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Dosing API Equipment

Dosing systems are a line of hoppers, feeders, filling machines, and checkweighers that operate in sync to dispense materials accurately. Dosing is an essential feature of the packaging process, whether you’re filling shampoo bottles or tea bags. But dosing equipment is critical for formulations, too, particularly in the pharmaceutical and chemical industries. Imprecise dosing may cause quality degradation in the best-case scenario. In the worst scenario, it creates serious health risks.

Dosing

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)

Filling of transportation bags and discharging them into mix tanks or reactor vessels is often a source of contamination and there potential exposure of personnel to harmful substances.  Inadequate measures to avoid these issues often slow production and reduce profitability.  Experienced biopharmaceutical manufacturers know that equipment designed for general industry use often falls short and rigid containment and transfer solutions for the biotech industry are often awkward and inefficient. Producers that embrace flexible solutions designed specifically for the challenges of our industry will find an advantage over competitors.


<h2>A fast and clean flexible powder transfer system</h2>
ILC Dover is an industry leader in contained material handling solutions for high-tech manufacturers and end users including NASA. The company's EZ BioPac is a single use solution to contamination free powder transfer for the bioprocessing and pharmaceutical industries.  The system consists of a rigid polypropylene stand with an integrated plastic bag.  The stand holds the bag in an open funnel shape for filling and doubles as a lifting point when the bag is ready to be emptied from the bottom.  The bag is oversized and includes enough material to fold back over the stand during filling to protect the stand from any spillage during filling.  The funnel shape of the supported bag in the filling configuration allows for easy manual addition and subtraction of material to ensure accurate fill weights.  A charge neck at the bottom is clamped to your reactor vessel or fill the tank for discharging and a system of clamps is used to manually control material flow and seal the bag for disposal after it is empty.  Isolation of the contained material is thus maximized, greatly reducing cross-contamination of the powder by substances from the work area, and of the work area by the handled powder.

Flexible contained handling of powder transfer bags

Filling of transportation bags and discharging them into mix tanks or reactor vessels is often a source of contamination and there potential exposure of personnel to harmful substances.  Inadequate measures to avoid these issues often slow production and reduce profitability.  Experienced biopharmaceutical manufacturers know that equipment designed for general industry use often falls short and rigid containment and transfer solutions for the biotech industry are often awkward and inefficient. Producers that embrace flexible solutions designed specifically for the challenges of our industry will find an advantage over competitors.


<h2>A fast and clean powder transfer solution for maximum containment during both charging and offloading operations</h2>
ILC Dover is an industry leader in contained material handling solutions for high-tech manufacturers and end users including NASA. The company's DoverPac system provides high levels of reliable containment during both charging and offloading operations.  The system consists of a durable fabric bag with a tough plastic film liner.  The liner includes an upper sleeve for containment during the bag filling operation and a lower sleeve for containment during the offloading operation.  The fabric bag includes lifting points for crane hoisting and serves as a physical restraint keeping the liner and contained powder in a regular and protected shape during transport.  The discharging sleeve at the bottom of the liner includes 2 smaller lateral sleeves which allow for powder sampling for QC without breaking containment.  Both the upper and lower sleeves are manually clamped to your bulk storage hopper, mix tank, or reactor vessel and designed to be crimped, cut off, and eventually removed all while maintaining isolation and containment of the inside of the bag and the interior of your equipment.  In this way, the system provides maximum containment during powder transfer with the ease of use of a simple bag transfer material handling system.

Flexible contained powder charging solution

Poly bottles with split butterfly valves are often used to transfer powders from bulk containment equipment to the point of use while avoiding cross contamination.  However, rigid bottles present several challenges which hinder production and reduce process efficiency.  Experienced biopharmaceutical manufacturers know that equipment designed for general industry use often falls short and rigid containment and transfer solutions for the biotech industry are often awkward and inefficient. Producers that embrace flexible solutions designed specifically for the challenges of our industry will find an advantage over competitors.


