Description
INTRODUCTION
HOW INTRAVENOUS FLUIDS ARE CREATED
CLASSIFICATION OF SVP
PARENTERAL DRUGS
RESPULES
NEBULISING RESPULES FOR INHALATION
STERILE WATER FOR INJECTION OR WATER FOR RECONSTITUTION
OF DRY SYRUP
SVP AND DILUENTS
SVP & DILUENTS
AMPULES
VIALS
SMALL VOLUME PARENTERAL SOLUTION
PROPERTIES
TABLE 1. PHYSICAL PROPERTIES OF D-GLUCOSE
TABLE 2. SOLUBILITY OF DEXTROSE IN WATER
SOURCE OF MACHINES TECHNOLOGY
MARKET OVERVIEW OF PARENTERALS
GEOGRAPHICAL SEGMENTATION OF THE INTRAVENOUS SOLUTIONS
MARKET
COMPETITIVE LANDSCAPE AND KEY VENDORS
KEY VENDORS IN THIS MARKET ARE –
GROWTH DRIVERS, CHALLENGES, AND UPCOMING TRENDS: HOME TREATMENT
PRESENT MANUFACTURERS OF SVP
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
IDENTIFICATION:-
ASSAY:
REQUIREMENTS OF RAW MATERIALS AND SPECIFICATIONS
WATER FOR INJECTION
HDPE PHARMA GRADE LAMINATE/ PLASTIC ROLL
LABELING
IDENTIFICATION
HEAVY METALS
BASIS OF BFS TECHNOLOGY
BLOW FILL SEAL (BFS) AND FORM FILL SEAL (FFS) TECHNOLOGY
CONCEPT OF BFS
FORMULATION ASPECT OF SVP {SMALL VOLUME PARENTERALS}
FORMULATION ASPECTS:
THERAPEUTIC AGENTS.
VEHICLES.
ADDED SUBSTANCES (ADDITIVES)
1) ANTIMICROBIALS.
2) ANTI OXIDANTS.
3) BUFFERS.
4) BULKING AGENTS.
5) CHELATING AGENTS.
6) PROTECTANTS.
7) SOLUBILIZING AGENTS.
8) TONICITY ADJUSTING AGENTS.
9) SURFACTANTS.
VEHICLES:
WATER FOR INJECTION (WFI):
STERILIZED WATER FOR INJECTION (SWFI):
BACTERIOSTATIC WATER FOR INJECTION (BWFI):
PRETREATMENT OF WATER FOR INJECTION
REVERSE OSMOSIS (RO):
DISTILLATION:
TERMINAL STERILIZATION:
BLOW FILL SEAL (BFS):
MANUFACTURING PROCESS OF SMALL VOLUME PARENTERALS {SVP}
FORM-FILL-SEAL TECHNOLOGY OR BLOW, FILL-SEAL TECHNOLOGY
FILTRATION (MEMBRANE):-
STERILIZATION (AUTOCLAVING):-
STERILIZATION (BY MOIST HEAT):-
COMPLETION/FINALISATION OF STERILE PRODUCTS:-
PRODUCT CONTAINERS AND CLOSURES:-
PROCESS FLOW DIAGRAM FOR PARENTERALS
COMPARISION OF SVP AND LVP
FLOW DIAGRAM OF MANUFACTURING OF I.V. FLUIDS
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
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
ADDRESSES OF PLANT & MACHINERY SUPPLIERS (IMPORTED)
SUPPLIERS OF PLANT AND MACHINERY (INDIAN)
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
EMPTY IV BAG MANUFACTURER AND SUPPLIER IN INDIA
CONSULTANT FOR SVP
SUPPLIERS OF COMPLETE PLANT AND MACHINERY
CONSULTANT OF TURNKEY PROJECT SUPPLIER OF THE PLANT
AND MACHINERY
CLEAN ROOM SUPPLIERS
MACHINERY CATALOG
APPENDIX – A:
1. COST OF PLANT ECONOMICS
2. LAND & BUILDING
3. PLANT AND MACHINERY
4. FIXED CAPITAL INVESTMENT
5. RAW MATERIAL
6. SALARY AND WAGES
7. UTILITIES AND OVERHEADS
8. TOTAL WORKING CAPITAL
9. COST OF PRODUCTION
10. PROFITABILITY ANALYSIS
11. BREAK EVEN POINT
12. RESOURCES OF FINANCE
13. INTEREST CHART
14. DEPRECIATION CHART
15. CASH FLOW STATEMENT
16. PROJECTED BALANCE SHEET
