printable-sheet-specifications-xi-i-pdf

printable-sheet-specifications-XI-I.pdf

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

Parenterals

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

Pre-filled Syringes

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

Vials

After being used to contain the blood of martyrs after death or to store the anointing oil of French monarchs, today ampoules are the first choice in packaging injectables. You create ampoules by melting the glass tube into the desired shape and seal them at the neck by melting the top of the glass tube. The only way for you to extract the contents from an ampoule is by breaking the glass at its breaking point, making it perfect for single dose applications only.

Ampoules

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

Pharmaceutical cartridges

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

Can hold up to 8 heads

Zero air consumption required for movement

Integrated weighing and quality control

Easy sterilization using H2O2

Built to cGMP and FDA standards

Aseptic filling equipment is crucial for sensitive products, as they need to be filled into their primary packaging in an environment free from contamination caused by harmful bacteria, viruses, or other microorganisms. Choosing an aseptic filling solution requires consideration of the physical form of the product, the type of primary packaging, the volume to be dosed per package, and the production speed. Aseptic fillers are widely used for cleaning, filling, and sealing pre-sterilized vials, cartridges, ampoules, and syringes in the pharmaceutical industry. Aseptic filling is also used in the food industry to process for example, dairy products that need harmful bacteria's minimized, or ensure shelf-stable products that do not require refrigeration. In these industries, aseptic equipment is integrated into the production line for maximum isolation and sterilization. And, can either be configured as an automated or manual process, depending on standards that the products require.

Aseptic filling equipment

Sterile Filling Solutions

Pharmaceutical

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

Dosing systems are a line of hoppers, feeders, filling machines, and checkweighers that operate in sync to dispense materials accurately. Dosing is an essential feature of the packaging process, whether you’re filling shampoo bottles or tea bags. But dosing equipment is critical for formulations, too, particularly in the pharmaceutical and chemical industries. Imprecise dosing may cause quality degradation in the best-case scenario. In the worst scenario, it creates serious health risks.

Dosing

Almost all manufacturers will require industrial storage systems and solutions at some point during their production process. The raw materials that go into your products need dedicated storage solutions to protect them from spoilage and contamination before they enter the manufacturing cycle. Storage usually refers to particular storage space. For example, having enough warehouse storage. Or clearing out a production facility for more floor space.  However, in this case, we are referring to the equipment and solutions that make storage manageable and easier. Such equipment includes solutions such as storage racks, pallet racks and shelving systems. These are just some of many storage options available to manufacturers. Advanced technology facilitates the management of heavy duty and high density tank and silo systems by automating the delivery system and linking it with the rest of the production line.

Storage

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

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

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

Packaging

Process

Batch

Continuous

liquid

solid

XI-I is specially designed by i-Dositecno for pharma filling, able to fill sterile liquid and powder in doses from 1 to 500 mls into vials and syringes.

Sterile filling of liquids and powders for the pharmaceutical and cosmetic industries requires flexible automation to accommodate format changes and

Sterile filling line for injectables - Making.com

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Sterile filling line for injectables

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