Single-Use Sensors. Excellence in bioprocessing measurement. Data File #F808-DST-001-Rev2

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1 Data File #F808-DST-001-Rev2 Single-Use Sensors Excellence in bioprocessing measurement Secure Measure Acquire Reinforce Trust Minimize contamination, maximize single-use container integrity Obtain real-time ph, DO, temperature, and headspace pressure Collect drift-free data from pre-calibrated sheaths Meet cgmp regulations with lot traceability and loop validators Rely on USP Class VI / traceable and certified wetted materials

2 Single-Use Sensor Solutions Finesse has designed an innovative range of single-use sensors to measure the four fundamental process parameters: ph, dissolved oxygen, temperature, and headspace pressure. The sensor sheaths are sealed into an insertion port and sterilized in place, 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 control system, our single-use sensors provide accurate measurements that enable the creation of an optimal cell culture environment TruTorr Headspace Pressure Sensor The TruTorr pressure sensor is a single-use solution for measuring headspace pressure and preventing rupture of a bioprocess 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 Sensors 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).

3 Single-Use Sensor Solutions SmartPuck ph+do2 Sensor SmartPuck sensors leverage the technology behind TruFluor ph and DO sensors in a compact pre-calibrated assembly that uses a Finesse SmartChip to provide accurate, drift-free measurements. The SmartPuck also incorporates the TruFluor temperature 316L stainless steel thermal window for highly accurate readings. These process variables are monitored through a Finesse G3 Controller to create the best possible cell culture environment. Such closed loop feedback control allows the cell growth process to be optimized for cell density, viability, productivity, and reproducibility. 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 be used as a process value. TruFluor DO sensors are based on oxygen quenching of fluorescence, whereas TruFluor ph sensors are based on dual lifetime referencing. The ph+do 2 SmartPuck combines all 3 sensors in one unique unit with the same features as the individual readers. Minimize Contamination Risk Integrity Finesse single-use sensor sheaths are designed to be pre-inserted in disposable bioreactor bag ports and irradiated with the bag in order to preserve the sterile barrier. SmartPuck sensors are welded securely into Finesse single-use SmartBag or SmartVessel bioprocess containers. Leachables and Extractables All wetted materials in these sensors are USP Class VI compliant and ACDF, and gamma-radiation safe to 50 kgy. The results are available from Finesse for auditing purposes. Certificates are also available for all wetted materials.

4 Single-Use Sensor Solutions External Transmitters 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 SmartChip and provide diagnostic information. Output signals for ph, DO and temperature are all analog (4 to 20 ma). External Transmitter Blade Transmitters TruFluor and TruTorr digital transmitter blades are rail mounted in a Finesse bioreactor controller. All blades provide automatic input of calibration data from the SmartChip and provide diagnostic information 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 provides alarms and connectivity monitoring capability. Blade Transmitters SmartSensor Loop Validation TruFluor ph and TruFluor 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 independently. 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 reader and results in an equivalent ph or DO value measured by the transmitter. ph Validator DO Validator Smart Calibration SmartChips All Finesse single-use Sensors 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 when 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.

5 Single-Use Sensors TruFluor ph+do2 ENVIRONMENTAL SPECIFICATIONS SmartSensors Single-Use TruTorr TruFluor ph TruFluor DO Operating Temperature 15 C to 45 C (59 F to 113 F) 4 C to 45 C (39.2 F to 113 F) Operating Pressure (Typical) Storage Temperature Storage Relative Humidity Altitude 1 bar / 14.7 psi 0 C to 60 C (32 F to 140 F) 10% to 90% (non-condensing) m (40000 ft) Materials USP Class VI USP Class VI and 316L EP Stainless Steel PERFORMANCE SPECIFICATIONS 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% 0 2 / 0 to 250% air-sat Limit of Detection 0.7 mbarg / 0.01 psig 0.03% 0 2 Relative Accuracy C: ±0.014 barg / ±0.2 psig or ±2% of the reading, whichever is greater (inc. drift 21 days) ±0.05 ph over calibration range after a 2-point calibration using 0.3 to 0.8 ph units of C: depends on sampling method and off-line analyzer used for 1-point C: ±<1% at 20.95% 0 2 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) 1-point standardization optional Pre-calibrated (SmartChip) 2-point calibration required prior to operation, 1-point standardization available Pre-calibrated (SmartChip) 1-point standardization or 2-point calibration optional Gamma Radiation Standard range: 26 to 38 kgy (for radiation doses outside of this range contact Finesse directly) Cross Sensitivity None IPA + Water Organic solvents (e.g. Toluene, Acetone, Benzene, Methylene Chloride), Sulfur Dioxide and Chlorine Gases Temperature Accuracy Temperature Precision Automatic compensation over operating range ±0.25 C between 4 C and 45 C; ±0.15 C between 15 C and 40 C ±0.1 C

