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API mixing Equipment

Industrial mixing equipment is used to combine two or more solid, liquid or gaseous segregated ingredients into a homogenous single product. The choice of mixing technology depends largely on the physical state of the ingredients and the desired final product. But the sensitivity of the ingredients, the process temperature, and pressure requirements are also critical factors. All these parameters result in a wide range of industrial mixers.

Mixing

API making equipment must observe rigorous quality control standards across the entire manufacturing process. The pharmacodynamic properties of active pharmaceutical ingredients API make them highly sensitive to their environment, making API manufacturing and production a tightly regulated field.

Active pharmaceutical ingredients (API)

Reliable mixing and agitation are essential to any quality production process that involves a fluid. This need is even more acute in the production of pharmaceutical products where utmost precision and consistency are required. Experienced biopharmaceutical manufacturers know that equipment designed for general industry use often falls short of the tight quality and hygienic standards of our industry and that producers who embrace high quality pharmaceutical grade equipment will have an advantage over competitors.


<h2>Precise and powerful magnetically coupled agitation designed for superior hygiene and customized to your vessel and process needs</h2>
Mavag AG is a world leader in production of shaftless magnetic agitators for the pharmaceutical and biotechnology industries. The company's smaller scale and focus on their tradition of Swiss craftsmanship ensuring the impeccable product quality that customers need. The MavaDrive magnetic agitators are a series of agitators made by Mavag AG that use a magnetic coupling between the drive motor which is outside the process vessel and the agitator unit which is inside the containment vessel. The coupling is achieved using powerful permanent magnets attached to the agitator components on either side of the vessel wall. The magnets create a field that travels through the vessel wall and transmits mechanical power from the motor to the agitator without penetrating the wall. Thus removing a potential source of contamination and leakage due to the difficulty of sealing the containment vessel around a traditional rotating shaft. The units use high quality ceramic bearings in the agitator head to limit required maintenance. They are highly configurable with options available for top and bottom mounting to the containment vessel and in available torques from 0.5 to 250 Nm. Many agitator designs are available and Mavag AG can use specialized software and engineering to select the optimal agitator for your vessel and application.

Magnetic agitator

Manufacturers need production mixing equipment that is capable, flexible, and easy to maintain. Accurate mixing form a reliable, user friendly machine will give plant managers the peace of mind and worry free operation they need to focus on improving other areas of their process. A high quality piece of equipment allows for low maintenance, easy cleaning, enables the direct feed of solids and liquids, mixing and dispersing of the vessel contents, heating or cooling of the product, and processing under vacuum or under pressure.
<h2>A universal mixing system with precise, reproducible results and safe operation</h2>
The Master Plant homogenizing and emulsifying system from IKA was designed specifically to meet the production mixing needs of the pharmaceuticals industry but has also proven useful in the production of food, beverages, cosmetics, and chemicals.  Several mixing heads are interchangeable depending on the process and desired results.  Each mixing head can be heated or cooled to control product temperature simultaneous to the mixing process. Flexible PTFE scrapers move with the mixing head and keep product from adhering to the vessel walls. Products of up to 100.000 mPas viscosity can be processed.  The GMP homogenizing systems  can be fully discharged without the need for additional pumping and are available in capacities from 10 to 4.000 liters.

GMP homogenizing system

<span style="font-weight: 400;">For the efficient mixing of larger batches of pharmaceutical compounds and high-shear mixer provides the optimum results. A digital user interface and fully automated material entry and exit controls increase operational efficiency and ease of use.</span>
<h2>Larger batch mixing with high levels of automation and control</h2>
<span style="font-weight: 400;">The Sejong Pharmatech M Series is a production-scale high-shear mixer with advanced features. Available in a range of sizes to suit your exact requirements, it’s able to mix batches of up to 600 litres.</span>

<span style="font-weight: 400;">The M Series mixers features fully automatic openings and a specially designed outlet that allows for the complete discharge of the completed mixture.</span>

<span style="font-weight: 400;">Digital control touch panel allows for easy single-person operation and the machine has achieved full ATEX Mechanical Equipment certification.</span>

High-shear mixer

Manufacturing pharmaceutical solids like tablets requires using a proper blender to blend dry powders into a homogenous mixture. Having a blender that can accommodate various blending container sizes allows easy adjustment of the production volume.


<h3>Blending homogenously dry powder batches using a stationary blending device</h3>
The Container Blenders PM from Bohle is a blending system for fine solids and powders in pharmaceutical applications. The system features a wide variety of blending containers with various capacities that can handle square or round containers. Each blending container can be used to mix powders effectively at a range between 20% to 85% of its total container volume for densities ranging from 0.2 to 1.2 kg/L. The blending process is done in a closed system; each container has an inner lid for filling.

The blending system rotates at 6 rpm with an option to increase the speed depending on process requirements. It can be equipped with a chopper that operates at a speed of approximately 750 rpm to break solid lumps and chop small amounts of ingredients.

Product changeover can be done quickly by simply exchanging the blending container. The entire system can also be used as a milling station for bin-to-bin product transfer.

