Single-Use Sensors. TruFluor and TruTorr Excellence in bio-processing measurement

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1 Data File #808-DST-001-Rev1 Single-Use Sensors TruFluor and TruTorr Excellence in bio-processing measurement Secure Minimize contamination, maximize single-use container integrity Measure Obtain real-time ph, DO, temperature, and headspace pressure Acquire Collect drift-free data from pre-calibrated sheaths Reinforce Meet cgmp regulations with lot traceability and loop validators Trust Rely on USP Class VI / gamma radiation resistant wetted materials

2 Single-use Sensor Solutions Finesse has designed an innovative range of single-use sensors specifically to optimize cell growth in single-use bioreactors. TruFluor and TruTorr sensors measure the four fundamental process parameters: ph, dissolved oxygen, temperature, and headspace pressure. Finesse sensors seal reliably into an insertion port, so that process sterility is guaranteed. Finesse single-use sensors implement a patented optical design using only USP Class VI materials to optimize performance while maximizing reliability. All sensors are pre-calibrated and provide full traceability information using a gamma radiation resistant SmartChip. Whether a retrofit to a 3rd party controller or an integral component of a Finesse G3 system, Finesse single-use sensors provide accurate measurements that enable the controller to create a perfect cell culture environment. TruTorr Pressure Sensor TruFluor ph SmartReader TruFluor DO SmartReader TruFluor Sheath TruTorr: High accuracy single-use headspace pressure sensor The TruTorr pressure sensor is a single-use solution for measuring headspace pressure and preventing rupture of a bio-process container. A TruTorr loop consists of a disposable pressure sensor, a cable, and a transmitter blade that is seamlessly integrated into a Finesse bioreactor controller. TruFluor ph and TruFluor DO: Accurate and reliable sensors for better process control TruFluor ph and TruFluor DO single-use measurement solutions consist of an optical probe with an embedded temperature sensor. A TruFluor loop consists of a disposable sheath, an optical reader, a cable, and a transmitter (blade or external). 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 316 L 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.

3 Minimize contamination risk Integrity Our single-use sensors can be pre-inserted in disposable bioreactor bag ports and irradiated with the bag in order to both preserve and guarantee the sterile barrier. Leachables and Extractables All Finesse single-use sensor materials have undergone USP Class VI and gamma radiation (up to 50 kgy) testing. The results are available at Finesse for auditing purposes. Certificates are also available for all wetted materials. Transmitters: External or Blade 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 diagnostics. Output signals for ph, DO and temperature are all analog (4 to 20 ma). External Transmitter TruFluor and TruTorr blades (or digital transmitters) are rail 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. Blade Transmitters ph Validator DO Validator Smart Sensor Loop Validation TruFluor ph and DO 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 temperature sensor is validated individually. The validator employs a stable light source to simulate the fluorescence emission of an optical measurement of ph and DO. This signal is detected by the TruFluor reader and results in an equivalent ph or DO value measured by the transmitter. 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.

4 Single Use Sensor Specifications TruTorr TruFluor ph TruFluor DO ENVIRONMENTAL Operating Temperature 15 to 45 C / 59 to 113º F 4 to 45 C / 39.2 to 113 F Operating Pressure (Typical) Storage Temperature Storage Relative Humidity Altitude 1 bar / 14.7 psi 0 to 60 C / 32 to 140 F 10 to 90% (non-condensing) m / ft Materials USP Class VI USP Class VI and 316 L EP Stainless Steel PERFORMANCE Sample Rate Settings 1 Second 1 Second to 30 Minutes Measuring Range 0 to 0.48 barg / 0 to 7 psig 5.5 to 8.5 ph 0 to 52.5% O2 / 0 to 250% air-sat Limit of Detection 0.7 mbarg / 0.01 psig 0.03% O2 Relative Accuracy ±0.05 ph over calibration range after a 2-point calibration have 0.3 to 0.8 ph units of separation C: ±0.014 barg / ±0.2 C: Depends on C: < ±1% at 20.95% O2 or ±2% of the reading, whichever is greater (inc. drift 21 days) method and off-line analyzer used for 1-point standardization Response Time (T90. Agitated) < 1 second < 60 seconds < 40 seconds Drift (21 days) 13.6 mbarg / 0.2 psig <0.05 ph units for a standard process (5 second sampling rate) Calibration Pre-calibrated (SmartChip) Pre-calibrated (SmartChip) Pre-calibrated (SmartChip) 1-point standardization optional 2-point calibration required 1-point standardization prior to operation. 1-point standardization available. or 2-point calibration optional Gamma Radiation kgy is the standard range. For radiation doses outside of this range, please contact Finesse directly. Cross Sensitivity None IPA + water Organic solvents (e.g. toluene, acetone, benzene, methylene chloride), sulfur dioxide and chlorine gases. Temperature Automatic compensation ±0.25 From 4 to 45 C Accuracy over operating range ±0.15 From 15 to 40 C Temperature Precision ±0.1 C