6 External Transmitter TruFluor ph+do2 SPECIFICATIONS TruFluor ph TruFluor DO Power Supply Signal Outputs (Isolated / 4 to 20 ma) Output Accuracy ma 1x ph / 1x Temperature ±0.05 ma 1x DO / 1x Temperature Transmitter Diagnostics Calibration RFI/EMI Operating Temperature Storage Temperature Relative Humidity LED failure, 4 to 20 ma loop errors, or zeroing errors Based on NIST-traceable standards, entered automatically using SmartChip, Optional 1- or 2-point calibration EN C to 45 C (39 F to 113 F) -20 C to 70 C (-4 F to 158 F) 10% to 90% (non-condensing) PHYSICAL DESCRIPTION Case Material Rating Dimensions (H x W x D) Mounting / Conduits Display Weight / Shipping Weight ABS NEMA 4X 157 x 157 x 103 mm (6.2 x 6.2 x 4.0 in) 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 / 1.5 kg (2 lb / 3 lb) Warranty: Each TruFluor Transmitter is warranted for one full year (12 months) from date of shipment against defects in material and workmanship.

7 Blade Transmitter SPECIFICATIONS TruTorr TruFluor ph+do2 TruFluor ph TruFluor DO Power Supply ma Signal Outputs Isolated / 4 to 20 ma / 1x Pressure Digital / 1x ph / 1x Temperature Digital / 1x DO / 1x Temperature Output Accuracy ±0.1 ma N/A Transmitter Diagnostics Calibration RFI/EMI Operating Temperature Storage Temperature Relative Humidity Internal diagnostics for sensor and loop Based on NIST-traceable standards, entered automatically using SmartChip, optional 1-point standardization EN C to 45 C (41 F to 113 F) 0 C to 65 C (32 F to 149 F) 10% to 90% (non-condensing) LED failure, 4 to 20 ma loop errors, or zeroing errors; Reported directly in Finesse TruBio control software Based on NIST-traceable standards, entered automatically using SmartChip, optional 1-point standardization or 2-point calibration; Can be read into TruBio with file transfer or memory stick PHYSICAL DESCRIPTION Case Material Aluminum Bracket Rating Dimensions (H x W x D) Mounting Display NEMA 1 (when mounted, same rating as enclosure) 130 x 35 x 128 mm (5.1 x 1.4 x 5 in) Mounted within utility tower (enclosure) Virtual transmitter in TruBio software (GAMP5) Weight / Shipping Weight 0.1 kg / 0.3 kg (0.2 lb / 0.6 lb) 0.2 kg / 0.4 kg (0.4 lb / 0.8 lb) Warranty: Each TruFluor Transmitter is warranted for one full year (12 months) from date of shipment against defects in material and workmanship. Blade transmitters are only sold to approved OEM customers or as spare parts for Finesse control systems.

8 Validator ENVIRONMENTAL SPECIFICATIONS TruFluor ph TruFluor DO Operating Temperature Storage Temperature Storage Relative Humidity Altitude Materials 15 C to 35 C (59 F to 95 F) 0 C to 65 C (32 F to 149 F) 0% to 100% (non-condensing) m (40000 ft) USP Class VI and 316L EP Stainless Steel Finesse Solutions, Inc. Global Headquarters 3501 Leonard Court Santa Clara, CA USA Toll free Tel Fax sales@finesse.com Rating NEMA 4X PERFORMANCE SPECIFICATIONS Sample Rate Settings TruFluor ph Should be set at 1 second during the test TruFluor DO 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) ±0.15 ph (at ph = 6.5, 7.0, 7.5) ±0.35 ph (at ph = 8.5) ±1% Sat for all DO settings Europe Via Sogn Gieri 27a CH-7402 Bonaduz, Switzerland Benelux, Ireland & Scandinavia Van Slingelandtlaan JJ Zwijndrecht The Netherlands Calibration Pre-calibrated at factory by NIST-traceable method Asia-Pacific 3A Intl Business Park, #07-08 ICON@IBP Tower A Singapore Shanghai Every effort has been made to ensure the accuracy of the information in this document. However, Finesse reserves the right to change its products without notice. The following are Finesse Solutions, Inc. registered trademarks: TruView, TruBio, TruBio DV, TruBio µc, SmartOPC, TruService, TruTorr, TruFluor, TruLogic, TruConnect, TruMigrations, TruCables, TruHousings, SmartGlass, SmartRocker, TruDO, TrupH, SmartFactory, SmartChip, SmartSystems, SmartBag, SmartPuck, SmartReader, SmartBag Reader, SmartTray, SmartController, SmartSensor , Finesse Solutions, Inc. All other trademarks are the property of their respective owners.