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Maker - Product Challenge

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API Formulation Equipment

Formulation technologies are an integral process in many industries such as pharma and food. Chemical mixtures require strict handling to combine the separate ingredients into the homogenized recipe that makes your final product. Formulation technology stores, mixes and subjects the elements to a range processing parameters according to your specifications to develop the base material. The resulting formulas are then weighed, formed, packaged, or sent for further formulation.

Formulation

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)

A multipurpose unit in the research and development field. Some of the most common applications are galenic formulation, freeze drying experimentation, taxidermy, underwater archaeology, aliquot preservation,  diagnosis and other research.


<h2>Start your research with this multipurpose high-performance device</h2>
The LyoQuest laboratory, multipurpose and R&amp;D freeze dryer from Telstar Life-Sciences has been designed as a multipurpose unit for the research and development field. It is a small freeze dryer, more compact than most but in spite of its small size, its capacity is quite unbeatable. A state-of-the-art control system and a range of specially designed accessories make the LyoQuest a benchmark in its category.

The unit's design offers the best performance in the least possible space. Suitable for laboratories: compact and easy to install, solidly designed laboratory equipment. On a functional level, cooling management ensures optimum performance.

Multipurpose and R&D freeze dryer

Freeze dryer designed for aseptic and small-scale production of high-value products.


<h2>Industrial freeze dryer in a compact envelope</h2>
Lyotris from Telstar Life-Sciences is a lab scale production freeze dryer designed for the production of small batches of high-value pharmaceutical products. With a 1m2 loading surface and capacity for approximately 1,600 10R-type vials or 30 liters of bulk product. It has been specially designed for aseptic production in vials or in bulk and its novel fascia and door design provides easy isolator integration.

The GMP laboratory freeze dryer comes with all  the necessary components for an automatic cleaning (CIP) and steam sterilization (SIP) processes, filter integrity testing (WIT) and also incorporates an advanced SCADA system which includes Telstar's patented ‘Lyometrics' system; providing advanced real-time information on the freeze-drying process.

GMP laboratory freeze dryer

For pharmaceutical formulations that are highly active specialized capsule filling equipment is often required for operator safety and protection of product quality.  Full containment in a capsule filling process requires, minimal creation of dust, minimized product left-over in the machine, and operation with minimal operator interaction.  This specialized equipment offers these enhanced features including glove box operator access as well as all other capabilities expected from a top-of-the line pharmaceutical capsule filler.


<h2>Contained, safe encapsulation for highly active formulations.</h2>
The Securefill 12T from ACGE is a fully automatic  high containment encapsulation solution for highly active substances. The contained capsule filler is specifically designed to prevent any surface or airborne contamination escaping the machine which can be a risk to operator safety when working with highly active pharmaceutical formulations.  Contact between the operator and the formulation is eliminated greatly reducing the complexity and unreliability of other protective methods commonly used.

Part of the AF series of encapsulation machines which are currently running over 1,000 pharmaceutical production facilities world wide, the Securefill 12T has all the proven design benefits and flexibility of the other machines, with added containment and operator protection features.  Capacity of the contained capsule filler is up to 12,000 capsules per hour.

Contained capsule filler

Vacuum drying is used to remove moisture from sensitive materials. Drying small batches in the laboratory for R&amp;D work or removing moisture from high-potency active pharmaceutical ingredients requires careful handling and control.
<h2>Vacuum dry small batches and HPAPI's</h2>
LaboDry from Italvacuum is a laboratory-scale, vacuum tray, drying oven designed to meet small batches and high potency API production requirements. It features a separate cells construction and has been designed for glove box installation. It can be fitted with skid-mounted auxiliary accessories. LaboDry is available in in AISI 316L (1.4404), AISI 904L (1.4539) and ALLOY C-22 (2.4602) construction to meet the requirements of appropriate material for product contact. LaboDry is ideal for laboratory use and the pharmaceutical industry.

