Genetic Engineering & Biotechnology News

SEP15 2017

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

Issue link: http://gen.epubxp.com/i/869753

Contents of this Issue

Navigation

Page 68 of 77

GENengnews.com | SEPTEMBER 15, 2017 | 31 remain accurate throughout the lifetime of the operations. Testing Single-Use Sensors To demonstrate the performance of SUT sensors over time, laboratory studies on single-use pressure and conductivity sensors were carried out to provide data showing that the sensors will maintain their accuracy in continuous biomanu- facturing operations. In a related study, the long-term stability and accuracy of a UV/Vis/near-infrared spectroscopy (NIR) photometer was determined. Twelve single-use pressure sensors from three different lots representing two different materials of construction (polycarbonate and polysulfone) were held with a regulated pressure at 10 psi for 93 days. Data were logged continu- ously to spot any anomalies, and daily readings were recorded. At the end of the 93 days, the pressure was removed, and the atmospheric value was noted. The 12 sensors were then retested from 0 to 60 psi with the National Institute of Standards and Technology (NIST)- traceable equipment without retaring to 0 psi. The data from the accuracy retest are shown in Table 1. The results show all 12 sensors are well within their stated accuracy specifications after 93 days of exposure to 10 psi, and they returned to near zero psi when exposed to atmo- spheric pressure. A 35-day static continuous laboratory test was carried out on single-use conduc- tivity sensors to provide data demonstrat- ing that the sensors will maintain their ac- curacy with long-term use. Commercially available NIST-traceable solutions of 2 mS and 15 mS were added to the flow paths of two sensors, and the ends were capped. Readings were taken daily over 35 days while the sensors remained at am- bient conditions. At the end of 35 days, the solutions were carefully transferred to new sensors and then measured Table 1. Pressure data from 12 sensors that were in continuous use for 93 days. The sensors were challenged with air through a NIST-traceable gauge and show excellent agreement with stated accuracy claims after the 93-day test period. NIST = National Institute of Standards and Technology. Table 2. Accuracy vs. NIST standards of a 280-nm UV photometer after being in continuous service for 93 days. CO N T I N U O U S B I O P R O C E S S I N G ➜ Dennis C. Annarelli, Ph.D., is a technical manager and Joshua Huang is a product test engineer at PendoTECH, Princeton, NJ. website: www.pendotech.com Table 2. Test Duration: 10/25/2016–1/26/2017 280 nm Standard UV (AU) 0.46 AU Standard 0.45 1.01 AU Standard 0.99 1.51 AU Standard 1.50 >2.00 AU Standard 2.03 Table 1. * = Polysulfone All others = PC Test Duration: 10/25/2016–1/26/2017 Sensor ID Applied Pressure (psi) Sensor Performance 0 5 10 20 30 40 50 60 1152607-05 -0.03 4.99 10.10 20.17 30.09 40.29 50.58 61.09 Pass 1152607-06 -0.04 4.97 10.05 20.19 30.09 40.56 51.22 62.15 Pass 1152607-07 -0.04 4.95 10.08 20.22 30.21 40.85 51.78 62.99 Pass 1152607-08 -0.05 4.93 10.01 20.05 30.10 40.49 51.52 62.67 Pass 1161066-05* -0.02 4.99 10.07 20.20 30.15 40.48 51.29 62.17 Pass 1161066-06* -0.03 4.99 10.07 20.19 30.13 40.50 51.26 62.14 Pass 1161066-07* -0.02 4.99 10.13 20.19 30.28 40.72 51.33 62.32 Pass 1161066-08* -0.03 4.98 10.07 20.12 30.17 40.41 51.11 61.93 Pass 1151819-05 -0.01 4.98 10.03 20.12 30.17 40.46 51.26 62.14 Pass 1151819-06 -0.04 4.98 10.09 20.14 30.16 40.67 51.35 62.29 Pass 1151819-07 -0.03 5.00 10.10 20.16 30.18 40.72 51.44 62.52 Pass 1151819-08 -0.01 5.00 10.06 20.19 30.27 40.72 51.44 62.42 Pass Acceptance Criterion (±) 2% 3% 3% 3% 5% 5% 5% All within specifications 0.10 0.30 0.60 0.90 2.00 2.50 3.00 Pressure Accuracy Verification Photometer Accuracy Verification

Articles in this issue

Links on this page

Archives of this issue

view archives of Genetic Engineering & Biotechnology News - SEP15 2017