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Maker - Product Challenge

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Changemakers

Injectables Containment Equipment

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

andocksysteme-asbv-splitvalve-brochure

Andocksysteme - SplitValve

andocksysteme-asbv-splitvalve-ptfe-brochure

Andocksysteme - SplitValve PTFE

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)

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

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

Landline telephones in the 1980s were minimalist gadgets that kept getting slimmer in the 1990s. In contrast, cell phones in the same period were bulky and cumbersome. And once they lost their charge, they turned into a giant paperweight. Then came a revolution in batteries and automation with lithium-ion battery manufacturing equipment. Mobile phones packed more power, recharged faster, and endured more recharge cycles. Above all, they were light and small, making cell phones the inseparable companions they are today. But Lithium-ion batteries power much more than phones. As a result, the world is seeing steady growth in battery manufacturing equipment and lithium-ion production lines.

Lithium-ion batteries

The inventor of the lithium-ion battery predicted that solid-state batteries would become commercially available by the mid-2020s, making them an attractive option for energy storage in a wide range of applications, including electric vehicles. This battery type promises a marked improvement in safety, power, and environmental impact compared to current battery packs that use a liquid electrolyte. However, recent breakthroughs in the lab don’t automatically translate into mass production. The complex processing requires specially-designed manufacturing technology to make solid-state batteries a real solution, especially for the automotive industry.

Solid-state batteries

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

Powder detergent is one of the most widespread washing solutions used in the laundry of fabrics. Since they contain no water, powder detergents are lighter than liquid detergent or pods, which results in cheaper transport and, thus, a more affordable choice for the end consumer. Although manufacturers can formulate their powder detergents differently, the detergent powder production process relies on a combination of builders, surfactants, and enzymes.

Powder detergent

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

Manual or automatic operation

Passive valve can be docked in two positions (180° turned)

Easy removal of the insert in contact with the product

Biggest range of valve sizes DN 50 to DN 300

Available in stainless steel 1.4404, optional HC 22 or other materials

Optional add-ons to increase the containment performance

Contained transfer systems are designed to safely transfer the product or waste items in or out of contained or sterile areas. Valves are used to regulate the flow in contained transfer systems. The choice of a suitable containment system depends on the form of source and target containers, the physical state of the product and the volume of the product to be transferred. These systems find applications in transferring pharmaceutical powders from drums to the process equipment, filling bulk chemicals in transportation bags or safely discharging them into mixing tanks.

Contained transfer systems

Chemical

Pharmaceutical

Containment Technology

The essential objectives of containment systems are personnel protection and preventing the release of toxic or infectious material into the environment. Containment is also used to prevent a product or sample from contamination by the external environment. In the chemical and pharmaceutical industries, containment solutions are used to protect the personnel from the leaking of airborne particles of hazardous substances, as powders or liquids are handled or transferred during processing.

Containment

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

Containment - Making.com

Containment Technology - 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 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

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

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

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

Process

R&amp;D

Safety &amp; Environment

Batch

Conveyor systems are used for moving materials from one location to another. Considerations for choosing a suitable industrial conveying system include the nature of the product, its physical state, the desired conveying rate, and sensitivity of the product to heat and mechanical shock. Conveying equipment is used in the food, pharmaceutical, chemical, biomass, and mineral industries to move materials around a warehouse as well as to transport bulk powders, granules, and grains for processing and filling. These types of systems are usually automated and there is a wide variety of solutions to choose when it comes to the type of conveyor. Types include screw, gravity, chain, roller and belt conveyors.

Conveying

solid

Split Butterfly Valves (SBV) from Andocksysteme provide a safe method of transferring sensitive product like active pharmaceutical ingredients.

Powder containment is the cornerstone of chemical and pharmaceutical manufacturing. Floating particles do not only represent efficiency loss but serious

High containment split butterfly valve - Making.com

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The marketplace for finding innovative production technology

Making.com

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

Cleaner surfaces with minimized dirt traps for easier cleaning and sanitation

Fixed door with accurate positioning for ease of operation

Mirror finished door provides extended visibility to underside of arm

Removable acetal inserts for replaceable high wearing surfaces

Easy installation to rigid wall structures

Logistics

Packaging

Continuous

liquid

A high-performance transfer port system that combines ultimate safety, simplicity of operation, and ideal cleaning, used in pharma.

