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Maker - Product Challenge

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API Formulation Equipment

Formulation technologies are an integral process in many industries such as pharma and food. Chemical mixtures require strict handling to combine the separate ingredients into the homogenized recipe that makes your final product. Formulation technology stores, mixes and subjects the elements to a range processing parameters according to your specifications to develop the base material. The resulting formulas are then weighed, formed, packaged, or sent for further formulation.

Formulation

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)

A multipurpose unit in the research and development field. Some of the most common applications are galenic formulation, freeze drying experimentation, taxidermy, underwater archaeology, aliquot preservation,  diagnosis and other research.


<h2>Start your research with this multipurpose high-performance device</h2>
The LyoQuest laboratory, multipurpose and R&amp;D freeze dryer from Telstar Life-Sciences has been designed as a multipurpose unit for the research and development field. It is a small freeze dryer, more compact than most but in spite of its small size, its capacity is quite unbeatable. A state-of-the-art control system and a range of specially designed accessories make the LyoQuest a benchmark in its category.

The unit's design offers the best performance in the least possible space. Suitable for laboratories: compact and easy to install, solidly designed laboratory equipment. On a functional level, cooling management ensures optimum performance.

Multipurpose and R&D freeze dryer

Freeze dryer designed for aseptic and small-scale production of high-value products.


<h2>Industrial freeze dryer in a compact envelope</h2>
Lyotris from Telstar Life-Sciences is a lab scale production freeze dryer designed for the production of small batches of high-value pharmaceutical products. With a 1m2 loading surface and capacity for approximately 1,600 10R-type vials or 30 liters of bulk product. It has been specially designed for aseptic production in vials or in bulk and its novel fascia and door design provides easy isolator integration.

The GMP laboratory freeze dryer comes with all  the necessary components for an automatic cleaning (CIP) and steam sterilization (SIP) processes, filter integrity testing (WIT) and also incorporates an advanced SCADA system which includes Telstar's patented ‘Lyometrics' system; providing advanced real-time information on the freeze-drying process.

GMP laboratory freeze dryer

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

Vacuum drying is used to remove moisture from sensitive materials. Drying small batches in the laboratory for R&amp;D work or removing moisture from high-potency active pharmaceutical ingredients requires careful handling and control.
<h2>Vacuum dry small batches and HPAPI's</h2>
LaboDry from Italvacuum is a laboratory-scale, vacuum tray, drying oven designed to meet small batches and high potency API production requirements. It features a separate cells construction and has been designed for glove box installation. It can be fitted with skid-mounted auxiliary accessories. LaboDry is available in in AISI 316L (1.4404), AISI 904L (1.4539) and ALLOY C-22 (2.4602) construction to meet the requirements of appropriate material for product contact. LaboDry is ideal for laboratory use and the pharmaceutical industry.

Laboratory-scale vacuum tray drying oven

Whether you want to improve the stability of nutrients, protect an active chemical agent or control the release rate of a given ingredient, you may benefit from a continuous solution that generates reproducible microspheres and is scalable from pilot to production capacities.
<h2>Rapid, uniform and reproducible microsphere formation</h2>
Both the INFINITY Mini and the INFINITY Lab from EmulTech’s Microfluidic Encapsulation System are versatile platforms for rapid uniform and reproducible microsphere formation for encapsulating small molecules, peptides and proteins, with a particle size of 1 μm and up. This system’s unique continuous flow technology provides high reproducibility, which reduces process development costs and eliminates out-of-spec material.

Microencapsulation system for your drug delivery system

<span style="font-weight: 400;">The efficient size reduction of granular powders is a key step in many pharmaceutical processes, and choosing the right equipment for your application can be vital. Conical mills offer excellent flexibility, as different forces can be achieved simply by changing the impeller type, and different particle sizes by changing the screen type.</span>
<h2>Highly flexible mill for a wide range of pharmaceutical powder preparations</h2>
<span style="font-weight: 400;">The Sejong Pharma CM Series of conical mills offers a range of milling head sizes to suit a variety of production volumes. Available in 500, 1000 and 2000 kg/hour versions, the CM Conical Mill is a fully portable mill, with electric height control allowing for operation into a range of output containers.</span>

<span style="font-weight: 400;">With easily interchangeable heads providing a wide variety of screen sizes and impeller variants, the CM series adds flexibility to your pharmaceutical powder production with reduced cost.</span>

<span style="font-weight: 400;">Easy to operate, with a simple electronic interface, the unit is also quickly and simply disassembled for cleaning thanks to a simple clamp action attachment system.</span>

Conical mill for drug formulation

It is rather difficult to successfully produce a pharmaceutical solid dosage forms with the desired properties such as size, morphology, hardness and friability. You need a solution that can transform fine heterogeneous powders into homogeneous blend of granules with bigger size and higher density in a short time and with repeatability. Wet granulation is carried out to convert fine and cohesive active ingredient and excipients, into more uniform, free-flowing granules that are optimised for downstream processing.
<h2>Achieve uniform particle size distribution for wet granulation</h2>
The High Shear Mixer Granulator from Romaco Tecpharm is configured to optimize the wet granulation process. It is used to turn a fine-powder heterogeneous mixture into a uniform granulation, with increased particle size and higher density.

The equipment offers you proper flow and compactness while having a shorter operational time. It can handle capacities ranging from 25 L to 1,400 L.The bottom impeller and the side chopper enables the intensive mixing in a short period of time. In addition, the equipment uses a synchronized system to avoid extrusion effect.

The high-shear granulator for drug formation processes the solid material down to the desired particle size, and the mixture is then pumped to the fluid bed dryer where the moisture is removed, leaving behind the granular product. During the process of wet granulation, the constituents of the oral solid dosage form blend are combined, along with agglutinative solution, to form granules with a homogenous composition.

Industrial high shear mixer granulator for drug formation

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.

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Horizontal vacuum dryer with eccentric agitator

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

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

Lowering heat stresses on API by reducing friction

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