The age group who are affected with the respiratory problems get relieved with help of Nebulization. A Nebulizer is a small machine that creates a mist out of liquid medication, allowing for quicker and easier absorption of medication into the lungs through nebulizer mask. It is less expensive and easy adaptable and commonly used for respiratory problems like chest congestion,Asthama etc. Nebulizers are low to moderate risk medical device and they need mandatory registration as per MDR2017.
CDSCO will be the central licensing authority who will approve the applications for Nebulizers manufacturing process in India. The manufacturer needs to apply for CDSCO manufacturing license and our team will assist you to complete the licensing process. The manufacturer of these products should follow the safety and efficacy principal as per the given guidelines. The person who wants to start the nebulizer manufacturing unit should be aware of manufacturing and regulatory process. Usually, nebulizers come in both electric or battery-run versions, and are both transportable (so you can bring with you) or supposed to sit down on a table and plug into a wall.
Both versions of nebulizers are made up of:
- a base that holds an air compressor
- a small container for liquid medication
- a tube that connects the air compressor to the drugs container
Above the medication container is a mouthpiece or mask you use to inhale the mist.
Types of Nebulizers:
Nebulizers have three types:
- Jet Nebulizers: Make an aerosol out of medicines using a compressed gas (like air). These are the common sort of nebulizers.
- Ultrasonic nebulizers: These are more commonly used in hospitals and typically are not for personal use.
- Mesh nebulizers: Mesh nebulizers use a mesh cap with tiny holes that help dispense medicine in a totally efficient manner. Those nebulizers are more modern and frequently extra powerful than jet nebulizers.
Technical Features of Nebulizer manufacturing:
- Manufactured from soft, non-toxic medical grade material.
- Made from a clear aerosol mask, perfect for long use.
- Star lumen tube to avoid fortuitous blockage.
- Made up of a kink-resistant PVC tube.
- Integrated nasal clip for stable fixation over the patient’s nose.
- Elastic strap/band is for proper mask placement.
- Tube length: 200cm.
Nebulizers Manufacturing Process:
Injection Moulding Machine
Injection moulding is a forming process using moulds. Materials such as artificial resins (plastics) are heated and melted, after which sent to the Mold in which they may be cooled to shape the designed form. Due to the resemblance to the technique of injecting fluids using a syringe, this system is called injection moulding.
Mechanical
This kind of device is used to toggle the machine for building up the tonnage on the side of the machine, that does not open because of injection pressure.
Hydraulic
This machines despite are not that nearly precise, and are the predominant type in most of the world.
Electric
The electric press also known as electric machine technology, reduces the cost by means of cutting the consumption of energy. Electric press is said to be quieter, faster, and have the best accuracy.
Sterilization plant
For the sterilization process here, they must use ethylene oxide. Ethylene oxide (ETO) referred as the gas used for low-temperature sterilization. It’s normally used to sterilize instruments or devices and all those products that have to be sterilized but cannot stand high temperatures.
Raw Material Used in Nebulizer Manufacturing :
- Polyvinyl chloride (PVC)
- Elastic strap/band
- Acrylonitrile butadiene styrene (ABS)
- Polypropylene (PP)
- High density polyethylene (HDPE)
How do nebulizers work?
A nebulizer delivers liquid medication thru pressurized air. While individuals with asthma typically use both nebulizers and inhalers, occasionally, a nebulizer are easier to use, However, when airways become narrow — like during an asthma attack — an inhaler is mostly preferred, because a nebulizer can take some time to set up.
Examples of medications used in nebulizers include:
- Bronchodilators are drugs that help to open up the airway.
- Medical-grade saline (saltwater) solutions are solutions that help break up mucus in the lungs.
- Antibiotics are used to treat infections.
The Use of Nebulizers in different conditions, includes:
- chronic obstructive pulmonary disease (COPD)
- asthma
- bronchiectasis
- cystic fibrosis
- pulmonary fibrosis
Nebulizers are also helpful in delivering medication during palliative care and to very young children
Top reasons to start Nebulizers manufacturing unit?
Growth has been seen in Nebulizer manufacturing, as per the data from various sources the revenue from the industry is expected to grow by 6.5% through 2020 to 2027.Nebulizers are part of home care services. One can encash the opportunity lies in nebulizer manufacturing market. Driving factors which are contributing in Nebulizers manufacturing process are:
- Growing market size- due to the respiratory disease and outbreak of Covid-19 accelerated the demand for nebulizers.
- Home care service product – Large number of people especially geriatric population opting to buy medical equipment for home use.
- Technological advancement.
- Government encouraging medical device manufacturing start-up by launching news schemes and updating regulations to reduce import dependency.
In nutshell we can say, technological advancements in healthcare devices, growing geriatric patients all over the glob contribute in marketplace boom. These factors show huge opportunities in nebulizers market, these opportunities attract manufacturer /importer to start the venture. These manufacturers/importers should consider all the necessary regulations before entering to the market. As medical device regulatory consultant we provide assistance to medical device manufacturer as well as importer in whole manufacturing set up to regulatory completions. You can easily connect with us for any query related to this.
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