A high-performance transfer port system that combines ultimate safety, simplicity of operation, and ideal cleaning, used in pharmaceutical and

Transfer system for high-containment environments - Making.com

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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

Microprocessor air flow control

Lighting unit constructed outside the working area, lightning level 800 lux

Inlet HEPA with an efficiency of 99,95%

Exhaust HEPA filter with an efficiency of 99,97%

Pre-filter construction at the inlet HEPA and the exhaust HEPA

A biosafety cabinet is an enclosed, ventilated workspace for safely working with materials potentially contaminated with pathogens in the laboratory. A laminar flow bench is an enclosed space designed to prevent contamination of sensitive samples; it draws in air through a HEPA filter and directs it smoothly towards the user to protect the sample from contamination. The choice of a suitable biosafety cabinet or bench depends on the type of sample and the defined biosafety level ranging from 1 (unlikely to cause disease) to 4 (causes very serious human or animal disease).

Biosafety cabinets

Biological safety cabinet class III is a laboratory isolator designed according EN 12469.

Specially designed for the handling of microbiological agents, when working with indigenous or exotic pathogenic agents that pose a moderately high risk

Biological safety cabinet class III - Making.com

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Working chamber & hatches in stainless steel 304

Microprocessor air flow control equipped with one sensor

Front window placed under a small angle for ergonomics, easily removed for maintenance

Stainless steel dripping tray underneath the air grids to remove spoil liquids

Glove systems (2 or 4), portsØ250 mm, with cuff ring system and latex gloves

Barrier isolator systems create a physical and an aerodynamic barrier between the operator and the work process. The product or process inside the isolator can only be manipulated through the use of gloves or a robotic arm. Choosing an isolation system involves considering the safety regulations (for example; operator protection or cGMP standards), positive or negative pressure specifications, and monitoring and control requirements. Barrier and isolator systems are used in the pharmaceutical industry for sterile processes such as injectable drug filling and cytotoxic drug compounding. Barrier systems and isolators are integrated into full production lines and the most important thing is to control and monitor airflow.

Containment isolators

Sterilator from Telstar Life-Science is a positive-pressure isolator, which provides laminar airflow in the working chamber.

Ideal for products which have no biological risk but require high sterile conditions. Start working in the lab under high sterile conditions Sterilator

Positive pressure isolator - Making.com

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Enhanced levels of operator protection (Class ISO 5)

Fully configurable to meet the specific needs

Minimizes cross contamination risk from other products/processes

Flexibility to handle a large range of container types (i.e. fibre kegs, bags, IBC's, etc.)

  Capability to integrate additional process equipment

Downflow booths employ recirculatory airflow to provide the highest levels of operator protection from harmful airborne contaminants during powder handling operations such as charging and dispensing. The choice of a downflow booth depends on the desired level of operator protection, the size and type of containers that need to be handled inside the booth, and the need to integrate additional processing equipment with the booth. Downflow booths are frequently used in pharmaceutical, cosmetic, fine chemical, food, and nanotechnology applications.

Downflow booths

The downflow booth from Telstar Life-Science operates on a re -circulatory airflow principle.

Provides the highest levels of operator protection from potentially harmful airborne contaminants generated during manual powder handling operations such

Downflow booth - Making.com

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Low cost manually operated single port testing device

Constructed of acetyl or 316L stainless steel

It can be designed to suit all types of Telstar ACE glove ports as well as other port brands

Cannabinoids are natural compounds obtained from the Cannabis sativa plant. Delta-9-tetrahydrocannabinol or THC is a psychotropic substance. Cannabidiol, or CBD, is non-psychotropic and often used for nutraceutical purposes. Cannabinoid equipment extracts THC and CBD from the plant and prepares the substance for formulations that treat pain, nausea, anxiety, and inflammations. Cannabinoids are processed in various forms, including creams, capsules, and oils.

