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)