Container blender for pharmaceuticals

Multi-staged rotor/stator mixers generate the high shear forces required to disperse the finest micro-emulsions and suspensions. A rotor /stator dispersing machine that combines extremely fast rotation and resultant tip speeds creates even greater shearing action for super-fine dispersal during API and vaccine processing.


<h2>GMP rotor/stator dispersion with ultra-high shear for nano-scale particle emulsions and suspensions</h2>
The DISPAX-REACTOR DRS from IKA is a GMP ultra-high shear dispersing machine used to achieve the finest micro-emulsions and suspensions. Extremely high shear rates (up to 190.000 1/s) combined with a fine generator geometry enable the crushing of droplets and solids particles down to the nanoscale. The resulting product has long-term stability, which reduces the need for emulsifying agents and thickeners. Because of the extremely high energy density, other dispersing aids can be reduced or possibly eliminated.

The DRS is usually equipped with a two-stage rotor-stator system (generators). The high tip speed of 40 m/s (10.000 fpm) often negates the need for a third stage. The ultra-fine dispersing machine, designed with the same high quality features as the ULTRA-TURRAX UTL and the DISPAX-REACTOR DR, is especially well suited for challenging pharmaceutical-grade applications.  The units are designed for easy and reliable scalability, and sizes are available with flow rates from 70 to 40.000 liters per hour.

GMP dispersing machine for liquid formulations

Proper mixing and homogenization are essential to achieve a reliable, efficient, and fine-quality product with precisely defined active ingredient properties. However, these processes can prove to be challenging in the pharmaceutical industry.
<h2>Achieves perfect homogenization of APIs with three-dimensional mixing</h2>
TURBULA<span data-contrast="auto"><sup>®</sup></span>, a 3D shaker mixer from WAB-GROUP<span data-contrast="auto"><sup>®</sup></span>, is designed for uniformly mixing powdery substances with diverse particle sizes and specific weights. It excels in handling both wet and dry components, like powder inhalers or API.  Based on the Schatz geometric theory, its distinctive three-dimensional motion incorporates rotation, translation, and inversion. It facilitates a dynamic and harmonious mixing of the API with the carrier material. This constant, rhythmic pulsing motion of the shaker container ensures exposure to a vibrant, homogeneous mixing. Available in a range of configurations to accommodate container volumes spanning from 0.1 to 55 liters, the 3D shaker mixer proves its versatility across various pharma industries, R&amp;D labs, as well as pharma production plants.

3D powder mixer for active pharmaceutical ingredients

In the pharmaceutical industry, ensuring consistent and efficient mixing of active ingredients during granulation is crucial for achieving uniform product quality. High-shear mixing is particularly essential for large-scale production batches where precise blending and particle size distribution are important.
<h2>Guarantee efficient mixing and granulation</h2>
The HSM 1200 by ACG World is an advanced high-shear mixer designed for large-scale pharma production. With a capacity ranging from 360 to 960 liters, it handles substantial batch sizes efficiently. The ergonomic design of the product bowl, combined with a well-placed access platform, ensures easy and GMP-compliant operations. Equipped with a Z-shaped impeller and a multi-blade chopper, the mixer offers superior centrifugal force to prevent dead zones, ensuring uniform binder distribution and optimal particle-size distribution. Its multiple charging and discharging systems, along with a highly efficient vent air filtration system, enable quick, dust-free raw material transfer and easy wash-in-place (WIP) cleaning. Integrated cleaning nozzles enhance the simplicity of cleaning both the product bowl and discharge areas, minimizing downtime. This makes the HSM 1200 particularly suited for the stringent requirements of the pharmaceutical industry.

High-shear mixer for large-scale pharmaceutical production

In pharmaceutical and chemical laboratories, precise temperature control and uniform mixing are crucial for successful synthesis reactions. Managing these parameters can be challenging without the right technology, particularly when working with varying material viscosities and reaction requirements.
<h2>Efficiently manage temperature and mixing in reactions</h2>
The Across International R100 series jacketed glass reactor is designed for synthetic reactions of various materials under controlled temperature and vacuum conditions. This system includes adjustable stirring speeds and a constant pressure feeding funnel, ensuring uniform addition of materials to the vessel. The built-in condenser recovers materials at a controlled rate, aiding efficient processing. Featuring solvent-resistant PTFE on all seals, the reactor provides durability for long-term use. Digital speed and temperature displays offer clear operational visibility. The heavy-duty stainless steel supporting framework with lockable casters enhances both mobility and stability. This jacketed glass reactor is compliant with UL, CSA, and CE standards, making it a reliable choice for laboratory applications.

100l laboratory jacketed glass reactor

In chemical laboratories and industrial facilities, safe and efficient synthesis reactions often require the use of reactors that can operate under controlled temperatures and vacuum conditions. This becomes particularly crucial when dealing with flammable solvents and volatile reactions.
<h2>Safe synthesis with controlled temperature and vacuum</h2>
The 50L jacketed glass reactor from Across International is designed for synthetic reactions of various materials in a controlled environment. This reactor features an explosion-proof motor and controller, ensuring safe operation with flammable solvents such as ethanol and methanol. The dual jacketed design allows for vacuum drawing from the outer jacket to maintain precise temperature control and prevent frost formation. Constructed with high borosilicate glass and PTFE sealing components, the reactor is resistant to heat, cold, and corrosion. It includes an adjustable stirring rate for high torque or speed and a built-in condenser for material recovery. The system is supported by a heavy-duty stainless steel frame with lockable casters for easy mobility.

