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Maker - Product Challenge

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Changemakers

Injectables drying

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

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

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

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

<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

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

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

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

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

Flexible use: with a touch screen user interface

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

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

Industrial Drying Equipment

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

Find Industrial drying equipment for your manufacturing process and connect with a global network of leading production technology suppliers.

Drying &#8211; Making.com

Industrial Drying 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

Process

R&amp;D

Batch

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

liquid

solid

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 &#8211; Making.com

The marketplace for finding innovative production technology

Making.com

Offers design flexibility to address the requirements

Reduce costs through reduction of cycle times

Reliable and trouble-free process

Integrated and customized solutions for pharmaceutical production

Loading and unloading systems

Liquid

Custom engineered freeze dryer is designed for freeze drying high-value products, such as: vaccines, cytostatics, antibiotics

For either bulk format or liquid in vials, ampoules or syringes, the Lyomega units are designed for freeze drying high value products, such as: vaccines,

Custom engineered freeze dryer &#8211; Making.com

Covers freeze drying areas from 4 m2 to 50 m2

Easy maintenance access to all elements and optimizing the total space necessary

Ensures high product homogeneity during the freezing, primary and secondary drying stages

  Allows the user to readily interpret the machine's operation and obtain information on the process required for decision making

  In compliance with FDA 21 CFR part 11 electronic record guidelines

The Lyonomic Series from Telstar Life-Sciences are state of the art freeze-drying systems.

Designed to perform clinical trials, pilot, and small scale or large scale industrial drying processes, in accordance with the strictest GMP and

GMP freeze dryer &#8211; 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

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 &#8211; Making.com

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

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

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 &#8211; 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 &#8211; Making.com

brochure_-hmbv_drying-pdf

Brochure_-HMBV_Drying.pdf

It took the scientific community almost 70 years to agree on the name ‘protein’ and discard the popular alternative, proteid. But protein powder processing still needed another five decades to be commercialized in the 1950s. Once extraction and purification could be industrialized, protein powder soon became a basic staple supplement.

Protein powder

When he was in Haiti in 1493, Christopher Columbus noticed that the natives were bouncing on rubber balls made from the milky sap of Hevea brasiliensis, also known as a rubber tree native to South America. The milky sap was nothing but latex, the source material for natural rubber. Latex processing technology includes equipment for coagulation techniques and rollers for natural latex and a sequence of mixers, pumps, and sieves for synthetic latex.

Latex

Best Features of the reconstituted product (shape, color, volume)

Preservation sensitive compounds and high-temperature properties: vitamins, proteins, enzymes, etc

Limitation of oxidation reactions

Very low final moisture of the lyophilized product: high stability

Compatible with aseptic conditions: production of sterile products

Biomass

Ceramic

Chemical

Feed

Food

Metal

Mineral

Ceramics are defined as inorganic and non-metallic materials. Tthey are typically brittle, hard, and elastic as well as resistant to heat and corrosion; in fact, after shaping them into the desired shape, they are heated in an oven called kiln at very high temperatures (1,000 °C to 1,600 °C). Kaolinite and aluminum oxide are the best-known examples of ceramics.

Ceramics

Due to their potential hazardous nature, chemicals are classified for proper identification and safety during production. Chemical classification depends on their properties, structures and functions. In the chemical industry, you can regard them as basic chemicals such as acids, chemical products to produce plastic materials and finished chemicals for use in cosmetology. As a manufacturer or engineer, you want to know their reactivity when using chemical processing equipment.

Chemicals

Our food chain starts in the soil, growing crops and livestock. But between the fields and the stores, there is a line of industrial food processing equipment. Processes may be as minimalistic as cleaning fruit and as complex as homogenizing milk alternatives made from pressed legumes. In each case, processing technology is an important link in the food production chain.

We carry dozens of metals around every day. The ubiquitous smartphone is built with no less than 20 metals, each with specific behaviors and purposes. Metals are a pervasive class of materials that have defined entire eras of human development. It is no exaggeration to say that metal processing equipment is the core of our metallic world. But, paradoxically, this manufacturing technology itself is mainly made of metal.

The nearly 5,000 known minerals on earth share some characteristics to be classified as minerals – they are inorganic, solid, naturally occurring elements and have a particular chemical formula and an ordered internal geometric structure. However, minerals are not all the same. One way to divide them is based on their physical characteristics such as hardness, luster, color, and shape. For example, the diamonds we use to make jewelry are very hard minerals while talc is a soft mineral; gold is a shiny mineral while others are less so.

Minerals

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

Pigments are colorants that are not soluble in the host material and scatter light and are therefore opaque. Pigments can be organic or man-made and derive from animals, plants, rocks or minerals and metal oxides, like for example titanium oxide.

Pigment

Can it be said that we live in the Plastic age? Basically, yes. From pillows over toothbrushes, and packaging to utensils, plastic is a widely used material in our day-to-day lives. But what is it? Plastics are synthetic or semi-synthetic materials built of polymers that are easily shaped into various structures with the help of plastic processing equipment such as extruders and molders.

Plastics

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

The Active Freeze dryer from Hosokawa Micron uses very low temperatures and vacuum to dry your product.

