Project 3 - Design and Development of Disposable Syringe (Medical Technology)

Disposable Syringes Market Recent Developments

• In 2022, Sharps Technology, Inc. patented, best-in-class, single-use smart safety syringe products, and is pleased to announce that the company completed its acquisition of Safeguard Medical’s syringe manufacturing facility in Hungary.
• In June 2021, Terumo Pharmaceutical Solutions client, ViiV Healthcare, recently announced the United States Food and Drug Administration (USFDA) approval of Cabenuva, Cabenuva is combined in a kit with Terumo's SurGuard 3 safety hypodermic needles and 5ml LL disposable syringes for convenience, reduced cross-contamination, and to reduce the probability of needlesticks.

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The global disposable syringes market was estimated at USD 6.73 billion in 2021 and is predicted to reach USD 11.02 billion by 2030, expanding growth at a CAGR of 5.6% over the forecast period 2022 to 2030.

Key market Insights:

As a substitute for the glass hypodermic needles, disposable plastic syringes have been launched. These are used in all the healthcare services across the globe to provide medicines to uncountable patients following this breakthrough. Syringes are accessible in bulks and are among other items, can be used to administer medications via intravenous, intramuscular or intradermal routes. Disposal of them can have impact on the environment which is a major concern. This is ill-suited to demand for supportable growth, but healthcare organization is growing worldwide in response to the growing demand for decent medical care and the rise in chronic diseases, drug administration is becoming increasingly prevalent. In any healthcare environment, it is a actual simple operation, and disposable syringes are an integral part. Dealings like the latest COVID-19 epidemic make investing in the future more profitable for the market for disposable syringes. The growth of the global demand for disposable syringes is motivated by an increase in the incidence of needle stick injuries, increased healthcare spending worldwide, supportive government policies, and a rise in chronic conditions and infectious diseases. However, costly disposable syringes for protection and access to various distribution modes inhibit the growth of the market. On the other hand, in developed countries, the rise in untapped capacity generates new prospects in the coming years.

Crucial factors accountable for market growth are:

• Increasing number of patients at risk of developing stroke
• Increasing patient awareness
• Increased health care expenditure
• Large pool of geriatric population

COVID-19 Impact on Global Disposable Syringes Market

The implications on the overall market, including both the demand side and supply side viewpoints, of the Covid-19 pandemic will be played out and analyzed. All nations around the globe have conducted life saving immunization programs for different diseases and viral infections, increasing the market for disposable syringes. In addition, the WHO has proposed the use of disposable and auto-disable syringes to obtain blood samples from 19 patients with Covid, which in turn helps prevent transmission through healthcare facilities.

Future of Global Disposable Syringes Market

Key companies like Baxter International and Fresenius Kabi AG are aiming towards profitable development by accepting strategies like mergers and acquisitions, weighty investments in the industrial facilities that is expected to fuel the worldwide market growth in near future. This tendency is likely to continue and will enhance growth of the aiming industry in forecast time frame. Also, stringent government regulations regarding usage of secure and engineered devices in medical sector will flourish target market growth over the forecast time frame.

Scope of the Disposable Syringes Market

Segment Analysis:

The Safety Syringe Segment Is Predictable To Lead the Product Segment of Disposable Syringes Market Revenue

On the basis of type safety syringe division was dominant with significant share in 2020. The growth of the safety syringe is owing to benefits that safety bulbs offer outruns their duration of existence even at low cost over disposables, which further shifts the preference toward safety syringes.

Therapeutics Segment Is Likely to Take over the Application Segment of Disposable Syringes Market Revenue

On the basis of application the global market is segregated into therapeutics and immunization applications. The therapeutics application segment is anticipated to hold share in the global market in the near future. Immunization application segment will grow at moderate CAGR in the next 10 years.

North America is Valued to be the Major Market for Disposable Syringes

The study report delivers prospects and trends of disposable syringes products across different geographical regions counting Europe, North America, Latin America, Asia-Pacific, Middle East, and Africa. However, regionally, the disposable syringes market is dominated by North America due to high incidence of diseases and growing preference for injectable drugs. Also, disposable syringe producers are also investing by launching new products in the countries U.S. and Canada. Availability of advanced healthcare infrastructure, presence of key market players, and government initiatives are among the major factors to fuel growth of the target industry in the North America. Europe constitute a share more than 20% of the global in 2020. Presence of key operating players in the countries of the region is expected to help the development of the Europe market in the coming years of the forecast period. Asia Pacific disposable syringes market is anticipated to grow at significant CAGR over the forecast period.