Laboratory-scale vacuum tray drying oven

Whether you want to improve the stability of nutrients, protect an active chemical agent or control the release rate of a given ingredient, you may benefit from a continuous solution that generates reproducible microspheres and is scalable from pilot to production capacities.
<h2>Rapid, uniform and reproducible microsphere formation</h2>
Both the INFINITY Mini and the INFINITY Lab from EmulTech’s Microfluidic Encapsulation System are versatile platforms for rapid uniform and reproducible microsphere formation for encapsulating small molecules, peptides and proteins, with a particle size of 1 μm and up. This system’s unique continuous flow technology provides high reproducibility, which reduces process development costs and eliminates out-of-spec material.

Microencapsulation system for your drug delivery system

<span style="font-weight: 400;">The efficient size reduction of granular powders is a key step in many pharmaceutical processes, and choosing the right equipment for your application can be vital. Conical mills offer excellent flexibility, as different forces can be achieved simply by changing the impeller type, and different particle sizes by changing the screen type.</span>
<h2>Highly flexible mill for a wide range of pharmaceutical powder preparations</h2>
<span style="font-weight: 400;">The Sejong Pharma CM Series of conical mills offers a range of milling head sizes to suit a variety of production volumes. Available in 500, 1000 and 2000 kg/hour versions, the CM Conical Mill is a fully portable mill, with electric height control allowing for operation into a range of output containers.</span>

<span style="font-weight: 400;">With easily interchangeable heads providing a wide variety of screen sizes and impeller variants, the CM series adds flexibility to your pharmaceutical powder production with reduced cost.</span>

<span style="font-weight: 400;">Easy to operate, with a simple electronic interface, the unit is also quickly and simply disassembled for cleaning thanks to a simple clamp action attachment system.</span>

Conical mill for drug formulation

It is rather difficult to successfully produce a pharmaceutical solid dosage forms with the desired properties such as size, morphology, hardness and friability. You need a solution that can transform fine heterogeneous powders into homogeneous blend of granules with bigger size and higher density in a short time and with repeatability. Wet granulation is carried out to convert fine and cohesive active ingredient and excipients, into more uniform, free-flowing granules that are optimised for downstream processing.
<h2>Achieve uniform particle size distribution for wet granulation</h2>
The High Shear Mixer Granulator from Romaco Tecpharm is configured to optimize the wet granulation process. It is used to turn a fine-powder heterogeneous mixture into a uniform granulation, with increased particle size and higher density.

The equipment offers you proper flow and compactness while having a shorter operational time. It can handle capacities ranging from 25 L to 1,400 L.The bottom impeller and the side chopper enables the intensive mixing in a short period of time. In addition, the equipment uses a synchronized system to avoid extrusion effect.

The high-shear granulator for drug formation processes the solid material down to the desired particle size, and the mixture is then pumped to the fluid bed dryer where the moisture is removed, leaving behind the granular product. During the process of wet granulation, the constituents of the oral solid dosage form blend are combined, along with agglutinative solution, to form granules with a homogenous composition.

Industrial high shear mixer granulator for drug formation

In the pharmaceutical industry, ensuring sterility and precise control in Active Pharmaceutical Ingredient (API) production is critical. Challenges often include contamination risks, inefficient processing workflows, and manual operation bottlenecks that jeopardize product quality and safety.
<h2>Automate and optimize sterile Api powder processing</h2>
The sterile API production line from Austar provides an all-encompassing solution for powder treatment in sterile API workshops. This system includes raw material weighing, formulation, closed feeding in reactors, sterile conveying, and transferring. Key features encompass sterile weighing and packaging, automatic bag-opening, automated measuring, capping, sealing of tins, and CIP/SIP systems. With cutting-edge powder processing technology and extensive engineering experience, this production line ensures enhanced productivity and safety. Austar’s system leverages extensive automation, significantly reducing manual intervention and workflow inefficiencies. The engineering team adheres to rigid project management protocols, providing comprehensive and traceable verification documents for regulatory compliance. This system is designed to help pharmaceutical companies speed up time to market, enhance operational benefits, and maintain consistent product quality.

