Medical IV Solution/Fluid

MEDICAL IV SOLUTION/FLUID

[EIRI/EDPR/4758] J.C.: 2978INR, 2978US$

INTRODUCTION

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.

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            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%

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

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

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:

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

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.

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

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)