<h2>A powder transfer solution for split butterfly valve operations with excellent product recovery and no required cleaning</h2>
ILC Dover is an industry leader in contained material handling solutions for high-tech manufacturers and end users including NASA. The company's Standard Doverpac SF system is a powder transfer solution for split butterfly valve operations that replaces the polybottles traditionally used in these applications.  The system consists of a rugged plastic bag with a split butterfly valve type adapter on the bag’s sole opening. After interfacing with your equipment via the split butterfly valve, the bag is filled and removed and its side of the valve adapter closed. Its contents are then carried to the next point of use and emptied from the bag via the split butterfly valve interface. The bag is one time use and disposed of after emptying—avoiding the need for cleaning and cleaning validation.  New bags are stored in a tightly folded package—reducing the storage space required when compared to poly-bottles. The plastic bags are specifically designed for optimum powder flow and product recovery rates better than 99.5% can be achieved.  A removable and reusable physical restraint consisting of a durable fabric sling with integrated lifting features is available for use to contain and protect the plastic bag during transfer operations.  Use of the physical restraint allows exposure to pressure differentials up to .499 bar with a 2x safety factor.

Flexible contained charging for split butterfly valves

Transferring powders from drums to process equipment such as reactors or mills can create dusty and hazardous conditions in a manufacturing environment and can be a source of worker exposure to hazardous substances in the pharmaceutical and bioprocess industries. Experienced biopharmaceutical manufacturers know that equipment designed for general industry use often falls short and rigid containment and transfer solutions for the biotech industry are often awkward and inefficient. Producers that embrace flexible solutions designed specifically for the challenges of our industry will find an advantage over competitors.


<h2>Safely and easily empty powder drums without sacrificing containment</h2>
ILC Dover is an industry leader in contained material handling solutions for high-tech manufacturers and end users including NASA. The company's flexible contained drum transfer system allows operators to empty the powdered contents of drums used in the pharmaceutical and bioprocess industries without exposure to the contents. The contents are also protected from potential contamination during the transfer process using this equipment. A flexible containment chamber made from ILC Dover’s rugged Armorflex material is anchored to a raised stainless steel frame using ergonomic bungee cords. The containment chamber includes a discharge sleeve, a drum sleeve, and 2 glove sleeves for operator manipulation of the drum lid and internal liner under contained conditions. A closed drum is placed on the integrated pneumatic drum lift and the drum sleeve is attached. The discharge sleeve is attached to a ring in the frame designed to interface with downstream process equipment. The containment chamber is at a height off the floor which allows the powder to be gravity fed into downstream process equipment or containment solutions placed under it. The operator then raises the drum to the containment chamber with the simple actuation of a lever and opens the lid using the integrated glove sleeves. This manual interaction allows the operator to ensure that all powder flows out of the drum liner to the next process stage without being directly exposed to it. When the drum is empty, its spent liner is placed inside of it and its lid replaced. It is then lowered back to the floor and discarded. The sleeves in the flexible containment system are twisted closed and crimped off ensuring no powder contamination of the surrounding environment. The containment chamber is then discarded and the process repeated for each new drum to be transferred.

Flexible contained drum transfer system

Flexible intermediate bulk containers known as FIBC’s are commonly used in a wide variety of industrial processes. The pharmaceutical and bioprocess industries; however, require a higher degree of containment and a more carefully designed container. Experienced biopharmaceutical manufacturers know that equipment designed for general industry use often falls short and rigid containment and transfer solutions for the biotech industry are often awkward and inefficient. Producers that embrace flexible solutions designed specifically for the challenges of our industry will find an advantage over competitors.


<h2>A bulk transport and storage bag with superior product containment</h2>
ILC Dover is an industry leader in contained material handling solutions for high-tech manufacturers and end users including NASA. For transport and storage of bulk materials of a potentially more hazardous nature, the company has developed a bulk bag system with superior containment characteristics. Traditional FIBC’s often do not provide enough containment for use in the pharmaceutical and bioprocess industries. Their use in these industries can cause, compromised facility cleanliness, cross-contamination, and risk of employee exposure to unnecessary hazards. The G2PAC system from ILC Dover provides the same benefits as traditional FIBC’s like integrated lifting features and a 35” cubed size for easy use with standard pallets. However, this system also includes features that make it much more effective at containing products during transfer and storage. An inner liner is included made of ILC Dover’s ArmorFlex material that includes sleeves that are clamped to interfacing process equipment ensuring containment during transfer.  Individual sleeves are included to support both charging and offloading operations. The system can achieve containment levels down to 100ug/m^3 on an 8 hour TWA.

Flexible contained powder discharge into FIBC’s

Powdered products are handled every day in the pharmaceutical and bioprocess industries and an efficient means of filling drums while maintaining containment is needed to ensure safe and profitable production processes. Experienced biopharmaceutical manufacturers know that equipment designed for general industry use often falls short and rigid containment and transfer solutions for the biotech industry are often awkward and inefficient.  Producers that embrace flexible solutions designed specifically for the challenges of our industry will find an advantage over competitors.


