Plastic IV Bags Project Report

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A sterile bag is used to hold fluids supplied intravenously or through the veins to a patient during intravenous therapy. Medicine mixtures, blood for a blood transfusion, and saline for hydration are all examples of fluids. Intravenous administration of medicines or fluids guarantees that the medicines or fluids are disseminated throughout the patient’s body as quickly as feasible via the bloodstream To distinguish it from an IV bolus, often known as an IV “push,” which is a syringe injection straight into a vein via an IV cannula, or through an injection port on the bag, IV therapy using an intravenous bag is often referred to as an IV “drip.”

Introduction

The IV fluid regulations are administered intravenously or through the bloodstream. This fluid was delivered by an intravenous line, either a packet or a bag. A tiny tube, commonly referred to as an “IV,” is put into a person’s veins. Fluids are given this way for a variety of reasons, including rehydration after being dehydrated due to illness or excessive physical activity, treatment of any infection or disease where eating is impossible, when a person is being operated on and also after the operation, during cancer treatment, and pain management using certain medications.

Most IV fluids come in pre-packaged plastic bags composed of soft plastic or vinyl compounds and range in size from 10ml to 3000ml. As these products are used for medical purposes, so they must be free from phthalates such as DEHP di (2- ethylhexyl) phthalate, BBP (Benzyl butyl phthalate), DBP (Dibutyl phthalate), DnHP (Di-n-hexyl Phthalate), and DIDP (Diisodecyl phthalate).

The product must also be free from plasticizers or additives that are either PBTs (Polybutylene terephthalate), VPVBs (Very Persistent and Very Bio-accumulating), or known or likely to be carcinogenic, mutagenic, or reproductive or development toxicants, or endocrine-disrupting supported the Red List of Chemicals. Plasticizers, such as DEHP, improve the strength and flexibility of finished products, particularly PVC. On the other hand, DEHP is one of the eight substances listed in the Environmental Protection Agency’s (EPA) “Phthalate Action Plans.” The phthalate’s toxicity has been a source of worry for the EPA.

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Types of Bags

For IV fluids, three types of bags are often used: glass bottles, PVC, and non-PVC (i.e., Polypropylene and Polyethylene). The glass bottles are made up of three parts: the glass bottle, the rubber seal, and the aluminum seal. Due to complications encountered during transit, these bottles are no longer in use. Apart from that, it is always possible to be reused, and all reused bottles are extremely polluted, making sterilisation difficult even with powerful jets. The PVC bags are made of pharma-grade PVC and come in a single piece. These are single-use bags that can be squeezed for bolus fluid delivery in an emergency. Nowadays, the “Form-filled” technology is used, eliminating the need for manual handling of the bags during the filling process. They are available in both bag and bottle form. While most solutions do not interact with PVC, some pharmaceuticals may, and these drugs come with instructions not to use PVC bags, bottles, or pipes.

Non-PVC bags are a bit like PVC bags and do not cause any reaction. They can also be filled by either the “form-fill” technology or within the sort of bottles that will be sealed after filling. Some of the major advantages of using the Non-PVC IV bags can be list as follows:

• These bags are free from phthalates which have known to be carcinogenic.
• They can be self-collapsible.
• As they are free from DEHP, so no leaching of the plasticizer into the bag solution.
• Environment friendly: Unlike other PVC bags, it does not release the dioxins of HCL.
• These cannot be reused, and hence no need to worry about sterilization.

Market potential

The market for non-PVC IV bags is expected to increase by 9.8% from 2021 to 2028, with a value of 1.51 billion dollars in 2020. The demand is primarily for increased public knowledge of the negative environmental implications of utilising PVC IV bags and the impact of phthalates on human health. Furthermore, there is an increasing demand in oncology treatment, namely for “Chemotherapy” and “Targeted drug delivery,” as most therapeutic compounds are susceptible to interaction with plasticizers that have the potential to convert to harmful agents. This discrepancy can be remedied by utilising IV bags composed of polyethene, polypropylene, polyolefin, ethylene vinyl acetate, and other materials that are free of plasticizers.

Product uses

Uses of the Plastic IV bags can be listed as follows:

• The most significant use of Plastic IV bags is for the body’s hydration during different medical processes.
• They’ve also been used to deliver various drugs and therapies, such as volume expanders, blood-based products, blood replacements, medications, and nutrients intravenously.
• They have been used in the treatment of cancer therapy through intravenous treatment.
• They have been used for Blood transfusion processes.
• Parenteral nutrition is the act of providing required nutrients to a person through an intravenous line. This is utilized in people that are unable to urge nutrients normally by eating and digesting food. A person receiving parenteral nutrition will give an intravenous solution that can contain salts, dextrose, amino acids, lipids and vitamins.
• The contrast agent has been introduced intravenously during the imaging processes, such as the CT scan and MRI imaging. The contrast agent is then injected into the saline solution in the IV bag.
• IV rehydration techniques used for the athletes.

Raw material requirement

• Polyolefin (PL732), a combination of polypropylene and a thermoplastic polymer made of Ethylene butylene copolymer and Polystyrene, are the basic materials needed to make Non-PVC IV bags (Styrene ethylene butylene styrene or SEBS). SEBS is a thermoplastic polymer that behaves like rubber without going through the vulcanization process. SEBS is a tough and adaptable material that resists heat and UV rays and is simple to work with. To improve their performance, SEBS elastomers are frequently mixed with other polymers. SEBS can be used in place of PVC in various applications because it does not include any liquid plasticizers.
• Other materials that can be used to make the bags include PL 146(specially formulated PVC), CL3861 (PVC and DEHP), CLX (PVC and TEHTM), PL 1240 (PVC and TEHTM), and XT612 (PVC and DEHP).
• Other materials include high kink resistance, non-toxic medical grade PVC tubes for the mouths of the bags, HDPE, packing material, and printing ink, in addition to the polymer film.

