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Hard gelatin capsules 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

The two-piece capsule is a visual shorthand for all types of medical remedies. Advances in technology have made the production of hard-gelatin capsules a convenient delivery method for drugs and other ingested substances. But the simple solution requires micrometric precision to be manufactured to the proper pharmaceutical standards.

Hard gelatin capsules

Staying competitive in today's highly dynamic and highly regulated pharmaceutical production market requires encapsulation equipment with the utmost process control and batch documentation.  Quick changeover, and accurate dose control are required as well as enhanced features like environmental sensors, online weight adjustment and automated documentation and reporting.  Successful modern producers use these next-generation features to maintain an edge of competitors with more traditional equipment.


<h2>A complete automatic encapsulation solution with state-of-the-art accuracy controls and reporting functionality.</h2>
The Legend 2500 from ACG-PAM is a fully automatic capsule filler with next generation design which greatly enhances production speed and efficiency.  ACG-Pam has over three decades of experience in the pharmaceutical manufacturing industry and the success of the company's AF series of encapsulating machines which are installed in over 1,000 facilities across the globe provides a knowledge base and industry expertise that is second to none.  The Legend 2500 encapsulation represents the application of this knowledge and experience specifically to improve upon existing encapsulation systems and better meet the needs of today's pharmaceutical producers.

The system includes Industrial PC based controls, online weight adjustment, and a screw type auger for use with the widest variety of formulations.  The need for an extra doing disc when filling doses are 50% of slug length is eliminated by use of a slug length adjustment kit.  Anti-jamming features for trouble free capsule loading and automatic lubrication are also included.  The system makes use of integrated environmental sensors, a stand-alone security enabled IPC control pedestal, and full 21 CFR Part 11 compliant reporting to ensure an encapsulation process that is accurate, controlled, and well documented.

Easy to validate capsule filler

Pharmaceutical manufacturers require maximum yield from their encapsulation process for efficient production and competitive results.  Leaving expensive pharmaceutical formulations in the encapsulation machine as left-over or dust is wasteful and inefficient.  Equipment with all the features required for accurate high quality encapsulation as well as enhancements for minimized dust creation and product loss will give users a distinct advantage over the competition.


<h2>A complete encapsulation solution for maximum yield</h2>
The ZRO 90T system from ACGE is a production scale capsule filler from the AF series of capsule fillers that is currently running in over 1,000 production facilities throughout the world.  The AF series of machines is built for regulatory compliance, revenue optimization, and flexibility giving pharmaceutical manufacturers the features they demand such as formulation and dosing control, minimal product loss, a wide range of peripheral equipment, and globally available support.

The ZRO 90T machine has all the benefits associated with the series as well as additional features to minimize formulation loss during processing and maximizing yield.  The capsule filler includes ACGE's patented ZRO technology which minimizes dusting and separation by containing the formulation within the dosing disk.  This technology reduces formulation waste and maximizes powder use efficiency for maximum yield.

High-yield capsule filler

Capsule filling should be a worry-step in pharmaceutical and nutraceutical manufacturing.  The right equipment is capable of fully automatic operation, includes accurate dose control, is easily changed over between products, and includes supporting accessories for smooth integration with other processes.  A high quality capsule filler will give plant managers peace of mind and allow them to focus on improving other aspects of their operation.


<h2>A complete, automatic encapsulation solution</h2>
The AF series from ACG-Pam is a production scale capsule filler line that is currently running in over 1000 production facilities throughout the world.  The AF series of machines is built for regulatory compliance, revenue optimization, and flexibility giving pharmaceutical manufacturers the features they demand such as formulation and dosing control, minimal product loss, a wide range of peripheral equipment, and globally available support.

The automatic capsule fillers can output from 6,000 to 200,000 capsules per hour and can handle powder, microtablet, and pellet, and capsule-in-capsule filling.  They include ACG-Pam's patented ZRO technology which reduces dusting and product loss during operation as well as other features designed for revenue optimization and machine efficiency.  The AF series machines in production have handled over 3,000 different formulations and ACG-Pam's support personnel have developed the expertise and knowledge based needed to tailor an encapsulation solution for even the most difficult formulations.

Automatic capsule filler

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

Innovators in the highly regulated and highly dynamic pharmaceutical market place need equipment that is worry-free and flexible enough to vary products and process variables as new products are developed.  Laboratory capsule filling machine must be easy to maintain, allow for rapid tooling change-over, and provide tightly controlled process variables and automatic operation in order to ensure results that are reproducible at the production scale.


<h2>A complete encapsulation solution for the laboratory</h2>
The AFT-T Lab system from ACGE is a laboratory capsule filler from the AF series of capsule fillers that is currently running in over 1000 production facilities throughout the world.  The AF series of machines is built for regulatory compliance, revenue optimization, and flexibility giving pharmaceutical manufacturers the features they demand such as formulation and dosing control, minimal product loss, a wide range of peripheral equipment, and globally available support.

The AFT-T Lab machine has all the benefits associated with the larger equipment in the series but on a scale appropriate for laboratories.  The machine can output up to 6,000 capsules per hour for powder filling and 5,000 capsules per hour for pellet filling.  It uses a 1.1 kW primary motor.  It weighs about 1,200 Kg and occupies only 2.25 square meters of floor space making it the perfect scale for any pharmaceutical laboratory.

