I.V. Solution/Fluid (FFS Technology) (Cap: 1,44,000 Bottles/Day)

I.V. SOLUTION/FLUID (FFS TECHNOLOGY) (CAP: 1,44,000 BOTTLES/DAY)

[EIRI/EDPR/4493] J.C.: 2709XL

COST ESTIMATION

Plant Capacity                          1,44,000 Bottles/Day  

Land & Building (6640 sq.mt.) Rs. 6.80 Cr    

Plant & Machinery                   Rs. 7.00 Cr 

Working Capital for 1 Month    Rs. 3.90 Cr 

Total Capital Investment          Rs. 18.39 Cr 

Rate of Return                          33%

Break Even Point                     53%

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 INJECTIONS

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)