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Maker - Product Challenge

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API Separatation Equipment

Industrial separation equipment encapsulates the separation process which is to separate components of a liquid mixture, for recovering dissolved solids from liquids. The choice of a suitable technology depends on the identification of the key physical or chemical property, such as size, mass, density, or boiling point, which sets the product of interest apart from the rest of the components. Separation technology is widely used in the pharmaceutical and chemical industries for the isolation of active ingredients and high-purity chemicals. As well as in waste management and recycling industries.

Separation

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)

<span style="font-weight: 400;">In the highest volume pharmaceutical production environments, capsule filling needs to be extremely accurate whilst providing increased throughput in order to improve efficiency. Equipment that is designed to minimize downtime becomes particularly important in larger-scale production.</span>
<h2>Highest performance capsule filler for large volume production line</h2>
<span style="font-weight: 400;">The Sejong Pharmatech F180 series is a high capacity capsule filling solution with cutting edge features that can operate at up to 184,000 units per hour.</span>

<span style="font-weight: 400;">The F180’s proprietary drive system has been designed to offer maximum speed and performance whilst minimizing maintenance through reduced vibration. In addition, the modular nature of the system allows for rapid and straightforward replacement of individual components, keeping downtime to a minimum.</span>

<span style="font-weight: 400;">Further innovation includes the provision of an automated capsule jam removal system. Using high pressure air, the machine can self-clear without the need for any disassembly, saving valuable time.</span>

<span style="font-weight: 400;">Because increased speed must not lead to a reduction in quality, the F180 is fitted with a 5 stage compression moulding system to ensure the optimum capsule fill even at highest speeds.</span>

<span style="font-weight: 400;">In addition, the comprehensive AWC (automatic weight control) functions reject any doses that are not filled within tolerance, as well as automatically rejected any faulty capsules that have not fully closed, or where the capsule sleeve has been damaged.</span>

<span style="font-weight: 400;">To meet your exact needs and offer full flexibility, the F180 is able to handle a wide variety of encapsulated dosage types, including powders, pellets and tablets. It can also fill capsules with a mixture of these doses, allowing scope for the production of a large number of products.</span>

<span style="font-weight: 400;">The control system is fully 21CFR part 11 compliant, with graphical touchscreen control for ease of operation and monitoring of performance.</span>

High capacity capsule filler

For the classification of delicate granular material, screen tumblers make an excellent alternative where high throughput is still required with gentle handling. This is important to many processes in the chemicals, pharmaceuticals and food industries, where traditional vibratory sieves and graders are too harsh for delicate materials.


<h2>High capacity tumbler for delicate, dry materials</h2>
The Virto VTU 2400 is a purpose-designed high capacity tumbler sieve capable of achieving up to 95% efficiency for particle sizes as small as 20 microns.

Especially suitable for multi-stage separation of fine, lightweight and difficult to screen products, the VTU 2400 uses three-dimensional movement for class-leading performance with powders and granules. The exact nature of the movement can be adjusted to suit your requirements.

The tumbler screen can use meshes down to 20 microns, can be supplied with anti-clogging systems composed of FDA-certified rubber spheres or ultrasound systems to your specification.

All product contact parts are constructed of AISI 304 stainless steel, and ATEX certification and full FDA conformity is available on request.

The VTU 2400 is available with 1 to 5 sieving decks, and offers a total mesh size of 4.5m2 for maximum productivity.

Solidly built for enhanced reliability, the VTU 2400 tumbler sieve is energy-efficient and quiet in operation, making it suitable for a wide range of applications.

Tumbler sieve for classifying and dedusting granular materials

Many pharmaceutical production processes involve the use of products that have naturally hardened within their transport container and need to be conditioned before they are able to be used as inputs to the production process. Traditionally manual methods of percussion, using mallets for example, have been used, but these are unsatisfactory from both a safety and efficiency point of view. A dedicated system for the manipulation of a wide range of container types provides a professional, safe and automated conditioning process that improves productivity.
<h2>Automated drum conditioning systems for a wide range of pharmaceutical containers</h2>
The PalPharMassage from Palamatic is a custom-designed range of drum and container conditioning solutions designed to meet the needs of the pharmaceutical industry.The range includes conditioners that can handle various containers - fibre and plastic drums, kegs, sacks, and other flexible containers.

Featuring full PLC control with an intuitive touchscreen HMI, the PalPharMassage is simple to operate with infinitely variable controls for distance into container, torque, speed and time. Recipe programming further simplifies operation by allowing for “one touch” automated operation.

Giving you complete flexibility to fit your exact requirements, the PalPharMassage unit can be specified in fixed or mobile formats and is robustly constructed for longevity and reliability. Built from 304 to 316L stainless, the whole range is fully cGMP compliant and can be specified to meet ATEX requirements.

