I.V.

FLUID MANUFACTURING UNIT

[EIRI/EDPR/4074] J.C.: 2211XL

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%

www.eiriindia.org 1
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.

www.eiriindia.org 2
Basic IV Setup

Let's take a look at the most basic possible setup for an IV:

The drip chamber is located just below the IV bag; inside this chamber we can see the
fluid drip down from the bag into the IV tubing. This is where we measure the speed
of a manual IV setup; we look at this chamber and count the number of drops we see
per minute. So, for example, if we count 25 drops over the period of 60 seconds, we
would say that the IV is infusing at a rate of 25 drops per minute, or 25 gtt/min. (In
reality, we may not count the number of drops in a full minute; we can, for example,
count the number of drops we see over a period of 15 seconds, and then multiply that
number by 4 to get the number of drops in a full minute.)

www.eiriindia.org 3
 CONTENTS

INTRODUCTION
STANDARD IVF & ELECTROLITES
THE AIMS OF IV FLUID ADMINISTRATION SHOULD BE TO
BASIC IV SETUP
LOCATION- ODISHA
MAP
DISTRICTS OF ORISSA
TRANSPORT NETWORK OF ORRISA
RAIL TRANSPORT
AIR
PORTS
PARADEEP PORT
GOPALPUR PORT
DHAMARA HARBOUR
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
0.33% 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)
NURSING CONSIDERATIONS FOR HYPERTONIC SOLUTIONS
DARROW’S SOLUTION
COLLOIDS
HUMAN ALBUMIN
DEXTRANS
LOW-MOLECULAR-WEIGHT DEXTRANS (LMWD)
HIGH-MOLECULAR-WEIGHT DEXTRANS (HMWD)
IV FLUID/ELECTROLYTE THERAPY

www.eiriindia.org 4
NORMAL SALINE
VOLUME EFFECTS OF NS
RINGER'S FLUIDS
ADVANTAGE:
DEXTROSE SOLUTIONS
EFFECT OF DEXTROSE IN FLUID:
VOLUME EFFECTS

5%D

DNS
5 % DEXTROSE COMPOSITION:
DEXTROSE SALINE (DNS)
DEXTROSE WITH HALF STRENGTH SALINE
ISOLYTE G,M,P,E
METRONIDAZOLE IV SOLUTION
ECONOMIC PROFILE
MARKET SURVEY
APPLICATION INSIGHTS
VOLUME INSIGHTS
INDIA LARGE VOLUME PARENTERAL (LVP) MARKET SHARE INSIGHTS
NORTH AMERICA AT THE FOREFRONT OF THE GLOBAL INTRAVENOUS
(IV) SOLUTION MARKET
AFRICA’S PHARMACEUTICAL 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.
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
DEXTRAN 110 INJECTIONS
SODIUM CHLORIDE AND DEXTROSE INJECTION
ASSAY:
BASIC RAW MATERIALS

www.eiriindia.org 5
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):-
1.6.3 THE STERILIZER SHALL BE DOUBLE ENDED TO PREVENT MIX-UPS.
1.7. STERILIZATION (BY DRY HEAT):-
LIST OF MACHINERY IV BAG PRODUCTION FORM FILL AND SEAL MACHINE
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
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

www.eiriindia.org 6
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
MULTIPLE EFFECT WATER DISTILLATION PLANT
MIXER
STORAGE VESSEL
RAW MATERIAL SUPPLIER
SODIUM LACTATE
NACL
KCL
CACL2
PRODUCT PHOTOGRAPHS
QUERY FROM CUSTOMERS
FISCAL INCENTIVES
FOR 10 MILLION BOTTLES PER MONTH WHAT KIND OF EQUIPMENT
WILL BE REQUIRED
LIST OF COMPANIES MANUFACTURING PLANT MACHINERIES AND
TOOLS REQUIRED
COST OF EACH EQUIPMENT
LIST OF RAW MATERIAL REQUIRED
LIST OF SUPPLIER OF RAW MATERIAL
COST OF RAW MATERIAL
BREAK DOWN MANUFACTURING COST
HOW MANY EMPLOYEES REQUIRED AND SALARY OF EACH EMPLOYEE?
SELLING PRICE
APPROVALS REQUIRED
LIST OF CONSULTANT THAT CAN HELP US IN GETTING THE APPROVAL

www.eiriindia.org 7
WHAT IS THE OPTIMUM PRODUCTION QUANTITY DEPENDING ON THE
DEMAND FOR A PLANT IN ODISHA

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)

www.eiriindia.org 8
 COST ESTIMATION

Plant Capacity 4,00,000 Nos/Day

Land & Building (6000 sq.mt.) Rs. 3.56 Cr
Plant & Machinery Rs. 82.63 Cr
Working Capital for 1 Month Rs. 11.02 Cr
Total Capital Investment Rs. 97.77 Cr
Rate of Return 34%
Break Even Point 50%

www.eiriindia.org 9