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Is your technology great for making Active Pharmaceutical Ingredients? 

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Over <strong>20,000 organic monthly</strong> users find us when searching for production technology in Google. We rank<strong> top #3 positions</strong> in Google globally for keywords like <em>tablet making equipment, pharmaceutical formulation technology, equipment for manufacturing creams,</em> or <em>industrial capsule fillers</em><strong><em>.</em></strong> We also had over <strong>35,000 pageviews</strong> related to processing and packing different formulations dosage forms and packing them in blisters or containers.

Making.com is a growing platform for finding production technology

Manufacturers need production mixing equipment that is capable, flexible, and easy to maintain. Accurate mixing form a reliable, user friendly machine will give plant managers the peace of mind and worry free operation they need to focus on improving other areas of their process. A high quality piece of equipment allows for low maintenance, easy cleaning, enables the direct feed of solids and liquids, mixing and dispersing of the vessel contents, heating or cooling of the product, and processing under vacuum or under pressure.
<h2>A universal mixing system with precise, reproducible results and safe operation</h2>
The Master Plant homogenizing and emulsifying system from IKA was designed specifically to meet the production mixing needs of the pharmaceuticals industry but has also proven useful in the production of food, beverages, cosmetics, and chemicals.  Several mixing heads are interchangeable depending on the process and desired results.  Each mixing head can be heated or cooled to control product temperature simultaneous to the mixing process. Flexible PTFE scrapers move with the mixing head and keep product from adhering to the vessel walls. Products of up to 100.000 mPas viscosity can be processed.  The GMP homogenizing systems  can be fully discharged without the need for additional pumping and are available in capacities from 10 to 4.000 liters.

GMP homogenizing system

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

Separating solids from liquids by filtration requires frequent cleaning or replacement of the filter medium during maintenance to keep an optimum volume flow rate and effective separation. By using a self-cleaning filter unit that can effectively remove solids from the filter medium, maintenance is kept to a minimum, and the operating life of the filter is prolonged.


<h2>Dry and remove solids in filter media using rapid counter-current flow and pressure</h2>
The FUNDABAC, from Dr. Mueller, is a self-cleaning filtration system for various industrial applications such as chemicals, minerals, and pharmaceuticals. The system is equipped with a cloverleaf-shaped candle filter element where the solids from the process fluid are collected on the surface of the filter medium and form a cake. The filter element consists of six outer tubes and a central tube. The filtrate goes downwards through the six external tubes before rising through the central tube and out of the filter.

The system has a patented heel volume filtration where the remaining unfiltered fluids at the bottom of the vessel are pumped back to the top. From there, they are sprayed evenly inside the vessel through a nozzle while applying pressure to ensure maximum filtration. The system also features cake washing after filtration, spraying a wash liquid on the filter element.

Cakes around the filter media can be dried by forcing gas through the heel volume filtration until the remaining liquid is displaced. Removing the dried cake can be done by using pressurized gas such as steam or nitrogen in the reverse process flow, or counter-current flow, of filtration. This allows the filter medium to expand and the cakes to crack and fall when the maximum deflection of the filter medium is reached. The cakes can be collected at the bottom flange of the vessel. All these self-cleaning features are done within the closed filter vessel, lessening the chance of contamination.

Self-cleaning candle filtration system

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

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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)

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

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

The topical route is a convenient route for the self-administration of drugs. But turning a pharmaceutical formulation into an easy-to-use cream involves specialized cream manufacturing equipment. Topical dosage forms are essentially an emulsion of oil and water.  But the ratios can be changed to process it into lotions, ointments, and gels.

Cream

Parenteral preparations refer to drugs using non-oral means of administration. Injectables, such as needles and syringes, are used to deliver a drug into the systemic circulation directly in the veins, muscles, under the skin, or in the tissue.

