An injectable is any drug administered into the body via injections. It needs to be sterile as it bypasses the natural defences of the body and acts against pathogens. For this reason, the injectable manufacturing procedure is subject to strict regulations. Therefore, injectable manufacturing facilities need to be equipped explicitly for aseptic production. This article discusses sterile injectables, the types of injectables and the primary injectable filling machines used in the pharmaceutical industry.
Injectable Preparations or Injectables
Injectables are called Injectable preparations or parental preparations and are administered into the body via injections. These sterile preparations are also called implantation or parental infusion. They are prepared using rigorous methods to ensure sterility of the infusion and avoid contamination by foreign bodies, such as bacterial endotoxins, microorganisms and pyrogens.
What are Sterile Injectables?
Sterile injectables are a class of drugs or medications that are absorbed via the digestive tract or the bloodstream, or blood vessels. It is challenging to administer these drugs, but the benefit is that they are absorbed quickly by the body and eliminate the chances of a first-pass effect. In simple words, almost 100% of the drug or medication is bio available.
Types of Injectables
From general injectables to cytotoxic injectables, the pharma industry develops various types of injectable filling lines or machines for almost all types of injectables in accordance with strict sterile regulations. Here we look at different injectables and their types.
General injectables
General injectables are commonly called shots and consist of fluids, liquid medications or nutrients that are administered directly into the body. The health care professional or doctor uses injections o administer injectables such as vaccines and other medications into the skin, bones, muscles or veins of the person. There are various types of injectables manufactured by the pharmaceutical industry and used for various medications in the body.
Cytotoxic Injectables
Cytotoxic injectable drugs belong to the most crucial drug class and are used to treat prevalent oncological disorders. These injectable drugs have cellular degeneration properties and are very effective in eradicating cancerous cells. Cytotoxic injectables are generally prescribed by the oncologist as the first line of treatment for various types of cancer.
Cytotoxic injectable drugs are also called chemotherapy and are known for their severe side effects like follicle toxicity, bone marrow depression, and anaemia. Most cytotoxic injectables are off-patient drugs and are easily available as generics in the market.
Cytotoxic injectable manufacturing companies exercise special caution and sterility guidelines when making the drug for market use.
Freeze Drying Injectables
Lyophilization or freeze drying technique is often used in the pharmaceutical industry to increase the lifespan of medical drugs, such as injectables and vaccines. A rapid removal of water from the ingredients and sealing it in the vial allows for easy storage and shipment of injectables across long distances. These injectables could later be reconstituted into their original form and administered to the patient as sterile liquid injectables. Freeze drying of the injectables further increases product stability and allows effective management of the drug during transportation.
The injectable or pharmaceutical ingredients are first frozen and then placed under the vacuum, which causes the ice to transform directly from its solid icy form to vapour form without passing through the liquid phase. The total absence of water molecules from the drug increases its longevity and makes it easily portable. The Lyophilization process includes three unique and independent processes, viz, freezing, sublimation or primary drying and desorption or secondary drying.
Liquid Injections
Liquid injectables are a part of pourable pharmaceutical formulations that contain a mixture of non-drug components (excipients) and active drug components suspended or dissolved in mixtures of solvents or a single suitable solvent. These pharmaceutical preparations are designed to deliver the maximum therapeutic response to a specific health issue in a target population that has difficulty swallowing solid drug forms. Liquid injectables are also widely utilised to produce rapid therapeutic effects for acute health issues.
Powder Injections
Powder injections are defined as a solid, dry substance, made up of finely split drugs with or without any excipients and are intended for external or internal use. These are solid substances manufactured to be finely divided and are mainly obtained by grinding or crushing the prenatal preparation or the drug.
When adequately prepared, these powder injections have a small and uniform particle size and look elegant. Generally, powder injections are traditionally more stable and easily portable than liquid injectables. Plus, powder injection drugs are readily soluble, allowing the body to absorb the medicine quickly.
Beta Lactum Drugs (injectables)
Beta-lactam drugs or antibiotics contain the beta-lactam ring in their chemical structure, hence the name beat lactam antibiotics. These antibiotics can effectively treat various gram-negative, gram-positive and anaerobic bacteria.
Beta-lactam antibiotics are among the most commonly prescribed medications and have various clinical applications. Since their introduction in the 1930s, they have been very effective against deadly bacterial infections and illnesses.
Non-Beta Lactam Drugs (injectables)
To treat bacteria that are resistant to beta-lactam drugs, there has been a need for different antibiotic medications with varying modes of action and structures.
