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Maker - Product Challenge

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Changemakers

Injectables sterilization

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

“How clean does my equipment needs to be?” 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.

&nbsp;

Water for injection

ipros_company-brochure-pdf

Ipros_Company-brochure.pdf

ipros_biopharma-pdf

Ipros_Biopharma.pdf

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)

Your earliest memory of medicine is probably a jar of cough syrup with a plastic dosing spoon attached. Although widely produced as remedies for children, medicated syrups are also available for adults. Making cough syrup starts by dissolving active ingredients into a purified water and sugar solution. But it is the distinct flavorings and colorants that persist in people’s minds long after the illness is cured.

Cough syrup

Bespoke integrated CIP/SIP solutions to meet your exact requirements

Rapid ROI thanks to reduced costs, reduced labour, reduced cycle time

Incorporation in any existing pharmaceutical equipment

Qualified Project/Process Engineer assigned to your project from start to finish

Pharmaceutical

Industrial Sterilization Equipment

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

Connect directly with world leading manufacturers of industrial sterilization equipment and find technology to build or improve your production line.

Sterilization &ndash; Making.com

Industrial Sterilization 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

Liquid

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

Logistics

Process

R&amp;D

Continuous

Industrial cleaning equipment is used to wash or disinfect machinery and the production/warehouse area. It may also be used to sterilize the product, equipment, tools, floor or work surfaces and to purify or clean the product by removing impurities. Choosing a suitable cleaning system depends on the type of product or equipment to be cleaned, the sensitivity of the product to heat, pressure, and chemicals, and the level of sterility desired.

Cleaning

liquid

An increasingly vital part of high quality pharmaceutical production is a dedicated Clean in Place/Wash in Place/Sterilize in Place system (CIP / WIP /

Cleaning and sterilization systems &ndash; Making.com

We open production technology to everyone

Making.com

steriline_depyrogenating-tunnels_st-pdf

STERILINE_Depyrogenating-Tunnels_ST.pdf

Wide variety of tunnels to suit every requirement

Highly efficient compact design reduces operating costs

Up to 38,000 pcs/h for the most demanding of production lines

Fully compliant with cGMP, GAMP and 21CFR Part11

Depyrogenation Systems

Sterilization of vials, ampoules and syringes before filling is a vital step in the production of regulated pharmaceuticals. Traditional sterilization

Vial sterilization tunnel &ndash; Making.com

Surgical instruments still involve a significant degree of manual craftsmanship to manufacture. But advances in surgical instruments technology today intertwine with expert handiwork to produce precise tools that make the difference between life and death.

Surgical instruments

A missing tooth can wipe a smile off your face. But high-precision engineering is filling the gap with dental implants manufacturing equipment. Advanced technology produces safe implants from biomaterials that fuse with the jawbone.

Dental implants

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

High production capacity

GMP design and complies with the applicable European standards

Customized configuration

Hazard and operability (HAZOP) and safety tests

Operational safety

Industrial autoclaves are hermetic containers that kill microorganisms such as bacteria, viruses, and spores by using steam under high pressure. The steam is pumped at a higher pressure than normal atmospheric pressure to reach a temperature of 121–140 °C. As steam is pumped into the main chamber of the autoclave, it replaces air and creates a vacuum seal. The pressure vessel kills pathogens and microbes, but industrial autoclaves may also be used to reinforce composite materials, and laminate surfaces. Sensitive products such as foods and pharmaceuticals typically use wet steam autoclaves to sterilize containers and instruments because moisture can penetrate tight areas. But other applications, such as wood treatment or rubber vulcanizing, may also be subjected to dry steam techniques.

Industrial autoclaves

Batch

solid

Ethylene Oxide sterilization chamber offers the best performance for the terminal sterilization of temperature-sensitive medical-health products.

Designed for the terminal sterilization of temperature sensitive medical-health products in large batches. The most efficient sterilization agent EtO

Ethylene oxide sterilization chamber &ndash; Making.com

Ergonomic and flexibility

Fully sanitary design

A mixture of pure vapor and air is used for sterilization

Easy to operate

Telstar Life-Sciences’ Steridelta A autoclaves are steam and air mixture sterilization autoclaves specially designed for sterilizing large batches of parenteral solutions.

Specially designed for sterilizing large batches of parenteral solutions. The best performance for the terminal sterilization of parenteral solutions

Steam and air mixture sterilization autoclave &ndash; Making.com

Safe process, using at least 3 safeties for any critical functions

Modular design, and 100% customizable to customer needs

High efficiency, optimizing energy consumption and cycle time

Fulfilling ATEX 2014/34/EU, ISO 11135, EN1422, GMP, etc.

The Inoxtorres ethylene oxide sterilizers (EO/ETO) propose a modular design in order to divide the risk to have a potential explosive atmosphere.

When medical devices like syringes, catheters, dialysis cartridges, plastic dressings and sutures have to be sterilized, precautions should be taken if

Ethylene oxide sterilizer &ndash; Making.com

romaco-macofar-tunnel-datasheet-pdf

Romaco-Macofar-Tunnel-datasheet.pdf

A dishwasher tablet is an essential detergent. It consists of a pressed mixture of sodium and potassium salts, surfactant, fragrance, and other filler agents, mixed with the help of tablet making machines. The products’ use in America and Europe is high, unlike in the Asian continent, where the price limits its usage. Its global market size will reach $990 million in 2026 from $475.6million in 2019, according to Grand View Research forecasts.

