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Containment technology for making API Equipment

The essential objectives of containment systems are personnel protection and preventing the release of toxic or infectious material into the environment. Containment is also used to prevent a product or sample from contamination by the external environment. In the chemical and pharmaceutical industries, containment solutions are used to protect the personnel from the leaking of airborne particles of hazardous substances, as powders or liquids are handled or transferred during processing.

Containment

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)

Create a physical barrier between the operator and the product. More flexible than an isolator, a RABS is open, in most cases, so the air flows freely out of the RABS and into the surrounding room.


<h2>Protect the product from contamination without losing access to the process</h2>
The RABS from Telstar Life-Sciences provide protection by delivering an aerodynamic barrier over a critical process zone and bio-decontamination is usually manual. RABS when installed in ISO 7 environments already have a good class of cleanroom air therefore the RABS can provide ISO 5 in the critical zone.

Because RABS are being used more and more in aseptic processing they have developed to an extent where there are various types, such as the Closed RABS (cRABS), which consists in air passing through the critical zone, and it is filtered before it spills into the cleanroom or is recirculated back through the supply filters of the RABS.

Restricted-access barrier systems

Designed for sterile product and Potent API’s either with low or high OEL requirements.


<h2>Advanced aseptic processing from full filling lines to stand alone single isolators</h2>
The aseptic barrier systems from Telstar Life-Sciences work providing product protection in all process areas against external environment, operator and bacterial growth contamination. Airflow systems may be unidirectional or turbulent. Interfaced with H2O2 generators to provide validated automated surface sterilization internal to the Isolator.

From full filling lines to stand alone single Isolators, barrier systems are designed to provide solutions adhering to regulatory standards and guidelines. Running at positive pressure during normal conditions with auto change to negative in the unlikely event of system breech, when toxic products are involved.

Telstar Aseptic Barrier Systems are guaranteed to comply with relevant standards and demands set by the regulatory bodies to ensure conformance and clients satisfaction, including: ISO 14644-1 Cleanroom &amp; Associated Controlled Environment, FS 209E Airborne Particulate Cleanliness, cGMP Guidelines (current Good Manufacturing Practices), ISPE guidelines (The Society of Pharmaceutical and Medical Device Professionals), FDA (Food and Drug Administration, MCA (Medical Control Agency), and  American Glovebox Society Guidelines.

Aseptic barrier systems

A high-performance transfer port system that combines ultimate safety, simplicity of operation, and ideal cleaning, used in pharmaceutical and biopharmaceutical manufacturing.
<h2>High-integrity locking system, preventing accidental containment breach</h2>
The Containment Transfer System (CTS) product range from Telstar Life-Sciences is a versatile combination of technologies that provides you with the flexibility to safely and securely transfer products in high containment environments. A number of sizes and design options are available to suit your containment requirements, security needs, and budget.

Contained transfer systems are specially designed as the safest method for transferring product/waste or items in or out of contained or sterile areas. Totally mechanical system (no power needed) with safety devices to prevent incorrect operations (not operator dependent) and with color indicators on the locking mechanism provide visual feedback of the transfer's port status.

Transfer system for high-containment environments

Testing device of the containment capability of gloves, which is as important as the other parts of the integrated system; and a simple, accessible means of checking interface integrity is critical.


<h2>Testing system to enable fast, easy measurement of glove containment efficiency</h2>
Glove Tester from Telstar Life-Sciences is a low cost manually operated single port testing device designed to allow both in situ and offline testing.

Constructed of acetyl or 316L stainless steel, the device uses air pressure to check glove integrity. It can be designed to suit all types of Telstar ACE glove ports as well as other port brands. The tester inflates the glove at +500Pa pressure for a period of at least five minutes. A leak is indicated by a drop in the pressure reading of the display gauge. An optional colour indicator gives an instant pass/fail assessment.

Glove tester

Designed to allow operators to perform sterility testing in an aseptic environment providing assurance of material integrity.


<h2>For ultimate containment of all API and potent compounds, where the containment capability is crucial</h2>
The Half-suit tester from Telstar life-Sciences is the most likely component of the isolator which mission is to suffer wear and tear and thus develop leaks. Due to it works in the critical zone, guarantees special attention at the design stage and when monitoring protocols are developed.

The containment capability of half-suits is therefore as crucial as any other part of the integrated system, and a simple, accessible means of checking interface integrity is critical.