These parenteral formulations are pharmaceutical dosage forms that have strict regulations on being sterile, pyrogen-free, and free from visible particulate matter including reconstituted sterile powders. Solutions, suspensions, emulsions, and gels with APIs intended for administration by injection are usually supplied in vials, ampoules, pre-filled syringes, or pens to facilitate ease of use.

Injectables

The click and puff of inhalers is a universal signal for respiratory conditions. Inhalers quickly grew into preferred drug delivery systems for asthma and COPD. Dry inhaler powder formulation produces a more stable drug than liquid dosage forms. Moreover, inhaler ingredients are more resistant to bacterial growth.

Dry inhaler powder

Suppositories consist of active pharmaceutical ingredients encased in a non-active base material. The sustained release of medication makes suppositories a preferred option for the long-term treatment of chronic conditions like diabetes, anemia, and AIDS.

Suppositories

While still forbidden in many countries, there's plenty of room for the use of cannabidiol, or CBD. It’s the second most present active ingredient of the cannabis plant and, no, it won’t get anybody high. What it does, really, once it’s out of the CBD oil processing equipment, is to provide many well-being and health benefits. They go from treating depression and anxiety to relieving pain and unmanageable diseases' symptoms.

CBD oil

After being used to contain the blood of martyrs after death or to store the anointing oil of French monarchs, today ampoules are the first choice in packaging injectables. You create ampoules by melting the glass tube into the desired shape and seal them at the neck by melting the top of the glass tube. The only way for you to extract the contents from an ampoule is by breaking the glass at its breaking point, making it perfect for single dose applications only.

Ampoules

Which dosage forms can your technology make better? 

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

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

Who knew that dragee and tablet making had something in common?

The sweet connection to the pharmaceutical world lies in the art of coating, which has its roots in the confectionery industry. Both dragee and tablet coating involves the application of a layer of material – sugar for dragee and a polymer film for tablets - around a core, be it a nut or a drug substance.

But as you may know, in the pharmaceutical industry, rules and regulations are kings. According to the pharmacopeias, coated tablets must pass the test on uniformity of dosage units. Obtaining a uniform coating across all tablets in a batch may seem simple, but it is actually a complex process involving spraying, mixing, and drying.


<h2>Can you guess what might cause tablet coatings to be uneven?</h2>
How about improper mixing, inconsistent drying, or poor atomization? All those factors can cause uneven coating thickness…and that’s where the coater design comes in.

For instance, a pan with a small bed surface may not provide enough space for the tablets to move freely, causing uneven coating distribution. Or if the tablet bed is not flat, this can lead to tablets accumulating in the center or on the sides of the pan.

If the baffles are not properly designed, they can cause dead spots that the coating solution may not be able to reach. In addition, the number of nozzles and nozzle-to-nozzle distance can lead to areas of undercoating or overcoating.
<h2>Good things come in threes.</h2>
We talked with <a href="https://lbbohle.com/" target="_blank" rel="noopener">L.B. Bohle</a>'s technology expert, Tobias Borgers, on the ins and outs of their coating machine, and what makes it stand out in the industry.

“<em>Bohle technology contains three unique design principles which assure a good coating uniformity,</em>” explains Tobias.

First, the pan geometry provides a large tablet bed surface which allows the incorporation of a high number of spray guns, resulting in time savings of up to 40% during the coating process.

Second, helical baffles offer continuous and homogenous axial mixing within the tablet bed, preventing the formation of dead zones and minimizing tablet damage or twinning by avoiding acceleration peaks.

Third, the air principle allows for drying to occur within the tablet bed while keeping the rest of the coater and the spray guns cool.

“<em>In this way, spray losses are reduced to a minimum which leads to coating efficiencies of &gt;95%,”  </em>Tobias concludes.

Remember, coating isn’t just for candies. However, while an uneven coating on candy may only result in an unpleasant look and taste, a poorly coated pharmaceutical tablet can severely affect the patient's health.

The sweet world of pharmaceutical tablets - The trifecta for achieving coating uniformity

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