50l jacketed glass reactor with explosion-proof motor

In pharmaceutical and chemical manufacturing, certain raw materials cannot be processed in a dry state. These materials require a reliable method to form granules with uniform size and high solubility, mitigating dust and cross-contamination issues during processing.
<h2>Ensuring homogeneous and rapidly soluble granules</h2>
The MG Series from Alexanderwerk is a moist granulation system designed to process moist and pasty materials using counter-rotating cylinders. This system excels at producing granules with diameters ranging from 1.0 mm to 10.0 mm. Moist granulation involves adding a liquid to dry materials, forcing the mixture into a granulating extrusion cylinder, compressing it, and cutting it into granules. The MG Series is known for its quick disassembly, facilitating easy cleaning and maintenance. Models like the GA 65, G 1/100, G 1/168, and G 1/244 cater to different throughput needs, from 100 kg/hr to 2000 kg/hr. The process is essential in industries such as pharmaceuticals, chemicals, food, and nutraceuticals to ensure product uniformity and stability. Alexanderwerk's moist granulators are ideal for situations where air entrapment must be minimized and active ingredients evenly distributed.

Moist granulation system for pharmaceutical and chemical industries

In the pharmaceutical and chemical industries, developing sterile products that require precise drying and mixing processes is crucial. The challenge lies in achieving gentle drying of varied materials, from moist powders to wet suspensions, without compromising product integrity.
<h2>Dry, mix, and react with precision under vacuum</h2>
The 3-in-1 Vertical Vacuum Dryer and Mixing Reactor by Amixon is a highly versatile solution designed to handle dry, moist, and viscous materials at variable filling levels. The system features a spiral mixing blade that initiates a three-dimensional flow, ensuring thorough blending and efficient drying. This vacuum and pressure-tight unit is fully temperature controlled with heating options such as steam, thermal oil, or water for the mixing vessel, arms, and spiral blade. Compliance with FDA and 3-A Sanitary Standards makes it suitable for sterile operations, meeting EHEDG requirements. Ideal for processes that require deagglomeration, the unit can be fitted with high-speed cutting rotors. Its compact design and top-driven shaft mechanism reduce the space needed while maintaining high standards for surface finish, catering to pharmaceutical and sanitary requirements.

Vertical vacuum dryer and mixing reactor

In the production of food and beverage products, maintaining a consistent texture and particle size is crucial. Challenges arise with products containing pieces, requiring gentle handling to prevent damage or maintaining specific solid-liquid ratios.
<h2>Homogenizes and pumps products with pieces</h2>
The TP22 from Bertoli (Interpump Group) is an industrial homogenizer designed to handle products containing pieces up to 60mm. With a power capacity of 9.2 kW and maximum pressure of 16 bar, it achieves a throughput of up to 12000 liters per hour. This equipment operates with two pistons (2xØ120) and ensures constant solid-liquid ratios, making it ideal for applications in the food and beverage sector. It features an automatic greasing system that consumes 2 kg/1500h of NSF H1 grease, contributing to lower maintenance costs. The TP22 requires a minimum feeding air pressure of 7 bar with air consumption at 42 Nm³/h. Its extended maintenance program ensures long-term reliability and efficiency in operation.

Industrial homogenizer for food and beverage applications

In pharmaceutical production, ensuring uniform mixing and minimizing degradation of active pharmaceutical ingredients (APIs) is crucial. Traditional batch processes can lead to inconsistencies and higher degradation rates, leading to inefficiencies and increased costs.
<h2>Continuous mixing and dispersion of Apis</h2>
The ZSK Pharma Extruder from Coperion excels in continuous mixing of pharmaceutical ingredients. Featuring a modular barrel design customizable to product needs, it ensures intensive mixing with minimized product degradation. The extruder utilizes high torque, accommodating high throughput rates while maintaining low product temperatures. Constructed in GMP design, it uses FDA-compliant materials for all product contact parts. With specific torque up to 18 Nm/cm³ and maximum speeds up to 1,200 rpm, the ZSK Pharma Extruder can handle throughputs from 1 to 10 kg/h in laboratory settings. The advanced control system simplifies operations, while the compact design facilitates easy cleaning and maintenance. Ideal for pharmaceutical hot melt extrusion and wet extrusion of APIs, this extruder is a versatile tool for enhancing product bioavailability and creating controlled-release formulations.

Pharmaceutical twin screw extruders

In pharmaceutical and fine chemical research, achieving consistent granulation and mixing in small batches is a critical challenge, requiring precise control over shear forces and homogeneity. Without efficient tools, R&D operations face setbacks, increasing both time and costs.
<h2>Intuitive high-shear mixing for lab-scale batches</h2>
The P1-6 laboratory mixer from Diosna is designed for high-quality mixing, granulating, and pelletizing in a compact form. This equipment features cylindrical-conical mixer geometry and an integrated chopper tool. These innovations ensure perfect homogeneity and optimal Active Pharmaceutical Ingredient (API) distribution in granulations. The mixer is capable of handling batches from 0.04 to 2.7 kg and operates with a range of chopper speeds from 220 to 2,200 min-1. Its intuitive plug-and-play system and tool-free scale-up make it particularly user-friendly. Additionally, the optional spheronizer attachment allows for efficient pellet production, catering to diverse laboratory needs. The P1-6 occupies minimal lab space (950x550x550 mm) while delivering reliable and reproducible results.

