GLUCOSE & SODIUM CHLORIDE SALINE
[EIRI/EDPR/1577] J.C. 296
INTRODUCTION
Intra venous 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
When saline is injected intravenously, it compensate the deficiency of sodium ions when dextrose is injected it gives energy due to glucose content of it when dextro-saline is given in combination, it replanishes the dehydration as well as gives energy thereby recouping debility syndrome and also in general take care of malaise.
Intravenous fluids are chemically prepared solutions that are administered to the patient. They are tailored to the body’s needs and used to replace lost fluid and/or aid in the delivery of IV medications. For patients that do not require immediate fluid or drug therapy, the continuous delivery of a small amount of IV fluid can be used to keep a vein patent (open) for future use. IV fluids come in different forms and have different impacts on the body. Therefore, it is important to have an understanding of the different types of IV fluids, along with their indications for use.
How Intravenous Fluids are Created
There are several types of IV fluids that have different effects on the body. Some IV fluids are designed to stay in the intravascular space (intra, within; vascular, blood vessels) to increase the intravascular volume, or volume of circulating blood. Other IV fluids are specifically designed so the fluid leaves the intravascular space and enters the interstitial and intracellular spaces. Still others are created to distribute evenly between the intravascular, interstitial, and cellular spaces. The properties that an IV solution has within the body depends on how it is created and the specific materials it contains. It also de- termines the best type of IV solution to use in relation to the patient’s needs.
The majority of an IV solution is sterile water. Chemically, water is referred to as a “solvent.” A solvent is a substance that dissolves other materials called “solutes.” Within IV solutions, the solutes can be molecules called electrolytes (charged particles such as sodium, potassium, and chloride) and/or other larger compounds such as proteins or molecules.
Today, a growing number of pharmaceutical manufacturers are using advanced aseptic processing technologies to minimize operator intervention and contamination risk in the filling and packaging of liquid parenteral drugs. One of these technologies is form-fill-seal (FFS), in which a polymeric material is formed and sealed inline to a container of choice, while the container is being filled.
FFS offers cost savings over conventional aseptic processing in glass. Traditional parenteral filling and packaging requires 23 steps and individual machines for filling, stoppering and capping. In contrast, FFS requires one piece of automated machinery, and takes place in six seconds or less.
The entire FFS process is performed under a class-100 laminar flow, preventing external contamination. The fully automatic, computer-controlled technology allows for filling and packaging of up to 3, 00,000 bottles of IV fluid per day. Nitrogen purging options are available for sensitive formulations such as amino acids.
COST ESTIMATION
Plant Capacity 1,00,00,000 Bottles/Day
Land & Building (12,000 sq.mt.) Rs. 4.17 Cr
Plant & Machinery Rs. 8.65 Cr
Working Capital for 2 Months Rs. 4.36 Cr
Total Capital Investment Rs. 18.25 Cr
Rate of Return 51%
Break Even Point 45%
CONTENTS
INTRODUCTION
KEY TERMS
DEXTROSE
DEXTROSE SALINE INJECTION
PROPERTIES
REQUIREMENTS OF RAW MATERIALS
ABOUT BLOW-FILL-SEAL (BFS) TECHNOLOGY
ECONOMIC PROFILE
WORLD MARKET CONSUMPTION
MEDICAL BLOW-FILL-SEAL
SOURCE OF MACHINES TECHNOLOGY
USES AND APPLICATION
SOME GENERAL INTRAVENOUS FLUIDS
MARKET SURVEY
ADDITIONAL MARKET POSITION
INDIAN PATENTS LAW, TRADE LAW & TAXATION
'TAX'ING INDIAN PHARMA
PRESENT MANUFACTURES OF I.V FLUIDS
SPECIFICATION OF INDIAN PHARMACOPEIA ON I.V FLUIDS DEXTRAN INJECTION
DEXTRAN 110 INJECTION
B.I.S. SPECIFICATIONS FOR PLASTIC I.V. BOTTLES
SODIUM CHLORIDE AND DEXTROSE INJECTION
WATER THE EXCELLENT SOLVENT USED IN PHARMACY
BASIC RAW MATERIALS
REQUIREMENTS OF RAW MATERIALS AND SPECIFICATIONS
MANUFACTURING PROCESS OF FFS TECHNOLOGY
ADVANTAGES OF B.F.S. VS. GLASS
"B.F.S." THE BLOW FILL SEAL TECHNOLOGY
MANUFACTURING PROCESS UNDER B.F.S./F.F.S.
SCHEMATIC DIAGRAM OF BFS PRODUCTION PROCESS
FLOW DIAGRAM OF MANUFACTURING OF I.V. FLUIDS
PLANT LAYOUT
SCHEMATIC DIAGRAM OF FFS PLANT LAYOUT
GENERAL PLANT LAYOUT
EFFLUENT TREATMENT AND DISPOSAL
TOLERANCE LIMITS FOR INDUSTRIAL EFFLUENT DISCHARGE
WASTE TREATMENT
TYPICAL WASTE SOLIDS CHARACTERISTICS
SPECIFICATION OF EFFLUENT DISCHARGE OF PHARMACEUTICAL INDUSTRY
MANPOWER
IMPLEMENTATION SCHEDULE
SCHEMATIC DIAGRAM OF PRODUCTION PLANT PROCESS
LIST OF MACHINERY IV BAG PRODUCTION FORM FILL AND SEAL MACHINE
CIP SYSTEM
GUIDE TO GOOD MANUFACTURING PRACTICE (GMP) FOR
MEDICINAL PRODUCT PRINCIPLE
GENERAL
CLEAN ROOM AND CLEAN AIR DEVICE CLASSIFICATION
CLEAN ROOM AND CLEAN AIR DEVICE MONITORING
ISOLATOR TECHNOLOGY
BLOW/FILL/SEAL TECHNOLOGY
TERMINALLY STERILISED PRODUCTS
ASEPTIC PREPARATION
PERSONNEL
PREMISES
EQUIPMENT
SANITATION
PROCESSING
STERILISATION
STERILISATION BY HEAT
MOIST HEAT
DRY HEAT
STERILISATION BY RADIATION
STERILISATION WITH ETHYLENE OXIDE
FILTRATION OF MEDICINAL PRODUCTS WHICH CANNOT BE
STERILISED IN THEIR FINAL CONTAINER
FINISHING OF STERILE PRODUCTS
SUPPLIERS OF RAW MATERIALS
EMPTY IV BAG MANUFACTURER AND SUPPLIER IN INDIA
INDUSTRIAL ETP PLANT MANUFACTURE/SUPPLIER
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)
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