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Project Report On I.V. Fluid Manufacturing Unit

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The key takeaways are that intravenous (IV) fluids are used to restore or maintain fluid and electrolyte balance when oral intake is not possible. Standard IV fluids include saline solutions, glucose solutions, lactated Ringer's solution, and colloid solutions.

Standard IV fluids and electrolytes include NaCl, glucose, sodium lactate solution, Ringer's lactate, water for injection, sterile water for irrigation, and potassium chloride solutions.

The aims of IV fluid administration are to avoid dehydration, maintain effective circulating volume, and prevent inadequate tissue perfusion during periods when oral intake is not possible.

I.V.

FLUID MANUFACTURING UNIT


[EIRI/EDPR/4079] J.C.: 2219XL

INTRODUCTION

Intravenous fluids, also known as intravenous solutions, are supplemental fluids used
in intravenous therapy to restore or maintain normal fluid volume and electrolyte
balance when the oral route is not possible.

IV fluid therapy is an efficient and effective way of supplying fluids directly into the
intravascular fluid compartment, in replacing electrolyte losses, and in administering
medications and blood products.

STANDARD IVF & ELECTROLITES

- NaCl 0.18 – 2.7%


- Glucose 2.5 - 50%
- Sodium Lactate (Hartmanns’s) Solution
- Ringer Lactate
- Water For injection
- Sterile Water for Irrigation
- Sodium Chloride 0.9% for irrigation
- Sodium Chloride 0.18 – 0.45% and Glucose 4 – 10 %
- Potassium Chloride 0.15 – 0.3% in Sodium Chloride 0.9%
- Potassium Chloride 0.15 – 0.3% in Glucose 5%

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The aims of IV fluid administration should be to

 Avoid dehydration

 Maintain an effective circulating volume

 Prevent inadequate tissue perfusion during a period when the patient is unable
to achieve these goals through normal oral fluid intake

“Intravenous fluids have a range of physiologic effects and should be considered to be


drugs with indications, dose ranges, cautions, and side effects.”

The intravenous route is the fastest way to deliver medications and fluid replacement
throughout the body, because they are introduced directly into the circulation.

Intravenous therapy may be used for fluid volume replacement, to correct electrolyte
imbalances, to deliver medications, and for blood transfusions.

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CONTENTS

INTRODUCTION
STANDARD IVF & ELECTROLITES
THE AIMS OF IV FLUID ADMINISTRATION SHOULD BE TO
BASIC IV SETUP
LET'S TAKE A LOOK AT THE MOST BASIC POSSIBLE SETUP FOR AN IV:
LOCATION- ERODE, TAMILNADU
GEOGRAPHICAL POSITION
CLIMATE
TRANSPORTATION
BY ROAD
BY RAIL
TOURISM
TYPES OF IV FLUIDS
IV SOLUTIONS CAN ALSO BE CLASSIFIED BASED ON THEIR PURPOSE:
CRYSTALLOIDS
GENERAL CHARACTERISTICS OF CRYSTALLOID
ISOTONIC IV FLUIDS
0.9% NACL (NORMAL SALINE SOLUTION, NSS)
DEXTROSE 5% IN WATER (D5W)
LACTATED RINGER’S 5% DEXTROSE IN WATER (D5LRS)
RINGER’S SOLUTION
HYPOTONIC IV FLUIDS
0.45% SODIUM CHLORIDE (0.45% NACL)
0.33% SODIUM CHLORIDE (0.33% NACL)
0.225% SODIUM CHLORIDE (0.225% NACL)
2.5% DEXTROSE IN WATER (D2.5W)
HYPERTONIC IV FLUIDS
HYPERTONIC DEXTROSE SOLUTIONS
DEXTROSE 10% IN WATER (D10W)
DEXTROSE 20% IN WATER (D20W)
DEXTROSE 50% IN WATER (D50W)
NURSING CONSIDERATIONS FOR HYPERTONIC SOLUTIONS
DARROW’S SOLUTION
COLLOIDS