Top Players contending in the Market:

The key players are concentrating on research and development is anticipated to lead the disposable syringes market. Foremost players challenging in global disposable syringes market are:

• Fresenius Kabi AG
• Flextronics International Vita Needle Company
• Braun Medical, Inc.
• Baxter International, Inc.
• Terumo Corporation
• Novo Nordisk
• Henke-Sass, Wolf
• Retractable Technologies, Inc.
• UltiMed, Inc.
• Covidien
• Becton, Dickinson and Company.

For the superior understanding the current state of the disposable syringes market and for most policies of the country, Precedence Research predicts the upcoming development of the disposable syringes industry.

Key Market Developments:

• In 2015, B Braun a leading player has launched the Stimuplex Ultra 360, which is echogenic peripheral nerve block needle technology.

Major Market Segments Covered:

By Type

• Conventional Syringes
• Safety Syringes
• Retractable Safety Syringes
• Non-retractable Safety Syringes

By Application

• Immunization Injections
• Therapeutic Injections

By End User

• Hospitals
• Diagnostic Laboratories
• Blood Banks
• Pharmaceutical Industry (B2B) (Prefilled Syringes)

By Geography

• North America
  • • U.S.
    • Canada
• Europe
  • • Germany
    • France
    • United Kingdom
    • Rest of Europe
• Asia Pacific
  • • China
    • Japan
    • India
    • Southeast Asia
    • Rest of Asia Pacific
• Latin America
  • • Brazil
    • Rest of Latin America
• Middle East & Africa (MEA)
  • • GCC
    • North Africa
    • South Africa
    • Rest of Middle East & Africa

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The first plastic syringes were created in the 1950s. However, it was not until the 1960s that plastic syringes began to replace glass syringes. The main reason for this change was that plastic syringes were less likely to break than glass syringes. Additionally, plastic syringes were less likely to cause infection than glass syringes.

A syringe is a small pump with a plunger attached to a cylindrical tube. syrinx, which means tube, is the root of the word syringe. During the first century BC, the Roman Empire made the first use of syringes. In 1650, Blaise Pascal developed a syringe to apply fluid mechanics to objects. In the medical and health fields, the syringe is one of the most common tools. It’s difficult to imagine a medical device more commonplace and yet so useful than the plastic disposable syringe. Phil Brooks, an African American inventor, invented the disposable syringe in 1974.

Prior to plastic, an older generation of nurses delivered medication using only glass syringes from the late 40s to the early 50s, and were skilled at measuring and ensuring proper cleaning and sanitizing of their instruments.

When Chance Brothers glassworks of England first invented glass syringes with interchangeable parts, they were able to achieve sterility in large quantities. Disposable, single-use, pre-sterilized, syringes, and needles, which we use today, were not widely available until 1953.

Glass, plastic, and stainless steel are the most commonly used materials for syringes. Most commonly used glass syringes are microliters, which are ideal for oxygen sensitive samples and have low volume errors.

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Figure-7.

Latest added Global Disposable Syringe Market research study by HTF MI offers detailed product outlook and elaborates market review till 2026. The market Study is segmented by key regions that is accelerating the marketization. At present, the market is sharping its presence and some of the key players in the study are ADNIP, Abu Dhabi Medical Devices Company, IBN Sina Medical Factory, Dickinson & Company, Nipro Corporation, Becton, SAAPP (FZC) LLC., Baxter International Inc., Medtronic PLC., Terumo Corporation, Smiths Group Inc. & B. Braun etc. The study is a perfect mix of qualitative and quantitative Market data collected and validated majorly through primary data and secondary sources.

This report studies the Global Disposable Syringe market size, industry status and forecast, competition landscape and growth opportunity. This research report categorizes the Global Disposable Syringe market by companies, region, type and end-use industry.
Scroll down 100s of data Tables, charts and graphs spread through Pages and in-depth Table of Content on " Disposable Syringe Market by Type (, Conventional Syringes & Safety Syringes), by End-Users/Application (Hospital, Clinic, Pharmacy, Research Institute & Others) and Region - Forecast to 2026". Early buyers will get 10% customization on study.

to Avail deep insights of Global Disposable Syringe Market Size, competition landscape is provided i.e. Revenue Analysis (M $US) by Company (2018-2020), Segment Revenue Market Share (%) by Players (2018-2020) and further a qualitative analysis is made towards market concentration rate, product/service differences, new entrants and the technological trends in future.

