Production of I.V. Fluids (Saline and Dextrose). Intravenous Solution (IV) Manufacturing Business with Blow-Fill-Seal (BFS) Technology.

Production of I.V. Fluids (Saline and Dextrose).

Production of I.V. Fluids (Saline and Dextrose)..jpg

Fluids are given when someone’s body fluid volume falls. There are a number of things which can cause a drop in fluid volume. Vomiting and diarrhea are a classic example, which is why people are encouraged to drink fluids when they are sick, to keep their fluid volume stable. Another cause is blood loss, which causes problems both because people lose blood products, and because they experience a loss in fluid volume. Electrolyte levels in the blood can also become unstable as a result of rapid changes in fluid volume, in which case intravenous fluids can be used to restore the balance.

Intravenous fluids are fluids which are intended to be administered to a patient intravenously, directly through the circulatory system. These fluids must be sterile to protect patients from injury, and there are a number of different types available for use. Many companies manufacture packaged intravenous fluids, as well as products which can be mixed with sterile water to prepare a solution for intravenous administration.

Intravenous fluids can be broken into two broad groups. Crystalloids such as saline solutions contain a solution of molecules which can dissolve in water. When crystalloids are administered, they tend to create low osmotic pressure, allowing fluid to move across the blood vessels, and this can be linked with edema. Colloids contain particles which are not soluble in water, and they create high osmotic pressure, attracting fluid into the blood vessels. Blood is an example of a commonly administered intravenous colloid.

Infusion therapy as a basic toll of modern medical care enables the physician to restore and stabilize homeostasis states quickly and completely.

In nursing homes and hospital where patients are suffering from acute dehydration or considerable debilitating conditions, the intra venous fluids are used as I.V. drips. The basic function of I.V. fluids is to replenish the body fluids. Although there are a number of I.V. fluids but generally three types of I.V. fluids are used in hospitals as I.V. drips.

Uses and Applications

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

  • Treatment of discarded water and electrolyte metabolism, especially in severe cases.
  • Therapy of acid base in balances.
  • The volume substitution and volume replacement in surgery of accident victim suffering blood loss.
  • Paratral nutrition for severally ill and post-operative patients.
  • Aqueous isotonic injection (5%) of dextrose is given as intravenous injections to increase the column of circulating blood in the shocks and haemorrhages and to counteract dehydration. When it is desired to replace excessive salt loss also glucose is injected along with sodium chloride.

Intravenous fluids can also be used as a route of medication administration. If a doctor wants to delI.V.er a small amount of medication over an extended period of time, it can be dissolved in a bag of intravenous fluids and set on an infusion pump which delivers the medicated fluid directly into the blood. They are also commonly used to assist with surgical recovery; people who receive fluids after surgery tend to experience better recovery than people who do not.

Intravenous Fluids Market is expected to witness growth of international market with respect to advancements and innovations including development history, competitive analysis and regional development forecast.

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

Demand : Past and Future
Year (In Million bottles)
1990-91 165
2000-01 565
2001-02 633
2002-03 712
2003-04 799
2004-05 865
2005-06 975
2006-07 1100
2007-08 1238
2008-09 1378
2009-10 1545
2010-11 1725
2011-12 1940
2012-13 2150
2013-14 2365
2014-15 2630
2015-16 2885
2016-17 3210
2017-18 3570
2018-19 3945
2019-20 4375
2024-25 7200

 

The growth of the global intravenous solutions market is driven by several factors. The increasing incidence of gastrointestinal disorders, diabetes, and cancer is one of the major factors that are expected to increase the rate of adoption of intravenous solutions among consumers. The rising popularity of intravenous vitamin C therapy in cancer treatment is one of the major trends in the intravenous solutions market. The intravenous vitamin C solution has been observed to have an increased toxicity to cancer cells and improve the patients’ quality of life.

Intravenous fluids are extensively used to treat electrolyte imbalances, maintain fluid balance, and replace fluid losses. These fluids are dispensed in volumes ranging from 25-1,000 milliliters and are available in either plastic bags or glass bottles. A complete mixture of all essential nutrients is also available in multi-chamber bags, and these bags are gaining immense popularity among numerous end-users.

The global Intravenous (I.V.) solutions market was valued at USD 6.9 billion in 2015 and is projected to grow at a CAGR of 7.8% over the forecast period. The emergence of this market is attributed to the fast growing geriatric population and prevalence of malnutrition in the elderly and pediatric population.

North American Intravenous Solutions Market, By Type

North American Intravenous solutions market, by Type.png

Blow-Fill-Seal (BFS) Technology

In blow-fill-seal (BFS) technology, which is a form of advanced aseptic manufacturing, the container is formed, filled, and sealed in one continuous, automated system.  A primary advantage of this technology is reducing human intervention, which reduces the risk of microbial contamination and foreign particulates. BFS has long been used in liquid pharmaceutical applications, including small containers, such as ophthalmic and respiratory drug ampoules, as well as larger volume containers, such as saline or dextrose solutions. More recently, BFS technology has been expanding into injectable and into biologics, including vaccines and monoclonal antibodies (mAbs).

 

Advantages of BFS Technology:

  • 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.
  • 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.
  • 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, antisepsis and wound care.
  • 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 sterilised by autoclaving as polypropylene has greater thermostability.
  • 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.

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.

The process is multi-stepped: first, pharmaceutical-grade plastic resin is vertically heat extruded through a circular throat to form a hanging tube called the parison. This extruded tube is then enclosed within a two-part mould, and the tube is cut above the mould. The mould is transferred to the filling zone, or sterile filling space, where filling needles (mandrels) are lowered and used to inflate the plastic to form the container within the mould. Following the formation of the container, the mandrel is used to fill the container with liquid. Following filling the mandrels are retracted and a secondary top mould seals the container. All actions take place inside a sterile shrouded chamber inside the machine. The product is then discharged to a non-sterile area for labeling, packaging and distribution.