Telstar ACE offers custom-built testing systems to enable fast, easy measurement of half-suit containment efficiency. The Telstar Half-suit Tester is designed to allow both in situ and offline testing.

Half-suit tester

Provides the highest levels of operator protection from potentially harmful airborne contaminants generated during manual powder handling operations such as sampling, charging and dispensing.


<h2>Remove airborne particles from the operator's breathing zone</h2>
The downflow booth from Telstar Life-Science operates on a re-circulatory airflow principle. Clean laminar flow air is supplied from the ceiling, suppressing any dust clouds generated during any processing operation and removing airborne particles from the operator's breathing zone (OEL &lt; 100 µg/m3).

The fact that the booth works with a net inward airflow, ensures airborne contamination cannot escape into the external environment completing the many advantages of this effective containment system.

Down flow booths are frequently used in Pharmaceutical, Cosmetic, fine Chemical, Food and Nanotechnology industries.

Downflow booth

HEPA filtered vertical laminar airflow (down flow) creates an ISO 14644-1 (Class 5) work area and prevents ambient air entering the work area, ensures product protection.


<h2>Create a class 5 work environment for non-hazardous materials</h2>
Telstar vertical clean benches ensure optimum product protection with HEPA filtration. Heavy duty construction and reliability make them convenient in the long term for all sectors of application and environments. Vertical laminar flow cabinets can be made in special sizes and can be customized to suit particular applications.

Special models have been developed to create the optimum work environment for PCR (polymerase chain reactions) and for lab environments. Down flow booth models are available that work fully with recirculated laminar HEPA filtered air (Telstar V-100) or partially recirculated laminar HEPA filtered air (Telstar V30/70).

Vertical laminar flow cabinet

HEPA filtered horizontal laminar airflow (crossflow) creates an ISO 14644-1 (Class 5) work area and prevents ambient air entering the work area, ensures product protection.


<h2>Particularly well adapted to hospital, control laboratories and life science environments</h2>
Horizontal Laminar Flow benches from Telstar Life-Science have a wide and high working space with a continuously flushed frontward by a particle free HEPA filtered and laminar airflow; which speed prevents contamination from operator and lab environment. The laminarity of the flow prevents cross contamination between the items handled in the working space.

Offering the highest product protection possible in an open system. It makes them particularly suitable for the handling of non-hazardous products, sensible to dust and/or to contamination such as injectable medicines, cell and tissue cultures, food sample preparation for sterility testing as well as micromechanics, optics, electronics.

Horizontal laminar flow benches

Ideal for products which have no biological risk but require high sterile conditions.


<h2>Start working in the lab under high sterile conditions</h2>
Sterilator from Telstar Life-Science is a positive-pressure isolator, which provides laminar airflow in the working chamber, making it ideal for products that require high sterile conditions.

This equipment not only provides a high level of containment against external contamination, but avoids the risk of cross contamination as they provide laminar air flow to the working chamber.

Positive pressure isolator

Used for products biologically hazardous, that also require minimized cross contamination.


<h2>Start working with hazardous substances thanks to this perfectly adapted device</h2>
The Cytolator from Telstar Life-Science is a negative-pressure isolator, which works providing laminar airflow within the working chamber while ensures a minimum of cross contamination. The Cytolator main chamber pressure (vs. ambient) is negative to the room. Both the main chamber and pass-through are always negative to the room, and provide protection to the product, user and environment.

An additional third HEPA H14 prefiltration stage right below the workbench adapts the isolator to the requirements in the manipulation of hazardous substances like the preparation of cytotoxic medicines as prescribed in some countries recommendations.

Negative pressure isolator

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

Flexible disposable containment systems in the form of specially designed plastic bags are an excellent choice for addressing powder transfer challenges.  However the bags must be sealed in a way that economical, easy to use, and above all,  reliable.  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 reliable bag closure system designed for pharmaceutical processing</h2>
ILC Dover is an industry leader in contained material handling solutions for high-tech manufacturers and end users including NASA. The company's CripmLoc system reliably closes flexible containment systems (often in the form of a plastic bag) to ensure containment and contamination avoidance during and after powder transfer operations for the pharmaceutical and bioprocessing industries.    The system includes an ergonomically designed applicator gun and one-time-use plastic crimps of various sizes.  Two plastic crimps are loaded into the gun in preparation for the closing operation.  Each crimp completely closes the bag when installed.  Two crimps are simultaneously installed by a single actuation of the gun.  Cutting between the crimps thus allows areas of the bag to be separated from one another without losing containment of either section.  The flexible containment system is twisted in the area to be closed with the plastic crimp clamping the twisted material together maintaining closure.  Each crimp also includes a snap-in-place cap that covers the cut end of the twisted bag—further ensuring containment and resistance to infiltration of contaminants.  Crimps are readily removed by the gun by applying pressure to a particular surface of the closed crimp causing it to separate—this avoids the issue of potential plastic shard contamination when other closing devices are cut or broken during removal.

