes photo-degradation of the active sensing element. The design has been optimized to provide accurate in-situ measurement of pH and dissolved oxygen using phase fluorometric detection in real-time. The temperature measurement leverages a 316L stainless steel thermal window embedded in the sheath, and provides accurate results that can also be used as a process variable.

TruFluor® DO sensors are based on oxygen quenching of fluorescence, whereas TruFluor® pH sensors are based on dual lifetime referencing. There is no detectable photo-induced drift in a 3-week period sampling at 2-second intervals for either of these sensors.

 

Transmitters: External or Blade


TruFluor® External Transmitter

The TruFluor® pH or DO external transmitter is a remote pipe or panel mounted instrument which is plug-and-play with any TruFluor® pH or DO reader. All external transmitters allow automatic entry of calibration and traceability data from the sheath SmartChip and provide diagnostic information. Output signals for pH, DO and temperature are all analog (4 to 20 mA).


TruFluor® Blade Transmitter

TruFluor® and TruTorr blades (or digital transmitters) are mounted in a Finesse bioreactor controller and do not have a display or keypad. All blades provide automatic input of calibration data from sheaths containing a SmartChip and provide detailed diagnostics to the bioreactor control system. The Virtual Transmitter module in Finesse TruBio® software allows full access to all of the blade’s functions, simulates a physical transmitter, and adds alarms and connectivity monitoring capability.

Smart Sensor Loop Validation

Trufluor Ph Validator

pH Loop Validator

TruFluor® pH validators are designed to test the overall function of a TruFluor sensor loop. The transmitter, the cable, and the reader are tested as a system to determine the efficacy and veracity of the optical phase measurements. The validator employs a stable light source to simulate an optical measurement of pH. This signal is detected by the TruFluor® reader and provides an equivalent pH value measured by the transmitter.

TruFluor® pH Single-Use Sensor

Environmental

Operating Temperature 4°C to 45°C / 39.2°F to 113°F
Operating Pressure (Typical) 1 bar / 14.7 psi
Storage Temperature 0°C to 60°C / 32°F to 140°F
Storage Relative Humidity 10% to 90% (non-condensing)
Altitude 12192 m / 40000 ft
Materials USP Class VI and 316L EP Stainless Steel

Performance

Sample Rate Settings 1 Second to 30 Minutes
Measuring Range 5.5 to 8.5 pH
Relative Accuracy ±0.05 pH over calibration range after a 2-point calibration using 0.3 to 0.8 pH units of separation
Accuracy @37.5°C: Depends on sampling method and off-line analyzer used for 1-point standardization
Response Time (T90. Agitated) < 60 seconds
Drift (21 days) <0.05 pH units for a standard process (5 second sampling rate)
Calibration Pre-calibrated (SmartChip) 2-point calibration required prior to operation. 1-point standardization available.
Gamma Radiation Standard range: 26 to 38 kGy (for radiation doses outside this range contact Finesse)
Cross Sensitivity IPA + water
Temperature Accuracy ±0.25°C between 4°C and 45°C
±0.15°C between 15°C and 40°C
Temperature Precision ±0.1°C

 

TruFluor pH Validator

Environmental

Operating Temperature 15°C to 35°C / 59°F to 95°F
Storage Temperature 0°C to 65°C / 32°F to 149°F 
Storage Relative Humidity 0% to 100% (non-condensing)
Altitude 12192 m / 40000 ft
Materials USP class VI and 316L EP stainless steel
Rating NEMA 4X

Performance

Sample Rate Settings Should be set at 1 second during the test
Measuring Range 5.5 to 8.5 pH
Measure of Reference 5.5, 6.5, 7.0, 7.5, 8.5
Accuracy (at 20 °C) ±0.25 pH (at pH = 5.5) ±0.15 pH (at pH = 6.5, 7.0, 7.5)
±0.35 pH (at pH = 8.5)
Calibration Pre-calibrated at factory by NIST-traceable method

 

External Transmitter

Physical Description

Case Material ABS
Rating NEMA 4X
Dimensions (w x h x d) 157 x 157 x 103 mm / 6.2 x 6.2 x 4.0 in
Mounting / Conduits Remote, panel or pipe mounted (kit included) Pg 13.5 conduit fittings accepted
Display 4 line, 20 character display Character height of 4.8 mm
Weight (Shipping Weight) 1 kg /1.5 kg (2 lb / 3 lb)

Specifications

Power Supply 24 VDC @ 150 mA
Signal Outputs (Isolated 4 to 20 mA) 1x pH / 1x temperature
Output Accuracy ±0.05 mA
Transmitter Diagnostics LED failure, 4 to 20 mA loop errors, or zeroing errors
Calibration Based on NIST traceable standards Entered automatically using SmartChip. 1- or 2-point calibration optional
RFI/EMI EN-61326
Operating Temperature 4°C to 45°C / 39°F to 113°F
Storage Temperature -20°C to 70°C / -4°F to 158°F
Relative Humidity 10% to 90% (non-condensing)

 

TruFluor® pH Blade Transmitter

Physical Description

Case Material Aluminum bracket
Rating NEMA 1 (when mounted has same rating as enclosure)
Dimensions (H x W x D) 130 x 35 x 128 mm / 5.1 x 1.4 x 5 in
Mounting Mounted within utility tower (controller enclosure)
Display Virtual transmitter in TruBio® software (GAMP5)
Weight
(Shipping Weight)
0.2kg / 0.4lb
(0.4kg / 0.8lb)

Specifications

Power Supply 24 VDC @ 150 mA
Signal Outputs Digital / 1x pH / 1x temperature
Output Accuracy N/A
Transmitter Diagnostics LED failure, 4 to 20 mA loop errors, or zeroing errors.
  Reported directly in Finesse TruBio® control software
Calibration Based on NIST-traceable standards. Entered automatically using SmartChip. Optional 1-point standardization or 2-point calibration. Can be read into TruBio® Software with file transfer or memory stick.
RFI/EMI EN-61326
Operating Temperature 5°C to 45°C / 41°F to 113°F
Storage Temperature 0°C to 65°C / 32°F to 149°F
Relative Humidity 10% – 90% (non-condensing)

TrupH

Sterilizable sensors for superior performance