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Production of I.V. Fluids (BFS Technology).

 

Production of I.V. Fluids (BFS Technology). Profitable Business of Intravenous Solutions, Intravenous Fluids.

Intravenous fluids are fluids that are supposed to be administered to a patient intravenously, directly through the circulatory system. These fluids should be sterile to protect patients from injury, and there are variety of various varieties out there to be used.

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Intravenous fluids also can be used as a route of medication administration. If a doctor wants to deliver a small quantity of medication over an extended period of your time, it will be dissolved {in adoring in an exceedingly in a very} bag of intravenous fluids and set on an infusion pump that delivers the medicated fluid directly into the blood.

Related Projects: - Pharmaceutical, Drugs, Fine Chemicals, Bulk Drug Intermediates,

Advantages of BFS Technology:

Ø  Blow-fill-seal technology enables the manufacture of preservative-free single-unit doses. PreservatI.V.es are recognized as potentially harmful to the sensitive mucosae of the eyes, nose, and lungs, so this is an enormous benefit to sensitive patients.

Ø  Another advantage of unit-doses is that they ensure that the patient takes the correct amount of product, especially when dealing with highly potent compounds, i.e. those therapeutically active at a low concentration.

Ø  Sterile unit-doses are portable and easy to use individually, excellent properties for today’s active lifestyles.  Blow-fill-seal (BFS) single doses are an ideal solution for use in ophthalmology, respiratory diseases, rhinology, and antisepsis and wound care.

Ø  Blow-fill-seal technology reduces personnel intervention making it a more robust method for the aseptic preparation of sterile pharmaceuticals. BFS is used for the filling of vials for parenteral preparations and infusions, eye drops, and inhalation products. Generally the plastic containers are made up of polyethylene and polypropylene. Polypropylene is more commonly used to form containers which are further sterilized by autoclaving as polypropylene has greater thermo stability.

Ø  Blow Fill and Seal technology is mainly used for pharmaceutical solutions. The examples of pharmaceutical solutions that can be packaged are injectable solutions, antibiotics, ophthalmological drops, suspensions, infusion solutions, solutions for dialysis, solutions for irrigation and solutions for hemofiltration.

Ø  The basic concept of BFS is that a container is formed, filled, and sealed in a continuous process without human intervention, in a sterile enclosed area inside a machine. Thus this technology can be used to aseptically manufacture sterile pharmaceutical liquid dosage forms.

Features:

1. 100% film utilization: No waste edge between bags, reducing both material and energy consumption.

2. Special I.V. bag design: each bag saves 10mm film than others.

3. Reliable heating and welding system: Leakage rate less than 0.03%.

4. Quick changeover: 0.5-1 hour to switch from one size to another.

5. Stable transmission system: only needs 1 control system, 1 HMI and 1 operator.

6. Safe filling nozzle: No solution overflows, no particles generation.

7. Auto faulty rejection system detected by the machine.

8. Production line length is reduced by 1/3, both workshop and air conditioning and cleaning area are reduced by 1/3, greatly reducing the initial investment and future running cost.

9. Simple structure, more stable and reliable performance.

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Uses and Applications

Ø  There are four main ranges of application of highly specialized intravenous infusion solutions:

Ø  Treatment of discarded water and electrolyte metabolism, especially in severe cases.

Ø  Therapy of acid base in balances.

Ø  The volume substitution and volume replacement in surgery of accident victim suffering blood loss.

Ø  Paratral nutrition for severally ill and post-operative patients.

Ø  Aqueous isotonic injection (5%) of dextrose is given as intravenous injections to increase the column of circulating blood in the shocks and hemorrhages and to counteract dehydration. When it is desired to replace excessive salt loss also glucose is injected along with sodium chloride.

Ø  Dextrose solution is used during postoperative period when sodium extraction is reduced.

Ø  Dextrose solution with concentration of 10-15% is used as diuretic for increase in urine flow.

Ø  Dextrose solutions of 5% normal saline are used for restoring fluid volume in circulation of an emergency as in accidents with hemorrhage.

Ø  Saline solution is used when large amount of sodium has been lost by vomiting or by gastric or intestinal duodenal aspiration or through an alimentary fistula.

Ø  Dextrose monohydrate is used as supplement to cow's milk in part of feeding.

Ø  Hypertonic dextrose solution (25-50%) is in medical treatment partly because they are believed to strengthen heart muscles. Hypertonic solutions are used in intravenous injection to relieve intractable pressure in-patient with hydrocephalus and meningitis.

Market Outlook

Technologies utilized in the production of IV fluids are Blow-Fill-Seal (BFS) Technology and type fill seal (FFS) technology. BFS and FFS are a variety of advanced aseptic manufacturing technique, in which the container is created (in case of BFS and in FFS pouch is formed), filled, and sealed in one continuous, automated system. A primary advantage of those technologies is to reduce human intervention, which is able to reduce the risk of microorganism contamination and foreign particulates. Thus, these technologies are wont to aseptically manufacture sterile pharmaceutical liquid.

Related Videos: - Production of I.V. Fluids (Saline and Dextrose)

IV Fluids (FFS) Technology

I.V. (Intravenous Liquids) Fluids Manufacturing Unit.

The primary costumers for these manufacturing units are Hospitals, Clinics, Dialysis centers, Home care settings. The global Intravenous Fluid market size was valued at US$ 8,372.0 million in 2019 and is expected to witness a CAGR of 6.1% over the forecast period (2019 – 2027). The emergence of the IV Fluid market is attributed to the fast-growing geriatric population and the presence of malnutrition in the elderly and pediatric population.

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Increasing launches and regulatory approvals for Intravenous Fluid injection is expected to drive the growth of the global Intravenous fluid market. Launches of new Intravenous fluid injections for the treatment of various diseases such as dehydration, gastrointestinal diseases are expected to drive the Intravenous fluid market growth

 Demand & Market Growth Rates of I.V. Fluid Sets in India:

Past and Future Year

Bottles in Million

2015-16

2885

2016-17

3210

2017-18

3570

2018-19

3945

2019-20

4375

2024-25

7200

 

 

COST ESTIMATION

Six Cavity 500 ml Bottles                              :                               39,600 Bottles per Day

Eight Cavity 500 ml Bottles                          :                               30,800 Bottles per Day

Cost of Machinery                           :                               Rs. 46,50,0000

 

Key Players:-

Ø  Abaris Healthcare Pvt. Ltd.

Ø  Ahlcon Parenterals (India) Ltd.

Ø  Axa Parenterals Ltd.

Ø  Infutec Healthcare Ltd.

Ø  Kokad Pharmaceutical Laboratories Ltd.

Ø  Parenteral Surgicals Ltd.

Ø  Pharmazell (India) Pvt. Ltd.

Tags:-

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