Sterile Api production line for powder treatment

Scaling up microbiological synthesis processes from the laboratory to small-scale production requires precise and reliable equipment. This is vital for applications in pharmaceutical production, veterinary chemicals, and biotechnology research centers.
<h2>Facilitates efficient scale-up and small-scale production</h2>
The BRS pilot fermentors and bioreactors by Brs Biotechnology Equipment serve as a crucial link between laboratory-scale experiments and larger production scales. These units, with volumes ranging from 5 to 80 liters, are designed for small-scale pilot production of agricultural and veterinary chemicals, pharmaceutical production, and diverse biotech processes. Their platform-mounted, open-frame modular construction allows easy access for maintenance and operations. Central connections for steam, water, and air minimize start-up time and effort. Advanced models feature automatic air flow metering, optical density sensors, and remote control systems via SCADA. The fermentors support a wide range of processes involving enzymes, bacteria, fungi, algae, and various cell cultures. Compliant with GMP and FDA standards, they are optimized for medium and process optimization in research settings.

Pilot fermentors for biotech processes

During the synthesis of radiopharmaceuticals, ensuring operator radioprotection and maintaining sterility and cleanliness are critical challenges. Effective containment of radioactive materials and prevention of contamination are vital for safe and compliant operations.
<h2>Ensure radioprotection and sterility in synthesis processes</h2>
The MIP Series Shielded Cell by Comecer is designed to host automatic modules for the production and research of radioisotopes and radiopharmaceuticals. This solution provides comprehensive radioprotection and decontamination features. The work chamber is sealed, shielded on every side, and kept under negative pressure, ensuring safe working conditions. With options for 75 mm or 100 mm lead shielding and compliance with Class B air quality standards (at rest), the MIP Series accommodates various synthesis modules, including large, complex systems like HPLC. Additionally, the system features an advanced drawing system for vial extraction without chamber opening, further enhancing safety and operational efficiency. The MIP Series includes a touch-screen operator panel for real-time monitoring, stainless steel fluid supply lines, and an array of customizable features such as tele-manipulators and autoclaves. It meets cGMP guidelines, making it suitable for advanced research and routine production.

Shielded cell for radiopharmaceutical synthesis

Maintaining high product quality standards and precise process control in pharmaceutical manufacturing demands accurate metering of bulk solids. Achieving this level of precision is crucial for feeding upstream wet granulators, controlling tablet press lubrication, and more.
<h2>Enable precise bulk solid metering</h2>
The Gericke high-precision loss-in-weight gravimetric feeders are designed to ensure accurate metering of bulk solids in pharmaceutical applications. Integrated into the Gericke Formulation Skid (GFS), these feeders provide continuous manufacturing support and can function as standalone units. They are ideal for feeding upstream wet granulators, hot melt extrusion, and other critical processes. The feeders support controlled feeding to mills and micronizers, and are also used for batch feeding and automated dispensing of excipients and active pharmaceutical ingredients (APIs). With high precision metering, they enable enhanced product quality and operational efficiency. The feeders are designed to integrate seamlessly into existing systems and provide easy monitoring and control.

Gravimetric feeders for pharmaceutical applications

When working with small production batches in pharmaceutical processes, maintaining product quality and batch uniformity is crucial. Traditional drying methods may not suffice for such stringent requirements, making precise freeze drying techniques essential.
<h2>Ensures consistent drying with advanced technology</h2>
The MINIMAX by IMA is a GMP-compliant, small-scale freeze dryer designed to meet the specific demands of handling small production batches. Based on the successful LYOMAX concept, MINIMAX provides scalable lyophilization technologies from formulation to full commercial production. With several configurations available, it offers shelf areas ranging from 1.0 up to 3.9 m², and ice condenser capacities from 29 to 78 kg, with minimum condenser temperatures of –75°C. It is equipped with Process Analytical Technologies (PAT) to optimize drying outcomes and gives a data-rich environment for monitoring. It supports non-aqueous solvents and high-potent products processing and can integrate with isolation technology and automatic vial-loading systems. The patented FUSION™ shelf technology ensures higher-quality heat transfer, enhancing process reliability. Designed with redundancy and configurable options, the MINIMAX provides a reliable and versatile drying solution.

Small-scale freeze dryer for pharmaceutical applications

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]

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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

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

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.

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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

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