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Crimping system

Maintaining the purity of products as well as avoiding worker exposure to potentially harmful substances are critical to any biotech process and often there is no better way than a glove box to achieve these goals while allowing for manual handling of the materials. 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 quickly implemented, low capital expenditure glove box for the biotech industry with excellent operator ergonomics</h2>
ILC Dover is an industry leader in contained material handling solutions for high-tech manufacturers and end users including NASA.  Making use of the company’s ArmorFlex brand of rugged plastic film designed for the biotech industry, the DoverPac Flexible Containment Technologies line of containment solutions are a glove boxes ready to be used to support your process with little capital expenditure and low implementation time.  The glove boxes consist of a stainless steel frame built to your requirements that is lined with a layer of ArmorFlex film.  The Armorflex is clear and highly flexible but is supported by the frame to form a convenient operator workspace.  Gloves and sleeves are integrated into the film and supported at the front of the frame.  Using these sleeves, an operator can manipulate items in the chamber without risk of exposure to contamination. The use of the simple frame and flexible clear plastic film make these units less expensive than traditional glove boxes while allowing better operator ergonomics by avoiding a fixed rigid containment box and limited viewing ports.

Flexible enclosures

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

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

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

Drawing a sample for evaluation from a running process is not a simple task, especially when dealing with sensitive products. Sampling can break product containment and lead to issues with product quality as well as pose health hazards in the work environment.


<h2><strong>Take samples from a running process without compromising containment</strong></h2>
The ASAM Andocksysteme sampler is the first valve in the pharmaceutical and chemical industry capable of taking a sample from a running process under high containment requirements. The sampler consists of two parts each with one-half of a sphere. The active part of the sampler is firmly attached, with a pad-flange, to the process container from which sample is to be taken. The passive part of the sampler is equipped with a split valve with integrated bore hole and a container for the product sample. The sampler can also be connected to a glove box for evaluation. The containment values achievable are less than 0.01µg/m3.

The contamination-free sampler ASAM can be directly integrated to dryers, agitators, centrifuges, silos, product tubes and other process containers. The halves of the split valves with their specific PTFE seals make SIP and CIP applications possible by means of a special tool.

High containment sampler

Valves fitted in blenders and dryers can have dead spaces that prevent complete processing of the product and negatively affect quality. Ordinary valves can also be difficult to clean and often need dis-assembly for complete cleaning.


<h2><strong>Control product flow with completely opening valves</strong></h2>
Ball valves from Andocksysteme are used in piping, blenders, mixers, dryers, reactors, agitator vessels and sluices to fully allow or completely shut the flow of a product. A segment ball valve consists of a housing and a ball segment supported on both sides by maintenance-free bearings and sealed with an inflatable seal. Andocksysteme ball valves allow even difficult flowing products to pass the valve's unobstructed full bore in a short amount of time. They can be used as both inlet and outlet valve.

Andocksysteme ball valves are also available with CIP nozzles or retractable CIP lances for cleaning without disassembly. They are ideal for dryers and blenders as they have a minimum of dead space which increases product quality. All Andocksysteme ball valves are certified according to air quality control TA-Luft VDI 2440.

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High containment segment ball valve

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

Thermal and mechanical changes can lead to stresses in industrial piping systems. These stresses can be transferred to components causing misalignment and leakages. They may also cause inaccuracies in weighing and other sensitive measurements.


<h2><strong>Connect chutes and process equipment without pipe stress</strong></h2>
Andocksysteme offers a wide range of compensators and bellows to eliminate misalignment and stress-related issues. These components provide a reliable, stress-free connection between transfer chutes and process equipment with strict weighing requirements. They are ideal for transfer of powders in the pharmaceutical industry. A complete range of injection mold tooling allows Andocksysteme to produce compensators and bellows in the desired length and thickness.

