www.eiribooksandprojectreports.com 1
ENGINEERS INDIA RESEARCH INSTITUTE
4/54, Roop Nagar, Delhi-110007 (India)
Phone: 9289151047, 9811437895, 9811151047
E-mail: eiri@eiriindia.org
Website: www.eiriindia.org
MEDICAL IV SOLUTION/FLUID
[EIRI/EDPR/4758] J.C.: 2978INR, 2978US$
Intravenous fluids, in general are used as I.V drips for patients in nursing homes
and hospitals suffering 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.
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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
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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
IV FLUID FOR METABOLIC PATIENT
0.9% SODIUM CHLORIDE 10% GLUCOSE 500ML BAG
0.45% SODIUM CHLORIDE 10% GLUCOSE 500ML BAG
0.45% SODIUM CHLORIDE 5% GLUCOSE 500ML BAG
0.18% SODIUM CHLORIDE 10% GLUCOSE 500ML BAG
REQUIREMENTS OF RAW MATERIALS
TABLE I: REQUIREMENT FOR DEXTROSE MONOHYDRATE
INTRAVENOUS FLUID COMPOSITION
CRYSTALLOIDS
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DEXTROSE
NORMAL SALINE
HARTMANN’S SOLUTION
COLLOIDS
IV BAGS MARKET
MEDICAL FLUID BAG MARKET
COVID-19 IMPACT
MEDICAL FLUID BAGS MARKET SHARE
SOURCE OF MACHINES TECHNOLOGY
USES AND APPLICATION
SOME GENERAL INTRAVENOUS FLUIDS
SPECIFICATION OF INDIAN PHARMACOPEIA ON I.V FLUIDS DEXTRAN
INJECTION
DEXTRAN 110 INJECTIONS
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
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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:
MANUFACTURING PROCESS FOR IV BAGS
IT INVOLVES STEPS:-
IV BAG PRODUCTION
RAW MATERIAL SAMPLING AND DISPENSING
THE PRODUCTION OF IV SOLUTION PRODUCTION LINE CONSISTS OF FIVE
MAIN PHASES:
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IV BAG PRODUCTION OPTIONS
IV BAG SEMI AUTOMATIC MANUFACTURING PROCESS
LABELLING
IV BAG FULL AUTOMATIC MANUFACTURING PROCESS
PRODUCTION PROCEDURE FOR PARENTERAL DRUGS
THE MANUFACTURING OF PARENTERALS INVOLVES THE FOLLOWING STEPS;
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
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4. MOULDING PROCESS
5. FILLING PROCESS
6. SEALING PROCESS
7. MOULD OPENING PROCESS
FILTRATION AND FILLING:-
STERILIZATION:-
QUALITY CONTROL:-
THE WHOLE PROCESS CONSISTS OF THE FOLLOWING STEPS:-
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
THE PRODUCTION OF I.V. SOLUTION PRODUCTION LINE CONSISTS OF 5 MAIN
PHASES:
1. WATER PURIFYING
2. DISTILLATION
3. SOLUTION FILLING
4. STERILIZATION
5. PACKING
A TYPICAL FFS PROCESS WORKS AS FOLLOWS.
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SUPPLIERS OF RAW MATERIALS
SUPPLIERS OF POTASSIUM PERMANGANATE
SUPPLIERS OF SODIUM CHLORIDE (I.P. GRADE)
SUPPLIERS OF DEXTROSE
ADDRESSES OF PLANT AND MACHINERY SUPPLIERS
SUPPLIERS OF STERILIZING EQUIPMENTS
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
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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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COST ESTIMATION
Plant Capacity 24,000 Bags/Day
Land & Building (5000 sq.mt.) Rs. 2.96 Cr
Plant & Machinery Rs. 5.27 Cr
Working Capital for 3 Months Rs. 7.14 Cr
Total Capital Investment Rs. 16.22 Cr
Rate of Return 27%
Break Even Point 56%

Project Report MEDICAL IV SOLUTION/FLUID

  • 1.
    www.eiribooksandprojectreports.com 1 ENGINEERS INDIARESEARCH INSTITUTE 4/54, Roop Nagar, Delhi-110007 (India) Phone: 9289151047, 9811437895, 9811151047 E-mail: eiri@eiriindia.org Website: www.eiriindia.org MEDICAL IV SOLUTION/FLUID [EIRI/EDPR/4758] J.C.: 2978INR, 2978US$ Intravenous fluids, in general are used as I.V drips for patients in nursing homes and hospitals suffering 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.
