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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