<h2>A disposable drum liner  for continuous production of powders</h2>
ILC Dover is an industry leader in contained material handling solutions for high-tech manufacturers and end users including NASA. For powder discharge into drums, the company has developed the Dover Pac system. The Dover Pac Continuous Liner is typically used to offload powders from vessels into drums for the pharmaceutical and bioprocess industries. The liners interface directly with existing process equipment including down-flow booths and isolators. The liners are continuous which both eliminates cross-contamination of powders, and enhances operation efficiency by eliminating the need for the operator to constantly place new liners over a discharge nozzle as with traditional drum liners. The liners are shipped in pack lengths of 15 M to 45 M with each standard drum using about 1.5 M of liner material. Drums are continuously filled until the liner pack is spent. Spent packs are easily replaced by an operator without breaking the containment of the powder. The continuous liners are available for use with 580mm, 355mm, or 200mm canisters with adapters available for interfaces to smaller canisters if required.

Flexible contained powder discharge into drums

In many laboratory applications and production processes, smaller quantities of powder products need to be dosed into lab equipment or tiny containers. Similarly, in pilot plants where production processes are simulated, lesser volumes of dry material need to be metered and dispensed.


<h2><strong>Accurately dose small quantities of powders</strong></h2>
The compact Hethon feeder 30 is capable of delivering at rates ranging from 15 ml per hour to 35 liters per hour, depending on the screw utilized and the material to be dosed.

The flexible hopper can hold up to 1 liter of product, but the working volume may be increased to 1.2 liters by adding the optional extension hopper.

Paddles situated against the outside of both converging hopper walls are mechanically rocked back and forth to prevent bridges or rat-holes, assuring efficient filling of the feed screw for optimum volumetric performance, even with very small doses.

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Small feeder with flexible wall hopper

If you need to process high value food, pharmaceuticals or chemicals, there is no room for error when measuring. Having a reliable measuring equipment to measure small amounts of powders is crucial to maintain product quality. This is important to avoid incorrect testing results or poor product quality. An efficient and carefully calibrated measuring system is required by most of the relevant ISO standards and essential to achieve accurate results.


<h2>Increased efficiency and accuracy during microdosing</h2>
Alba’s Dosing System Micro allows fast and high precision dosing of free-flowing powders and granules, ensuring that dosing is no longer a bottleneck in the production process. It can be used as a stand-alone device or incorporated in programmable logic controlling systems. It is highly accurate, when dosing and storing small amounts of powders with a dosing capacity starting from 200 mg onwards.

The gravimetric powder microdosing 0.400 - 2 g is configured to handle challenging micro-ingredients while reducing wastage and increasing production. It has a modular design allowing great flexibility when it comes to specific process requirements. It is equipped with extremely precise dosing units making it highly efficient. These units can be used for precise powder dosing in processes that can allow a dosing time of 7 – 15 seconds. It keeps a constant check on the flow and weight of the material fed. Its adaptive control algorithm adjusts the frequency of the vibrating feeder.

Gravimetric powder microdosing 0.400 - 2 g

Powders and granules are commonly dosed for the manufacturing of pharmaceuticals, nutraceuticals and high-value foods. Highly accurate dosing and tight sealing is crucial in these production processes to maintain product quality and avoid any errors. You thus need a dosing solution which is made to measure micro-ingredients accurately while being able to meet the strictest requirements of pharmaceutical industry.


<h2>Highly accurate and efficient dosing system</h2>
Alba’s Dosing system MILLI is a gravimetric dosing system which can help you achieve fast and highly precise dosing of free-flowing powders and granulates. It has a dosing capacity of 1-100g depending on the characteristics of your powder. It can be used both as a stand-alone device or incorporated in programmable logic controlling systems.

The gravimetric powder microdosing 2 - 100 g has a modular design which makes it very flexible to be customised according to your specific needs. Its adaptive control algorithm adjusts the frequency of the vibrating feeder by keeping a constant check the flow of material and weight. It thus guarantees high accuracy throughout the dosing range. It has extremely accurate dosing units which only requires a dosing time of 7 – 15 seconds. It is also certified to be used in explosive zones 21 and 22.

Gravimetric powder microdosing 2 - 100 g

Micro-dosing powders of high-value food or chemical products can be challenging when high precision and zero error is required. You need a highly accurate and efficient dosing solution of relatively large quantities of micro-ingredients which can meet the the relevant ISO standards.


