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Injectables inspection

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

cmp-pharma-brochure-pdf

CMP-Pharma-brochure.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

Lower cost option than fully-automatic systems

  Wide range of container sizes allows for maximum flexibility

Improves throughput speeds compared to fully manual inspection without reducing quality

Complies with current GMP regulations. Software in compliance with 21 CFR part 11

Fill level inspection ensures that each container is filled with exactly the desired volume of the product during a liquid filling operation. While transparent containers can utilize optical sensors for level detection, difficult to see through containers, such as cans or cartons lined with aluminum, must be scanned using X-rays. When choosing fill level inspection equipment, the size, shape, and opacity of the container must be considered. The production speed, the desired accuracy, and the amount of foaming on the liquid surface are also important parameters to consider. Fill level inspection systems are used to comply with quality control standards.

Fill level inspection systems

Chemical

Cosmetic

Pharmaceutical

Industrial Inspection Equipment

Industrial inspection equipment is used for checking compliance with health, safety, and quality control standards. For that reason, inspection systems are most commonly utilized in the food and pharmaceutical industry but, they are also used in other industries too. Inspection solutions are often integrated into a production process or production line. Visual inspection systems perform checks to detect variation in size, shape, and color and ensure the presence of labels and closures. Check-weigh systems help ensure that product packages are not under or over-filled. Metal detection systems can help guard against the presence of foreign objects in product containers and X-ray inspection equipment is used to detect physical defects and to ensure high quality package seal integrity.

Inspection

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

Inspection &#8211; Making.com

Industrial Inspection 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

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

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

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

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

R&amp;D

Safety &amp; Environment

Batch

Filling lines are used extensively in all industries, such as food, pharmaceutical, chemical, and cosmetics, to accurately package different products into a container suitable for that product. Although the filling process is at the very end of the production line, it is no less important than the earlier steps. Last but not least, the idiom that dates back to 1382 when John Wyclif wrote the firste the laste, and the laste the firste, indicates just that the last things on a list are just as valuable as the previous ones. In this case, this idiom fits perfectly.

Filling

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

liquid

solid

CMP Pharma's SV inspection machine allows your operators to inspect handling containers and pre-filled syringes- from just 1ml capacity up to 1000ml.

If you need to increase the efficiency of your manual inspection process for liquids or freeze-dried products without compromising quality, the latest

Semi-automatic inspection machine for ampoules, vials or cartridges &#8211; Making.com

The marketplace for finding innovative production technology

Making.com

Fast throughput with a wide-range of standard and optional inspections to maximise your production efficiency

Easy to install and use

  Complies with current GMP regulations. Software in compliance with 21 CFR part 11

Leak Detection Systems

Packaging

Continuous

The CMP SA12J is an inspection machine for pre-filled syringes and inspects for contaminating particles, fibres, glass, filling level and flange defects.

Manufacture of pre-filled syringes requires the highest quality inspection processes. Traditional automatic inspection systems are cumbersome and complex.

Flexible automatic inspection machine for syringes &#8211; Making.com

The body produces earwax to protect the ear canal from microbial growth. But no one wants too much protection of this kind. Thankfully, simple solutions are available over the counter to medicate excess cerumen. Besides wax removal, eardrops and OTIC manufacturing provides an effective delivery technique to treat infections or administer anesthetic.

Eardrops

Efficiency of a fully automated system in a format that's compact and easy to install

Wide range of inspection options possible

Fully customisable with a range of back and bottom lights and camera options

The SA12 from CMP is a flexible, fully automatic inspection machine for liquids and freeze-dried products and used for ampoules, vials or cartridges.

If you are looking to improve the efficiency of your inspection system then you need to find the right balance between cost and features. Traditionally,

Flexible automatic inspection machine for ampoules, vials, cartridges &#8211; Making.com

Efficiency of a fully automated system in a format suitable for smaller-scale production lines

Easy to install and operate

The SA6 from CMP Pharma has been designed specifically to bring the benefits of fully-automated inspection to small batch production.

Inspect small batch production of ampoules, vials, or cartridges using automated machinery designed for large-scale production was not cost-effective. The

Small automatic inspector for ampoules, vials, or cartridges &#8211; Making.com

Intuitive assembly and disassembly with no tools required

Small footprint, easy to store

Easily foldable frame saves space and inspection surfaces fold together to prevent damage

Ergonomic design with height and angle adjustment for greater operator comfort

Compliant with European Pharmacopoeia Specification 2.9.20 and US Pharmacopoeia USP chapter 41 (1790), section 6.1

Inspection of jars and bottles is an essential part of any reliable bottle filling operation. Beverage bottles need to be inspected for foreign objects, contaminants, or any residual liquid before filling. After filling, the bottles need to be checked again to ensure the desired fill level, no leaks or potential label problems. Bottles generally travel along conveyors that feed them into the system whereby non-contact optical inspection takes place. This process is usually automated and uses technology to scan the bottles for any potential issues. Considerations for selecting bottle inspection equipment include the size, shape, and material of the bottles, production speed, and the relevant inspection parameters. Bottle inspection equipment is widely used in the food industry to ensure compliance with quality control procedures as well verification.

Bottle inspection systems

<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

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

In the pharmaceutical industry, an inspection of liquids in vials or ampoules for air bubbles or particulate contamination is critical. Some of these

Laboratory liquid viewer for transparent glass bottles &#8211; Making.com

Intuitive assembly and disassembly require no technical expertise

In the pharmaceutical industry, an inspection to detect any particulate contamination in solutions contained in colored glass bottles is not so easy to

Laboratory liquid viewer for colored glass bottles &#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.

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 &#8211; 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

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

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

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? &#8211; 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? &#8211; Making.com

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

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

Injectables inspection

Which injectables inspection equipment do you need?

Semi-automatic inspection machine for ampoules, vials or cartridges

Flexible automatic inspection machine for syringes

Flexible automatic inspection machine for ampoules, vials, cartridges

Small automatic inspector for ampoules, vials, or cartridges

Laboratory liquid viewer for transparent glass bottles

Laboratory liquid viewer for colored glass bottles

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