Application Note USD 3054 Mixing of Aluminum Hydroxide Gel in Water with the PadMixer® System Mixing system: PadMixer 1000 system Mixing biocontainer: 500 L Mixer biocontainer Application mixing type: Liquid-liquid The PadMixer system is a scalable single-use mixing system. The heart of this mixer is an innovative top-mounted mixing paddle that allows effective and uniform mixing in demanding applications, such as preparation of contained high-solids solutions or mixing of high-viscosity liquids. Introduction Alhydrogel (aluminum hydroxide gel) is a common pharmaceutical adjuvant. However, maintaining it in a homogeneous aqueous suspension can be challenging because alhydrogel tends to settle over time. Once settled, the viscous alhydrogel lower layer can be difficult to remix. In this experiment, a PadMixer 1000 system was fitted with a 500 L mix biocontainer and used to prepare 500 L of a 1.4 g/L alhydrogel suspension. Several mixing parameters were evaluated to determine their impact on mixing efficacy. The objective was to obtain effective mixing with the lowest feasible paddle speed, thus minimizing the risk of foaming or shear-related product damage. Figure 1 Comparison of Top and Bottom Sampling Mixing of Alhydrogel 1.4 g/L in water in a 500 L biocontainer 600 Turbidity / NTU 500 30 RPM, 9º angle, 30 days sedimentation 30 RPM, 9º angle, 1 day sedimentation 400 300 200 100 0 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 Time / Minutes Experimental A 500 L biocontainer was filled with 432 L of DI water and 68 L of 10.3 mg/mL alhydrogel. Once mixed, this resulted in a suspension containing 700 g aluminum in 500 L (i.e. 1.4 g/L, or 0.14% w/v Al). The content of the biocontainer was allowed to settle for 24 hours to ensure sedimentation. Once settled, the content was agitated using the PadMixer 1000 system. During mixing, samples of the mixed liquid were taken at 15 second intervals and tested for homogeneity using a turbidity meter (Figure 1). A series of mixing tests were performed to evaluate the effect of various paddle speeds and paddle angle settings. After each mixing test, the liquid was allowed to settle for 24 hours before the next test was performed (Figure 2). Results Figures 1 and 2 show typical results for mixing under various conditions. In most cases, the alhydrogel was evenly dispersed within the first 60 seconds. Even with the gentlest mixing conditions (30 rpm paddle speed at 9° paddle angle), mixing was complete within 120 seconds. Figure 2 Effect of Mixing Speed and Mixing Angle Mixing of Alhydrogel 1.4 g/L in water in a 500 L biocontainer 600 Turbidity / NTU 500 30 RPM, 9º angle 40 RPM, 15º angle 70 RPM, 12.5º angle 70 RPM, 15º angle 90 RPM, 15° angle 400 300 200 100 0 0 1 2 3 Time / Minutes 4 5 Conclusions The paddle mixing action of the PadMixer 1000 system is capable of high mixing efficiency in viscous liquid-liquid applications, even when operated at its least vigorous, lowest-shear settings. Visit us on the Web at www.pall.com/mixing E-mail us at allegro@pall.com Corporate Headquarters Port Washington, NY, USA +1.800.717.7255 toll free (USA) +1.516.484.5400 phone biopharm@pall.com e-mail International Offices Pall Corporation has offices and plants throughout the world in locations such as: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands, New Zealand, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, the United Kingdom, the United States, and Venezuela. Distributors in all major industrial areas of the world. To locate the Pall office or distributor nearest you, visit www.pall.com/contact. European Headquarters Fribourg, Switzerland +41 (0)26 350 53 00 phone LifeSciences.EU@pall.com e-mail The information provided in this literature was reviewed for accuracy at the time of publication. Product data may be subject to change without notice. For current information consult your local Pall distributor or contact Pall directly. Asia-Pacific Headquarters Singapore +65 6389 6500 phone sgcustomerservice@pall.com e-mail © 2015, Pall Corporation. Pall and are trademarks of Pall Corporation. ® indicates a trademark registered in the USA and TM indicates a common law trademark. Filtration.Separation.Solution. is a service mark of Pall Corporation. 7/15, PDF, GN15.6231 USD3054