Data File #F808-DST-003-Rev1. TruFluor DO Single-Use Sensor

Transcription

1 Data File #F808-DST-003-Rev1 TruFluor DO Single-Use Sensor

2 TruFluor DO Single-Use Sensor TruFluor SmartSensors The TruFluor DO and temperature single-use sensor consists of a disposable sheath, an optical reader, and a transmitter. The sheath is sealed into an insertion port of a disposable bioreactor bag and sterilized in place, so that process sterility is guaranteed. TruFluor single-use sensors implement a patented optical design using only USP Class VI materials, are pre-calibrated and provide full traceability information using a gamma radiation resistant SmartChip. 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. Features Sheath, optical reader, and blade or external transmitter Minimal longterm drift Gamma radiation resistant SmartChip for self-calibration and lot traceability USP Class VI, gamma radiation resistant wetted materials Plug-and-play TruFluor DO SmartReader: Minimize drift and photo-degradation 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 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.

3 TruFluor DO Single-Use Sensor External Transmitter The TruFluor DO external transmitter is a remote pipe or panel mounted instrument which is plug-and-play with any TruFluor DO SmartReader. All external transmitters allow automatic entry of calibration and traceability data from the SmartChip and provide diagnostic information. Output signals for ph and temperature are all analog (4 to 20 ma). Blade Transmitters TruFluor DO 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. SmartSensor Loop Validation The TruFluor DO validator is designed to test the overall function of a TruFluor DO 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 dissolved oxygen. This signal is detected by the reader and results in an equivalent ph value measured by the transmitter. Smart Calibration SmartChip TruFluor DO 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.

4 TruFluor DO Sensor ENVIRONMENTAL SPECIFICATIONS Operating Temperature Operating Pressure (Typical) Storage Temperature Storage Relative Humidity Altitude Materials 4 C to 45 C (39.2 F to 113 F) 1 bar / 14.7 psi 0 C to 60 C (32 F to 140 F) 10% to 90% (non-condensing) m (40000 ft) USP Class VI and 316L EP Stainless Steel PERFORMANCE SPECIFICATIONS Sample Rate Settings Measuring Range 1 Second to 30 Minutes 0% to 52.5% 0 2 / 0 to 250% air-sat Limit of Detection 0.03% O 2 C: ±<1% at 20.95% O 2 Response Time (T90 Agitated) Calibration Gamma Radiation Cross Sensitivity <40 Seconds Pre-calibrated (SmartChip) 1-point standardization or 2-point calibration optional Standard range: 26 to 38 kgy (for radiation doses outside of this range contact Finesse directly) Organic solvents (e.g. Toluene, Acetone, Benzene, Methylene Chloride), Sulfur Dioxide and Chlorine Gases 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

5 TruFluor DO External Transmitter SPECIFICATIONS Power Supply Signal Outputs (Isolated / 4 20 ma) Output Accuracy Transmitter Diagnostics Calibration RFI/EMI Operating Temperature Storage Temperature Relative Humidity ma 1x DO / 1x Temperature ±0.05 ma 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.

6 TruFluor DO Blade Transmitter SPECIFICATIONS Power Supply Signal Outputs Output Accuracy Transmitter Diagnostics Calibration RFI/EMI Operating Temperature Storage Temperature Relative Humidity ma Digital / 1x DO / 1x Temperature N/A 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 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) PHYSICAL DESCRIPTION Case Material Rating Dimensions (H x W x D) Mounting Display Weight / Shipping Weight Aluminum Bracket 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) 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 sellable to approved OEM customers or as spare parts for Finesse control systems.

7 TruFluor DO Validator ENVIRONMENTAL SPECIFICATIONS Operating Temperature Storage Temperature Storage Relative Humidity Altitude Materials Rating 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 NEMA 4X PERFORMANCE Sample Rate Settings Measuring Range Should be set at 1 second during the test 0% to 100% Sat Measure of Reference 0, 25, 50, 75, 100 Accuracy (at 20 C) Calibration ±1% Sat for all DO settings Pre-calibrated at factory by NIST-traceable method

8 Finesse Solutions, Inc. Global Headquarters 3501 Leonard Court Santa Clara, CA USA Toll free Tel Fax Europe Via Sogn Gieri 27a CH-7402 Bonaduz, Switzerland Benelux, Ireland & Scandinavia Van Slingelandtlaan JJ Zwijndrecht The Netherlands 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.