I.V. SOLUTION/FLUID (FFS TECHNOLOGY AND CATHETER)
[EIRI/EDPR/4605] J.C.: 2822XL
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 20,45,000 Nos/Day
Land & Building (24,000 sq.mt.) Rs. 52.70 Cr
Plant & Machinery Rs. 57.05 Cr
Working Capital for 1 Month Rs. 43.91 Cr
Total Capital Investment Rs. 155.72 Cr
Rate of Return 46%
Break Even Point 37%
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 FOR IV FLUID
TABLE I: REQUIREMENT FOR DEXTROSE MONOHYDRATE
INTRAVENOUS FLUID COMPOSITION
CRYSTALLOIDS
DEXTROSE
NORMAL SALINE
HARTMANN’S SOLUTION
COLLOIDS
CATHETER LENGTH, SIZE AND TYPE
CATHETER LENGTH
BALLOON SIZE
TYPES
DIAMETERS:
STRAIGHT-SINGLE USE CATHETERS
2-WAY FOLEY CATHETERS (RETENTION CATHETERS)
CURVED OR COUDE
3-WAY FOLEY CATHETER
BRIEF DESCRIPTION OF CATHETER
DIALYSIS CATHETER
THE LINE CAN BE USED FOR:
PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)
TUNNELED CATHETERS
UROLOGY CATHETER
CENTRAL VENOUS CATHETER
RAW MATERIALS FOR CATHETER
DESIGN
SILICONES
POLYVINYL CHLORIDE
CHEMICAL COMPOSITION OF LATEX
USES, ADVANTAGES & DISADVANTAGES
ADVANTAGES OF CVC FOR DIALYSIS:
SHORT TERM OPEN ENDED CATHETER
PERIPHERALLY INSERTED CENTRAL CATHETER
TUNNELED CATHETERS
IMPLANTABLE VENOUS ACCESS DEVICES
CENTRAL VENOUS CATHETER
TYPES OF CENTRAL VENOUS CATHETERS
THE TYPE OF CVC INSERTED DEPENDS ON THE:
CENTER VENOUS CATHETERS: OPEN-ENDED OR CLOSED-ENDED
OPEN–ENDED
CLOSED-ENDED
SHORT-TERM CATHETERS
IMPLANTABLE VENOUS ACCESS DEVICE (IVAD)
LSR (LIQUID SILICONE RUBBER)
PROCESS OF LIQUID SILICONE FOLEY CATHETER
TECHNOLOGY OF CATHETER
PROCESSING COATED CATHETERS
PROCESSING STEP OF FOLEY CATHETER
PHOTOGRAPHS
MELT PUMPS
MELT PUMPS WITH MULTI-LAYER DIE
OPEN CALIBRATION TANK
BALLOON FORMING MACHINE
DUAL FLUTING AND WRAPPING MACHINE
TWO-LAYER HIGH-PRECISION STRAND LINE
WINDER, HAUL-OFF WITH DIAMETER CONTROL & VACUUM CALIBRATION
DIE & CARRIAGE, PREHEATING SYSTEM & UNWINDER FOR SUPPORTING WIRE
CONTROL SYSTEM
CATHETER DESIGN AND MATERIALS
MATERIAL DIFFERENCES
CATHETER DESIGN
TIP DESIGN
CATHETER OVER NEEDLE DEVICES
CATHETER THROUGH NEEDLE/CANNULA
NEEDLE DESIGN
CATHETER SIZE
MULTILUMEN CATHETERS
HUB OPTIMIZATION & INTEGRATION OF HIGH-PERFORMANCE CATHETERS
TUBING ASSEMBLY
HUB-CATHETER
STANDARD HUB SPECIFICATIONS
BOND STRENGTH
HUB DESIGN AND MANUFACTURING OPTIMIZATION
LIQUID SILICONE FOLEY CATHETER MANUFACTURING EQUIPMENTS AND CATHETER MOULD
VERTICAL LIQUID SILICONE RUBBER (LSR) INJECTION MOLDING MACHINE
ABOUT MACHINE
OTHER MACHINE STYLE:
THE MAIN FEATURE OF THE VERTICAL LSR MOLDING MACHINE:
SOURCE OF MACHINES TECHNOLOGY FOR IV FLUID
USES AND APPLICATION
SOME GENERAL INTRAVENOUS FLUIDS
SPECIFICATION OF INDIAN PHARMACOPEIA ON I.V FLUIDS DEXTRAN 40 INJECTION
DEXTRAN 110 INJECTIONS
B.I.S. SPECIFICATIONS FOR PLASTIC I.V. BOTTLES
SODIUM CHLORIDE AND DEXTROSE INJECTION
ASSAY:
BASIC RAW MATERIALS FOR IV FLUID
REQUIREMENTS OF RAW MATERIALS AND SPECIFICATIONS FOR IV FLUID
WATER FOR INJECTION
HDPE PHARMA GRADE LAMINATE/ PLASTIC ROLL
LABELING
IDENTIFICATION
HEAVY METALS
MARKET OVERVIEW OF FOLEY CATHETER
MARKET OVERVIEW OF IV SOLUTION
COMMON REASON FOR USING CATHETER
DESIGN AND PROCESS DETAILS OF CATHETER
A FOLEY CATHETER
QUALITY CONTROL
SEQUENCES IN CATHETER MANUFACTURE
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
PLASMA EXPANDERS
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 FOR IV FLUID
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):-
SUPPLIERS OF RAW MATERIALS
SUPPLIERS OF POTASSIUM PERMANGANATE
SUPPLIERS OF SODIUM CHLORIDE (I.P. GRADE)
SUPPLIERS OF DEXTROSE
SUPPLIERS OF PLANT AND MACHINERY FOR IV FLUIDS
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
SUPPLIERS OF COMPLETE PLANT AND MACHINERY FOR IV FLUID [IMPORTED]
CONSULTANT OF TURNKEY PROJECT SUPPLIER FORIV FLUIDS
CLEAN ROOM SUPPLIERS
ADDRESSES OF MACHINERIES SUPPLIERS FOR CATHETER
SUPPLIERS OF OPEN CALIBRATION TANK
SUPPLIERS OF TWO-LAYER HIGH-PRECISION STRAND LINE
SUPPLIERS OF WINDER
SUPPLIERS OF HAUL-OFF WITH DIAMETER CONTROL
SUPPLIERS OF VACUUM CALIBRATION
LIST OF EQUIPMENTS (MACHINERIES) FOR CATHETER THROUGH EXTRUSION PROCESS
MAIN COMPONENTS OF A CATHETER EXTRUSION LINE
EXTRUDER
MELT PUMPS
GRAVIMETRIC FEEDING
DIES
VACUUM CALIBRATION AND COOLING
DIAMETER CONTROL
WINDERS
CUTTING UNITS
UNWINDER FOR SUPPORTING WIRE
PREHEATING SYSTEMS
PROCESS CONTROL WITH PROTOCOL LING
CLEAN-ROOM CONDITIONS
TWO-LAYER HIGH-PRECISION STRAND LINE
CONTROL SYSTEM
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)