The internal diameter of the compensator is matched to the diameter of the process-chute to eliminate difficult to clean crevices or ledges and allow effective WIP/CIP. Andocksysteme bellows and compensators offer a range of material hardness and connection standards. Material choices include FDA compliant white and black EPDM, Viton, silicone (on request) and FFKM / FFPM elastomers for particularly aggressive duties.

Bellows for pharmaceutical powders

Transfer of sensitive and toxic bulk goods across process units requires specialist handling to prevent cross-contamination and satisfy stringent GMP requirements. Often complex stainless steel assemblies are used which require expensive validation and cleaning processes.
<h2>Handle any volume of sensitive substance easily with safe zip-lock docking system</h2>
The clever Flecotec system from Rommelag Flex uses the Flecozip to form a dust-tight connection between process units and transport containers, preventing contamination during decanting, filling and taking samples.
For use in the pharmaceutical, chemical and food industries, the external zip fastener technology allows joining of two blown film containers by creating a dust-tight seal that can then be opened as required.
Available in various sizes and configurations, the connecting film containers can have ring openings, integrated gloves or simple sealed bags for samples or transportation and are connected to the process unit by means of a Flecotric tri-clamp.

Flexible containment zip

When sampling or transferring hazardous substances and sensitive bulk goods, a dust-tight seal is vital to prevent contamination. Stringent protection requirements can make this an expensive and lengthy process.
<h2>Connect process units and single-use blown film containers with secure, disposable clamping system</h2>
Flecotric containment tri-clamps are available in various sizes that match standard process unit connection diameters from 2’’ to 12’’ and are often used to integrate the Rommelag Flex Flecozip connection with process units.
The transfer containers range in size from a few millilitres to 100 litre capacity and are simply disposed of after use.
The tri-clamp system connects and seals with the help of two locking rings and is supplied with a regular TC gasket to allow use with other standard docking systems.

Flexible containment docking solution

In automated systems where controlled discharge of powders and bulk solids is required with a high degree of cleanliness, power operated valves need to be reliable and quick-cleaning. They must not jam, being strong enough to handle dense material flow without causing any damage to the product.


<h2>Remote, automatic and hygienic control of material flow</h2>
The Mucon K Series product range of pneumatic or electric actuated iris valves utilises patented design features and moulded diaphragm technology to balance the requirements of quick disconnect, quick cleaning and hygienic design with the need for reliability and control system integration.

With geared electric motor or geared air motor operation, the valves are available in quick release or bolt mounted options. They are able to handle material densities of up to 1600 Kg / m³ through bore sizes of 150mm or 200mm.

In the food and pharmaceutical industries, the soft diaphragm and gentle action of the iris valve prevents damage to product, thereby significantly reducing waste.

Hygienic automatic iris valve

Hand-operated valves are required for the walls of clean rooms for glanding around cables, tubes or service pipes. They need to be strong yet gentle enough not to harm products and, where a high degree of cleanliness is vital, a regular strip down for cleaning is necessary.


<h2>Manually operate valve for easy control of powders and tablets</h2>
Mucon's K Series hand-operated iris valve features a hygienic, fully moulded diaphragm in a quick release or traditional flange mounting body design to suit a variety of applications.

Bore sizes of 100mm, 150mm, 200mm, 250mm and 300mm are available, with flange dimensions to DIN or ANSI patterns.

Rated for up to +1barg conveying pressure, the iris valves are able to handle material densities up to 1600 Kg / m³ and multi-notching is available for flow control.

Hygienic hand-operated iris valve

In the powder and bulk handling industries, in-line shut off valves are required to provide uninterrupted smooth bore flow when fully open and seal dust tight when closed.


<h2>Remotely shut off full bore material flow completely</h2>
With a patent application that boasts more than 53 innovative claims, the robust but simple Mucon SD-P slide gate valve is one of the most advanced valves of its type on the market today.

For use on low pressure conveying lines, in plastic pellet loading systems or with mixer fill/discharge chutes, the valve is available to discharge smooth flow in bore sizes of 100mm, 150mm, 200mm, 250mm or 300mm.

Powered by a low friction, high efficiency pneumatic cylinder, the slim valve can be remotely operated to achieve effective, fully sealed closure when required.

Slide gate valve

In large scale operations, modular and configurable valves are required to isolate and control dry powders, pellets, grains and granules.


<h2>Heavy duty isolation and control of bulk dry materials</h2>
The Mucon RGV roller gates slide valve's patented blade support system provides uninterrupted flow of material through the valve body, but can still accommodate an inlet deflector if required by the application.

