I.V.

FLUID MANUFACTURING UNIT

[EIRI/EDPR/4059] J.C.: 2193XL

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.)

The drip chamber must always be half full. If the drip chamber is too full, we will not
be able to see the drops to count them, and so we will be unable to determine the rate
at which the IV is infusing. If the drip chamber is not full enough, then this will allow
air to get into the IV tubing, which means that air would get into the patient's
circulatory system, which could be very dangerous, blocking a blood vessel or
stopping the heart.

www.eiriindia.org 3
 CONTENTS

INTRODUCTION
STANDARD IVF & ELECTROLITES
THE AIMS OF IV FLUID ADMINISTRATION SHOULD BE TO
BASIC IV SETUP
TYPES OF IV FLUIDS
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
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%D

DNS

www.eiriindia.org 4
5 % DEXTROSE COMPOSITION:
DEXTROSE WITH HALF STRENGTH SALINE
ISOLYTE G,M,P,E
PARACETAMOL 10 MG/ML SOLUTION COMPOSITION
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 NIGERIA?
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
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)

www.eiriindia.org 5
COMPOSITION OF IV FLUIDS
COMPOSITION OF COMMERCIAL I.V. FLUID AVAILABLE
FORM FILL SEAL TECHNOLOGY
1. FORM-FILL-SEAL TECHNOLOGY:-
1.3. TERMINALLY STERILIZED PRODUCTS.-
1.5 FILTRATION (MEMBRANE):-
1.7. STERILIZATION (BY DRY HEAT):-
LIST OF MACHINERY IV BAG PRODUCTION FORM FILL AND SEAL MACHINE
IV BAG PRODUCTION (IV PRODUCTION AND PACKING)
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
BLOW FILL SEAL IS SUITABLE FOR YOUR APPLICATION:
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

www.eiriindia.org 6
SODIUM CHLORIDE (I.P. GRADE)
DEXTROSE
SUPPLIERS OF PLANT AND MACHINERY
STERILIZING EQUIPMENTS
PM METER
LABELING MACHINES
TANKS
BOILER
FILTER PRESS
LABORATORY EQUIPMENTS
MIXER
RAW MATERIAL SUPPLIER
SODIUM LACTATE
NACL
KCL
CACL2
PRODUCT PHOTOGRAPHS
MACHINERY PHOTOGRAPHS
MULTIPLE EFFECT WATER DISTILLATION PLANT
MIXER
STORAGE VESSEL
BLOW FILL SEAL MACHINE
AUTOMATIC BOTTLE LABELLING MACHINES

www.eiriindia.org 7
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 48,000 Nos/Day

Land & Building (2000 sq.mt.) Rs. 1.68 Cr
Plant & Machinery Rs. 34.64 Cr
Working Capital for 1 Month Rs. 42 Lac
Total Capital Investment Rs. 37.03 Cr
Rate of Return 22%
Break Even Point 62%

www.eiriindia.org 9