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    I.V. Solution/Fluid (Production Capacity: 50,000 Bottles/Day of 500ml., 250ml. and 100ml.)

    I.V. Solution/Fluid (Production Capacity: 50,000 Bottles/Day of 500ml., 250ml. and 100ml.)
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    I.V. Solution/Fluid (Production Capacity: 50,000 Bottles/Day of 500ml., 250ml. and 100ml.)
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      I.V. SOLUTION/FLUID (PRODUCTION CAPACITY: 50,000 BOTTLES/DAY OF 500ML., 250ML. AND 100ML.)

      [EIRI/EDPR/4776] J.C.: 2996XL


      INTRODUCTION

      Intravenous fluids, in general are used as I.V drips for patients in nursing homes and hospitals suffer from acute dehydration or considerable debilitating conditions.  These I.V fluids replanish the body fluids. Though a number of I.V fluids are there, generally three types of I.V fluids are used in hospitals as I.V drips. They are as follows:-

      1. Dextrose injection fluid

      2. Dextrose and sodium chloride injection fluid

      Types of IV Fluid

      Crystalloid: Balanced salt/electrolyte solution; for msa true solution and is capable of passing through semi permeable membranes. May be isotonic, hypertonic or hypotonic. Normal Saline (0.9% NaCl), Lactated Ringer’s, Hypertonic saline (3, 5, & 7.5%), Ringer’s solution. However, hypertonic solutions are considered plasma expanders as they act to increase the circulatory volume via movement of intracellular and interstitial water into the intravascular space.

      Colloid: High-molecular-weight solutions, draw fluid into intravascular compartment via on cotic pressure (pressure exerted by plasma proteins not capable of passing through membranes on capillary walls).Plasma expanders, as they are composed of macromolecules, and are retained in the intravascular space.

      Free H2O solutions: provide water that is not bound by macromolecules or organelles, free to passthrough.D5W (5% dextrose in water), D10W, D20W, D50W, and Dextrose/crystalloid mixes. Blood products: whole blood, packed RBCs, FFP, Cryoprecipitate, platelets, albumin. Essentially all colloids.

      IVF can supply 3 things: fluid, electrolytes, & calories. In the non stressed, fasting state, the 150g per day inD5W at 125ml/h can provide enough carbohydrate to limit proteolysis. The most common uses for IVF: Acutely expand intravascular volume in hypovolemic states correct electrolyte imbalances Maintain basal hydration


      COST ESTIMATION

      Plant Capacity            50,000 Bottles/Day

      Land & Building (4000 sq.mt.)    Rs. 3.61 Cr

      Plant & Machinery                    Rs. 6.70 Cr

      Working Capital for 2 Months    Rs. 3.00 Cr

      Total Capital Investment          Rs. 14.72 Cr

      Rate of Return                          45%

      Break Even Point                      43%


      CONTENTS

      INTRODUCTION

      TYPES OF IV FLUID

      COMMONLY USED IV FLUIDS

      HOW INTRAVENOUS FLUIDS ARE CREATED

      IV FLUID/ELECTROLYTE THERAPY

      KEY TERMS

      DEXTROSE

      DEXTROSE SALINE INJECTION

      PROPERTIES

      TABLE I: PHYSICAL PROPERTIES OF D-GLUCOSE

      TABLE 2: SOLUBILITY OF DEXTROSE IN WATER

      REQUIREMENTS OF RAW MATERIALS

      TABLE I: REQUIREMENT FOR DEXTROSE MONOHYDRATE

      INTRAVENOUS FLUID COMPOSITION

      TABLE: COMPOSITIONS OF COMMONLY PRESCRIBED CRYSTALLOIDS;

      *PRESENT AS LACTATE, CONVERTED TO BICARBONATE BY THE LIVER

      CRYSTALLOIDS

      DEXTROSE

      NORMAL SALINE

      HARTMANN’S SOLUTION

      COLLOIDS

      MARKET OVERVIEW OF IV SOLUTION

      SOURCE OF MACHINES TECHNOLOGY

      USES AND APPLICATION

      SOME GENERAL INTRAVENOUS FLUIDS

      SPECIFICATION OF INDIAN PHARMACOPEIA ON I.V FLUIDS DEXTRAN 40 INJECTION

      DEXTRAN 110 INJECTIONS

      B.I.S. SPECIFICATIONS FOR PLASTIC I.V. BOTTLES

      SODIUM CHLORIDE AND DEXTROSE INJECTION

      IDENTIFICATION:-

      ASSAY:

