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

 

 

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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.

 

Related Projects: IV Fluids, I.V. solutions, Intravenous fluids, Normal Saline (NS, 0.9NaCl, or NSS), Lactated Ringers (LR, Ringers Lactate, or RL), Dextrose 5%, Normal Saline (Half Normal Saline, 0.45NaCl, .45NS), IV Fluids & Dialysis products - LVP/SVP Volume Parenterals

 

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.

 

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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 deliver 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.

 

Related Project: IV Fluid-Intravenous Fluid (BFS Technology) Manufacturing Plant

 

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.

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.

 

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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.

 

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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.

 

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·         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.

·         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.

 

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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.

 

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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.

 

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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.

 

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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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ENTREPRENEUR INDIA

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ABOUT NPCS

 

NIIR PROJECT CONSULTANCY SERVICES (NPCS) is a reliable name in the industrial world for offering integrated technical consultancy services. NPCS is manned by engineers, planners, specialists, financial experts, economic analysts and design specialists with extensive experience in the related industries.

Our various services are: Detailed Project Report,  Business Plan for Manufacturing Plant, Start-up Ideas, Business Ideas for Entrepreneurs, Start up Business Opportunities, entrepreneurship projects, Successful Business Plan, Industry Trends, Market Research, Manufacturing Process, Machinery, Raw Materials, project report, Cost and Revenue, Pre-feasibility study for Profitable Manufacturing Business, Project Identification, Project Feasibility and Market Study, Identification of Profitable Industrial Project Opportunities, Business Opportunities, Investment Opportunities for Most Profitable Business in India, Manufacturing Business Ideas, Preparation of Project Profile, Pre-Investment and Pre-Feasibility Study, Market Research Study, Preparation of Techno-Economic Feasibility Report, Identification and Section of Plant, Process, Equipment, General Guidance, Startup Help, Technical and Commercial Counseling for setting up new industrial project and Most Profitable Small Scale Business.

NPCS also publishes varies process technology, technical, reference, self employment and startup books, directory, business and industry database, bankable detailed project report, market research report on various industries, small scale industry and profit making business. Besides being used by manufacturers, industrialists and entrepreneurs, our publications are also used by professionals including project engineers, information services bureau, consultants and project consultancy firms as one of the input in their research.

Our Detailed Project report aims at providing all the critical data required by any entrepreneur vying to venture into Project. While expanding a current business or while venturing into new business, entrepreneurs are often faced with the dilemma of zeroing in on a suitable product/line.

 


And before diversifying/venturing into any product, wish to study the following aspects of the identified product:


• Good Present/Future Demand
• Export-Import Market Potential
• Raw Material & Manpower Availability
• Project Costs and Payback Period


We at NPCS, through our reliable expertise in the project consultancy and market research field, Provides exhaustive information about the project, which satisfies all the above mentioned requirements and has high growth potential in the markets. And through our report we aim to help you make sound and informed business decision.

 

The report contains all the data which will help an entrepreneur find answers to questions like:

• Why I should invest in this project?
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• What will be the market potential?


The report first focuses on enhancing the basic knowledge of the entrepreneur about the main product, by elucidating details like product definition, its uses and applications, industry segmentation as well as an overall overview of the industry sector in India. The report then helps an entrepreneur identify the target customer group of its product. It further helps in making sound investment decision by listing and then elaborating on factors that will contribute to the growth of product consumption in India and also talks about the foreign trade of the product along with the list of top importing and top exporting countries. Report includes graphical representation and forecasts of key data discussed in the above mentioned segment. It further explicates the growth potential of the product.

The report includes other market data like key players in the Industry segment along with their contact information and recent developments. It includes crucial information like raw material requirements, list of machinery and manufacturing process for the plant. Core project financials like plant capacity, costs involved in setting up of project, working capital requirements, projected revenue and profit are further listed in the report.


Reasons for buying the report:

• This report helps you to identify a profitable project for investing or diversifying into by throwing light to crucial areas like industry size, demand of the product and reasons for investing in the product.

• This report provides vital information on the product like its definition, characteristics and segmentation.

• This report helps you market and place the product correctly by identifying the target customer group of the product.

• This report helps you understand the viability of the project by disclosing details like raw materials required, manufacturing process, project costs and snapshot of other project financials.

• The report provides forecasts of key parameters which helps to anticipate the industry performance and make sound business decision.

 

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• We use reliable sources of information and databases.  And information from such sources is processed by us and included in the report.

