DISPOSABLE PLASTIC SYRINGE

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Generally speaking, syringes are instruments used to either insert or draw solutions from a larger body. Typically operated via a piston-pump system, they are the primary method by which a doctor or nurse would administer medication to their patients. Historically, syringes would be cleaned and reused. However, within more modern times the disposable syringe has risen in popularity over the traditional reusable syringe. The primary difference being that a disposable syringe is intended for one-time use and is then disposed of, typically into a contamination unit.

A Disposable syringe is a basic responding siphon comprising of a plunger (however in present-day syringes, it is really a cylinder) that fits firmly inside a round and hollow cylinder called a barrel. For syringe manufacturing plunger can be directly pulled and pushed along within the cylinder, enabling the syringe to take in and oust fluid or gas through a release hole at the front (open) part of the bargain.

The open part of the bargain might be fitted with a hypodermic needle, a spout or tubing to coordinate the stream into and out of the barrel. Syringes are as often as possible utilized in clinical medication to control infusions, imbue intravenous treatment into the circulatory system, apply mixes, for example, paste or oil, and draw/measure fluids.

Disposable syringes are becoming ever more common within the medical industry. This is due in no short part to both the want to streamline the workload and to prevent the spread of blood-borne illnesses. They’re also relatively cheap and easy to mass-produce allowing for a higher level of accessibility.

Disposable Syringe is an instrument which is used for injecting any liquid into the body of human beings or of animals. It consists of a cylinder and an air tight piston. These syringes are used for injecting the medicine into the body or into the nerve of the body which are not possible to take in through mouth or takes much time in mixing with blood.

These syringes are available in sizes varying from 2 C.C. to 100 C.C. Most popular and commonly used sizes are 2 C.C., and 5 C.C. Other sizes are also frequently used but up to lesser extent.

In this project, we are manufacturing the disposable syringes with the sizes are 2 ml, 5 ml, 20 ml and 50 ml.

Previously glass was used for making these syringes; the most commonly used glass is Pyrex glass. This glass is shock-resistant, temperature-resistant and has low thermal co-efficient of expansion. But with the development of plastic technology, this glass has been substituted by high grade plastics. Plastic can be used in place of glass for making syringes without any problem.

Plastic syringes are becoming more popular in the medical world due to its lower cost and higher accuracy. To test the efficiency of a syringe, close the tip with a finger and attempt to withdraw the plunger or piston. If the plunger and barrel fit perfectly, the vacuum created in the cylinder will prevent withdrawal of the plunger. The plunger should not be pulled to return rapidly due to the vacuum created or the barrel may be cracked.

With the development of pharmaceutical industries the use of syringes has also developed. About 70% pharmaceutical industries are in small scale sector. The output of the small scale sector covers a wide spectrum of formulations, which includes antibiotics vitamins, anti T.B. drugs, ant dysentery drugs, anti-rheumatics, haematinies, hormonal preparations, tranquilizers, analgesics and anti-phyreties. Indeed this is a very wider range of product mix. About 50 percent of the above listed drugs are injectable and for that purpose syringes are required.

Disposable Syringes are being used by doctors to inject medicines through intravenous or intramuscular ways for the treatment of diseases & also by research & development personnel. Disposable syringes are made of plastic material and are used in the field of medical and veterinary science. Due to their availability in sterilized condition, ready to use, and cost effectiveness, disposable syringes are fast replacing the age-old glass syringes. Moreover, the horror of AIDS worldwide has almost dispensed with the reuse of syringes and the demand of disposable syringes has increased phenomenally. Disposable syringes are mostly injection molded from polypropylene. Syringes are available in sizes of 1 ml, 2 ml, 5 ml and 10 ml, 50ml in a variety of designs and consist of either two or three components construction. The number and size of injection moulding machines required depend upon syringe construction, number of mould cavities, annual production.

Disposable Syringes made of plastic Material have been successfully used in medical and pharmaceutical practice for many years. The constantly increasing use of this type Syringe indicates its importance. Which is based mainly on the advantages it offers regarding cost and hygienic applications.

The manufacture of plastic syringes has been developed to such a degree that the products now satisfy the requirements and standards set by Hospital and physicians. At the same time they offer the best possible technique of application to the physician and the highest possible degree of safety to the patient.

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Description

INTRODUCTION
PROJECT LOCATION KARNATAKA OR MAHARASTRA
MAHARASTRA
KARNATAKA
PARTS OF SYRINGES
SYRINGES AND NEEDLES
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
INJECTION MOULDING MACHINE CAP
STERILIZATION PLANT (ETHYLENE OXIDE)
BILSTER PACKING MACHINE
SCRAP GRINDING MACHINE
AIR COMPRESSOR
WATER PUMP
CHILLING PLANT
MOULDS OF 2 ML, 5 ML, 10 ML, & 50 ML INCLUDING BARREL & PLUNGER
VACUUM DUST CLEANER
RUBBER-TIP WASHING MACHINE
FOIL STAMPING OR SCREEN PRINTING EQUIPMENT
LAB EQUIPMENT
WEIGHING DEVICES
GRANULATOR
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:
STERILITY
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 SURVEY
TWO-STEP DISPOSABLE AUTOINJECTOR DEVICES TO DRIVE GLOBAL MARKET
GLOBAL DISPOSABLE SYRINGES MARKET SHARE (%) IN TERMS OF VALUE, BY REGION,
NEEDLE-FREE SYRINGES HELP REDUCE NEEDLE REUSE AND PREVENT
CROSS CONTAMINATION
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 GLOBAL DISPOSABLE SYRINGES MARKET
DOCUMENTS REQUIRED FOR NOTIFIED MEDICAL DEVICE REGISTRATION IN INDIA
DRUGS COSMETICS ACT, 1940
NOTIFIED MEDICAL DEVICE REGISTRATION IN INDIA
INDIA MEDICAL DEVICE REGISTRATION
GOVERNMENT AUTHORITY
MEDICAL DEVICE STATUS
PRODUCT CLASSIFICATION
NOVEL MEDICAL DEVICES
REGULATORY PATHWAY
DEVICE CONFORMITY ASSESSMENT
QUALITY SYSTEMS CONFORMITY ASSESSMENT
EXCEPTIONS TO HOME COUNTRY APPROVAL REQUIREMENT
REQUIREMENTS FOR GRANT OF LICENSE IN FORM-28 FOR MANUFACTURE OF MEDICAL DEVICES IN INDIA
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:
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. TERM LOANS:
8. TOTAL LOAD:
9. 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
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)

Additional information

Plant Capacity

1,05,600 Nos./Day

Land & Building

(600 sq.mt.)

Plant & Machinery

US$ 180000

Rate of Return

26%

Break Even Point

69%