  • 2.
    www.eiribooksandprojectreports.com 2 Free H2Osolutions: 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
  • 3.
    www.eiribooksandprojectreports.com 3 CONTENTS INTRODUCTION TYPES OFIV 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 IV FLUID FOR METABOLIC PATIENT 0.9% SODIUM CHLORIDE 10% GLUCOSE 500ML BAG 0.45% SODIUM CHLORIDE 10% GLUCOSE 500ML BAG 0.45% SODIUM CHLORIDE 5% GLUCOSE 500ML BAG 0.18% SODIUM CHLORIDE 10% GLUCOSE 500ML BAG REQUIREMENTS OF RAW MATERIALS TABLE I: REQUIREMENT FOR DEXTROSE MONOHYDRATE INTRAVENOUS FLUID COMPOSITION CRYSTALLOIDS
  • 4.
    www.eiribooksandprojectreports.com 4 DEXTROSE NORMAL SALINE HARTMANN’SSOLUTION COLLOIDS IV BAGS MARKET MEDICAL FLUID BAG MARKET COVID-19 IMPACT MEDICAL FLUID BAGS MARKET SHARE SOURCE OF MACHINES TECHNOLOGY USES AND APPLICATION SOME GENERAL INTRAVENOUS FLUIDS SPECIFICATION OF INDIAN PHARMACOPEIA ON I.V FLUIDS DEXTRAN INJECTION DEXTRAN 110 INJECTIONS 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
  • 5.
    www.eiribooksandprojectreports.com 5 HEAVY METALS COMPOSITIONOF 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: MANUFACTURING PROCESS FOR IV BAGS IT INVOLVES STEPS:- IV BAG PRODUCTION RAW MATERIAL SAMPLING AND DISPENSING THE PRODUCTION OF IV SOLUTION PRODUCTION LINE CONSISTS OF FIVE MAIN PHASES:
  • 6.
    www.eiribooksandprojectreports.com 6 IV BAGPRODUCTION OPTIONS IV BAG SEMI AUTOMATIC MANUFACTURING PROCESS LABELLING IV BAG FULL AUTOMATIC MANUFACTURING PROCESS PRODUCTION PROCEDURE FOR PARENTERAL DRUGS THE MANUFACTURING OF PARENTERALS INVOLVES THE FOLLOWING STEPS; 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
  • 7.
    www.eiribooksandprojectreports.com 7 4. MOULDINGPROCESS 5. FILLING PROCESS 6. SEALING PROCESS 7. MOULD OPENING PROCESS FILTRATION AND FILLING:- STERILIZATION:- QUALITY CONTROL:- THE WHOLE PROCESS CONSISTS OF THE FOLLOWING STEPS:- 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 THE PRODUCTION OF I.V. SOLUTION PRODUCTION LINE CONSISTS OF 5 MAIN PHASES: 1. WATER PURIFYING 2. DISTILLATION 3. SOLUTION FILLING 4. STERILIZATION 5. PACKING A TYPICAL FFS PROCESS WORKS AS FOLLOWS.
  • 8.
    www.eiribooksandprojectreports.com 8 SUPPLIERS OFRAW MATERIALS SUPPLIERS OF POTASSIUM PERMANGANATE SUPPLIERS OF SODIUM CHLORIDE (I.P. GRADE) SUPPLIERS OF DEXTROSE ADDRESSES OF PLANT AND MACHINERY SUPPLIERS SUPPLIERS OF STERILIZING EQUIPMENTS 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
  • 9.
    www.eiribooksandprojectreports.com 9 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)
  • 10.
    www.eiribooksandprojectreports.com 10 COST ESTIMATION PlantCapacity 24,000 Bags/Day Land & Building (5000 sq.mt.) Rs. 2.96 Cr Plant & Machinery Rs. 5.27 Cr Working Capital for 3 Months Rs. 7.14 Cr Total Capital Investment Rs. 16.22 Cr Rate of Return 27% Break Even Point 56%