Compact laboratory mixer for high-shear granulation

Drying Active Pharmaceutical Ingredients (APIs) and fine chemicals while complying with cGMP and FDA guidelines is a stringent requirement faced by manufacturers aiming for consistent and high-quality end products.
<h2>Ensures uniform drying with efficient heat transfer</h2>
The MAVASPHERE® by GMM Pfaudler is a spherical vacuum dryer designed specifically for APIs and fine chemicals, offering excellent performance across various filling capacities. The dryer features minimal clearance between the vessel wall and agitator, which enhances uniform drying. To optimize heat transfer, the entire vessel is jacketed. Its eccentrically top-mounted agitator ensures uniform mixing and gentle drying. The design includes a discharge at the lowest point, ensuring complete product evacuation. Construction materials include stainless steel, Hastelloy, and special alloys, ensuring durability and compliance with industry standards. Additional features such as an effective lump breaker, quick discharge spherical disc valve, and minimal product hold-up make the MAVASPHERE® a reliable choice for industrial drying needs.

Spherical vacuum dryer for Apis and fine chemicals

In industries like pharmaceuticals and fine chemicals, drying heat-sensitive and highly viscous products often presents significant challenges. Traditional methods can result in product degradation due to excessive heat or uneven drying. A vacuum pan dryer can address these issues effectively.
<h2>Optimizes drying of sensitive, viscous products</h2>
The Comber Turbodry® agitated vacuum pan dryer, supplied by Heinkel Group, excels in drying sensitive, pasty, and other difficult products that become highly viscous during the drying process. The unique design adheres to cGMP and FDA guidelines, ensuring compliance for pharmaceutical and fine chemical applications. Its simultaneous axial and radial agitator movements achieve uniform mixing of the product mass, preventing the formation of lumps. This ensures the shortest possible drying times. A double mechanical seal system, which is externally interchangeable and can be either dry running, non-contacting lift-off, or liquid lubricated, enhances reliability. Constructed from high-quality materials such as stainless steel and Hastelloy C 22, the dryer supports a wide range of capacities from 100 to 6,000 liters. It operates at design temperatures from -10 to 150°C and pressures from full vacuum to +6 barg. Optional accessories, including dust filters with automatic back cleaning, CIP systems, and vacuum systems, further optimize its performance.

Vacuum pan dryer for heat-sensitive pasty products

In pharmaceutical manufacturing, ensuring uniform and high-quality coating of tablets is crucial. This process can face challenges such as inconsistent coating, high energy consumption, and operator exposure to potent Active Pharmaceutical Ingredients (APIs).
<h2>Uniformly coat tablets while reducing operator exposure</h2>
The PERFIMA by IMA is a perforated coating system designed for film and sugar coating. Its pan shape and central drum baffles ensure perfect mixing of cores, allowing batch sizes from 25% to 100% of the pan capacity. The system includes automatic loading and unloading, energy-efficient air ducts, and a Clean-In-Place system validated by the University of Parma. The PERFIMA is also suitable for containment installations, reducing operator exposure to hazardous APIs. Energy efficiency is further enhanced by an AHU that recovers treated air, maintaining optimal performance. The system supports diverse applications, from standard to dynamic tablet processing.

Industrial tablet coating solution

Pharmaceutical laboratories need compact equipment to handle and produce small amounts of granules from a mixture of wet and dry elements for R&amp;D applications. Furthermore, the granulation process requires short residence times in drying the products to easily identify and remove the defects without discarding the entire batch.


<h2>Automatic feeding, granulating, and quick drying of pharmaceutical  products</h2>
The QbCon 1 from L.B. Bohle is a continuous wet granulating and drying system for pharmaceutical laboratory scale applications. The system performs three processes: feeding, granulating, and drying. It features a twin screw granulator with a hinged barrel for easy access to its parts. The unit comes with a multi-position feeder and interchangeable ports, ensuring accurate gravimetric feeding of dry powder and using a pulsation-free pressurized feeder for granulation liquid.

The wet granules are gently dried by a moving fluid bed that provides short residence times and consistent product output. Its narrow residence time distribution allows easy traceability from the initial product to the final tablet or vice versa. The drying process parameters, such as airflow, temperature, and conveying speed, can be controlled and adjusted according to product requirements. The system allows for sampling wet and dry granulations without interrupting the ongoing processes. The system also has an innovative filter cleaning system to prevent clogging for longer hours of operation. The unit also features a complete WIP (Wash-in-Place) cleaning.

Continuous wet granulator and dryer for R&D

When taking a tablet, it is usually the job of our stomach to break down the medication to make it ready to be absorbed into the bloodstream. However, some drugs are not meant to be dissolved in the stomach because the acidic pH of the stomach can disintegrate the drug, making it no longer effective. Using tablet coating equipment that applies a polymer barrier to the tablet makes it possible to protect it from stomach acidity.