Competitive Analysis:
The major players are focusing highly on innovation in technologies to improving efficiency level. The industry growth outlook is captured by ensuring ongoing process improvements of players and optimal strategies taken up by companies to fight COVID-19 Situation. Company profile section of players such as ADNIP, Abu Dhabi Medical Devices Company, IBN Sina Medical Factory, Dickinson & Company, Nipro Corporation, Becton, SAAPP (FZC) LLC., Baxter International Inc., Medtronic PLC., Terumo Corporation, Smiths Group Inc. & B. Braun includes its relevant information like name, subsidiaries, website, headquarters, market rank, gain/drop in market position, historical background or growth commentary and top 3 closest competitors by Market capitalization / revenue along with contact information. Each company's revenue figures, Y-o-Y growth rate and gross & operating margin is provided in easy to understand tabular format for past 5 years and a separate section on recent development like mergers & acquisition, patent approval and new launch etc.

Market Segments: The Global Disposable Syringe Market has been divided into type, application, and region.

On The Basis Of Type: Conventional Syringes & Safety Syringes.
On The Basis Of Application: Hospital, Clinic, Pharmacy, Research Institute & Others

On The basis of region, the Disposable Syringe is segmented into countries, with production, consumption, revenue (million USD), and market share and growth rate in these regions, from 2015 to 2026 (forecast), see highlights below

• North America (USA & Canada) {Market Revenue (USD Billion), Growth Analysis (%) and Opportunity Analysis}
• South Central & Latin America (Brazil, Argentina, Mexico & Rest of Latin America) {Market Revenue (USD Billion), Growth Share (%) and Opportunity Analysis}
• Europe (The United Kingdom., Germany, France, Italy, Spain, Poland, Sweden, Denmark & Rest of Europe) {Market Revenue (USD Billion), Growth Share (%) and Opportunity Analysis}
• Asia-Pacific (China, India, Japan, ASEAN Countries, South Korea, Australia, New Zealand, Rest of Asia) {Market Revenue (USD Billion), Growth Share (%) and Opportunity Analysis}
• Middle East & Africa (GCC, South Africa, Kenya, North Africa, RoMEA) {Market Revenue (USD Billion), Growth Share (%) and Opportunity Analysis}
• Rest of World

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A disposable plastic syringe is a medical device they are made of plastic and have a needle at one end. The needle is usually covered with a cap. They are made of a barrel and plunger. Disposable plastic syringes are used once and then thrown away. The needle is attached to a plunger that controls the flow of fluid. The needle that can be attached or detached.

Visit this Page for More Information: Start a Business in Medical Disposables Industry

As the population continues to increase, more and more disposal syringes are used on patients every day in hospitals, doctor’s offices, nursing homes and clinics. In recent years, health providers have become more conscious of the need to safely dispose of these used syringes and other medical waste after procedures are complete.

Uses and Application of Disposable Plastic Syringe

1. A disposable plastic syringe is a medical device used to inject liquids into the body.
2. They are also used to administer medications and vaccines, as well as to draw blood for testing purposes.
3. They should be disposed of after one-time use or after every patient respectively.

4.  Plastic syringes are sterile, easy to use, and easy to dispose of, making them a safe and convenient option for both medical professionals and patients.

   Related Business Plan: Disposable Plastic Syringes

   5. They are also frequently used in research laboratories.
   6. The use of these products helps to reduce the spread of disease, and they are also more convenient for patients.

   Types of Disposable Plastic Syringe

   There are many types of disposable plastic syringes available on the market, and each has its own advantages and disadvantages. Some are designed for single use, while others can be reused multiple times. The type of syringe you choose will depend on your needs and budget. Some are designed for specific purposes, such as insulin injections, while others are more general purpose. The most common type is the luer lock syringe, which has a Luer-Lok fitting that allows it to be attached to an IV catheter or other medical device. Other types of disposable plastic syringes include slip tip syringes, which have a smooth tip that can be inserted into a vein without piercing the skin, and safety syringes, which have a retractable needle that helps prevent accidental needle sticks.