Pre-loaded and self wear compensating polymer seals help prevent the loss of process material, with all seals and guides replaceable whilst the valve is in-line.

Available in a range of standard sizes from 150mm (6") to 600mm (24") square, Mucon's manufacturing methods allow for easy production of custom sizes in square or rectangular configurations.

Roller gate valve

Containers for handling pharmaceutical and biopharmaceutical powders may be disposable, to avoid cross-contamination with other products. However, they must also be able to resist pin-holing and other accidental damage leading to powder loss. Their design should facilitate easy docking to related equipment enabling efficient transfer of powder.
<h2>Disposable Chargebags for Handling Powder Efficiently</h2>
Ezi-Dock’s single-use pharma charge bags are not only an ideal solution when it comes to convenience and cost-effective use. They also compete well with rigid containers owing to their special easy-docking rings. Moreover, their robust 2-ply design makes them easier to connect to pharmaceutical and biopharmaceutical equipment, as well as being an effective defence against pin-holing.

This versatile product is available in a variety of sizes including   2, 5, 10, 15, 25 and 40 litre capacity. It interfaces with a wide variety of pharmaceutical and biopharmaceutical equipment, and uses triple clamping rings for secure connections. They are supplied in individual sleeves, packed 25 bags per carton for easy storage and handling.

Single-use powder handling bag

Users who prefer rigid storage over single-use pharma charge bags, require lightweight solutions for easy handling, especially when storing and transferring active pharmaceutical ingredients. The containers must clamp securely to equipment to ensure no powder loss or cross-contamination and make efficient use of space when stored.
<h2>Bottles for Convenient Storage and API Powder Transfer</h2>
Ezi-Dock pharma process bottles were designed to be used with Split Butterfly Valves. They have unique square design ensuring a more compact footprint per unit of storage in pharmaceutical and biopharmaceutical laboratories. Their filling and dispensing necks feature a standard 6-inch Tri-Clamp neck design that uses an injection-moulded adaptor to connect to laboratory equipment receiving the product.

These versatile containers are available in a variety of sizes including 15, 25, 30 and 40 litre capacity. Bottles are in individual cartons packed in quantities of 84, 60, 48, and 36 respectively for space-efficient storage. They are made of high-density polyethylene that is blow-moulded to comply with the U.S. Pharmacopeia standard.

API powders storage bottle

Safe transfer of liquids and hazardous powders into systems can be a challenge in pharma, biopharma and chemical industries. That’s because the slightest possibility of exposure or spillage could cause cross-contamination. Butterfly valves are expensive and clumsy to operate. Technicians require a better solution that is cheaper, faster and easy to operate.
<h2>Disposable Transfer System for Safe Powders and Liquids Transfer</h2>
Ezi-Dock EZI_FLOW™ CSV4 all-plastic valves are a simple, effective solution for transferring liquids and powders in the pharma and biopharma sphere. Their innovative design delivers the ultimate combination of high containment and low cost. They are suitable for reactor charging, extruder charging, powder filling lines and many other applications.

The operator offers up a charge bag containing liquid or powder to the EZI_FLOW™ all-plastic valve. They turn a toggle lever next, to securely attach these parts together. After they have achieved a contained seal they release the charge bag contents through the valve.

Single-use containment valve

Pharma and biopharma laboratories need fast effective solutions for tightly sealing bags for isolation and waste disposal. They should insist on double-lock security to eliminate the possibility of accidental releases, and ensure the seal will last long enough to keep the contents secure for as long as required.
<h2>A High Containment Closing System for Long Term Sealing</h2>
The Ezi-Dock ezi-strap™ liner tie system is a fast, effective way for sealing sleeves and liners either manually, or pneumatically. Double-lock security effectively prevents accidental release, and it has useful anti-tamper and labelling capability. This is ideal for linear filling with materials sealed in a series of bags, or one-shot bag-out waste.

The ezi-strap™ system is user-friendly. It is strong and durable, and specially designed for ‘real world’ production environments. This product is hence ideal for relatively sensitive applications where spillage may result in troublesome contamination.

High containment closing system

Loading powder from a container source to vessels, tanks, or mixers that are under pressure may be hazardous as it tends to explode due to electrostatic charging from collision of the powder particles. Controlling the batch loading of powder particles avoids the risk of explosion and integrating this system into other loading processes can increase safety, hygiene, and production output.