Freeze-drying is used for dehydrating high-value products that are too sensitive for conventional drying processes. The product is dried by freezing,

Active freeze dryer &#8211; Making.com

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

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

All plastics are polymers, but not all polymers are plastics. Polymer production is a multi-step process that transforms raw materials into products that we use in our day-to-day life with the help of polymer process equipment such as extruders, calenders and injection molding machines.

Polymers

Smooth transition to the production plant

Best features of the reconstituted product (shape, color, volume)

Preservation sensitive compounds and high temperature properties: vitamins, proteins, enzymes, etc

The 1 liter laboratory scale freezer dryer from Hosokawa Micron is quicker and less labor intensive than traditional tray-type freeze dryers.

The laboratory-scale active freeze-drying is used for dehydrating high-value products that are too sensitive for conventional drying processes. The

Laboratory scale active freeze dryer &#8211; Making.com

Vitamin C is an essential nutrient, but the human species lost the ability to produce it biologically during the course of evolution. Instead, we source the substance either from whole foods or vitamin C manufacturing. The chemical characteristics of the natural nutrient and processed compound are the same, but supplements offer higher concentrations, especially to persons with nutrient deficiencies.

Vitamin C

Painting as an integral aspect of the human tradition dates to thousand years ago. Of the many properties of the product, the drying time is important to consumers. The thickness of the paint and environmental factors like humidity affect this parameter. Paint manufacturing equipment must include a humidity test chamber to assess the behavior of paint under different weather conditions.

Paint

Extracting sugar from beets became popular in continental Europe during the Napoleonic Wars due to the British blockades of cane sugar. This is thanks to the high sugar content derived from this crop. Also known by its scientific name, "beta vulgaris", The beets’ popularity steadily rose afterwards and today, 20% of all sugar in the world comes from beets. But all of this can't be possible without its seeds. The production and processing of sugar beet seeds includes different steps such as cleaning, priming, pelleting and coating.

Sugar beet seeds

Robust design in accordance with the latest standards/GMP requirements

Clean room design using membrane connection (motor below base plate)

Easy maintenance due to modular design

  Suitable for Ex zone 1 (according to directive 94/9/EC)

Pressure vessel design on request

Scraper Centrifuges

Industrial centrifuges are widely used for mechanical solid-liquid separation of components in the pharmaceutical and chemical industries. This is achieved by rapidly rotating the contents within a container to separate fluid of different densities or to remove liquids from solids.

Centrifuging

The Vertical Scraper centrifuges VBC (Vertical Bottom discharge Centrifuge) from Ferrum include many application areas in the solid-liquid separation due to the modularity and the comprehensive range of optional equipment.

Vertical Bottom discharge Centrifuges work discontinuously, discharging the solids to the bottom. They are suitable for the demanding continuous operation

Vertical scraper centrifuges &#8211; Making.com

Swivel open housing for optimum inspection of the process area

Reliable sealing of the bearing housing with sealing systems of the latest generation

Suitable for Ex zone 1 (according to directive 94/9/EC)

Cosmetic

According to a legend, Cleopatra soaked her sails in her perfume so that Mark Antony could smell her ships before they arrived. This is to say that, from soaps and shampoos to perfumes, conditioners and pomades, cosmetics have always been highly valued and used for their properties of aesthetic enhancement. Cosmetics are a broad class of topical agents applied for various purposes such as cleansing, protecting, beautifying, or otherwise altering your appearance. As a result, a wide array of processing equipment is used in the cosmetics industry.

Cosmetics

Synthetic fertilizers are made of nitrogen, phosphorus and potassium and are often produced as dry pellets or soluble product.

Synthetic fertilizer

The Vertical Peeler centrifuge is a new development of the centrifuge type VBC-S (Vertical Bottom discharge Centrifuge - Swivel Open Housing) from Ferrum.

A vertical peeler centrifuge is used to separate solids, usually to separate fine particles from suspension liquid feed mixtures in the pharmaceutical

Vertical peeler centrifuge &#8211; Making.com

Sanitary design

Robustness and reliability

Safety and easy operation

Quality guarantee

Feed ingredients

Industrial sterilization processes are employed in different industries to completely eliminate all living microorganisms from the final product. For instance, in food processing, sterilization equipment is used to produce a stable product with a long shelf-life by eradicating harmful bio-contaminants. Instead, in the medical field, sterilization technologies aim to prevent the transmission of microbes to patients by sterilizing all the tools and medical devices that come in contact with the patient. Most sterilization equipment, such as autoclaves, employs high-temperature pressurized steam to destroy bacteria and disinfect surfaces from spores. Other methods include radiation sterilization or using chemicals such as hydrogen peroxide for disinfection.

Sterilization

The PSG-E electrical pure steam generators consist of a vertical pressure container, in the form of a column.

Pure steam is defined as the steam which when condensed becomes WFI quality water in accordance with European and US Pharmacopoeia specifications. Low

Electrical pure steam generator &#8211; 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.

Injectables drying

Which injectables drying equipment do you need?

Pilot freeze dryer for scale up

Custom engineered freeze dryer

GMP freeze dryer

Compact laboratory freeze dryer

Multipurpose and R&D freeze dryer

GMP laboratory freeze dryer

Active freeze dryer

Laboratory scale active freeze dryer

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