Cannabinoids

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

Industrial measurement equipment is used as a crucial step before products leave the production line. These measuring instruments check for correct dosage and standards. Equipment for measurement and control employs a wide range of technologies to detect inconsistencies in volumes, sizes, weights, and fill levels as well as to inspect goods for quality against a set of criteria. Specialized measuring tools allow you to minimize the probability for error to its lowest possible, ensuring that both products and packaging meet your benchmarks.

Measurement &amp; Control

Complex processes call for continuous tracking and monitoring systems that help you to keep the manufacturing operation under control. The technology analyzes the components in the production phase for divergence in behavior or changes in conditions. Based on advanced software applications, monitoring platforms make sure that your products satisfy the quality criteria while they are being developed.

Monitoring

Drawing samples and testing them for conformity with preset quality standards allows manufacturing units to produce a consistent quality of the product. In a batch process, sample testing systems ensures that each batch meets the specified standards. In a continuous process, product and materials testing helps in the early identification of quality issues, saving significant time and resources, and preventing a sub-standard product from reaching the market. The selection of industrial testing equipment depends on the identification of key quality parameters. These parameters may include volume, weight, viscosity, hardness, particle size distribution, sterility, gauge and containment, among other parameters. Testing machinery need regular calibration to ensure that the parameters being tested are accurate. Some of the more common testing solutions include thermal imagers, scratch testers, optical inspectors and texture analyzers.

Testing

Glove Tester from Telstar Life-Sciences is a low cost manually operated single port testing device designed to allow both in situ and offline testing.

Testing device of the containment capability of gloves, which is as important as the other parts of the integrated system; and a simple, accessible means

Glove tester - Making.com

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Integrated system

  Easy measurement of half-suit containment efficiency

Allows both in situ and offline testing

316L stainless steel base

A flexible containment solution prevents product loss and ensures that personnel is not exposed to harmful substances by locking in the product as it is transferred from one container to another. The choice of a containment system depends on the physical state of the product, the type of container from which the product is being transferred, and the type of container to which it is being moved. Flexible containment solutions are widely used in the pharmaceutical, food, and chemical industries to comply with health and safety regulations.

Flexible containment solutions

The Half-suit tester from Telstar life-Sciences is the most likely component of the isolator which mission is to suffer wear, tear and thus develop leaks.

Designed to allow operators to perform sterility testing in an aseptic environment providing assurance of material integrity. For ultimate containment of

Half-suit tester - Making.com

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steriline_in-line-crabs-and-isolators-pdf

STERILINE_In-line-cRABS-and-Isolators.pdf

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

Engineered specifically for in-line aseptic production lines

2% or less leak rate

Maintains an ISO5 environment

Engineered to meet all relevant cGMP, GAMP and 21CFR Part11 requirements

Pharmaceutical production techniques often require isolation of compounds and chemicals from an external environment and operators to preserve sterility,

Closed restricted access barrier system - Making.com

https://making-tst.imgix.net/2018/10/Steriline-584_Inline-cRABS-and-ISO.jpg

getinge_4477_brochure-pdf

Getinge_4477_brochure.pdf

Ensures regulatory compliance with FDA 21 CFR Part 11

Facilitates effective bio-decontamination with integrated Steritrace unit

Offers flexible ventilation options to meet various aseptic requirements

Provides easy access to the chamber and hatch for maintenance

Enables safe waste removal with DPTE-BetaBag® system

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

When conducting aseptic processes such as sterile testing, small batch production, or compounding, contamination control is a critical challenge. Ensuring

Cost-effective rigid-wall isolator for aseptic applications - Making.com

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Complies fully with ISO 14644-7:2004 producing an EU GMP Grade A environment throughout the chamber

A minimum of log 6 reduction in spore forming micro-organisms is consistently achieved & validated using a BI challenge

  Sound ergonomic design of the unit is combined with thoughtful design-for-manufacture utilizing the latest techniques, assuring ease of assembly and efficient inspection and testing

Injectables Containment Equipment

Which injectables containment technology do you need?

High containment split butterfly valve

Transfer system for high-containment environments

Biological safety cabinet class III

Positive pressure isolator

Downflow booth

Glove tester

Half-suit tester

Closed restricted access barrier system

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