Detailed Project Report on small volume parenteral (svp)
Detailed Project Report on small volume parenteral (svp)
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SMALL VOLUME PARENTERAL (SVP)
[CODE NO.3988]
Brief Introduction to SVPs
The term ‘parenteral’ refers to injectable route of administration. It is actually derived from Greek words ‘Para’ which means ‘Outside’ and ‘Enteron’ which means ‘Intestine’. In other words, the word ‘parenteral’ refers to a route of administration other than the alimentary canal. The usual routes include the sub-cutaneous, intra-muscular, intra venous and SVP as well as LVP. It is an injection that is packaged in containers (or vials, cartridges, syringes, bottles, ampoules) labeled as containing 100 ml or less. As per the USP 24/NF 19, the definition of small volume parenteral is “Those preparations intended for injection through the skin or other external boundary tissue, rather than the alimentary canal – so that the active substances are administered using gravity or force directly into the blood vessel, organ, tissue or lesion”.
Details of Kinds of SVPs
The main kinds of SVPs are described below:
1. AMPOULES
These refer to sealed glass containers with an elongated neck that must be broken off. For easy breaking, most of the ampoules are weakened around the neck. These usually have a colored band around the neck.
Usually, to draw the contents of an ampule into a syringe, a 5 micron filter needle should be used. This is because there is a possibility that glass particles may have fallen inside the ampule when the top was snapped off. At times, it is advisable to wrap a small piece of gauze or alcohol wipe around the top of the ampule before breaking it.
2. VIALS
Various additives and drugs are packaged in vials either as liquids or lyophilized powders. There are usually sealed with a rubber stop and are made of glass or plastic. Usually, a needle is used to add or withdraw the contents.
Before withdrawal of contents, usually, equal volume of air is injected into the vial to pressurize it and assist in content withdrawal.
3. DRY POWDERS
These refer to freeze-dried or lyophilized formulations that must be reconstituted with some suitable solvent to make a liquid formulation. Drugs which are usually not stable in liquid form are put in powder form for use.
4. PREFILLED SYRINGES
These refer to syringes which are prefilled with drug solution. These consist of two kinds: cartridge type package and needle unit. Once the needle of the syringe is used, they are discarded. However, the holder is put to use again with a new unit.
Other Related Details of SVPs
Parenteral injections could include various products such as pharmaceutical products, biological products, biotechnology products, genetically engineered products, allergenic extracts, liposome and lipid products, radiopharmaceutical products, and others. The types of preparations could be drug injection, drug injectable emulsion, drug injectable suspension and others.
The containers usually used for parenteral packaging are glass, plastic and rubber. Parenterals are usually processed well before being put to use. These steps include: cleaning of containers, collection of materials, preparation of parenteral products, filtration, filling preparation in containers, sealing containers, sterilization, evaluation of parenteral preparation, labeling and packaging.
COST ESTIMATION
Plant Capacity : 120000 Nos
Land & Building (8000 sq.mt.) : Rs. 5.89 Cr
Plant & Machinery : Rs. 30.00 Cr
Working Capital for 2 Month : Rs. 3.26 Cr
Total Capital Investment : Rs. 39.77 Cr
Rate of Return : 24%
Break Even Point : 58%
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
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