IV set, also known as intravenous set, is a collection of devices used for administering intravenous treatments. IV sets are available in different styles that have been designed for specific therapeutic needs. These medical devices are essential for delivering safe and effective medical care. Using IV sets, fluids are directly delivered into the patient’s veins. These sets are used to treat dehydration, electrolyte imbalances, and deliver specific drugs. Are you planning to start an IV set manufacturing business in India? We have prepared this detailed guide just for you. Read on to find out more.

As different types of IV sets have different functions, healthcare professionals and IV set manufacturers need to have a clear understanding of the distinction. We have provided an overview of the types of IV sets used in the healthcare settings to help you start an IV set manufacturing business.

What are the different types of IV sets?

1. Vented IV Sets: These IV sets are ideal for rigid containers. Vented IV sets have a small vent that can be opened or closed, thereby allow air to enter and displace fluid as it leaves the container. This helps ensure a smooth flow. Vented IV sets are suitable for hard plastic or glass containers.
2. Non-Vented IV Sets: Non-vented IV sets are suitable for flexible plastic containers. These sets lack vents in the tubing and must be primed to remove air from the tube. Notably, the design of the non-vented set facilitates the creation of a vacuum within the plastic IV bag. This helps with controlled collapse of the bag as it empties.
3. Gravity Tubing: These tubes use gravity and flow rate regulators to administer medication. The IV bag is hung on a pole at a position above the patient. The spike is fitted in a sterile container that allows controlled flow of liquid through the trickle chamber. Moreover, the gravity will create the necessary pressure for medication delivery. Additionally, Y-sets, T-sets, V-sets, and unique three-way connectors are also connected to the IV set. These are used for seamless delivery of antibiotics or other continuous liquid infusions.
4. Filtered IV Sets: As these IV sets have micron filters for eliminating contaminants from IV products, they help improve infusion safety.  Filtered IV sets have 22 microns for bacteria filtration to 5 microns for filtering large particles. Filtered IV sets are compatible with a wide array of medications. Moreover, they help prevent phlebitis caused by contaminants in medications. The filters in the IV set safeguard patients from particulate matter, bacteria, and air emboli.

Starting an IV set manufacturing business

We have curated this guide to help you start an IV set manufacturing business in India. We have listed the raw materials as well as machinery and equipment required for manufacturing IV sets. Additionally, we have provided an overview of the process of manufacturing IV sets.

The IV set manufacturing process is precise and highly specialised. Additionally, it has to be carried out per regulatory guidelines and industry standards. Moreover, it is vital to source high-quality raw materials for manufacturing IV sets because the raw material quality will impact the final product quality. Robust quality control and assurance measures will be required to ensure proper functioning of the IV sets. Additionally, they will have to be checked for leakage. Moreover, the parts have to be labelled properly to avoid any confusion. Finally, the manufactured IV sets have to be sealed, packaged, and sterilised properly. Importantly, any defects, leakage, or imperfections have to be checked carefully, as they can have detrimental consequences for the patient. Hence, the IV set manufacturing process requires high levels of precision and attention to detail. Therefore, the process of manufacturing IV sets is strictly regulated to ensure patient safety.

Raw materials required for manufacturing IV sets

We have listed some of the raw materials you will require for starting an IV set manufacturing business. 

1. Highly kink resistant non-toxic medical grade PVC Tube
2. HDPE
3. Polypropylene
4. Nontoxic grade PVC
5. Filter (Nylon +HDPE)
6. Printing Ink
7. Packing Material

Machinery and equipment required for the IV set manufacturing process

• Set of moulds for various IV set components, drip chamber, spike protector, clamp, roller connector, male lure lock, airway spike, and airway cap
• Scrap guiding machine
• Weighing scale
• Injection moulding machine
• Sealing machine
• Automatic packaging machine
• Blister packaging machine
• Air compressor
• Chilling plant
• Testing equipment
• Electrical fittings and socket
• Water pump
• Sterilization Plant

All components of the IV set are manufactured using a moulding process. Then, they are sub-gathered in various subassemblies, such as drip chamber assembly, clamp, roller assembly, etc. After which, these subassemblies are then assembled along with the tube in a programmed assembly machine.

What is the IV set manufacturing process?

We have provided a basic outline of the IV set manufacturing process.

Filling

1. Check availability of all the required raw materials. Also, check for presence of contamination, as aseptic raw materials are vital for manufacturing IV sets.
2. Turn on the heating switch and set the requisite temperature for each segment.
3. Check for any defects using vernier callipers. Check the size, appearance issues, such as silver staining or weld marks.
4. Check and rectify performance issues, such as warpage or embrittlement.

Pressurizing

1. Conduct a thorough system check for any issues with the IV set assembly machine.
2. Engage the needle coat, rubber plug, centre bar, and injection needle.
3. Adjust the feeding speed of the machine using the vibrating container.

Cooling

1. Manufacture individual components of the IV set using the moulding processes.
2. Assemble the subcomponents of the IV set in the following subassemblies:
   • Drip chamber assembly: Airway spike, airway cap, drip chamber, spike protector, and disc filter.
   • Clamp and roller assembly: Clamp and rollers.
   • Male Luer assembly: Male luer lock connector and plain stopper.
   • Y connector sub-assembly: Y connector and rubber tube.

Remoulding

1. Assemble the subcomponents of the IV set on the final assembly machines.
2. Pack and seal the IV sets using the automatic packing machines.
3. Sterilize all the fully packed pouches in a sterilization plant.

Notably, each component of the IV set has a crucial role in ensuring the safe and efficient delivery of medications and fluids to patients. Hence, each individual component should be manufactured per industry standards. Additionally, special attention should be paid while assembling each component of the IV set.

Pharmadocx Consultants will help you easily secure the CDSCO license for IV set manufacturing business in India

Medical devices have a pivotal role in diagnosing, monitoring, and treating various medical conditions. Thus, their quality, safety, and efficacy have to be strictly regulated. IV sets are indispensable medical devices in hospital settings. Hence, similar to all other medical devices, IV sets are strictly regulated by the CDSCO regulatory guidelines. To manufacture IV sets in India, you need to mandatorily secure the CDSCO manufacturing license. The CDSCO guidelines can be confusing and difficult to comprehend. Not sure of the applicable CDSCO regulatory guidelines for manufacturing IV sets in India? Well, you have landed at the right place.

We at Pharmadocx Consultants will help you easily navigate through the CDSCO medical device regulatory guidelines. Our team will help you secure the CDSCO license for manufacturing IV sets in India in a hassle-free manner. Additionally, we can help you set up your manufacturing facility per regulatory and industry guidelines. Email at [email protected] or call/Whatsapp on 9996859227 to let us help you establish an IV set manufacturing business in India.