The process begins with the Extrusion of plastic granules in the form of a hot hollow pipe of molten plastic called a parison.

The following step is the Blow moulding of the container from the plastic granule. The parison is closed between the mould, and the container gets formed either by blowing sterile compressed air or by vacuum or by using vacuum as well as blowing. The container assumes the shape of the cavity in the mould. The container thus produced is open from the top and in its top part, the plastic is still hot and in molten state until the subsequent steps of filling and container sealing.

The subsequent step is filling of the formed container from the top, which is still open (and still in a “hot molten” state). Filling nozzles enter from the top of container and filling is done. Filling nozzles are specially designed and constructed to facilitate automatic cleaning and automatic sterilization. Additional functions of filling nozzles are to blow the bottles and also to provide an exhaust path for air in the container. The filling process can be carried out under a shower of sterile filtered air to avoid contamination during filling. The blower on the sterile air shower can have variable pressure which can be made to change automatically so as to maintain constant air pressure under various situations. The sterile air shower is validated at certain air pressure, and an automatic device can maintain the same pressure by automatically modulating the speed of the blower.

The next step is sealing the top of the container, which is still open and in a hot molten state. The top gets pressed between head moulds and as a consequence, the top part of the container gets formed, sealed and at the same time, gets cooled. The result is a hermetically sealed container.

The final steps are for De-flashing to remove the flash or scrap, trimming the containers and delivering the containers outside the machine. The whole process of extrusion, blowing, filling, sealing and removing scrap takes between 10 to 18 seconds depending upon the type and size of the container. The advantage of the Blow-Fill-Seal process is derived mainly from the fact that container is formed, quickly filled and sealed under protected environment automatically without human intervention.

BFS Machine

Professional normal saline I.V. fluids packaging machine is the latest production line with most advanced technology. It can automatically finish film feeding, printing, bag making, filling and sealing in one machine.

This BFS line can be used to automatically fill 50-5000ml general solution, special solution, dialysis solution, parenteral nutrition, Antibiotics, Irrigation and Disinfectant solution etc.

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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I.V. Fluids (Automatic Plant) Manufacturing Industry, Detailed Project Report, Profile, Business Plan, Industry Trends, Market Research, Survey, Manufacturing Process, Machinery, Raw Materials, Feasibility Study, Investment Opportunities, Cost and Revenue, Plant Economics, Production Schedule, Working Capital Requirement, Plant Layout, Process Flow Sheet, Cost of Project, Projected Balance Sheets, Profitability Ratios, Break Even Analysis

I.V. FLUID (Automatic Plant)

I.V. FLUID (Automatic Plant)

Intravenous fluids are fluids which are intended to be administered to a patient intravenously, directly through the circulatory system. These fluids must be sterile to protect patients from injury, and there are a number of different types available for use. Many companies manufacture packaged intravenous fluids, as well as products which can be mixed with sterile water to prepare a solution for intravenous administration.

I.V. fluids or Intravenous fluids are lifesaving drugs, which are widely used in surgery, pediatrics, urology, obstetrics and gynecology. They are given mostly to patients suffering from dehydration, diarrhorea, vomiting, gastroenteritis and excessive perspiration.

The growth of the global intravenous solutions market is driven by several factors. The increasing incidence of gastrointestinal disorders, diabetes, and cancer is one of the major factors that are expected to increase the rate of adoption of intravenous solutions among consumers. Thus, due to demand it is a good project for entrepreneurs to invest.

Few Indian Major Players are as under

  • AxaParenterals Ltd.
  • D.J. Laboratories Pvt. Ltd.
  • Baxter International Inc.
  • Amanta Healthcare
  • Aishwarya Healthcare

Market Outlook

Intravenous Solutions Market to Grow at 5.79% CAGR Driven by Growing Popularity of Intravenous Vitamin C Therapy in Cancer Treatment.

The global I.V. solutions market was valued at USD 6.9 billion in 2015 and is expected to reach a value of USD 13.79 billion by 2024. Key factors driving market expansion include the rapidly increasing natality rate including a high percentage of premature births and malnutrition.

The global market for I.V. Solutions is growing steadily. The market for I.V. Solutions is growing with the CAGR of 7.69% during the forecast period from 2016-2022. North America accounts for largest market share in 2015 and is expected to reach USD 6,543.4 million by 2022.

Top Global Markets to Export I.V. Fluid from India

S.NO. Country Quantity Of Export Export Value Of I V Fluid
 1 Export I V Fluid From India To Japan 2901800 12.95
 2 Export I V Fluid From India To Italy 1828000 7.26
 3 Export I V Fluid From India To Belgium 700060 3.13
 4 Export I V Fluid From India To Russian Federation 440030 2.009
 5 Export I V Fluid From India To United Kingdom 1258060 1.75
 6 Export I V Fluid From India To Germany 361160 1.68
 7 Export I V Fluid From India To Peru 740000 1.26
 8 Export I V Fluid From India To United Arab Emirates 654770 1.14
 9 Export I V Fluid From India To Philippines 650100 0.89
 10 Export I V Fluid From India To South Africa 881560 0.82

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Niir Project Consultancy Services

106-E, Kamla Nagar, Opp. Spark Mall,

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Email: npcs.ei@gmail.com  , info@entrepreneurindia.co

Tel: +91-11-23843955, 23845654, 23845886, 8800733955

Mobile: +91-9811043595

Website: www.entrepreneurindia.co  , www.niir.org

Tags

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