      BASIC RAW MATERIALS

      REQUIREMENTS OF RAW MATERIALS AND SPECIFICATIONS

      WATER FOR INJECTION

      HDPE PHARMA GRADE LAMINATE/ PLASTIC ROLL

      LABELING

      IDENTIFICATION

      HEAVY METALS

      COMPOSITION OF IV FLUID

      COMPOSITION OF COMMON IV FLUID (MEQ/L)

      COMPOSITION OF IV FLUIDS

      COMPOSITION OF COMMERCIAL I.V. FLUID AVAILABLE

      LARGE VOLUME PARENTERAL PREPARATION

      SOME EXAMPLES OF LVPS INCLUDE SOLUTIONS CONTAINING:

      ELECTROLYTE SOLUTIONS

      MILLIEQUIVALENT (MEQ)

      IN PLASMA;

      NOURISHING SOLUTIONS

      EXAMPLES:

      PLASMA EXPANDERS

      DEXTRANS:

      HUMAN SERUM ALBUMIN:

      PLASMA PROTEIN FRACTION:

      PRODUCTION PROCEDURE FOR PARENTERAL DRUGS

      PRODUCTION FACILITIES AND CONTROLS:

      1. CLEAN-UP AREA:

      2. PREPARATION AREA:

      3. ASEPTIC AREA:

      4. QUARANTINE AREA:

      5. FINISHING & PACKAGING AREA:

      CONTROLLED ENVIRONMENT REQUIRED FOR PARENTERAL PREPARATION:

      CLASSIFICATION OF CLEAN ROOMS:-

      ASEPTIC PROCESSING:-

      MANUFACTURING PROCESS OF I.V. FLUID (FFS TECHNOLOGY)

      A TYPICAL FFS PROCESS WORKS AS FOLLOWS:

      PROCESS FLOW DIAGRAM

      PROCESS IN DETAILS

      1. DISTILLED WATER PREPARATION

      2. SOLUTION PREPARATION

      3. INJECTION BLOW MOULDING

      4. MOULDING PROCESS

      5. FILLING PROCESS

      6. SEALING PROCESS

      7. MOULD OPENING PROCESS

      FILTRATION AND FILLING:-

      STERILIZATION:-

      QUALITY CONTROL:-

      SWOT ANALYSIS

      FORM FILL SEAL TECHNOLOGY

      1. FORM-FILL-SEAL TECHNOLOGY:-

      1.5 FILTRATION (MEMBRANE):-

      LIST OF MACHINERY IV BAG PRODUCTION FORM FILL AND SEAL MACHINE

      IV BAG PRODUCTION (IV PRODUCTION AND PACKING)

      IV BAG EMPTY PRODUCTION LINE

      1.  WATER PURIFYING

      2.  DISTILLATION

      3.  SOLUTION FILLING

      4.  STERILIZATION

      5.  PACKING

      A TYPICAL FFS PROCESS WORKS AS FOLLOWS.

      SUPPLIERS OF RAW MATERIALS

      SUPPLIERS OF POTASSIUM PERMANGANATE

      SUPPLIERS OF SODIUM CHLORIDE (I.P. GRADE)

      SUPPLIERS OF DEXTROSE

      SUPPLIERS OF PLANT AND MACHINERY

      SUPPLIERS OF PM METER

      SUPPLIERS OF LABELING MACHINES

      SUPPLIERS OF TANKS

      SUPPLIERS OF BOILER

      SUPPLIERS OF FILTER PRESS

      SUPPLIERS OF LABORATORY EQUIPMENTS

      SUPPLIERS OF MIXER

      EMPTY IV BAG MANUFACTURER AND SUPPLIER IN INDIA

      SUPPLIERS OF COMPLETE PLANT AND MACHINERY

      CONSULTANT OF TURNKEY PROJECT SUPPLIER OF THE PLANT AND MACHINERY

      CLEAN ROOM SUPPLIERS


      APPENDIX – A:

      01. PLANT ECONOMICS

      02. LAND & BUILDING

      03. PLANT AND MACHINERY

      04. OTHER FIXED ASSESTS

      05. FIXED CAPITAL

      06. RAW MATERIAL

      07. SALARY AND WAGES

      08. UTILITIES AND OVERHEADS

      09. TOTAL WORKING CAPITAL

      10. TOTAL CAPITAL INVESTMENT

      11. COST OF PRODUCTION

      12. TURN OVER/ANNUM

      13. BREAK EVEN POINT

      14. RESOURCES FOR FINANCE

      15. INSTALMENT PAYABLE IN 5 YEARS

      16. DEPRECIATION CHART FOR 5 YEARS

      17. PROFIT ANALYSIS FOR 5 YEARS

      18. PROJECTED BALANCE SHEET FOR (5 YEARS)

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