Manufacturers of topical ointments, gels and lotions used in biopharmaceuticals and personal care products face several key product quality challenges during their mixing process. The more you understand the nature of these challenges, the better you can design processing equipment to optimize your quality and productivity.
Topical products are one of the most viscous manufactured products; the viscosity can range from similar to water to more than 1,000,000 cps. The mixing system for these products must have enough power to move heavy batches of ingredients to achieve consistent mixing. Robust design and construction of drive systems, mixing components, and containers are necessary to generate this mixing capability and ensure a long service life, especially under high-volume processing conditions.
In addition to the powerful mixing effect of moving batches throughout the container or mixing system, high-viscosity biopharmaceutical and personal care products also require heavy-duty, counter-rotating agitation to thoroughly mix batch ingredients. When the viscosity approaches and exceeds 10,000 cps, the mixing effect of the traditional high-shear mixer becomes limited to local agitation near the high-shear mixer. This may mean that little or no mixing occurs in the rest of the container.
All ointments, gels or lotions require precise distribution of their active ingredients throughout the batch. This ensures that each product package contains the exact same percentage of active ingredients. Achieving this consistent ingredient dispersion also requires trouble-free introduction of individual ingredients and elimination of bubbles during batch mixing and processing, both of which are best done under vacuum in the container.
Manufacturers of biopharmaceuticals and personal care products may initially consider several types of mixing systems to process high-viscosity topical products:
However, for high-viscosity products, this design is inefficient. Due to the limited number of mixing rods in this mixing method, the mixing effect is weakened, which will increase the mixing time and may leave a bag of unmixed ingredients at the bottom of the container.
The disadvantages of each of these mixing options—the inefficiency of traditional dual mixing vessels and multiple mixing vessels, and the high cost of the bottom shear recirculation system—for the search for the most effective and cost-effective mixing solution It is a challenge for process engineers. Their high-viscosity biopharmaceutical or personal care products.
The Lee Industries Tri-Mix™ Turbo-Shear™ mixing system combines powerful scraping agitation with a unique proprietary high-shear mixing device to mix miscible and immiscible ingredients commonly used in biopharmaceutical and personal care products . It is specifically designed to handle viscosity up to 2,000,000 cps and particle size as small as 2 microns. Through its unique design, the Tri-Mix™ system overcomes the shortcomings of the traditional double-head mixing system and multi-container processing. It is also much cheaper than the more complex bottom shear recirculation mixing system. The Tri-Mix™ system can provide a variety of customized configurations to meet various product and process requirements for high-viscosity biopharmaceutical and personal care products.
Designing a processing system for high-viscosity biopharmaceutical products can be a demanding process, and many factors need to be considered. To learn more about how Lee Indusries can help you meet these challenges, download the Biopharmaceutical Process Engineering Service Guide: Vessel and Tank Design for Demanding Biopharmaceutical Process Applications.
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Topics covered: pharmaceuticals, biotechnology, FDA, gene therapy, clinical trials, drug pricing, etc.
Through high-risk litigation, active patent practices, and a little luck, Amgen may extend Enbrel's monopoly to 2029, which is more than 30 years after its approval.
Aduhelm's sales in the third quarter were only US$300,000, which was far below expectations due to its approval and doctors’ reluctance to prescribe.
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