Enteric Coated Tablets

Microtablets range between 1 and 4 millimeters, making the dosage form an excellent delivery system in polypharmacy. The size of the products makes them easier pills to swallow, but microtablets production brings a unique set of complexities.

Microtablets

L.B. Bohle is a technology leader in machines, systems and processes for the pharmaceutical, chemical, food and nutraceutical industries. Our focus is on equipment for tablet manufacturing.

Continuous wet granulation and drying have been widely discussed in pharmaceutical research and development (R&amp;D) and industry. Daniel Emanuele from the Dortmund University of Applied Sciences and Robin Meier from L.B. Bohle set out to test if the QbCon® 1 from L.B. Bohle is suitable for extended process times and meets the quality standards of the market.


<h2>The research zoomed into three metrics</h2>
The research focused on measuring moisture content, residence time distribution, and granule size distribution of the granulator and dryer. The results indicate that the dryer achieves very precise and consistent residence time distributions, resulting in uniform drying of granules across different size categories. The process consistently produces granules with the desired moisture content and particle size over extended periods. By adjusting the conveying speed of the granules in the dryer while keeping other parameters constant, the researchers were able to determine the limits for specific process/formulation combinations, primarily influenced by the depth of the fluid bed.

The ability to monitor the process in real time makes the QbCon® 1 an ideal choice for introducing continuous wet granulation, especially with its innovative drying process.

See it in the video!

[embed]https://youtu.be/XRyCPRNM9jE[/embed]

&nbsp;

Scientifically tested continuous drying for your tablets

Pharmaceutical

Pharmaceutical powders provide longer shelf life and better stability than liquid dosage forms. But the processing of pharmaceutical powders is crucial for growing segments besides pharmacy. Functional foods and cosmetics formulated with active ingredients and excipients depend on powdered forms to fulfill their promises.

Pharmaceutical powder

Pharmaceutical developments walk side by side with health advances to provide new medicines, treatments, and therapies that have increased life quality and extended life expectancy by years. Pharmaceutical manufacturing equipment helps deliver products to a great deal of the population, but there’s a significant share that doesn’t benefit from them yet. Over 2 billion people cannot get the medicines they need, according to the United Nations Industrial Development Organization, and local production might be a way to provide for these people.

Pharmaceuticals

Among all dosage forms in use today, tablets constitute the most common one. They are pharmaceutical solid dosage forms containing active ingredients and excipients such as diluents, binders, glidants, and lubricants. Using tablet making equipment, these solid dosage forms are made by compression of granules or powder blends and then shaped by molding.

Tablets

In pharmaceutical industries, where large-volume production is the norm, compactors or granulators are used to turn powdered materials into granules. As hydraulic systems are commonly utilized in these granulators, the compressibility is affected by the properties of the oil used. Certain oils can be compressed more than others and their properties degrade over time and are affected by temperature fluctuations.


<h2>Compacting dry powder into granules using an electromechanical roller drive</h2>
The Dry Granulator BRC 100 from L.B. Bohle, is a compacting system that turns powdered materials into granules for pharmaceutical industry applications. The system utilizes an electromechanical roller drive to provide precise control, consistent compressibility, and minimal material loss compared to hydraulic systems that rely on oil properties to drive the rollers.

This setup offers less maintenance as it does not require oil changes and an oil cooling system. The system has a flexible sieve setup allowing for the use of either a conical sieve or an oscillating sieve to obtain the desired granule size of the product coming out from the rollers. The granulator comes standard with integrated WIP (Washing in Place) nozzles for effective and easy cleaning. The entire system can be assembled or disassembled quickly, which helps improve maintenance and installation.

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Dry granulator for pharmaceutical powders

Chewable tablets are suitable for patients who have difficulty swallowing. Chewable tablet formulation masks the natural flavors of pharma drugs and alters their aftertaste. But besides the taste, chewable tablets favor the bioavailability of pharmaceutical ingredients.

Chewable tablets

Pharmaceutical innovations, particularly with highly potent active ingredients (HPAIs), are thriving largely in oncology medication. However, ensuring safety for both operators and patients is paramount. L.B. Bohle has sought to make sure that your medicine comes with the highest quality and that your operators stay safe during the dry granulation process.


<h2>Safe production = safe medicine</h2>
If we look at pharmaceutical production at containment level OEB 5, which has high potency and toxicity, you must make sure that there is absolutely no direct contact between your operators and the medical substances.  L.B. Bohle has tackled the concerns and can integrate them within their BRC dry granulators. Features such as glove boxes for safe handling and an integrated isolator unit in the compacting unit comply with manufacturing guidelines while prioritizing safety and efficiency.

The granulators have a containment port underneath the sieve unit for the removal of granules and a containment port for flake sample collection. You can also remove the product from inside the granulator residue-free with integrated WIP equipment.

Are you eager to learn more? <a href="https://lbbohle.com/pharma-whitepaper-pharma-product-brochures">Bring yourself up to speed with the whitepapers from L.B. Bohle.</a>

Aim your safety standards high, while granulating dry

Multilayer tablets are a popular fixed-dose combination (FDC) offering a range of release profiles for effective drug delivery. Multilayer tablet technology solves challenges to API consistency, allowing manufacturers to develop formulations from incompatible ingredients while optimizing the release profile for immediate release and controlled release.

