impulse Mixing Study Summary

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1 impulse Mixing Study Summary Single-use mixing performance: rapid preparation of media powders in low- and high-viscosity solutions

2 Contents Overview 2 Materials and equipment 3 Test methods and results 4 Conclusion 7 Overview Background Thermo Fisher Scientific contracted with Foster Wheeler Biokinetics, an industry leader in the full-service engineering, design, construction, and validation of biopharmaceutical facilities worldwide, to perform mixing studies on the Thermo Scientific impulse Single-Use Mixer (S.U.M.). The impulse S.U.M. uses irradiated disposable Class VI compliant process contact surfaces; each mixing BioProcess Container (BPC) contains a patented bottom-mounted mixing device. The product is available in volumes from 30 5,000 L. The mixing device is an integrated part of the BPC and its shape is engineered with multiple slots and film flaps. The flaps open and close as the mixing device moves up and down within the mixing BPC. On the downstroke, the flaps close and energy is directed toward the bottom of the mixing BPC and up the sidewalls. On the upstroke, the flaps open, allowing the fluid to flow through the slots, thus producing one-way flow and very effective mixing. Introduction This study presents the overall mixing performances of the impulse S.U.M. for large-scale preparation of media. The sizes selected for this study are 250 L (jacketed), 750 L, and 1,500 L. This range of sizes represents the impulse system s mixing performance in small, medium, and large vessels. This summary has been developed from evaluation tests that were performed in the Millersburg, Pennsylvania testing center on July 18, The following tests were performed: Dissolving of phosphate-buffered saline (PBS) in water PBS is a common buffer salt, which settles to the bottom of liquids Dissolving of sodium chloride in a corn syrup/water solution two different concentrations were used to simulate medium- and high-viscosity liquids Mixing bovine serum albumin a media powder that floats on the surface, and can be difficult to hydrate with water Temperature mapping in a jacketed impulse S.U.M. mixing water Calibrated instruments were used and the measuring parameters were recorded over time. 2

Materials and equipment Standard single-use mixing BPC for impulse system Sizes: 250 L, 750 L, 1,500 L impulse mixing system equipment Sizes: 250 L, 750 L, 1,500 L Mixing devices 250 L: 12 in.

3 Materials and equipment Standard single-use mixing BPC for impulse system Sizes: 250 L, 750 L, 1,500 L impulse mixing system equipment Sizes: 250 L, 750 L, 1,500 L Mixing devices 250 L: 12 in. diameter and 8 in. stroke 750 L: 17 in. diameter and 8 in. stroke 1,500 L: 21 in. diameter and 8 in. stroke Instruments, meters, and testers used in this study ph: Oakton, multiparameter PCSTestr 35 Conductivity: YSI Pro Plus, with cable and conductivity probe Optical density: Ocean Optics USB4000 Spectrometer, serial number usb4a00240 Temperature recorder: Monarch Instruments DataChart 6000 Viscometer: Cannon-Fenske Routine Viscometer, cst range Chemical supplies used in this study Sodium chloride Potassium chloride Sodium phosphate monobasic Potassium phosphate monobasic Bovine serum albumin Corn syrup Upstroke Downstroke 3

4 Test methods Mixing of PBS in water (low viscosity) The objective of this test was to measure the time required to mix common buffer salts in a low-viscosity solution (water) using the impulse S.U.M. PBS, a common buffer salt that sinks to the bottom of vessel, was used as the test ingredient. Tests were performed on the 250 L, 750 L, and 1,500 L vessels. 250 L mixer conductivity with time After 2 minutes of mixing, the conductivity measurements the 250 L of water within 2 minutes. 750 L mixer conductivity with time After 1.5 minutes of mixing, the conductivity measurements the 750 L of water within 1.5 minutes. 1,500 L mixer conductivity with time After 30 seconds of mixing, the conductivity measurements the 1,500 L of water within 30 seconds. 4

5 Test methods Mixing of sodium chloride in corn syrup/water (medium and high viscosity) The objective of this test was to measure the time required to mix a common buffer salt in medium- and high-viscosity solutions (corn syrup/water) using the impulse S.U.M. Tests were performed on the 250 L S.U.M. with sodium chloride as the test ingredient. Medium- and high-viscosity solutions were achieved by mixing corn syrup with water: 75% by volume corn syrup presents a medium-viscosity solution, while an 82% by volume concentration is considered a high-viscosity solution. Medium viscosity Initial temperature: 25.5 o C Viscosity as measured: cst Density of mixer contents was determined by weighing 50 ml of the corn syrup solution Weight of syringe with 50 ml of corn syrup: g Density: g/50 ml or g/ml Viscosity of solution in cp (density x cst): 170 cp After 4.5 minutes of mixing, the conductivity measurements the 250 L of 170 cp corn syrup solution within 4.5 minutes. High viscosity Initial temperature: 28.4 o C Viscosity as measured: 587 cst Density of mixer contents was determined by weighing 50 ml of the corn syrup solution Weight of syringe with 50 ml of corn syrup: 67.2 g Density: 67.2 g/50 ml or g/ml Viscosity of solution in cp (density x cst): 790 cp After 20 minutes of mixing, the conductivity continued to increase with time at a rate of about 1% per minute. The test was concluded after 41 minutes of mixing. 5

6 Test methods Test methods Mixing of media powder in water The objective of this test was to measure the time required to mix media powders in water using the 250 L impulse S.U.M. Bovine serum albumin (BSA) was used to simulate media powder components resembling amino acids and supplements. BSA is a hydroscopic powder that lies on top of water until dissolved. BSA dissolution progress was measured using optical density measurements at 280 nm (OD 280 ), and recorded with time. Temperature mapping (water) The objective of this test was to measure the temperature uniformity within the mixing BPC of the impulse S.U.M. Tests were performed on the 250 L S.U.M. with water as the test ingredient. Four thermocouples equally spaced vertically in the bag recorded the temperature of the process fluid over time during heat-up and cool-down cycles. After 4 minutes of mixing, the optical density measurements These results indicate that the powder was dissolved in 250 L of water within 4 minutes. Heating cycle Analysis of heating thermocouple data indicated that all data were well within success criteria of +/- 1 o C variation Heating cycle Variance Time (min) Cooling cycle Analysis of cooling thermocouple data indicated that all data were well within success criteria of +/- 1 o C variation Cooling cycle Variance Time (min) 6

7 Conclusion The results of the study indicate that the impulse's unique mixing device mixes powders and solutions efficiently in small, medium, and large vessels. Buffer salts are dissolved in water in less than 4 minutes. Buffer salts dissolve in a medium-viscosity solution within 5 minutes. The mixing system proved to be effective at mixing buffer salts in high-viscosity solutions close to 1,000 cp. The results indicated that after 20 minutes of mixing, the conductivity of the solution changed by 1% every minute, eventually reaching maximum conductivity after 41 minutes. Media powders, which tend to float and resist hydration, were dissolved within 4 minutes. The vessel jacket designs of the impulse S.U.M. proved effective at maintaining temperature uniformity throughout the process fluid during heat-up and cool-down cycles. Find out more at thermofisher.com/sut 2016 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. COL

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