Manufacturers of topical ointments, gels and lotions for BioPharma and personal care products face several critical product quality challenges in their mixing processes. The better you understand the nature of these challenges, the better you will be able to design processing equipment to optimize your quality and productivity.
Topically-applied products are among the highest viscosity manufactured products; viscosities can range from water-like to more than 1,000,000 cps. Mixing systems for these products must have sufficient power to move thick, heavy batch ingredients for consistent blending. Robust, heavy-duty design and construction of the drive system, mixing components and vessel are a must, to produce this mixing power and ensure long service life, especially in high-volume processing conditions.
In addition to powerful mixing action to move the batch throughout the vessel or mixing system, high-viscosity BioPharma and personal care products require heavy-duty, counter-rotating agitation to adequately blend batch ingredients. As viscosities approach and exceed 10,000 cps, the mixing action of a conventional high-shear mixer becomes confined to a localized agitation near the high-shear mixer. This can mean little or no mixing action occurs throughout the rest of the vessel.
All pharmaceutical ointments, gels or lotions require precise distribution of their active ingredients throughout the batch. This ensures every single product package contains the exact same percentage of the active ingredients. Achieving this consistent ingredient dispersion also requires trouble-free introduction of individual ingredients and elimination of air bubbles during batch mixing and processing, both of which are best accomplished under vacuum in the vessel.
BioPharma and personal care product manufacturers may initially consider several types of mixing systems for processing high-viscosity topical products:
For high-viscosity products, however, this design is inefficient. Due to the limited amount of mixing bars on this style of agitation, the mixing action is reduced, which can increase mixing time and potentially leave pockets of unmixed ingredients at the bottom of the vessel.
The disadvantages of each of these mixing options—the inefficiency of conventional dual-mixing vessels and multiple mixing vessels, and the high cost of bottom-shear recirculating systems—are a challenge to process engineers seeking the most efficient and cost-effective mixing solution for their high-viscosity BioPharma or personal care products.
The Lee Industries Tri-Mix™ Turbo-Shear™ mixing system integrates robust scrape surface agitation with a unique, proprietary high-shear mixing unit to blend miscible and non-miscible ingredients commonly used in BioPharma and personal care products. It is built to handle viscosities as high as 2,000,000 cps and particle sizes as small as two microns. Through its unique design, the Tri-Mix™ system overcomes the drawbacks of conventional dual-head mixing systems and multiple vessel processing. It is also significantly less expensive than more complex bottom-shear recirculating mixing systems. The Tri-Mix™ system is available in many customized configurations to meet a wide variety of product and process requirements for high-viscosity BioPharma and personal care products.
Designing a processing system to handle high-viscosity BioPharma products can be a demanding process, and there are many factors to consider. To learn more about how Lee Indusries can help you meet these challenges, download the Guide to BioPharma Process Engineering Services: Vessel and Tank Design for Demanding BioPharma Processing Applications.
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MAIA Biotechnology last week became the first biotech company to price an IPO since late May, and the fifth cancer drug developer to do so this year.
A prolonged market downturn has halted a yearslong run of momentum for startup drug companies and their backers. Despite the pullback, many still view the industry's foundations as strong.
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Topics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more.