Multi-layer tablets

Whether you are making pharmaceuticals, chemicals, or nutraceuticals, you will need to blend your ingredients. Depending on your product and production needs, finding a suitable blender is the utmost priority, but it can prove to be a challenge. L.B. Bohle has tackled the need and come out with a wide array of blenders, adjustable for your processing needs and goals.


<h2>Five solutions to fit your needs</h2>
Their portfolio of blenders can be scaled up to 12,000 liters with standard exchangeable containers up to 2,400 liters. You can choose from five different pick-up systems.

First, you can request standard load arm and clamps, with containers docked using electronically monitored quick clamps for your blender. In this solution containers up to 1,200 liters, mounted on an undercarriage, can be adapted without additional lifting equipment. Additionally, you can opt for a chopper installation whose drive is integrated into the load arm.

Secondly, you can request a blender version where the system can be swiveled around its vertical axis. This design comes with a huge advantage: long service life and extremely low maintenance requirements!

Did this spark your interest and are you curious to find out about the other systems? <a href="https://lbbohle.com/pharma-whitepaper-pharma-product-brochures">Read more on the whitepapers from the L.B. Bohle team.</a>

Discover the best mix for your blending application

Chemical

Due to their potential hazardous nature, chemicals are classified for proper identification and safety during production. Chemical classification depends on their properties, structures and functions. In the chemical industry, you can regard them as basic chemicals such as acids, chemical products to produce plastic materials and finished chemicals for use in cosmetology. As a manufacturer or engineer, you want to know their reactivity when using chemical processing equipment.

Chemicals

Eating is more than just nutrition, but we have found ways to increase the nourishing power of our foods. Nutraceuticals manufacturing, from vitamin C powder and probiotics to omega 3 oil, is a concentration of natural ingredients and health supplements that complement our diets. While dietary supplements are not quite haute cuisine, the process of extraction and purification is no less a blend of science and art.

Nutraceuticals

Producing the finest micro-emulsions and suspensions requires a mixing machine that generates extremely high shear.  Multi-staged rotor/stator dispersing machines work well for this purpose because of the high shear forces applied to the mixture at each rotor/stator stage.  A rotor /stator dispersing machine that also incorporates extremely fast rotation and resultant tip speeds for even greater shearing action will lead to the creation of super-fine emulsions and ensure the success of your process.
<h2>Top-of-the-line rotor/stator dispersion with utlra high shear for nano-scale particle emulsions and suspensions</h2>
The DISPAX-REACTOR® DRS from IKA is an inline ultra high shear dispersing machine used to achieve the finest micro-emulsions and suspensions. Extremely high shear rates (up to 190.000 1/s) combined with a fine generator geometry enable crushing of droplets and solids particles down to the nanoscale. The resulting product has long-term stability which reduces the need for emulsifying agents and thickeners. Because of the extremely high energy density, other dispersing aids can be reduced or possibly eliminated.

The DRS is usually equipped with a two-stage rotor-stator system (generators). The high tip speed of 40 m/s (10.000 fpm) often negates the need for a third stage. The ultra-fine dispersing machine, designed with the same high quality features as the ULTRA-TURRAX® UTL and the DISPAX-REACTOR® DR, is especially well suited for challenging pharmaceutical applications.  The units are designed for easy and reliable scalability and sizes are available with flow rates from 70 to 40.000 liters per hour.

Ultra-fine dispersing machine for emulsions and suspensions

Used in the pharmaceutical industry to produce tablets and capsules, among others, pharmaceutical granules are made to enhance the uniformity and flow of powder, increase the density of the blend and reduce dust and, therefore, toxic exposure. The choice of the granulation process, whether it is wet, dry, or direct compression, as well as the selection of appropriate pharmaceutical granulation equipment, depends on the specific drug being formulated.

Pharmaceutical granules

Built upon its world-leading laboratory equipment, IKA Process is a game changing manufacturer of dispersing machines, homogenizers, stirrers, jet flow agitators, and kneading machines.

In the pharmaceutical industry, change often moves at a snail’s pace due to stringent regulations, but it does happen.



Traditionally, API manufacturers relied on the dry milling process, which begins with crystallization or precipitation within a liquid medium, where crystals form and grow. These crystals are separated using a centrifuge, dried, and finally subjected to dry milling before tableting.

As APIs became more potent, dry handling became problematic due to dust generation, causing cleaning issues and product loss. Furthermore, stricter ATEX regulations for handling hazardous powders have expedited the demand for change.

It’s not as simple as just mixing dry ingredients together, and voila, you have your API. APIs are always, and I mean always, synthesized within a liquid medium to form solid crystals. If liquid is always a part of the equation, why not control the growth of those crystals already in the crystallization step?