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HUMAN ALBUMIN
DEXTRANS
LOW-MOLECULAR-WEIGHT DEXTRANS (LMWD)
HIGH-MOLECULAR-WEIGHT DEXTRANS (HMWD)
IV FLUID/ELECTROLYTE THERAPY
NORMAL SALINE
VOLUME EFFECTS OF NS
RINGER'S FLUIDS
ADVANTAGE:
DEXTROSE SOLUTIONS
EFFECT OF DEXTROSE IN FLUID:
VOLUME EFFECTS
5% DEXTROSE COMPOSITION:
DEXTROSE SALINE (DNS)
DEXTROSE WITH HALF STRENGTH SALINE
10% DEXTROSE & 25% DEXTROSE
ISOLYTE G,M,P,E
PARACETAMOL 10 MG/ML SOLUTION COMPOSITION
QUALITATIVE AND QUANTITATIVE COMPOSITION
METRONIDAZOLE IV SOLUTION
ECONOMIC PROFILE
MARKET POSITION
APPLICATION INSIGHTS
VOLUME INSIGHTS
INDIA LARGE VOLUME PARENTERAL (LVP) MARKET SHARE INSIGHTS
NORTH AMERICA AT THE FOREFRONT OF THE GLOBAL INTRAVENOUS
(IV) SOLUTION MARKET
BUSINESS JUSTIFICATION
PRODUCTS
WHY IV FLUID?
GLOBAL INTRAVENOUS SOLUTION MARKET: KEY TRENDS
GLOBAL INTRAVENOUS SOLUTION MARKET: SEGMENTATION
GLOBAL INTRAVENOUS SOLUTION MARKET: REGIONAL ANALYSIS
GLOBAL INTRAVENOUS SOLUTION MARKET: COMPETITIVE LANDSCAPE
MAJOR FIVE IV FLUID MONITORING DEVICES COMPANIES:
B. BRAUN MELSUNGEN AG
BAXTER INTERNATIONAL INC.
BECTON, DICKINSON AND CO.

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FORTIVE CORP.
ICU MEDICAL INC.
SOURCE OF MACHINES TECHNOLOGY
USES AND APPLICATION
SOME GENERAL INTRAVENOUS FLUIDS
SPECIFICATION OF INDIAN PHARMACOPEIA ON I.V FLUIDS DEXTRAN
40 INJECTION
DEXTROSE INJECTION WHEN DETERMINED BY THE FOLLOWING METHOD
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
HEAVY METALS
COMPOSITION OF IV FLUID
COMPOSITION OF COMMON IV FLUID (MEQ/L)
COMPOSITION OF IV FLUIDS
COMPOSITION OF COMMERCIAL I.V. FLUID AVAILABLE
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)
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.
BASIC OF BFS TECHNOLOGY
BLOW FILL SEAL EQUIPMENT

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BFS MOLDS AND TOOLING
BFS TRIALS
PROCESS
1. BLOW MOLDING
2. FILLING
3. SEALING
BLOW FILL SEAL MACHINES
ASEPTIC PACKAGING
BLOW FILL SEAL (BFS) AND FORM FILL SEAL (FFS) TECHNOLOGY
MANUFACTURING PROCESS OF I.V. FLUID
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:-
THE WHOLE PROCESS CONSISTS OF THE FOLLOWING STEPS:-
PROCESS FLOW DIAGRAM
FLOW DIAGRAM OF MANUFACTURING OF I.V. FLUIDS
SUPPLIERS OF RAW MATERIALS
POTASSIUM PERMANGANATE
SODIUM CHLORIDE (I.P. GRADE)
DEXTROSE
SUPPLIERS OF PLANT AND MACHINERY
STERILIZING EQUIPMENTS
PM METER
LABELING MACHINES
TANKS
BOILER
FILTER PRESS
LABORATORY EQUIPMENTS
MIXER
MACHINERY PHOTOGRAPHS

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MULTIPLE EFFECT WATER DISTILLATION PLANT
MIXER
STORAGE VESSEL
BLOW FILL SEAL MACHINE
AUTOMATIC BOTTLE LABELLING MACHINES
RAW MATERIAL SUPPLIER
SODIUM LACTATE
NACL
KCL
CACL2
PRODUCT PHOTOGRAPHS
QUERY FROM CUSTOMERS
FISCAL INCENTIVES

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 48,000 Nos/Day


Land & Building (3000 sq.mt.) Rs. 3.02 Cr
Plant & Machinery Rs. 6.23 Cr
Working Capital for 1 Month Rs. 1.22 Cr
Total Capital Investment Rs. 10.75 Cr
Rate of Return 28%
Break Even Point 56%

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