Automatic laboratory capsule filler

Use of liquid filled hard capsules is increasingly popular with today's pharmaceutical manufacturers.  Bioavailability and patient compliance are enhanced with drugs delivered in this form.  Production of these liquid filled capsules requires equipment that can handle a wide variety of liquids including lipids and waxes, and automatically produce consistent sealed capsules as well as efficiency and high machine up-time to ensure profitability.


<h2>Automatically fill and seal hard capsules with any pharmaceutical liquid</h2>
Fluidocap F40 is a fully automatic machine for filling hard pharmaceutical capsules with liquid an sealing them.  It is provided by ACGE-Associated Capsules a world leader in pharmaceutical machinery manufacturing. Traditionally liquid doses have been provided in soft gel-cap form and have presented drug makers with the common problems of high cost, wastage, cross contamination, migration of the drug into the capsule, and low bioavailability.

The Fluidocap range of machines address these issues by allowing the filling and sealing of hard capsules with liquid compounds rather that relying on soft gelcaps.  The hard capsules can be filled with a wide range of formulations including lipid-based products, high viscosity pastes, and wax type products. They are sealed with a gelatin band. The capsule filler for liquid is designed for high volume production use and can produce up to 40,000 capsules per hour. Combinations filling including pellets in liquid is also possible using special attachments.

Automatic capsule filler for liquid solutions

A recent important change in the industry is the trend toward providing liquid doses contained in hard capsules.  The right equipment is need to develop processes to fill hard capsules with the wide variety of liquids used by today's pharmaceutical producers.  Laboratory equipment that is capable of handling waxes and lipids, automatically sealing the capsules, and maintaining a tightly controlled process suitable for scaling to production levels will give pharmaceutical innovators an edge of the competition.


<h2>Fill and seal hard capsules with any pharmaceutical liquid</h2>
Fluidocap 1000 is a semi-automatic machine for filling hard pharmaceutical capsules with liquid an sealing them.  It is provided by ACGE-Associated Capsules a world leader in pharmaceutical machinery manufacturing.  Traditionally liquid doses have been provided in soft gel-cap form and have presented drug makers with the common problems of high cost, wastage, cross contamination, migration of the drug into the capsule, and low bioavailability.

The Fluidocap range of machines address these issues by allowing the filling and sealing of hard capsules with liquid compounds rather that relying on soft gelcaps.  The hard capsules can be filled with a wide range of formulations including lipid-based products, high viscosity pastes, and wax type products.  They are sealed with a gelatin band.  The Fluidocap 1000 capsule filler for liquid is designed for laboratory use and can produce up to 1000 capsules per hour but can easily be scaled up to commercial level production.

Laboratory capsule filler for liquid solutions

<span style="font-weight: 400;">By employing a weight sorter that is fully flexible and able to handle a wide variety of dose shapes and sizes you can benefit from reduced equipment cost and improved production. Such flexibility without the requirement to change machine parts is now available for large scale production facilities.</span>
<h2>Easy to use, fully flexible weight sorter for large scale production</h2>
<span style="font-weight: 400;">The SADE SP440 from CI Precision is a highly accurate, easy to operate and fully flexible dosage weight sorter for use in larger-scale production environments. Featuring a single 150l hopper and 4 weighing channels for bulk operations at up to 22,000 units per hour and an easy-to-use operator interface, the SADE SP440 is accurate to within +/- 2mg.</span>

<span style="font-weight: 400;">Designed with flexibility in mind, the SADE SP440 can handle a wide range of tablets and capsules, switching between them with no requirement for changing physical parts to accommodate different dose types. The SADE is able to weigh tablets up to 20mm x 24mm, and capsules from 5 through to 00 size (larger sizes may be accommodated). The machine is also able to be quickly and easily dismantled for cleaning and sanitizing.</span>

<span style="font-weight: 400;">The unit has the ability to reclaim “good” product from a weight-rejected batch, saving valuable product and producing less waste. The unit records all sort operations and can print reports direct to a printer or send to a PC.</span>

High capacity weight sorter for tablets &amp; capsules

The billions of microbes living in our gut have a significant impact on gastrointestinal health, mood, and behavior. Every individual develops their microbiome community. Probiotic processing technology makes sure that harmful bacteria never outnumber good citizens.

Probiotics

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

The fizz of effervescent tablets is commonly associated with a vitamin C boost. But the soluble pill is an excellent drug delivery method for pediatric and geriatric patients. Sometimes referred to as carbon tablets, manufacturing effervescent tablets binds biocarbonate and citric acid that produce the smooth hiss as they dissolve in liquid.

Effervescent tablets

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

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

Softgel capsules fast-track the delivery of medication to the bloodstream. Unlike solid pills, they do not need to be broken down by the body before the drugs can be absorbed. Moreover, they are optimal vehicles for oils and fat-soluble formulations that cannot be compressed into tablets.