And this is where wet milling came into play. This approach allows early particle size control during precipitation, enhancing pharmaceutical manufacturers’ control over the API’s final particle size and distribution.
<h2>“<em>The value of an idea lies in the using of it</em>.” – The benefit of early particle size reduction</h2>
We had a chance to speak with Werner Kanzinger, <a href="https://www.ikaprocess.com/en/Products/Process-plants-cph-18/?gclid=Cj0KCQjwmICoBhDxARIsABXkXlLSTjoDkEyEOxqysB6am7wNW99asG4jDKpXJpsQO5pzSj_wv8ZdyHYaAlsvEALw_wcB">IKA</a> Vice President, one of the first to use wet milling for API production. Creating new pharmaceuticals requires starting from scratch and developing principles in the R&amp;D world. To address this need, IKA introduced an innovative three-stage inline dispersing technology called the <a href="https://www.ikaprocess.com/en/Products/Pilot-plants-cph-40/magic-LAB-csb-MLAB/">Magic Lab</a>.

“<em>We knocked on every door in the R&amp;D world and were surprised how the technology was well-received. The industry recognized its</em><em> potential to simplify production through early-stage particle size reduction,” </em>Werner explains.

According to Werner: “<em>Even at a half-liter batch, APIs are very valuable and pricey. As production scales up to 1000 liters per batch, the cost can be over 1 million, and nobody wants to take any risk.”</em>

To serve the industry across diverse production scales, IKA replicated Magic Lab’s success on a larger scale, ensuring consistent milling outcomes without compromising quality.
<h2>No dust, no fuss - Wet milling is here to simplify your life by shortening your production time</h2>
In dry milling, solid materials undergo high-speed impact and shearing forces, generating airborne dust particles. This dust settles on equipment, necessitating extensive cleaning to prevent cross-contamination.

“A w<em>et mill is already designed to create a high-turbulence environment, which helps with dust reduction</em>,” Werner continues.

Additionally, wet mills are easier to clean than dry mills due to their smaller and less complex internals, requiring less time and effort. Operating already during the crystallization step, wet milling allows for localized energy application. This reduces energy consumption compared to drum mills.

“<em>IKA three-stage inline technology allows for complete drainage after use. The product flows from the top to the bottom through a three-stage rotor-stator, progressively reducing particle size from coarse to fine. Since it’s vertically installed, no product remains inside, making cleaning straightforward,</em>” Werner concludes.

Just remember, it is better to move forward at a snail’s pace than backward at any pace.

Wet milling: The revolution in the API production

Biopharmaceuticals are drugs in which the active substance is manufactured or extracted from biological origin materials. They are usually produced in bioreactors by plant cells, microbial cells, yeast cultures, or mammalian cells. Also known as biomanufacturing, they are used to either treat or diagnose and prevent a patient’s medical condition or disease. Biopharmaceuticals are typically complex macromolecules administered by injection or infusions, and examples include vaccines, serums, and insulin.

Biopharmaceuticals

The most important part of a capsule is its contents. But if the shell is not carefully made, the dosage ingredients inside lose effectiveness. From molding to sizing, capsule manufacturing equipment forms perfectly-matching husks ready for filling. The simplicity of encapsulation revolutionized pharmaceuticals since it was introduced in the 19<sup>th</sup> century. However, capsules are changing to increase delivery efficiency and reduce the dependency on gelatin.

Capsules

<p class="filterable-grid__description">Liquid dosage forms are designed for easy absorption. The body quickly carries the active ingredients through the system and triggers the required response. But the greatest advantage of this medicinal type is its flexibility in formulation and dispensation. From lotions and syrups to drops and sprays, liquid solutions can be adapted to different administration routes including parenteral, topical, and oral. The fundamental liquid dosage manufacturing process involves dissolving or suspending solutes in a fluid. But that is not enough. A precise blend of excipients is needed to make the medicine go down.</p>

Liquid dosage forms

The building blocks of matter have driven the imagination of philosophers, scientists, and artists for millennia. But, for manufacturers, these elements have a more concrete existence as powders. Powder processing technology conditions these primary materials to create a vast range of products, from chemicals and foods to pharmaceuticals and ceramics.

Powder

Powder containment is the cornerstone of chemical and pharmaceutical manufacturing. Floating particles do not only represent efficiency loss but serious hazards too. Lack of tightness during the powder discharge process leads to cross-contamination and operational health risks.


<h3>Dock transfer systems squarely in place</h3>
The ASBV active/passive valve interface by Andocksysteme locks into position, minimizing exposure of material during powder discharge. The system has two split valves – one active, one passive – that can be easily and reliably centred on each other at a tolerance of ± 14 mm.

Once the units are docked, the valve discs open simultaneously, preventing exposure of the products during transfers. The dust-tight environment achieves contamination values lower than 1µg/m3.

The ASBV solution is fitted with EPDM seals and are optional with a wide range of materials, such as PTFE, offering top-range chemical resistance. All seals are made from FDA-approved materials and can handle a wide range of temperatures as well as explosion-proof executions.

Washing the ASBV interface is simple as the system can be connected to a WIP loop to flush out residual powders. These containment solutions serve applications with an exceptional performance and are easy to be integrated. Moreover, high quality parts and reduced complexity drives simple maintenance.

High containment split butterfly valve

Andocksysteme is a specialist in developing and engineering high-quality containment docking and solutions for bulk material.

