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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

<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

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

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

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

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