Softgel capsules

The nonproprietary name for HPMC – hydroxypropyl methylcellulose – is such a mouthful that it has two abbreviations. Hypromellose is the other one. The non-ionized material offers a safe alternative to gelatin capsules, especially as most common API and excipients are suitable HPMC capsule ingredients.

HPMC capsules

Making.com is a new online platform that helps makers find production technology quicker by grouping it around the products they make.

What's new in pharmaceutical packaging?



During <a href="https://www.pharmapackeurope.com/en/home.html" target="_blank" rel="noopener">Pharmapack</a>, we met Chantal Younes, Key Account Manager at <a href="https://www.csptechnologies.com/" target="_blank" rel="noopener">Aptar CSP Technology</a>, who introduced us to the world of active packaging.

The pharmaceutical industry is subject to strict regulations, so that's why manufacturers are very meticulous when formulating their products but especially about their packaging, which must keep their products safe. Due to the formulation or active ingredient, pharmaceutical products can present significant stability issues if they come in contact with moisture or oxygen.

This is where Aptar CSP Technology comes in. Aptar CSP Technology has developed several active packaging solutions to protect pharmaceutical products and ensure extended shelf life.

The company has developed a new class of highly engineered polymer compounds that protect drug products, probiotics, and drug delivery systems from impurities, oxygen, and moisture. The polymer can be extruded into a film, injection molded, or blow molded.

#Changemaker: Ready to protect your pharmaceutical products from moisture?

Pharmaceutical

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

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

<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

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

Sensum specialises in the development and production of automatic visual inspection systems for the pharmaceutical and nutraceutical industry.

Thousands of different capsules are produced every day, so it is inevitable that some of them will come out <a href="https://www.sensum.eu/posts/reasons-for-most-common-capsule-defects/">defect</a> in shape or size, with a colour deviation, cracks, dents or maybe a missing print. However, a defective capsule in a package can lead to unpleasant consequences. A complaint or even loss of brand are the worst-case scenario for a manufacturer.  Reliable detection of defects depends on quality of inspection system, where 3 key aspects have to be considered: optical system, mechanical manipulation and image analysis.


<h2>Using different light modes to see various capsule defects</h2>
Have you ever tried taking a picture of someone with the sun on the background? The result will be a dark silhouette. This is not the best outcome, if you need well visible face, but could be a great picture if you are looking to hide it. Similarly, in industrial inspection, different light shows different defects. In capsule inspection, backlighting helps to analyze capsule’s shape and size. On the other hand, backlighting alone cannot see every anomaly, like color deviation. Each defect requires a different light mode. In short, diffuse light detects dirt, dots, and colour defects, while 3D surface imaging can spot defects such as dents and cuts on capsules and embossing, engraving or coating defects on <a href="https://making.com/products/tablets">pharmaceutical tablets</a>. Working together, the three different light modes can provide a better inspection and end-product quality.
<h2>How does mechanical manipulation impact visual inspection?</h2>
There are plenty visual inspection technologies with different manipulation. However, to be sure that defects are not overlooked by the system, proper mechanical manipulation is just as important as having different light modes in the optical system. For example, suboptimal <a href="https://making.com/products/capsules">capsule</a> movement during image acquisition can make images blurry. Aiming for a machine that has gentle and reliable mechanical manipulation (controlled movement of products) combined with different lighting modes, leads to better defect detection.

Last but not least, image analysis and inspection software need to allow reliable detection of defects on images, simple sensitivity setting for various measurements and quick setting of recipes for new products. Watch the video below to see how <a href="https://www.making.com/equipment/high-speed-visual-inspection-system-for-tablets/">Sensum Spine</a> is able to inspect up to 630.000 capsule per hour performing up to 18 images per product .

[embed]https://www.youtube.com/watch?v=viNPErB2BBs[/embed]

How reliable imaging plays an important role in capsule visual inspection

It is strange how two tablets can belong to the same but at the same time to a different category depending on how the tablet itself is classified. For example, chewable tablets and effervescent tablets have two different routes of administration but both belong to the category of uncoated tablets. Uncoated tablets are prepared by compression of granules in which no coating is added after compression. They may be single-layer or multi-layer tablets.

Uncoated tablets

Did I take my medicine this morning or not?

Let's be honest. How often have we asked ourselves this question and failed to find an answer simply because… our memory sometimes doesn’t serve us right!

&nbsp;

Coming to the rescue of patients who need to keep track of their chronic medication and adhere to their daily treatment plan is FebriSol, a scratch-card calendar developed by Studio Fundi.

At <a href="https://www.pharmapackeurope.com/en/home.html" target="_blank" rel="noopener">Pharmapack</a>, we had the pleasure of meeting Ricky Stoch, the founder of <a href="https://studiofundi.com/" target="_blank" rel="noopener">Studio Fundi</a>, who showed us how simple it is to use FebriSol.

All the patient has to do is scratch off the day’s metallic coating that will reveal the check mark after taking the pill.

Current solutions for daily tracking are inconvenient and expensive.  FebriSol is a low-cost alternative that can help you keep track of your medicine every day.

#Changemaker: Keep track of your medicine every day with FabriSol sticker

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Hard gelatin capsules formulation

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Hard gelatin capsules formulation Equipment

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