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Maker - Product Challenge

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Changemakers

Some of the vaccines in use today were originally developed decades ago. But advances in research, expertise and vaccine development equipment provide immunizations from bacterial and viral diseases (antibodies and cell therapy) to more people every year. The Covid 19 pandemic highlights the urgent need to scale up the production of vaccines and ensure an automated as well as reproducible manufacturing environment.

Vaccines

The word parenteral comes from Greek and means outside the intestine (para=outside and enteron=intestine). In fact, when it comes to parenterals, we are referring to those dosage forms that are administered directly into the bloodstream using a hypodermic needle, avoiding going through the gastrointestinal tract. Using parenteral filling equipment, parenteral solutions are placed in containers such as vials, syringes, or ampoules.

Parenterals

A pre-filled syringe or PFS is a single-dose disposable syringe that is supplied loaded with the substance to be injected. By using a pre-filled syringe filling machine, you can have excellent dosage accuracy due to the exact filling of medications. During administration, safety from potential contaminants is also ensured as they are directly injected after opening. To further minimize the risk of contamination, pre-filled syringes are often filled and sealed in a sterile environment using stainless steel equipment.

Pre-filled Syringes

During crime scene investigations in any movie, you've probably seen forensic scientists collecting evidence and biological samples in small containers. Here, these are the vials, used to store medicines, especially in liquid form, or laboratory samples. Often made of glass or plastic, vials can be labeled as single-dose vials or sterilized and reused more than once. They are also available with various closure systems depending on the material and storage requirements.

Vials

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

Pharmaceutical cartridges are glass containers of cylindrical shape, suitable for liquid or solid pharmaceutical dosage forms. Generally, these are designed for a specific apparatus such as pre-filled syringes and autoinjectors. Drugs that can be placed in cartridges using a pharmaceutical cartridge filling equipment include insulin, dental anesthesia, and other emergency drugs for allergies.

Pharmaceutical cartridges

If you've ever heard the acronym WFI spoken, know that we're not talking about wireless technology to connect your computer. WFI stands for water for injection, a sterile water used as a solvent to dilute other solutions for injections to the body. Traditionally, WFI was only produced through the distillation process using water for injection equipment until other methods such as reverse osmosis, electrodeionization, and ultrafiltration were developed.

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Water for injection

<em>“How clean does my equipment needs to be?” </em>That's what manufacturers often wonder about in order to meet the high sterilization standards the pharmaceutical industry demands. Lending manufacturers helping hand have been single-use bags, also known as disposable, first introduced in the late 1990s. They immediately gained popularity because they reduce the risk of cross-contamination, minimalize cleaning and sterilization demands, and require a low capital cost.

Single-use bags

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)

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

Reliable operation: control system fully re-engineered with new options

Flexible use: with a touch screen user interface

Possibility to save the work carried out and to export data to other platforms (Excel) with the LyoLogger data acquisition software

Easy to clean

Chamber in AISI 316 stainless steel

It goes by many names. Freeze drying, lyophilization, or cryodesiccation is a form of dehydration that involves freezing the product to remove its water content and then removing the ice by sublimation – this means going from the solid to the gaseous state without going through the liquid phase. Freeze dryers are widely used in the pharmaceutical industry to increase the shelf life of products such as vaccines and other injectables. Due to their ability to best preserve the flavors, freeze dryers are used for food preservation in the food industry by dehydrating high-value products such as seasonal fruits or coffee. Industrial freeze drying systems are usually comprised of multiple components including vacuum pumps, stainless steel condensers, some form of heating and lastly, a chamber for drying where the materials are placed and processed.

Freeze dryers

Pharmaceutical

Formulation Technologies

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

Connect directly with world leading manufacturers of formulation technologies and find technology to build or improve your production line.

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Formulation Technologies and Equipment - Making.com

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

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

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

R&amp;D

Batch

Industrial drying machines are designed to remove moisture from your product. But the drying process must cater to variations in the state of matter and molecular structure of the input material. Industrial dryer technology exploits the modes of heat transfer (convection, conduction, radiation, evaporative cooling) to control the moisture content.

Drying

liquid

Multipurpose and D freeze dryer from Telstar Life-Sciences have been designed to be a multipurpose unit in the research and development field.