The most common alternative to a penicillin antibiotic ( the most widely known beta-lactam antibiotic) is a non-beta-lactam antibiotic called vancomycin or Vancocin. Though initially introduced in 1958, its use was superseded by the beat lactam antibiotics since they provided a less toxic and cheaper alternative to bacteria infection treatment. In recent years, medical interest in vancomycin has surged again. Many medical scientists see non-beta-lactam antibiotics as the most suitable alternative to the evolved bacteria resistant to beta-lactam antibiotics.
Injectable Lines in Pharmaceutical Industry
Injectable filling lines are extensively preferred in the pharmaceutical industry to pack the vaccines and liquid injectables into vails and other sterile secure containers. These lines are also called injectable filling machines and perform large precise operations of filling injectables into vials, ampoules, bottles, and other sterile medical containers.
Injectable filling machines consist of multiple filling heads, which enable the manufacturer to achieve higher filling rates and enhance productivity. Therefore, these filling machines are also called injectable filling lines. The basic design of the injectable filling machine includes the filling head and the conveyor. The filling head has multiple nozzles which fill the vails precisely with the prescribed volume. Depending on the use, there are many variants of injectable filling lines. The different types of injectable filling machines are as follows:
Injectable Liquid Filling Machine
The liquid filling line or machine functions under high pressure. Therefore, it could also be classified as liquid pressure filling. In this process, the liquid injectable flows into the storage bottle depending on the weight when the pressure in the fluid reservoir becomes equal to the air pressure in the bottle.
The injectable liquid filling lines are easy to operate and fill the precise amount of liquid into bottles, containers or gallons. The filling mechanism built into the machine allows it to adjust the filling rate and quantity as per the size of the bottle or the container without replacing any components. These machines are equipped with sensors which can automatically stop the process in the absence of any bottle on the belt.
Digital Liquid Filling Machine
The digital liquid-filling machine is the most preferred liquid-filling line in the pharmaceutical industry. It has various operator-friendly features and automatic operations that make it more efficient and allow it to achieve the best filling rates in shorter turnaround times easily.
The digital liquid filling machine has an easy-to-use interface which enables access to every filler function, including diving nozzle indexing, and allows better system control. The machine operates on a stable supply of electricity and automatically adjusts itself under specific low-power situations. The digital filters can quickly scan for any errors in the filling line before the finalization of the packing container.
Vial Filling Machine
The vial filling line is the most economical machine of the lot, as it requires less area than other filling lines and could be easily installed within a compact space. Plus, the machine requires a single operator to run the filling line. The filling station has sensors to monitor and reject the unfilled vials. It ensures zero wastage and maximum efficiency.
The weight-checking machine in the vial filling line is a unique feature that allows the filing line to automatically check the weight of every vial and ensure that every vial is filled with the same amount of injectables. These vials are easy to transport, and the injectables can be stored in the vails for extended periods.
Powder Filling Machine
The powder-filling line is the most utilized filling machine in the pharmaceutical industry to ensure better efficiency and higher productivity. For this reason, the powder filling machine is in very high demand in the pharmaceutical industry.
The powder filling line works at the speed of about 108 strokes per minute approximately. These machines are fully automatic and semi-automatic and run efficiently to achieve the best production outcomes. The powder filling machine is more reliable and durable when compared to other injectable filling machines. The drive mechanism of the filling line is user-friendly and compatible, which allows seamless operations with the option to increase production as and when required.
Ampoule Filling Machine
The ampoule-filling line is the most preferred machine for the ampoule-filling process in the pharmaceutical industry. These machines provide a higher rate of productivity and are beneficial for manufacturers which want to boost their productivity.
The most significant feature of the ampoule filling line is that it could entirely cover the filling product into a sterile glass without needing any external component like the rubber stopper that may come in direct contact with the injectable drug and risk contamination.
These machines are used to fill the injectables into the ampoules. The speed of the filling lines varies with the filling rate and the size and shape of the equipment. The ampoule coding machines have the ring banding to execute a perfect finish to the ampoule tips and ensure proper identification of the vials.
Orally administered drugs require careful handling during the manufacturing and packing process to avoid contamination. Because bacterial presence can affect the digestive system and cause illness, such is not the issue with injectable drugs. All they need is a sterile, filling environment.
Only three percent of injectables are utilized for immunizations. The rest are only therapeutic and are used to treat various health issues. A higher share of the sterile injectable market is dominated by biologics, while small molecular drugs occupy the small rest of the market. However, injectables are extremely important in medical science, and the pharmaceutical industry works together to ensure sterile injectables are provided to the medical science field to provide proper medical care to people.
Bottom Line:
Injectable manufacturing process in pharmaceuticals requires specialized equipment. With proper injectable filling machines and injectable lines output can be maximized with sterility protection. Adinath International is one of the leading injectable filling machine manufacturer in India.
Ampoule Filling Machine Video
Powder Filling Machine Video
Vial Filling Machine Video