 

Our Market Survey cum Detailed Techno Economic Feasibility Report Contains following information:

 

 

Ø  Introduction

·         Project Introduction

·         Project Objective and Strategy

·         Concise History of the Product

·         Properties

·         BIS (Bureau of Indian Standards) Provision & Specification

·         Uses & Applications

 

Ø  Market Study and Assessment

·         Current Indian Market Scenario

·         Present Market Demand and Supply

·         Estimated Future Market Demand and Forecast

·         Statistics of Import & Export

·         Names & Addresses of Existing Units (Present Players)

·         Market Opportunity

 

Ø  Raw Material

·         List of Raw Materials

·         Properties of Raw Materials

·         Prescribed Quality of Raw Materials

·         List of Suppliers and Manufacturers

 

Ø  Personnel (Manpower) Requirements

·         Requirement of Staff & Labor (Skilled and Unskilled) Managerial, Technical, Office Staff and Marketing Personnel

 

Ø  Plant and Machinery

·         List of Plant & Machinery

·         Miscellaneous Items

·         Appliances & Equipments

·         Laboratory Equipments & Accessories

·         Electrification

·         Electric Load & Water

·         Maintenance Cost

·         Sources of Plant & Machinery (Suppliers and Manufacturers)

 

Ø  Manufacturing Process and Formulations

·         Detailed Process of Manufacture with Formulation

·         Packaging Required

·         Process Flow Sheet Diagram

 

Ø  Infrastructure and Utilities

·         Project Location

·         Requirement of Land Area

·         Rates of the Land

·         Built Up Area

·         Construction Schedule

·         Plant Layout and Requirement of Utilities

 

Project at a Glance

Along with financial details as under:

 

  •     Assumptions for Profitability workings

  •    Plant Economics

  •    Production Schedule

  •    Land & Building

            Factory Land & Building

            Site Development Expenses

  •    Plant & Machinery

             Indigenous Machineries

            Other Machineries (Miscellaneous, Laboratory etc.)

  •    Other Fixed Assets

            Furniture & Fixtures

            Pre-operative and Preliminary Expenses

            Technical Knowhow

            Provision of Contingencies

  •   Working Capital Requirement Per Month

             Raw Material

            Packing Material

            Lab & ETP Chemical Cost

           Consumable Store

  •   Overheads Required Per Month And Per Annum

         Utilities & Overheads (Power, Water and Fuel Expenses etc.)

             Royalty and Other Charges

            Selling and Distribution Expenses

  •    Salary and Wages

  •    Turnover Per Annum

  •   Share Capital

            Equity Capital

            Preference Share Capital

 

  •    Annexure 1:: Cost of Project and Means of Finance

  •    Annexure 2::  Profitability and Net Cash Accruals

                Revenue/Income/Realisation

                Expenses/Cost of Products/Services/Items

                Gross Profit

                Financial Charges     

                Total Cost of Sales

                Net Profit After Taxes

                Net Cash Accruals

  •   Annexure 3 :: Assessment of Working Capital requirements

                Current Assets

                Gross Working. Capital

                Current Liabilities

                Net Working Capital

                Working Note for Calculation of Work-in-process

  •    Annexure 4 :: Sources and Disposition of Funds

  •    Annexure 5 :: Projected Balance Sheets

                ROI (Average of Fixed Assets)

                RONW (Average of Share Capital)

                ROI (Average of Total Assets)

  •    Annexure 6 :: Profitability ratios

                D.S.C.R

                Earnings Per Share (EPS)

               

             Debt Equity Ratio

        Annexure 7   :: Break-Even Analysis

                Variable Cost & Expenses

                Semi-Var./Semi-Fixed Exp.

                Profit Volume Ratio (PVR)

                Fixed Expenses / Cost 

                B.E.P

  •   Annexure 8 to 11:: Sensitivity Analysis-Price/Volume

            Resultant N.P.B.T

            Resultant D.S.C.R

   Resultant PV Ratio

   Resultant DER

  Resultant ROI

          Resultant BEP

  •    Annexure 12 :: Shareholding Pattern and Stake Status

        Equity Capital

        Preference Share Capital

  •   Annexure 13 :: Quantitative Details-Output/Sales/Stocks

        Determined Capacity P.A of Products/Services

        Achievable Efficiency/Yield % of Products/Services/Items 

        Net Usable Load/Capacity of Products/Services/Items   

       Expected Sales/ Revenue/ Income of Products/ Services/ Items   

  •    Annexure 14 :: Product wise domestic Sales Realisation

  •    Annexure 15 :: Total Raw Material Cost

  •    Annexure 16 :: Raw Material Cost per unit

  •    Annexure 17 :: Total Lab & ETP Chemical Cost

  •    Annexure 18  :: Consumables, Store etc.,

  •    Annexure 19  :: Packing Material Cost

  •    Annexure 20  :: Packing Material Cost Per Unit

  •    Annexure 21 :: Employees Expenses

  •    Annexure 22 :: Fuel Expenses

  •    Annexure 23 :: Power/Electricity Expenses

  •    Annexure 24 :: Royalty & Other Charges

  •    Annexure 25 :: Repairs & Maintenance Exp.

  •    Annexure 26 :: Other Mfg. Expenses

  •    Annexure 27 :: Administration Expenses

  •    Annexure 28 :: Selling Expenses

  •    Annexure 29 :: Depreciation Charges – as per Books (Total)

  •   Annexure 30   :: Depreciation Charges – as per Books (P & M)

  •   Annexure 31   :: Depreciation Charges - As per IT Act WDV (Total)

  •   Annexure 32   :: Depreciation Charges - As per IT Act WDV (P & M)

  •   Annexure 33   :: Interest and Repayment - Term Loans

  •   Annexure 34   :: Tax on Profits

  •   Annexure 35   ::Projected Pay-Back Period And IRR