5 Validator Specifications TruFluor ph ENVIRONMENTAL Single-Use Sensors TruFluor DO Operating Temperature Storage Temperature Storage Relative Humidity Altitude Materials Rating 15 to 35 C / 59 to 95 F 0 to 65 C / 32 to 149 F Typical 22 C / 71.6 F 0 to 100% (non-condensing) m / ft USP class VI and 316 L EP stainless steel NEMA 4X PERFORMANCE Sample Rate Settings Should be set at 1 second during the test Measuring Range 5.5 to 8.5 ph 0 to 100% Sat Measure of Reference 5.5, 6.5, 7.0, 7.5, 8.5 0, 25, 50, 75, 100 Accuracy (at 20 C) ±0.25 ph (at ph = 5.5) ± 1% Sat for all DO settings ±0.15 ph (at ph = 6.5, 7.0, 7.5) ±0.35 ph (at ph = 8.5) Calibration Pre-calibrated at factory NIST traceable method

6 External Transmitter Specifications TruFluor ph TruFluor DO PHYSICAL DESCRIPTION Case Material Rating ABS NEMA 4X Dimensions (w x h x d) 157 x 157 x 103 mm / 6.2" x 6.2" x 4.0" Mounting / Conduits Display Weight (Shipping Weight) Remote, panel or pipe mounted (kit included) Pg 13.5 conduit fittings accepted 4 line, 20 character display Character height of 4.8 mm 1 kg / 2lb (1.5 kg / 3 lb) SPECIFICATIONS Power Supply ma Signal Outputs 1x ph 1x DO (Isolated 4 to 20 ma) 1x temperauture 1x temperauture Output Accuracy Transmitter Diagnostics Calibration RFI/EMI Operating Temperature Storage Temperature Relative Humidity +/-0.05 ma LED failure, 4 20 ma loop errors, or zeroing errors Based on NIST traceable standards Entered automatically using SmartChip 1 or 2-point calibration optional EN to 45 C / 39 to 113 F -20 to 70 C / -4 to 158 F 10 to 90% (non-condensing)

7 Blade Transmitter Specifications TruTorr TruFluor ph TruFluor DO PHYSICAL DESCRIPTION Case Material Rating Aluminum bracket NEMA 1 (when mounted has same rating as enclosure) Dimensions (w x h x d) 35 x 130 x 128 mm / 1.4' x 5.1' x 5' Mounting Display Rack DIN Virtual transmitter in TruBio software (GAMP5) Weight (Shipping Weight) 0.1kg / 0.2lb (0.3kg / 0.6lb) 0.2kg / 0.4lb (0.4kg / 0.8lb) SPECIFICATIONS Power Supply ma Signal Outputs Isolated, 4-20 ma, 1x pressure Digital, 1x ph, 1x temperature Digital, 1x DO, 1x temperature Output Accuracy ± 0.1 ma N/A N/A Transmitter Diagnostics Internal diagnostics for LED failure, 4 20 ma loop errors, or zeroing errors. sensor and loop Reported directly in Finesse TruBio control software Calibration RFI/EMI Operating Temperature Storage Temperature Relative Humidity Based on NIST traceable standards. Entered automatically using SmartChip Optional 1-point standardization Optional 1-point standardization or 2-point calibration. Can be read into TruBio with file transfer or memory stick EN to 45 C / 41 to 113 F 0 to 65 C / 32 to 149 F 10 90% (non-condensing) Blade transmitters are only sellable to approved OEM customers or as spare parts for Finesse control systems.

8 For ordering information, please contact a Finesse sales representative. Toll free Tel Fax sales@finesse.com Finesse Solutions, Inc. Global Headquarters 3501 Leonard Court Santa Clara, CA USA Europe Via Sogn Gieri 27a CH-7402 Bonaduz, Switzerland Asia-Pacific 3A Intl Business Park, #07-08 ICON@IBP Tower A Singapore Warranty: Each TruFluor Transmitter is warranted for one full year (12 months) from date of shipment against defects in material and workmanship. Finesse Solutions, Inc., 2013