Manufacturing process

The production process for Plastic IV bags can be written as follows:

1. The procurement of the basic ingredients needed to create the IV bags is the first step. The raw materials for polypropylene and SEBS polymer blends are first de-dusted by a screening machine, and then the needed amounts of polymers are weighed. Compounding, which may be done in a mixing vessel, was used to mix the two polymers physically. The mixture is then poured into the single-screw extruder’s hopper.

2. The plasticized material was extruded through a die to transform it into sheet form. After slitting, the extruded sheet is cut to the desired size and transferred to the welding area. Donor and transfer tubing was created via extrusion of PVC composites. The tubes are then produced and trimmed to the proper length before being transferred to the welding department.

The extruder can be operated at a particular RPM value in the barrel melt mixing temperature range of profile of 200/220/220/230/230/200°C, where the latter refers to the die temperature.

3. They used an Ultrasonic cleaning to ensure that the polymer remained dust and oil-free.

4. The polymer is subsequently forced into a relatively cold closed mould cavity after being pre-heated in the cylindrical chamber of the “Injection Moulding section” to a temperature at which it flows.

Further Process

5. The IV bags are then produced in the next stage, known as “welding.” Between the electrodes is a polymer sheet, and a high-frequency current at a high voltage is delivered. The substance heats up quickly, causing the sealing to occur between the electrodes. The blood transfer ports, donor and transfer tubings, and the bag are held in the proper position. Clamps and needle covers have been put over the tubing, and welded bags have been cut. Following the inspection, the appropriate bags are sent to the labelling division.

6. The bags have been labelled with instructions and information for storage and handling conditions.

7. Pre-mixing the components (IP grade chemicals like sodium citrate, citric acid) and preparing the solution in pyrogen-free distilled water results in an anticoagulant solution. The GMP compliance was then wiped out of all operations. The anticoagulant solution was poured into the blood bags, then dispatched to be checked for coagulation.

8. The IV bags have then Sterilized in autoclaves and then sent to the packing section.

9. The packing has been done in a clean, laminar flow sterile area to avoid contamination at this stage.

10. Finally, a complete inspection was performed to ensure that particle matter, leaks, and other flaws were not present. They inspected bags were then packaged in foils and placed in inboxes. They’re then kept in a germ-free storage space until they’re ready to ship.

Plant & Machinery required

• Pellet de-dusting machine
• Single Screw Extruder
• Injection moulding machine
• Ultrasonic cleanser
• High-Frequency welding machine
• Hot foil stamping machine
• Tube marking machines
• Ethylene Oxide Sterilization Unit
• Volumetric filling machine
• Air compressor
• Centrifugal pump
• Water boiler

Key Points Cover in Sample Project Report 

Table of Contents

Apart from this, all the information is being provided. To help in preparing project reports.

FAQ’s

Why Is Manufacturing Demand Increasing for IV Bags? 

Many medical supplies are hard to acquire by these days due to the pandemic and other global occurrences. Part of the problem is the scarcity of IV bags. In general, IV bags of all types and sizes are in scarce supply. It puts pressure on the entire sector, from the companies that make the supplies to the hospitals that rely on them for patient care. COVID-19 is a significant element, but it is not the only one. Unfortunately, it occurred when medical supplies, including IV bags, were already in short supply.

Demand continues to climb not just because of COVID-19 but also because of a large range of other health issues and ailments. An intravenous system is what it’s called (IV). IV bags are used to administer fluids and medications to patients who cannot obtain the supplies themselves. Patients having surgery, for example, are given IVs that deliver vital fluids such as saline. The fluids are kept inside the bag and slowly dripped out through sterile tubes. In addition to blood, the bags are utilised to contain a variety of other liquid supplies.

Many IV bags have their design, which is designed to disperse whatever fluids are within. Furthermore, the bags are available in a range of sizes, from little to huge.

Baxter is the major source of IV bags. It generates a shortage of a specific type of IV bag when it develops trouble. This might have far-reaching consequences for medical professionals. However, now that the FDA has allowed new manufacturers to enter the market, several parties are working together to end the shortfall and increase overall supply using whatever tools are available. A new supply of IV bags is available in the medical field as a result of this.

Does the market for IV bags rising in the coming years?

The market will see substantial use of IV bags in the coming years, owing to the increasing penetration of healthcare services in distant locations. Given the inherent characteristics of IV bags in terms of storing, transporting, sterilising, and handling requirements, the market will continue to rise in the future.

The necessity for properly providing parenteral pharmaceuticals to individuals who find it difficult to take medicines orally remains one of the primary factors fueling market expansion. Chronic intestinal illnesses, renal failure, diabetes, hepatic failure, and cancer are treated using parenteral medicines. Drugs must be delivered intravenously to these people.

Furthermore, since the virus is spreading so fast, customers have been more conscious of personal cleanliness. As a result, manufacturers are concentrating on packing materials that provide contamination prevention throughout transit. The market for IV bags is predicted to develop as a result of these factors.

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