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API filling Equipment

Filling lines are used extensively in all industries, such as food, pharmaceutical, chemical, and cosmetics, to accurately package different products into a container suitable for that product. Although the filling process is at the very end of the production line, it is no less important than the earlier steps. Last but not least, the idiom that dates back to 1382 when John Wyclif wrote the firste the laste, and the laste the firste, indicates just that the last things on a list are just as valuable as the previous ones. In this case, this idiom fits perfectly.

Filling

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)

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

<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

Traditional horizontal form fill and seal sachet machines for lower volume lines are often fixed in the sachet type they can fill, restricting their flexibility and reducing cost-effectiveness. An entry-level sachet machine that has been purpose-designed to be able to produce a range of sachets adds value and increases the return on investment.


<h2>Flexible machine for packaging solids and liquids in flat sachets</h2>
The Bossar Packaging B1400 is a uniquely versatile HFFS machine designed for forming a variety of flat sachets and filling them with liquid or solid contents.

Robustly made, the B1400 uses traditional walking beam transport systems powered mechanically by cam drives. This offers good levels of reliability coupled with ease of maintenance and adjustment. Its well-engineered mechanical drive system keeps operating noise levels to less than 80dB.

B1400 can be fitted with up to 2 filling stations which allows a throughput of up to 220 sachets per minute. In standard configuration, the B1400 can fill 110 sachets per minute with up to 400cc of contents.

Flexibility is the B1400’s greatest strength. This machine can produce either flat 3- or 4-sided seal sachets, twin sachets, flat sachets with eurohole or display perforation, flat sachets with partial shape, or sachets for wet wipes.

Featuring a cleverly designed pouch-stretching station, the B1400 opens its sachets as wide as possible, enabling a higher filling grade.

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Entry level HFFS Machine for flat sachets

Active pharmaceutical ingredients demand high handling standards to prevent cross-contamination. Moreover, the processing of materials creates risks to occupational safety and health, especially where highly potent APIs are involved. But, while formulas may be kept separate during processing, loading them into different bagging machines leads to production inefficiencies.
<h2>Modular big bag filling equipment for powdered process bulk materials</h2>
Big Bag Filling station from Dec Group is a universal solution for the direct filling of big bags .  The station integrates into other process equipment like mixers or driers with gravity-assisted filling. In cases where headroom is limited, the station can be modeled for remote-filling instead. Here,  powder transfer technology moves the materials through a valve system for correct dosing.

The holding frame is either painted steel or stainless steel and has a big bag loop holder with a fast-release mechanism. The Big Bag Filling station includes a range of other solutions, including sieving, milling, metal detection and separation, sampling, weighing, and precise dispensing. The equipment uses a standard pallet jack for easy installation of pallets.

Big bag filling machine

In pharmaceutical manufacturing, handling highly potent active pharmaceutical ingredients (HPAPIs) such as oncological, hormonal, and antiviral compounds poses significant safety challenges. Ensuring operator safety and product integrity while maintaining high containment standards is critical.
<h2>Fill capsules with high containment and precision</h2>
The SECUREFILL 40T by ACG World is part of the SECUREFILL series, designed for high-level containment in capsule filling. Supporting occupational exposure band (OEB) up to level 4, this system ensures complete containment, avoiding operator contact within OEL range 1-10 µg/m³. It features a monoblock structure of SS316L with HEPA filters, a rapid transfer port (RTP), and glove ports. The accurate dosing mechanisms maintain a negative pressure environment, ensuring precise filling of oncological, hormonal, biopharmaceutical, and antiviral formulations. The integrated wet-in-place system conveniently wets all suspended particles, making cleaning efficient and straightforward. The SECUREFILL 40T can handle various capsule sizes from 00 to 5 at a maximum speed of 40,000 capsules per hour, making it ideal for medium to large production batches. Compatible with additional equipment like check-weighers, metal detectors, and de-dusters, this machine ensures the production of high-quality capsules under safe conditions.

