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.

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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.

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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.

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·         Properties

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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