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API Separatation Equipment

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

Separation

API making equipment must observe rigorous quality control standards across the entire manufacturing process. The pharmacodynamic properties of active pharmaceutical ingredients API make them highly sensitive to their environment, making API manufacturing and production a tightly regulated field.

Active pharmaceutical ingredients (API)

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

High capacity capsule filler

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

Tumbler sieve for classifying and dedusting granular materials

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

Drum conditioner

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

Sterile Filtration System for GMP-grade products

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

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

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

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

Conventional dryers are inefficient and can lead to significant mechanical and thermal stress on sensitive products. Non-uniform mixing can lead to lump formation and increased processing time. Vacuum dryer with eccentric agitator is designed to dry wet flowing powders from filtration and centrifuging processes.


<h2>Vacuum dry efficiently in an agitated paddle dryer</h2>
Planex® system from Italvacuum is a special horizontal vacuum paddle dryer with an eccentric agitator which revolves around its own axis while rotating tangentially to the drying chamber. It is ideal for drying wet feeds from filtration and centrifuging processes. Planex® is ideal for the production of active pharmaceutical ingredients (API), fine chemicals and intermediates. The efficient agitator action ensures perfect mixing and consumes three times less energy than conventional dryers. It also reduces the mechanical and thermal stress on the products which is important for delicate and temperature-sensitive applications. The tangential movement of the agitator prevents lump formation. Suitable for both crystalline and amorphous products, Planex® has a short cleaning downtime and complies with US FDA standards and cGMP regulations.

&nbsp;

Horizontal vacuum dryer with eccentric agitator

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

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

Lowering heat stresses on API by reducing friction

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

API Separatation Equipment

Which api separatation equipment do you need?

High capacity capsule filler

Tumbler sieve for classifying and dedusting granular materials

Drum conditioner

Sterile Filtration System for GMP-grade products

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