Containment capsule filler for highly potent drugs

In the pharmaceutical industry, handling highly potent active pharmaceutical ingredients (HPAPIs) requires advanced containment. These ingredients, often used in oncology and hormonal therapies, pose significant risks to operators and require strict occupational exposure limits (OELs) to ensure safety.
<h2>Fill capsules with potent drugs safely</h2>
The SECUREFILL 6T by ACG World is designed to fill capsules with oncological, hormonal, biopharmaceutical, and antiviral formulations. It complies with occupational exposure band (OEB) up to level 4, protecting operators from exposure to HPAPIs with OELs from 1-10 µg/m³. The system features a monoblock structure of stainless steel SS316L, HEPA filters, glove ports, and rapid transfer ports (RTP). The SECUREFILL 6T ensures efficient wet-in-place cleaning to capture suspended particles, providing safety and simplifying maintenance. It is ideal for small production batches and can process capsules of sizes ranging from 00 to 5 at a maximum speed of 6,000 capsules per hour. Its compatibility with check-weighers, metal detectors, and de-dusters further safeguards against contamination throughout the production line. This makes the SECUREFILL 6T a practical choice for industries handling highly potent and cytotoxic drug formulations.

Containment capsule filling system for highly potent drugs

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

Industrial homogenizer for food and beverage applications

In the field of nuclear medicine, ensuring precise and aseptic dispensing of radiopharmaceuticals is critical. The challenge is to maximize efficiency while minimizing operator exposure to radiation. High throughput and strict compliance with sterile production standards are essential.
<h2>Automates dispensing, filling, and inspection</h2>
The Automated Ioflupane I-123 Injection dispensing plant is an advanced solution designed by Comecer. It features a highly automated process capable of dispensing 360 vials per hour, with a batch capacity of 500 vials. The plant includes 12 shielded isolators optimizing transport, aseptic filling, visual inspection, and labelling systems. It integrates an automatic synthesis and purification system using HPLC, ensuring precise formulation and sterilization of 123I Ioflupane. The automatic vial filling machine encompasses vial stoppering, capping, crimping, and ensures 100% weight control for enhanced accuracy. Additional features include semi-automatic visual inspection for quality assurance, decontamination with VPHP, and reduced operator radio-exposure. Suitable for nuclear medicine applications, the plant guarantees efficient, sterile production with comprehensive automation enhancing productivity and safety.

Automated ioflupane i-123 injection dispensing solution

In the radiopharmaceutical industry, handling irradiated materials requires stringent safety measures and precise operations. The manipulation of solid targets during the production and dispensing of radiopharmaceuticals must adhere to current GMP guidelines to ensure safety and efficiency.
<h2>Handle and dispense irradiated materials safely</h2>
The SPECT Production Hot Cell by Comecer is a comprehensive system designed for the safe manipulation of irradiated materials. It includes seven hot cells connected by a transfer system called the 'Conveyor'. The cells feature shielding of 75 to 150 mm of lead and PVC working chambers. The lineup consists of various hot cells specialized for different tasks: a Receiving Hot Cell for receiving targets, a Recovery Hot Cell for storing materials, three Chemistry Hot Cells for synthesizing radiopharmaceuticals, and two Automatic Dispensing Systems equipped with robotic arms for precise calibration and dispensing. The system handles isotopes such as Tl-201 and Ga-67 and ensures seamless transfer of materials between different cells.

Hot cell system for solid target manipulation in radiopharma

In bulk antibiotic production, precise handling of active pharmaceutical ingredients (APIs) is critical to maintain product sterility and efficiency. The process requires isolating the powder, minimizing contamination risks, and ensuring accurate measurements throughout the tipping and filling stages.
<h2>Ensures aseptic conditions in bulk Api production</h2>
The Tipping & Filling Line for Bulk API Powder by Comecer is designed specifically for the sterile handling of antibiotic powders. This advanced plant features three fully automatic lines and a component preparation isolator to ensure the API powder remains uncontaminated. The system's stellar valve enables precise filling, achieving an accuracy of ±25g on a 10kg fill. An automatic cleaning-in-place (CIP) and sterilization-in-place (SIP) system guarantees all product contact parts are clean and sterile. Additionally, the system includes an automatic discharge station, washing, and drying within isolators, and an autoclave offloading process using an anthropomorphic robot under a Grade A isolator. This setup not only maintains the highest operational efficiency but also offers a fully automated process that meets stringent aseptic conditions.

Tipping and filling line for bulk Api powder production

In the pharmaceutical and healthcare industries, precision packaging is crucial for maintaining product integrity and ensuring accurate dosing. Challenges include handling small doses, maintaining sterility, and achieving high production speeds without compromising quality.
<h2>Package pharmaceuticals efficiently with multiple lanes</h2>
The PHS-100 from Enflex (part of the Coesia Group) is an intermittent stick pack system designed to meet stringent pharmaceutical and healthcare packaging requirements. The system operates with up to 24 lanes, allowing for speeds up to 1800 stick packs per minute (spm). This high-capacity throughput ensures efficient production while maintaining precise packaging standards. It is particularly suitable for OTC, other pharmaceutical and healthcare applications, and prescription packaging. The PHS-100’s design addresses challenges such as sterility and accuracy, ensuring each pack is consistent. Furthermore, the system offers easy switching between different batch sizes, optimizing flexibility for various production needs.