Available in a MAXI format that suits the widest range of container styles, the PalPharMassage is also available in an economical pneumatic-only MINI format for use with smaller containers.

Drum conditioner

Processing equipment used in industries regulated by GMP must ensure fully-sterile environments and complete CIP systems. This includes filtration units which should reliably separate solids from liquids while keeping them fully enclosed to avoid environmental contamination or operator contact. A self-cleaning hygienic filtration system is necessary to comply with strict regulatory requirements.
<h2>Separating solids from liquids using a self-cleaning candle filter</h2>
The STERIBAC, from Dr. Mueller, is a fully enclosed hygienic filtration system explicitly designed for industries where GMP must be followed. The system features a fully automated filtration process from filtering of liquids, washing of filter elements, and discharge of solid residues. During filtration, the fluid goes into a pressured chamber where the solids are collected on the outer surface of the filter medium while the filtrate passes through. Then, the filtrate goes into the perforated tubes before going up to a single central tube on the way out of the chamber. The collected solids are washed and dried before subjecting them to a reverse flow gas pressure shock wherein the filter medium expands, and the solids crack and fall to the discharge port.

The system also features patented heel volume filtration, where the unfiltered fluid at the bottom of the chamber is pumped back to the top and sprayed evenly to maximize the recovery of solids and liquids. Another feature is a patented spray washing system that effectively washes the internals of the filter system while using less washing liquid, which saves costs in every washing cycle. There are no mechanical moving parts and agitating devices in the chamber, which helps make CIP a straightforward procedure. The simple modular construction of the filtration elements allows variation in size, volume, and cake thickness in a closed system.

Sterile Filtration System for GMP-grade products

In biopharmaceutical production, removing contaminants such as viruses, proteins, and impurities from drug solutions is critical to ensure product safety and efficacy. Traditional filtration methods often struggle with these challenging requirements, necessitating advanced filtration technologies to maintain high purification standards.
<h2>Automate and optimize filtration processes</h2>
The Ultrafiltration & Depth Filtration & Poison-removal Filtration Facility from Austar is designed to meet the stringent needs of the biopharmaceutical industry. This system is compatible with Pall and Millipore membrane cassettes and adheres to ASME-BPE specifications to reduce drug solution residuals to the minimum extent. Its 3D modular design and ergonomic considerations ensure operational efficiency and user-friendliness. The facility includes an automatic control system, utilizing a PLC+PC setup to monitor and record pressure before and after the membrane, adjust system liquid supply flow, and log relevant process parameter curves. Customizable designs are available, ensuring the system fits your specific requirements.

Ultrafiltration and depth filtration system for biopharmaceuticals

In the pharmaceutical and chemical manufacturing sectors, handling fine chemical powders poses challenges such as cross-contamination, precise dosing, and minimizing exposure to hazardous materials. Ensuring flexibility, safety, and scalability of processes is crucial for manufacturers aiming to maintain high production standards.
<h2>Achieve precise powder handling and contamination control</h2>
The Fine Chemical Powder System by Austar is designed to address the complexities of managing fine powders in pharmaceutical and chemical manufacturing. This system is adaptable to various production capacities, from large-scale automated operations for single product manufacturing to smaller, multifaceted workshops for handling multiple products. The equipment ensures minimal cross-contamination through strong tightness and diverse equipment combinations. It includes isolating devices such as isolators, glove boxes, and αβ valves for handling highly toxic and active raw materials. Additionally, automated unpacking devices, dust-free feeding systems, and vacuum conveying systems streamline the handling of raw materials packed in 25kg bags. For larger batches, FIBC systems for material transfer and positive pressure feeding bins for non-toxic materials in smaller quantities are utilized, maintaining safety and operational efficiency.

Fine chemical powder system

In various industrial and laboratory environments, ensuring a contaminant-free and safe work area is pivotal. Handling hazardous materials and conducting sensitive chemical reactions require separation from the external environment to protect both the operator and the process integrity.
<h2>Ensures operator safety during complex operations</h2>
The Mini Plant Isolator from Comecer is an isolator designed to provide maximum protection for the operator during operations and to ensure the separation between the external environment and the interior of the isolator itself. The isolator comprises four main glovebox chambers: entrance chamber (A), chemical synthesis chamber (B), weighing chamber (C), and products discharge chamber. It operates under a turbulent flow of nitrogen atmosphere and monitors oxygen levels to maintain safety. The isolator is maintained at a negative pressure relative to the laboratory environment, which prevents contaminants from escaping. It is fully PLC controlled and easy to clean, thereby ensuring smooth operations and minimal downtime.