<h2>Save time with optimal dosing accuracy</h2>
Alba’s Dosing system DUPLEX is a gravimetric microdosing system which enables the fast dosing of small amounts of powders. It has unparalleled precision with 99.8% accuracy making it ideal to for implementing a good quality system. Its modular design also allows for a great amount of flexibility when it comes to specific process requirements.

Fast gravimetric powder microdosing 50 - 200 g is configured with a duplex or two-tier dosing technology. It requires a dosing time only between 8-12 seconds which is dependent on the characteristics of the material. This allows fast and accurate dosing of relatively large quantities from 50 - 200g of material. It is also equipped with a check-weighing function for the ejection of overweight dosages. This makes it particularly suitable for filling applications with zero tolerance to non-conforming end products.

Fast gravimetric powder microdosing 50 - 200 g

Having a reliable and accurate weighing and measuring solution is absolutely essential, especially in the pharmaceutical industry to maintain ingredient dosage quality. If you have a rather small production plant, you need a compact and ergonomic weighing scale to help increase efficiency.


<h2>Save costs with a more flexible weighing scale</h2>
Alba’s mobile scale is an industrial scale allowing a great amount of flexibility. It requires minimal space compared to floor scales as one mobile scale can be a substitute for several floor scales. It is very precise and can take load capacities of 30, 60, 100 and 150 kg. It is battery powered with a simple and convenient configuration making it easy to move around while working safely.

Hygienic mobile scale

Pharmaceutical powders in metered doses demand maximum filling precision. This is particularly challenging with materials in the micro-gram range. Fine powders may exhibit complex behaviors that develop into a bottleneck in the production line.
<h2>High precision multiple powder dosing in the mg range</h2>
µPTS from Dec Group is a patented technology offering precision dosing of minimal powder weights at a fast turnover. The PTS technology performs powder dosing from a &lt;1 mg in less than a second and with an accuracy rate reaching 2% RSD. The hopper is designed for powders with challenging flow properties to facilitate the powder transfer process. The system does not have an integrated filter, and it can dose ultra-fine and sticky materials.

The solution employs vacuum technology to transfer the powder to the calibrated chamber. Before dosing, the µPTS automates vial charging, positioning, and taring. The measured dose is then ejected using a piston and weighed ahead of filling. A linear motor may be regulated in a closed loop with a weighing device to change the volume automatically.

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Powder micro-dosing system

Dosing multiple powders in a batch process is time inefficient, especially when handling small quantities of materials. But dose precision is a more important consideration, leading manufacturers to give up on speed to preserve accuracy.
<h2>Precise powder dosing equipment with multiple filling capacity</h2>
sPTS from Dec Group provides for dosing of small, regulated amounts of powder at a predetermined frequency. Based on PTS technology, it allows small powder quantities for separate applications to be dosed simultaneously. The system has a dosing range of &gt;100 g and runs at a speed of 5 to 20 seconds. The technology operates with an accuracy of up to 5% RSD.

In the powder dosing operation, a fixed volume calibrated chamber is firstly filled under vacuum and then emptied under pressure. The sPTS system contains a filtration membrane in the upper section. As per the requirement of the packaging machines, this compact system can be mounted in a battery to fill multiple points concurrently.

Accurate multiple dosing system for powders

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 pharmaceutical manufacturing, precise and accurate dosing of powder is essential for maintaining product quality and compliance with industry standards. Traditional methods may fall short in achieving the required precision and control, leading to inconsistencies and inefficiencies in the production process.
<h2>Ensures accurate and continuous dosing of powders</h2>
The dosing and weighing system by Agierre is a specialized solution designed for bulk material handling in the pharmaceutical industry. Utilizing a rotary and dosing valve managed by an analogic electro-pneumatic system, this technology guarantees fine and precise dosing. The system allows powders to flow freely, ensuring continuous and accurate dosing of small to medium quantities. The high-performance setup can be customized according to client specifications, making it adaptable to various operational needs. Agierre's dosing system is ideal for applications requiring stringent dosing accuracy, such as the production of pharmaceuticals, where maintaining consistent quality is crucial. The system is also notable for its reliability and low maintenance requirements.

Powder dosing and weighing system

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 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 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.

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Horizontal vacuum dryer with eccentric agitator

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

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

Lowering heat stresses on API by reducing friction

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