The rise of high-potency ingredients (HPAPI) is taking medication into unchartered territory. Since the turn of the century, the pharmaceutical industry has developed a wave of targeted therapeutics formulated with more potent drugs in smaller doses.

Besides producing a more effective action against their biomedical targets, these innovative medicines are also lighter on excipients and provoke fewer side effects for patients. However, they do cause considerable side effects for manufacturers.


<h3>Higher potency can be too much of a good thing</h3>
HPAPI materials pose a risk of toxic exposure to operators. Process technology is designed to meet EHS guidelines, protecting handlers from hazardous substances. At the same time, it must also adhere to GMP standards to prevent contamination. However, the real danger lies at the inlets and outlets of the machines, as <a href="https://andocksysteme.de/en/" target="_blank" rel="noopener">Andocksysteme</a> Product Manager Duncan Ehrmann points out.

“It is all well and good when a mixer is blending chemicals, or a dryer is reducing moisture,” says Duncan. “But things get tricky while the materials are transferred from the mixer to the dryer.”

There is no such thing as a fully closed system; discharge will always release particles into the air. So, the challenge is to minimize that amount to the greatest extent possible.

The industry answer is the split butterfly valve principle, joining the ‘mouths’ of two systems and opening them synchronously. But engineering the concept into an actual pharma-grade interface is another story.
<h3>Big on seals, small on parts</h3>
Andocksysteme developed a valve solution that achieves contamination values lower than 1μg/m3. A primary contributor to this degree of containment is the minimalist construction of the interface. Designed with the bare minimum of separate parts, the valves significantly restrict roaming space for flowing powders.

"We designed  our technology with large seals  to cover the openings," explains Duncan, "A bigger seal exerts higher pressure, locking the active/passive valves tighter together.”

The state-of-the-art system meets the OEB 5 levels of protection required when handling ingredients with high pharmacological and toxic effects.

HPAPI particles move around a lot during processing. Their manufacturing cycles are long and winding, but high-containment valves hold them safely within that loop.

Closing the containment loop in HPAPI manufacturing

Conventional dryers are inefficient and can lead to significant mechanical and thermal stress on sensitive products. Non-uniform mixing can lead to lump formation and increased processing time. Vacuum dryer with eccentric agitator is designed to dry wet flowing powders from filtration and centrifuging processes.


<h2>Vacuum dry efficiently in an agitated paddle dryer</h2>
Planex® system from Italvacuum is a special horizontal vacuum paddle dryer with an eccentric agitator which revolves around its own axis while rotating tangentially to the drying chamber. It is ideal for drying wet feeds from filtration and centrifuging processes. Planex® is ideal for the production of active pharmaceutical ingredients (API), fine chemicals and intermediates. The efficient agitator action ensures perfect mixing and consumes three times less energy than conventional dryers. It also reduces the mechanical and thermal stress on the products which is important for delicate and temperature-sensitive applications. The tangential movement of the agitator prevents lump formation. Suitable for both crystalline and amorphous products, Planex® has a short cleaning downtime and complies with US FDA standards and cGMP regulations.

&nbsp;

Horizontal vacuum dryer with eccentric agitator

Italvacuum is specialised in vacuum drying technologies for the processing of wet feed materials to produce active pharmaceutical ingredients (API) or fine chemicals.

Without friction, we would not be able to walk, jot down notes, or slice a pie. Friction resists the relative motion of two objects that come in contact, generating grip between their surfaces.

But if you’re drying high-potency API, friction is the last thing you need. The force exerts mechanical and thermal stress on the ingredients that could destabilize the materials and compromise the quality of your end product.
<h3>A poor work of friction</h3>
High-potency <a href="https://making.com/active-pharmaceutical-ingredients-api">active pharmaceutical ingredients (API)</a> require thorough drying to ensure homogeneity in the production process. Once crystallized and isolated from organic solvents, the ingredients must be prepared into free-flowing materials ready for precision dosing, formulating, and formatting.

The drying step is a delicate process that converts the particles into workable materials without altering the chemical profiles developed during filtration. Vacuum drying is a cornerstone of this production stage. The method removes a high rate of bound moisture from materials at relatively low temperatures.

But the vacuum method solves one challenge and creates another. The agitator inside the drum spreads the ingredients over a broader area to expose trapped moisture to vaporization. Therefore, the blades on the agitator make direct contact with the surface of the HPAPI particles. This process creates friction at a millimetric level, producing heat.
<h3>It's a dryer, not a heater</h3>
Dario Penco, a technical engineer at <a href="https://www.italvacuum.com/en/" target="_blank" rel="noopener">Italvacuum</a>, says that adding thermal energy during the drying stage overheats the blend: “Subjecting sensitive materials to friction during the drying stage adds unnecessary heating and risks degrading the ingredients.”

The emergence of high-potency drugs has made this challenge even more pressing. The slightest distortions in the composition of the particles create a ripple effect across the manufacturing line.

Production engineering is developing new ways to overcome this hurdle and minimize friction occurring in a vacuum dryer. Novel design approaches to the blade profile reduce the physical contact with the materials and limit thermal stress significantly. Keeping temperatures at a constant ensures higher-quality pharmaceutical ingredients. And just like well-baked pizza, everyone wants a slice of that.

Lowering heat stresses on API by reducing friction

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