Mini plant isolator for laboratory protection

In the pharmaceutical and fine chemical industries, precise solids washing and separation are critical tasks. Operators often face challenges such as cross-contamination risk, time-consuming processes, and exposure to hazardous materials.
<h2>Manage solids separation and drying efficiently</h2>
The Agitated Nutsche Filter and Filter-Dryer by De Dietrich Process Systems is designed to meet stringent industry requirements for solid-liquid filtration and drying. This system excels in various tasks including filtration, reslurry washing, and drying under vacuum or convection. It supports multiple filter media options such as cloth, single layer metal screen, and multi-layer sintered metal, enhancing its versatility. A significant feature is the side discharge valve with metal-to-metal seals, eliminating issues with o-rings and ensuring a pressure-tight, cleanable design. The heated filter plate allows efficient heat transfer through all contact surfaces, enhancing drying capabilities. Additionally, the Gas Knife system facilitates total discharge by directing gas streams through small nozzles on the agitator blade. The filter-dryer is constructed from various materials such as 316L stainless steel and Alloy 20 for optimal compatibility with different applications. Designed by De Dietrich, the unit integrates seamlessly into pharmaceutical environments, and is available in configurations to handle highly potent materials with its rigid discharge glovebox and ergonomic design. For processes requiring sterile conditions, SIP capabilities are included to eliminate internal dead spaces.

Agitated nutsche filter and filter-dryer for pharmaceuticals

In chemical plants, the separation and purification of chemicals often face challenges due to the corrosive nature of certain materials. Traditional columns can deteriorate quickly, leading to increased maintenance and potential contamination.
<h2>Provide corrosion resistance and precise chemical separation</h2>
The glass-lined columns from GMM Pfaudler are designed to handle highly corrosive environments in chemical plants. With a shell made of glass-lined steel sections, they offer excellent corrosion resistance. These columns can be supported on brackets, rings, or skirts and come in customizable configurations to suit specific process requirements. The sealing at the body flanges employs the Pfaudler Gasket System 3000 with UF3000 compound. Internal components, made from materials like ceramic or PTFE, enhance the column's performance. Two designs support column internals: body flanges with donut rings for small diameters and a new support pin design to prevent leaks, ideal for large diameters. These columns can operate under a design pressure of 10.0 bar and temperatures between -24º and +200º C. Complete systems include structural steel modules or field-fabricated assemblies with ancillary equipment, ensuring ease of operation and maintenance.

Glass lined columns for chemical plants

In pharmaceutical or chemical industries, transferring sensitive powders safely and maintaining sterility are critical tasks. Ensuring both operator safety and the integrity of the product requires specialized equipment to mitigate contamination risks and handle potentially hazardous materials.
<h2>Ensure sterile powder transfer with split valve technology</h2>
The Sterisplit by Hanningfield Process Systems is a high-regulation split butterfly valve designed for the safe transfer of powders in sterile or potentially dangerous applications. It consists of two halves—active and passive—that mate to form a single valve, allowing powders to flow through while keeping the external surfaces clean. This design ensures that when undocked, the valve remains sterile and safe for handling. Made from stainless steel 1.4404 (AISI 316L), the Sterisplit is compliant with cGMP and EHEDG guidelines, and it is compatible with CIP (clean-in-place) systems. Applicable in processes involving dynamic substances, hormones, antibiotics, or toxic products, the Sterisplit provides reliable security for both the operator and the product. The device is available in various sizes (DN 50, DN 100, DN 150, DN 200, DN 250) and comes with FDA Certification, Material Certificate 3.1, and ATEX compliance.

Split butterfly valve for sterile powder transfer

In the pharmaceutical and chemical industries, the filtration of delicate and difficult-to-filter products is a significant challenge. Ensuring high product yield and minimal residual moisture during the filtration process is critical, particularly when dealing with high-potency active pharmaceutical ingredients (APIs).
<h2>Hermetically sealed for precise and efficient filtration</h2>
The Inverting Filter Centrifuge HF by Heinkel is designed to meet the demands of challenging filtration processes. Featuring a hermetically closed design, this centrifuge ensures contamination-free and automated operation. Its unique inverting mechanism allows for a residual heel-free product discharge, making it optimal for high-potent API products. The centrifuge integrates pressure added centrifugation (PAC) to significantly reduce residual moisture compared to conventional filtration methods. Available in multiple models ranging from the HF 300.1 to HF 1300.1, it offers capacities from 6.5 liters to 350 liters and centrifugal forces up to 1,500 x g. The units are constructed to handle demanding applications, characterized by their robust design and minimal installation within the housing and basket, ensuring the highest possible product yield.

Inverting filter centrifuge for high-potent Api products

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

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