Dishwasher tablets

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 wave of liquid soaps and detergents in the 1950s revolutionized home and personal care. Cheap and convenient, these off-the-shelf products fit perfectly into the lifestyle of the time. A few decades later, though, plastic waste put the sustainability of hygiene products into question. Refill tablet production technology answers that by eliminating single-use plastic. Instead of picking up a new bottle every time, end-users complete the formulation process in a multi-use container and with a simple instruction: just add water.

Refill tablets

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

There are slight differences between human and animal pharmaceuticals, but that dissimilarity is enough to create new production challenges. Veterinary tablets formulation reflects the diversity of enzymes that different species use to break down substances. Although the methods involved are comparable to human drug manufacturing, equipment and processes need to adapt to a wider dosage variability in veterinary tablets.

Veterinary 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

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

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

Compatible with full Macofar Sterile Lines

Process is continuously monitored and main parameters are printed

Conveyor belts prevent the vials sliding along the tunnel walls

Adjustable flaps guarantee uniformity of heat and temperature distribution

Your cooked foods are typically exposed to high heating conditions and could take a long time to drop to the right temperatures for further processing or packaging. Cooling tunnels consist of a series of blowers and exhaust hoods that rapidly extract the heat from your products as they travel on a conveyor belt.

Cooling tunnels

Packaging

Bottling equipment draws a measured quantity of your drink, food, or formulation from a holding tank and fills it into bottles. These bottles usually need to be checked, capped, labeled, and sealed for distribution. Bottling solutions differ in product metering system, sterilization level, and bottle type and sealing system depending on your production scale and product format and regulations. Bottling systems are utilized in a variety of industries. For example, in the food and beverage industry as well as in cosmetics and pharma.

Bottling

At last, you reached the final stage of processing your product - welcome to the packing world! Packing preserves and protects a product from damage, spoilage, and contamination while it makes its way from the production line to the consumer or further production. Depending on which industry your products belong to, the type of primary packaging equipment can change drastically. You need to pay careful attention to products with chemicals or hazardous substances since they can be potentially dangerous to human health.

Packing

Romaco Macofar Depyrogenation tunnels for ampoules, vials and bottles are designed to sterilize and depyrogenize ampoules and other glass containers.

Sterilize and depyrogenize ampoules, vials, bottles and similar glass containers. In-line depyrogenation of small glass containers Romaco Macofar

Depyrogenation tunnels for ampoules, vials and bottles &ndash; Making.com

Insulin is a hormone that controls blood glucose levels produced by the beta cells in the pancreas. As a medication, insulin was discovered by Frederick Banting and Charles Best in 1921, for which Banting was awarded a Nobel Prize in 1923. The insulin production process involves manipulating the biological precursor to insulin and cultivating it inside bacteria using specialized technology.

Insulin

Excellent temperature uniformity

Superheated water shower autoclave are sterilization autoclaves designed for sterilizing large batches of parenteral solutions.

Specially designed for sterilizing large batches of parenteral solutions. Excellent temperature uniformity can be rapidly obtained in the chamber by the

Superheated water shower autoclave &ndash; Making.com

Cell culture has been, over a little more than 100 years, an important method of research in laboratories. But medicine developments aside, we wonder if even the most positive of idealists could have also believed that cell cultures and tissue culture would possibly change the way – and what – we eat. From the lab to the dining table, there’s cell culture equipment to make even the unimaginable possible.

Cell cultures

Designed for processing a wide range of products

High technical performance adapted to a GMP setting

Used for applications that are not strictly GMP production related

The most recognized sterilization method when dealing with non-sensitive temperature products

Safe and reliable construction

Saturated steam GMP laboratory autoclave are sterilization units designed for processing a wide range of products.

For processing a wide range of products: solid, porous and liquids in a laboratory environment. Excellent performance for the sterilization of laboratory

Saturated steam GMP laboratory autoclave &ndash; Making.com

Highly robust and reliable

Sanitary design

The processed material emerges dry at the end of the cycle

Production performance

Drying cabinets consist of an enclosed chamber where products to be dried are placed on stainless steel trays. These drying systems reduce the relativity humidity allowing the moisture to evaporate quickly. Cabinet dryers are widely used for reducing the moisture content of sensitive products.

Drying Cabinets

Industrial ovens

Dry heat depyrogenation oven from Telstar Life-Sciences are designed for the sterilization and/or depyrogenation of pharmaceutical and biotechnology products.

Specially designed for the drying and sterilization of glass containers, vials or ampoules, and high-temperature resistant metal products using ultra

Dry heat depyrogenation oven &ndash; Making.com

Robustness and reliability

Safety and easy operation

Quality guarantee

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

The heating process is a step of raising the temperature of food, pharma, cosmetics, and many other types of products. You may employ different heating solutions for this process, depending on the type of product you intend to manufacture. Selecting the appropriate heater machine for your product is quite important since various products require different ranges of temperatures and different ways of heat transfer using exchangers. Industrial heating equipment varies in two ways - the type of material it can process and the reaction you want to achieve.

Heating

Telstar Life-Sciences’ PSG pure steam generator has a design which offers excellent performance for steam production for use in pharmaceutical production.

Pure steam is mainly used in the pharmaceutical industry and in biotechnology for sterilization, water for injection generation, clean room

Pure steam generator &ndash; Making.com

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

Feed ingredients

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

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 &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 liquid or, if unstable at higher temperatures, lyophilized form. 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.

Injectables sterilization

Which injectables sterilization equipment do you need?

Cleaning and sterilization systems

Vial sterilization tunnel

Ethylene oxide sterilization chamber

Steam and air mixture sterilization autoclave

Ethylene oxide sterilizer

Depyrogenation tunnels for ampoules, vials and bottles

Superheated water shower autoclave

Saturated steam GMP laboratory autoclave

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