<h2>Loading powders in vessels safely by using both pressure and vacuum</h2>
The PTS powder transfer system from Dec, is a system that uses pressure and vacuum to transfer dry or wet powder and granules from a source to the loading access of vessels, tanks, or reactors. These include very fine powders (&lt;1 micron), wet and cohesive powders (above 50% wetness, as well as low MIE powders (&lt;1 mJ). The system drives the powder into the vessels with no product retention, no particle damage, no segregation, and very low electrostatic charging. It is equipped with a filtration concept using a flat membrane that enables dense phase conveying at a low velocity of 1-3m/s and powder concentrations of 50 to 150 kg powder per kg air. It is also available in an explosion-proof design that can handle 10 bars. The system is hygienic and easy to clean with no need for dismantling.

Powder transfer system

Contamination is a major concern in powder handling, not least when processing pharmaceutical products and toxic materials. Highly potent APIs, in particular, require accurate dosing and safe containment throughout the transfer system.
<h2>Isolator system for API with high containment capability</h2>
IsoPharm from Dec Group is a small-scale weighing and dispensing system for processes involving highly potent APIs. The isolator has a single chamber design with a containment capacity of up to &lt; 1 μg/m<sup>3</sup>.

The unit includes an entry/exit airlock and a hinge open front access door. Besides offering closed-loop control and glove breach protection, it can be configured with 2, 3 or 4 gloveports. The system features internal radius corners and has a 0.6 Ra/&lt;22 Ra internal finish while noise levels run at circa 65dBa.

API containment isolator

Contained discharging is critical to the quality of filtration and drying processes. But pharmaceutical, biopharmaceutical, and chemical applications involve a range of ingredients. The entire process must ensure the hygienic and safe discharge of materials, particularly toxic ones.
<h2>Filter and tray dryer discharge isolator</h2>
The filter dryer discharge from Dec Group is a discharging isolator designed for onsite filter dryers. The system collects materials in a double-chamber glove box designed for sterile and toxic applications. The top chamber performs filter dryer sampling, powder discharge, and complete heel removal. The bottom chamber collects the powder into drums or bags.

The technology is adaptable to small or large-scale filter dryer systems and offers a containment rate of &lt; 0.1 μg/m<sup>3</sup>. Moreover, the discharge unit integrates with additional equipment such as conical mills, tray dryers, or lyophilizers.

In cases of limited height availability, the filter dryer discharge can be fitted with a single chamber isolator with powders collected into the bottom hopper.

Filter dryer discharging isolator

Powder processing for chemical compounds demands product-specific micronizing solutions. Varying material properties and particle characteristics must be considered to optimize the process parameters. But available solutions do not always cater to the particular needs of end products.
<h2>Product-specific micronizing isolator solutions with high containment capability</h2>
The MC DecJet micronizing isolator range from Dec Group is a patented system designed for sterile or highly active compounds. The system optimizes the production process depending on the product particle size characteristics, with micronizing rates up to 0.5 μm and a product recovery range of &gt;99%.

The system allows the regulation of process parameters like temperature, humidity, and cryogenic conditions. Additional available features include top and bottom exit systems, intermediate cyclones for particle fractionation, vertical milling, and special inserts for complex products.

High containment micronizing isolator

From GMP and HSE perspective material transfer is critical for chemical and pharmaceutical formulations. Risky substances, such as high-potency API, cadmium in batteries or other substances increase the complexity of processes, particularly in regard to safety. Containment solutions are, therefore, crucial for applications like powder handling during feeding, metering, discharge or even sampling.


<h3>Dispense, transfer and contain sampling ingredients with a single-use valve system</h3>
Andocksysteme developed a passive-passive split butterfly valve to discharge hazardous substances safely and reliably. The AVAX valve system meets the occupational exposure limits of ≤ 1 µg/m³ (OEB 5 requirements).

The hygienic components comply with the specific requirements of pharmaceutical and biopharmaceutical standards produced in a cleanroom environment. The solutions are also suitable for sterile applications.

The AVAX valve applies the bayonet coupling method to ensure superior containment performance during dispensing and handling.
This containment interface can be optionally be pre-fitted with different bag volumes and executions as complete product transfer solution serving different process challenges.

The system is also available in stainless steel and optional with an active flange execution. This range of versions is fully compatible and components fit seamlessly to each other no matter their material.

Single-use containment valves

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

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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