Intermittent stick pack machine for pharma and healthcare

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 pharmaceutical research and development, testing new active ingredients and producing small batches often require stringent user protection due to potential exposure to hazardous substances.
<h2>Ensure safe and controlled capsule filling</h2>
The Modu-C LS Containment from Harro Höfliger is a specialized capsule filling system designed for lab-scale and small batch production where high user protection is essential. This system, suitable for OEB Class 4 substances (1-10 μg/m³), incorporates a patented trolley system for rapid and flexible dosing system changes. It features the Modular Advanced Barrier System (MABS), providing robust containment while maintaining accessibility through large operator entries. The system offers a variety of dosing units, including drums, dosators, tamping stations, and options for pellets, tablets, mini-tablets, and liquids. With its no-cap-no-fill function, it minimizes product loss, and the integration of differential pressure measurement ensures precise control and inspection of capsules. The compact design facilitates easy operation and cleaning while supporting PRP functions for person-reduced production. It supports up to 25,000 capsules per hour and accommodates all common capsule sizes, making it ideal for producing test material for clinical studies, double blinding, and small batch productions.

Containment capsule filling system for lab and small batch production

In pharmaceutical and packaging industries, creating precise and customized portion packs is essential for patient safety and dosage accuracy. Ensuring the correct amount of active-ingredient powder in blister cavities presents a challenge due to varying particle sizes and densities.
<h2>Form, fill, seal, and punch primary packaging</h2>
The Omni FS by Harro Höfliger is a modular lab system designed for producing portion packs, such as blister sheets, with high precision. It consists of four workstations that can operate individually or in parallel, allowing for flexibility in production processes. The system includes semi-automatic dosing systems capable of filling both powders and liquids. The Omni FS can handle various tasks including forming, filling, sealing, cutting, and punching packaging materials. Notably, it is equipped with advanced dosing systems that accurately fill powder doses ranging from 10 to 5000 mg, accommodating particle sizes as small as 1 µm. The machine's adaptable design ensures seamless integration of additional stations as needed, making it suitable for diverse production requirements in the pharmaceutical and packaging sectors.

Lab machine for producing portion packs

In the pharmaceutical industry, ensuring the integrity and quality of each product container is critical. Failures in fill levels, closure tightness, and labeling can lead to costly recalls and compliance issues. An automated, precise, and comprehensive inspection system is needed to mitigate these risks.
<h2>Ensures quality with automated checks and rejections</h2>
The HEUFT PRIME is a compact full product inspection system designed specifically for the pharmaceutical, cosmetic, and care product industries. What sets the HEUFT PRIME apart are its integrated detection technologies that can inspect fill levels, closure presence and position, and label adherence. Infrared, high-frequency, and X-ray technologies enable precise fill level detection for both transparent and opaque containers. The closure detection module identifies missing, misaligned, or leaking closures with special sensor and optical technologies. Label checks are conducted using sensors that exploit the reflection characteristics of the container surface and label material. In addition, the HEUFT PRIME employs a serial fault detection mechanism to prevent recurring issues from affecting entire batches. Its high degree of automation, coupled with the audiovisual HEUFT NaVi user guidance system, makes it user-friendly. Furthermore, the system supports network-based documentation and remote maintenance for enhanced quality management.

Compact full product inspection system for pharmaceuticals

In pharma production, controlling the dosage and sterility of antibiotic powders is critical. Missteps can lead to compromised product quality and patient safety, making precision filling and stoppering essential.
<h2>Vacuum-pressure powder filling and dual dosing</h2>
The SMART PWD by IMA is designed for precise dosing and stoppering of pharmaceutical powders. This system can accurately fill vials using a vacuum-pressure method, handling up to two different powders concurrently. Each vial undergoes 100% in-process control (IPC), ensuring exact dosage. The pick-and-place stoppering system, driven by brushless motors, accommodates various vial sizes, enhancing operational speed and flexibility. Integrated options include capping and wetting in place, tailored for isolation technology. With a capacity of up to 150 vials per minute, the SMART PWD offers robust performance for antibiotic powder production, addressing both quality and efficiency.

Powder filling and stoppering for antibiotic production

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.

&nbsp;

Horizontal vacuum dryer with eccentric agitator

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

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

Lowering heat stresses on API by reducing friction

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