Detailed Project Report on disposable plastic syringe (Production Capacity: 100000 Numbers Per Day)

DISPOSABLE PLASTIC SYRINGE 

[CODE NO.4281]  

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.

COST ESTIMATION

Plant Capacity                               1,00,000 Nos/Day

Land & Building (3000 sq.mt.)  Rs. 1.96 Cr

Plant & Machinery                              Rs. 4.64 Cr

Working Capital for 1 Month           Rs. 2.45 Cr

Total Capital Investment                  Rs. 9.64 Cr

Rate of Return                                    48%

Break Even Point                               21%

• 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)