A multipurpose unit in the research and development field. Some of the most common applications are galenic formulation, freeze drying experimentation,

Multipurpose and R&D freeze dryer &ndash; Making.com

We open production technology to everyone

Making.com

The unit comes with a two-stage vacuum pump located inside the console

 All the critical parts are made out of AISI 316L stainless steel

Can display the condenser temperature and the vacuum level at all times

Auxiliary chamber for direct connection to the manifold

Suitable for working with biological samples or products with very low eutectic or collapse points

Process

solid

The LyoAlfa from Telstar Life-Sciences is a compact laboratory freeze dryer. It comes as a console and is mounted on casters which make it easy to install.

Particularly suitable for research centers requiring greater freeze drying capacity. Some of the most common applications are galenic formulation, freeze

Compact laboratory freeze dryer &ndash; Making.com

Reliable operation: non-proprietary control system via PLC (Siemens)

  Flexible use: high capacity for working with bulk materials, option to attach manifolds

Results reliability: temperature uniformity (shelf flatness, high quality components, upper radiation shelf), shelf heating and cooling rates (1 ºC/min), etc.

Easy recipe development: quality and adaptation of the temperature sensors (shelf, product and condenser) and vacuum. Temperature, pressure and time control system

The LyoBeta from Telstar Life-Sciences is a freeze drying unit for biological, pharmaceutical and food products formulation and "scale up" work, facilitating transfer technology to the R&D centers and production.

Designed for biological, pharmaceutical and food products formulation and "scale up" work. Best performance for technology transfer activities and work in

Pilot freeze dryer for scale up &ndash; Making.com

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EmulTech-infinity-lab-leaflet.pdf

emultech-infinity-mini-leaflet-pdf

EmulTech-infinity-mini-leaflet.pdf

Hyaluronic acid is a natural lubricant found in all mammals. An effective humectant, its molecules can hold a thousand times their weight in water. However, hyaluronic acid extraction is a complex biotechnological process that requires a specialized manufacturing technique.

Hyaluronic acid

Around a third of your natural protein composition is collagen. But the human body still finds good use for more of it, whether to reinforce joints or aid digestion. Collagen powder processing breaks the chains of amino acids into smaller units, allowing them to be consumed at higher concentrations without changing your diet.

Collagen powder

In 1682, Denis Papin found a method to remove collagen from animal bones, discovering gelatin. But it was the inventor Peter Cooper who developed gelatin powder processing. In 1845 he secured his invention with US patent 4084 for a dessert of gelatin powder called “portable gelatin”.

Gelatin powder

The system puts you on the Fast-Track to new product development, thanks to the unprecedented process control provided by EmulTech's Flow Calculator

User-friendly Plug and Play setup

Particles can be produced using all kinds of carrier materials

Process parameters on a single channel device can be easily transferred to multi-channel devices

The two halves of a capsule shell are separately filled with your selected material before they are then pressed against one another and closed. Automatic capsule fillers orientate the shells in the precise position, fill them with your specified formula a join the ends. Capsules are then de-dusted and polished by micro brushes before they are ready for packaging.

Capsule fillers

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

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

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

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 the pharmaceutical world, encapsulation refers to various techniques to enclose and protect the drug ingredients by forming the capsule shell. Encapsulation equipment changes depending on whether the manufacturer needs to produce a soft or hard gel capsule. For instance, encapsulation systems and machines for softgels control the entire process from start to finish because their shells are filled at the same time they are produced. On the other hand, the filling of hard gel capsules comes by separating the body from the cap, and after the filling operations, the two parts are sealed together again, forming the shell.

Encapsulation

The INFINITY Mini and Lab from Emultech are versatile platforms for rapid uniform and reproducible microsphere formation for your drug delivery system.

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

Microencapsulation system for your drug delivery system &ndash; Making.com

Manufactured to reach GMP

Automatic cleaning (CIP) and steam sterilization (SIP) processes

Provides advanced real-time information on the freeze-drying process

Capacity for approximately 1,600 10R-type vials

Combines industrial equipment specification and performance and small-batch flexibility in a compact envelope

GMP laboratory freeze dryer is a lab scale production freeze dryer designed for the production of small batches of high-value pharmaceutical products.

