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Maker - Product Challenge

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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)

When you consider shifting pharmaceutical mixing processes from batch to continuous, accurate in-line continuous blending can be a real challenge.


<h2>In-line continuous blender with fast reactivity and minimum residue</h2>
The Modulomix from Hosokawa Micron is a continuous modular mixer and it has been designed to be compact with fast reactivity, minimum residue and rapid start-up and shutdown protocols, very useful in pharmaceutical applications.

It is a very compact blender because you will be able to combine the Modulomix modular mixer with PTS, LIW feeders, continuous blenders, PAT technologies and even downstream processing, like (wet) granulation and/or compact. It is adaptable due to it lets you have two different mixing environments in one single phase, multiple Modulomix mixers can be cascaded in series.

In-line continuous blender

When you want to mix segregative, free-flowing powders and pastes that require perfect mixing quality and accuracy but require careful treatment, a conical screw mixer is a proven solution.


<h2>Gently mixing with perfect accuracy</h2>
The Vrieco-Nauta® conical screw mixer from Hosokawa Micron is a convective mixer with high mixing efficiency and accuracy for large volumes of up to 100.000 liters, specially designed for segregative, free-flowing powders and pastes. The conical vessel design allows a wide range of filling capacities and the mass flow characteristic design minimizes segregation upon discharge. Because there are no horizontal internal surfaces, products are completely discharged, minimizing product loss and providing for easy cleaning. Suitable for a wide range of processing activities in the pharmaceutical, food, plastic, metals &amp; minerals, nuclear, chemical, pigments and coatings industries.

Conical screw mixer

The Alpine Picoline is a series of miniature laboratory machines for processing samples down to 1 gram. The Picoline is ideally suited for research and development or for manufacturing expensive materials such as nano-particles, pharmaceuticals, plastics, ceramics, and specialty chemicals.


<h2>Designed for ease of operation, maintenance, and cleanability</h2>
Picoline from Hosokawa Alpine is a new series of eight individual machines specifically designed for the production of very small batches of between &lt;1g and several grams.

The Alpine Picoline equipment maintains, in miniature, the top engineering standards and leading-edge technology. With machines in the Alpine Picoline series for size reduction, classifying, and mixing.

Because the principle of operation of the Alpine Picoline machines is the same as that of large production-scale machines, R&amp;D departments can be confident that the transfer of a manufacturing process developed using a Picoline machine to a production-scale machine will be smooth and problem-free.

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Laboratory mill for small batches

When you need to mix cohesive powders with liquids or melt binders and require a homogenous end-product, a high-shear mixer can be used.


<h2>High-speed, intensive paddle mixer and agglomerator</h2>
The Cyclomix® from Hosokawa Micron is a multi-purpose high-shear impact mixer. It combines different processes in one single machine and is the ideal choice for intensive thermal processing of high energy input; high degree of dispersion and homogeneity and ultra-short cycle times.
The mixing vessel is conical shaped and has a central rotor that rotates at a speed up to 30 m/s. The speed of the rotor creates centrifugal forces that push the product to the vessel wall where the shape of the vessel causes an upward movement.

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High-shear impact mixer

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

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

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

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

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

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

Pharmaceutical

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

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

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

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

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.

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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

Find production technology for API mixing, and connect directly with leading machine manufacturers worldwide