Disposable Plastic Syringe (Capacity: 1,05,600 numbers per day)

DISPOSABLE PLASTIC SYRINGE

[CODE NO.4409] 

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                           1,05,600 Nos./Day

Land & Building (600 sq.mt.)  Rs. 68   Lac

Plant & Machinery                      Rs. 1.26 Cr

Working Capital for 1 Month    Rs. 60   Lac

Total Capital Investment           Rs. 2.73 Cr

Rate of Return                             26%

Break Even Point                        69%

INTRODUCTION

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, 2019

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)