Description
INTRODUCTION
PROJECT LOCATION – NORTH INDIA
CURRENT STATE OF PHARMA INDUSTRY IN NORTH INDIA
EMERGENCE OF NORTH INDIA ON INDIA’S PHARMA MAP
FUTURE PROSPECTS
PARTS OF SYRINGES
SYRINGES AND NEEDLES
VASCULAR ACCESS NEEDLE GAUGE RECOMMENDATIONS
TYPES OF SYRINGES
ANATOMY OF SYRINGES:-
SELECTING SYRINGES
SYRINGE SIZE CONTINUUM
SYRINGE TIPS
SYRINGE TIP SELECTION
SELECTING NEEDLES
ANATOMY OF A NEEDLE:-
NEEDLE GAUGE
NEEDLE LENGTH
NEEDLE SELECTION CONTINUMM
TYPES OF HYPODERMIC NEEDLES
BEVEL
GAUGE
COMMON GAUGES
DISPOSAL OR REUSABLE
USES AND APPLICATION
1. USED FOR EXTRACTION OF BLOOD:
2. USED FOR VACCINATION:
3. USED FOR INJECTING OF INSULIN:
4. USED FOR ADMINISTERING ANAESTHESIA:
B.I.S. SPECIFICATION
RAW MATERIAL & MACHINERY USED
RAW MATERIAL USED
RAW MATERIALS WHICH ARE USED IN THIS BUSINESS
MACHINERY & EQUIPMENTS
PROCESS FLOW CHART
MANUFACTURING PROCESS
LIST OF RAW MATERIAL
MANUFACTURING PROCESS AND SOURCE OF TECHNOLOGY
PP SYRINGES ARE MADE OF:
INSPECTION AND TESTING
FREEDOM FROM PYROGENIC MATERIAL
TEST FOR ABNORMAL TOXICITY
FREEDOM FROM EXTRANEOUS MATTER
LIMIT FOR EXTRACTABLE MATTER
GENERAL
LIMIT OF ACIDITY AND ALKALINITY
LIMIT FOR EXTRACTABLE MATERIAL
LUBRICANTS
NOZZLE
GRADUATION POSITION OF SCALE NUMBERING
FLANGE OF BARREL OR FINGER GRIPS
PISTON
DEAD SPACE VOLUM
MAXMUM DEAD SPACE
LEAKAGE TEST
LEAKAGE TEST BETWEEN BARREL AND PISTON
LEAKAGE TESTING
EXPEL AIR
ACCEPTANCE CRITERIA
PROCEDURE
ACCEPTANCE CRITERIA
THE TEST SHALL BE FOLLOWED AS BELOW:
MARKING OF UNIT CONTAINER
MARKING OF UNIT CONTAINER:
MARKING OF OUTER CONTAINERS:
PACKING:
OUTER CONTAINER
THE STERILIZATION PROCESS
METHODS
STEAM
DRY HEAT
MICROWAVES
ETHYLENE OXIDE
EQUIPMENT
STERILANT GASES
STERILIZATION CYCLE
QUALITY ASSURANCE
ADMINISTRATIVE MONITORING
MECHANICAL INDICATORS
CHEMICAL INDICATORS
BIOLOGICAL INDICATORS THUMBNAIL
STERILIZATION PICTURES
EOG SYSTEM STERILIZATION
MARKET POSITION
TWO-STEP DISPOSABLE AUTOINJECTOR DEVICES TO DRIVE GLOBAL MARKET
PRODUCT INSIGHTS
APPLICATION INSIGHTS
DISPOSABLE SYRINGES MARKET TOP KEY PLAYERS
BECTON DICKINSON LAUNCHES A BD INTEVIA 1ML DISPOSABLE AUTO INJECTOR
DISPOSABLE SYRINGES MARKET DYNAMICS-
ASIA PACIFIC IS EXPECTED TO WITNESS A FASTEST GROWTH IN THE GLOBALDISPOSABLE SYRINGES MARKET
DOCUMENTS REQUIRED FOR NOTIFIED MEDICAL DEVICE REGISTRATION IN INDIA