Freeze dryer designed for aseptic and small-scale production of high-value products. Industrial freeze dryer in a compact envelope Lyotris from Telstar

GMP laboratory freeze dryer &ndash; Making.com

<h2>Manufacturing parenteral formulations</h2>
Fragile molecules such as protein formulations would be destroyed using the alimentary canal and are therefore administered by injection. When making injectable formulations the drugs are stored in <strong>liquid</strong> or, if unstable at higher temperatures, <strong>lyophilized form</strong>. To ensure a stable active medium during storage and make the preparation isotonic with blood, liquid formulations combine active ingredients with a minimum amount of excipients such as solvents, solubilizers, suspending, and buffering agents, and antimicrobial preservatives.

Water for injections(WFI) is used as the vehicle for aqueous injections. For non-aqueous injections, fixed oils of vegetable origin are used as vehicles. Water for Injection is used in the preparation of medicines as a vehicle and sterilized water for injection is used when solving or diluting substances or preparations before use. WFI is obtained by distillation or reverse osmosis and meets all chemical requirements for PW (Purified Water) with an additional bacterial endotoxin parameter.

Lyophilized drugs allow storage at higher temperatures after freeze-drying is used to remove water from a liquid drug and create a solid powder or cake. In protein formulations, stabilizers are added to replace the water and preserve the molecule structure. Before administration, a lyophilized drug is reconstituted by combining a liquid diluent with the freeze-dried powder and mixing before injected into the body.

Applikon Biotechnology is specialized in human vaccine production systems, as well as in systems for the production of therapeutic agents using both cell culture and microbial cultures.

Their advanced bioreactor systems can be used from the initial screening stage up to full-scale production using the same platform to minimize scale-up risks and guarantee a short time to market in product development.

Vaccine development and production technology

Inspection of sealed glass vessels for contaminants, correct fill volume, sealing, and for example tip-cap effects or black spot particles. How convenient to cover all quality inspection requirements at once?

CMP Pharma’s NIKE-LT’s recirculation feature allows re-inspection following rejection by only one or two cameras (user selectable) which brings false rejection rates down reducing unnecessary wastage.

Visual and high voltage leak detection (HVLD) inspection

<h2>Sterile filling and packing of injectables</h2>
Sterile dosage forms must be free from any microorganisms, dust, fibers, and foreign particles, and should be isotonic. Although standards and legislation may differ worldwide there are several regulations to ensure the product or safe and effective new and generic drugs on the market such as USP/JP/EP standards and Current Good Manufacturing Processes (GMP) compliance.

Small-volume parenteral solutions (SVPs) are injections provided in containers 100 ml or less and can be designed for single and for multiple uses.  A large volume parenteral (LVP) is a single-use unit dose container of greater than 100ml designed to carry fluids, calories, and electrolytes.

For light-sensitive substances, colored glass containers such as vials or ampoules are used. If possible containers are made transparent for easier visual inspection. Containers are made, as far as possible, from material that is sufficiently transparent to permit visual inspection. Closures are equipped with a firm seal to prevent the entry of microorganisms and other contaminants while permitting the withdrawal of a part of the whole of the contents without removal of the closure. Closures for multidose containers are sufficiently elastic to allow the puncture to reseal when the needle is withdrawn.

Equipment for making injectables in action

Applikon next generation in microbioreactors

Vial filling line 

Injectables Equipment

Find process technology for making injectables and parenteral formulations and connect directly with leading equipment manufacturers worldwide

Injectables &ndash; Making.com

Production Equipment for Injectables - Making.com

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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

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

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

<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

What's new in pharmaceutical packaging? During Pharmapack, we met Chantal Younes, Key Account Manager at Aptar CSP Technology, who introduced us to the

#Changemaker: Ready to protect your pharmaceutical products from moisture? &ndash; Making.com

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

Deborah

Automatic visual inspection of vials, ampoules, and syringes is a well-known and established industrial practice. However, when it comes to small scale,

#Changemaker: Automated visual inspection for pharmaceutical applications. Small scale companies, are you in? &ndash; Making.com

#Changemaker: Automated visual inspection for pharmaceutical applications. Small scale companies, are you in?

Find production technology for Injectables formulation, and connect directly with leading machine manufacturers worldwide.

Injectables formulation

Which injectables formulation equipment do you need?

Multipurpose and R&D freeze dryer

Compact laboratory freeze dryer

Pilot freeze dryer for scale up

Microencapsulation system for your drug delivery system

GMP laboratory freeze dryer

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