   Read Similar Articles: MEDICAL DISPOSABLES

   Manufacturing Process of Disposable Plastic Syringe

   The manufacturing of disposable plastic syringes is a complex process. It begins with the raw materials being mixed together in large vats. Disposable plastic syringes are made through a process of injection molding. The first step in this process is to create a mold of the desired shape. Next, molten plastic is injected into the mold under high pressure.  The mixture is then placed into molds that are heated to high temperatures. Once the plastic has cooled and set, the mold is opened and the syringes are ejected. They are inspected for quality and then packaged for sale.

Benefits of Starting Disposable Plastic Syringe Business

If you're looking for a way to make some extra money, starting a disposable plastic syringe business could be the perfect solution. There are many benefits to this type of business. That is both eco-friendly and profitable.

This type of business is growing in popularity due to the many benefits it offers. For one, it's a great way to help the environment by disposing of harmful plastics.  First, it's a great way to help the environment by recycling disposable plastic syringes. Second, it's a great way to make money. Third, it's a great way to help people who are in need of medical supplies. Fourth, it's a great way to build relationships with other businesses. Fifth, it is a great way to reduce the spread of diseases.

Related Feasibility Study Reports: Disposable Plastic Syringes With Needles 

You’ll also be helping to keep your community safe by disposing of these potentially dangerous items properly. The demand for disposable plastic syringes is skyrocketing. Not only are they more sanitary than reusing syringes, but they're also much easier to come by. With a little bit of research and some start-up capital, you can be in this burgeoning industry in no time.

Global Market Outlook:

The global disposable syringes market size was USD 13.07 Billion in 2021 and is expected to register a revenue CAGR of 5.8% during the forecast period. Rapid technological advancements in auto injector syringes, increasing rate of immunization, rising demand for safety syringes, substantial improvement in syringe manufacturing processes, as well as growing consumer demand from the pharmaceutical industry are main factors driving market revenue growth. Plastic-based disposable syringes are utilized in the fields of medicine and veterinary research but disposable syringes are quickly taking place of traditional glass syringes, since they are readily available in sterilized conditions, ready to use, and are more affordable. In addition, easily disposable needles are quickly replacing well-established glass needles due to their availability in sterilized conditions, readiness for use, and economic competitiveness. Importance of this type of syringe is based primarily on benefits it provides in terms of cost and hygienic applications, as evidenced by the fact that its use is constantly expanding.

• Brands are constantly trying to survive the apparent competition in every sector. While it all comes down to the types of services and products that are offered, how they package themselves to consumers also comes into play. Most, however, often struggle with communicating their offerings to consumers. And this can be communicated via a value proposition and a mission statement. But what is the variance between the two? Let’s see below. 
  
  

• What is Value proposition?

  This is a declaration that communicates the value of a product to customers and why they should purchase the said item. Value propositions summarize how brands will deliver their promise and value that all the consumers will benefit from it. Value propositions show why a brand is unique and the best in the market. 

  Efficient value propositions are neither indirect, vague nor convey exaggerating promises. They are also keen on the level of competition in the sector and aim to stand out. 

  Here are 4 questions that value propositions aim to answer. 

  • WHAT- What problem can the product or service solve for the customer?
  • HOW- How does the brand aim to solve the problem?
  • WHO- Which group of customers have this problem?
  • WHY- Why should a customer get the problem solved by the brand?

  Value proposition also includes the consumers’ touchpoint with the brand, from the point of purchase, experience with the product and the price paid for the product. 

  What is Mission statement?

  A mission statement explains a brand’s purpose for being, in concise and simple terms. They should be clear and catchy. As such, they are generally short and are often a short paragraph or a single sentence. 

  Mission statements define a company’s value, culture, goals, ethics and agenda. It is significant to all players including employees, investors, suppliers, distributors, shareholders and the entire community. 

  The mission statement reveals 3 things:

  • What a company does- This could be a service or a product, and it is what makes the business run
  • How the company undertakes its work- This should be described in a non-technical way, such that any person can understand. 
  • Why a company engages in said work- This helps a brand stand out from others. It should be catchy and ethical. 