CHECKLIST FOR NOTIFIED MEDICAL DEVICE REGISTRATION IN INDIA:-
DRUGS COSMETICS ACT, 1940
NOTIFIED MEDICAL DEVICE REGISTRATION IN INDIA
ONLINE SYSTEM FOR MEDICAL DEVICES: – MD – MEDICAL DEVICES(CDSCOMDONLINE.GOV.IN)
INDIA MEDICAL DEVICE REGISTRATION
GOVERNMENT AUTHORITY
MEDICAL DEVICE STATUS
PRODUCT CLASSIFICATION
NOVEL MEDICAL DEVICES
REGULATORY PATHWAY
DEVICE CONFORMITY ASSESSMENT
QUALITY SYSTEMS CONFORMITY ASSESSMENT
REQUIREMENTS FOR GRANT OF LICENSE IN FORM-28 FOR MANUFACTURE OF MEDICAL DEVICES IN INDIA
C. ANNEXURES
ANNEXURE-I LIST OF STATE LICENSING AUTHORITIES
ANNEXURE-II
LIST OF ZONAL AND SUB-ZONAL OFFICES OF CENTRAL DRUGS
STANDARD CONTROL ORGANISATION (CDSCO)
PLANT LOCATION FACTORS
PRIMARY FACTORS
1. RAW-MATERIAL SUPPLY:
2. MARKETS:
3. POWER AND FUEL SUPPLY:
4. WATER SUPPLY:
5. CLIMATE:
SPECIFIC FACTORS
6. TRANSPORTATION:
A. AVAILABILITY OF VARIOUS SERVICES AND PROJECTED RATES
7. WASTE DISPOSAL:
8. LABOR:
9. REGULATORY LAWS:
10. TAXES:
11. SITE CHARACTERISTICS:
12. COMMUNITY FACTORS:
13. VULNERABILITY TO WARTIME ATTACK:
14. FLOOD AND FIRE CONTROL:
EXPLANATION OF TERMS USED IN THE PROJECT REPORT
1. DEPRECIATION:
2. FIXED ASSETS:
3. WORKING CAPITAL:
4. BREAK-EVEN POINT:
5. OTHER FIXED EXPENSES:
6. MARGIN MONEY:
7. TOTAL LOAD:
8. LAND AREA/MAN POWER RATIO:
MANUFACTURERS OF DISPOSABLE SYRINGE
COMPLETE PLANT SUPPLIERS FOR DISPOSABLE SYRINGES
SUPPLIERS OF RAW MATERIALS
POLYPROPYLENE GRANULES
SUPPLIERS OF THERMOPLASTIC ELASTOMER
SUPPLIERS OF ETHYLENE OXIDE
SUPPLIERS OF PRINTING INK
SUPPLIERS OF PACKING PAPER
SUPPLIERS OF PACKING BOXES
SUPPLIERS OF PACKING MATERIALS
DISPOSABLE NEEDLE
SUPPLIERS OF DISPOSABLE SYRINGE GASKET
SUPPLIERS OF PLANT AND EQUIPMENTS FOR DISPOSABLE SYRINGE/TURNKEY CONSULTANTS
INJECTION MOLDING MACHINE
SCREEN PRINTING MACHINE
STETRLIZING MACHINE
AUTOMATIC BLISTER PACKING MACHINE
SUPPLIERS OF EFFLUENT TREATMENT PLANT (ETP PLANT)
RAW MATERIAL PHOTOGRAPHS
POLYPROPYLENE
ETHYLENE OXIDE
PACKING PAPER
RUBBER GASKETS
NEEDLES
PRINTING INK
MACHINERY PHOTOGRAPHS
COMPLETE LINE
SYRINGE PRINTING MACHINE
AUTOMATIC SYRINGE ASSEMBLING MACHINE
PRODUCTION LINE DETAIL PHOTOS
BLISTER PACKING SYSTEM
MORE DETAILS
SYRINGE LOADING MACHINE
PRODUCT PHOTOGRAPHS
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)