  Mission statements can sell or ruin a company. As such, some brands go all the way to pay handsomely for a mission statement to be developed. Contrary to what most people think, mission statements are for small & large corporations, professionals, individuals and investors. 

  imilarities between Value proposition and Mission statement

  • Both improve the marketability of a brand by making it more appealing to the consumers

  Differences between Value proposition and Mission statement

  Definition

  A value proposition is a declaration that communicates the value of a product to customers and why they should purchase the said item. On the other hand, a mission statement is a phrase that explains a brand’s purpose for being, in concise and simple terms.

  Importance

  Value propositions show why a brand is unique and the best among the competitors. On the other hand, mission statements define a company’s value, culture, goals, ethics and agenda. 

  Components

  Value proposition answers the who, what, how and why questions concerning products and consumers. On the other hand, mission statements answer what a company does, how the company undertakes its work and why a company engages in said work. 

  A recent report on Disposable Syringes Market provides a detailed analysis of the industry size, revenue forecasts and geographical landscape pertaining to this business space. Additionally, the report highlights primary obstacles and the latest growth trends accepted by key players that form a part of the competitive spectrum of this business.

  Disposable Syringes Market Size 2020

  Disposable Syringes Market is valued at USD 7.29 Billion in 2018 and expected to reach USD 11.08 Billion by 2025 with the CAGR of 6.19% over the forecast period.

  Disposable Syringes Market Scope

  In general, a syringe is an instrument used to insert or extract a solution from a larger body. It is usually operated by a piston pump system, which is the main method of medical treatment of patients by doctors or nurses. The main difference between a normal syringe and the disposable syringe is that disposable syringes are intended for single use and are then usually thrown away in contaminated devices. Disposable syringes allow doctors to use the item once and then discard it, so that it does not cause contamination and can speed up medical care. In addition, it is very safe and also avoids sterilization because sterilization of the syringe is no longer left to the doctor or to medical staff, but since the syringes are disposable they are discarded and are no longer needed. Disposable syringes are commonly used in modern medicine to inject drugs and vaccines or to draw blood. They are also used to inject insulin to diabetics because diabetes is one of the fastest growing diseases in the world and requires regular insulin injections to control blood sugar levels in the body.

   

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  Global disposable syringes market is segmented on the basis of product type, syringe tip, application and by region. Based on product type, the market is segmented into conventional disposable syringes and safety disposable syringes. Based on syringe tip, the market is segmented into luer-lock tip, slip-tip, eccentric tips and catheter syringe tips. Based on applications, the market is segmented into immunization injections and therapeutic injections.

  The regions covered in this disposable syringes market report are North America, Europe, Asia-Pacific and Rest of the World. Based on country level, market of disposable syringes market is sub divided into U.S., Mexico, Canada, UK, France, Germany, Italy, China, Japan, India, South East Asia, GCC, Africa, etc.

  Disposable Syringes Market Top Key Players

  • Baxter International Inc.
  • Becton
  • Dickinson and Company
  • Cardinal Health
  • Braun Imaxeon Pty
  • Becton
  • Feel Tech
  • Covidien
  • Henke-Sass Wolf
  • Nipro Medical Corporation
  • Novo Nordisk A/S
  • Retractable Technologies, Inc.
  • Terumo, and Vita Needle Company.

  Disposable Syringes Market Latest News:

  Becton Dickinson Launches a BD Intevia 1mL Disposable Auto injector

  On November 15th, 2019; Becton Dickinson launched the BD Intevia 1 ml disposable auto-injector in two stages, a platform that combines an auto-injector and a pre-fill syringe in an integrated system. The design and checkpoint function of the BD Intevia 1 ml disposable auto-injector enables skin activation in two stages, allowing patients to control the injection. This design allows the pharmaceutical industry to use it for multiple drugs without customizing system components. It is equipped with a feedback indicator which can visually display the correct dose to the patient and trigger a click. These two considerations are designed to ensure patient compliance. Nine BD Intevia 1 ml single-use auto-injectors were studied in a series of user interface / device user groups to identify and eliminate or reduce the risk of using errors.

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  Disposable Syringes Market Dynamics-

  Some of the important factors that are driving the growth of the global syringes market are increasing prevalence of chronic diseases, increase in healthcare expenditure, growing lifestyle related diseases, etc. As per National Health Council, chronic diseases affect around 133 million Americans, which represents more than 40% of the country’s total population. By 2020, this number should reach 157 million, including 81 million under several conditions. Additionally, the increasing geriatric population and improving healthcare infrastructure are also driving the growth in global syringe market. As per WHO statistics, from 2015 to 2050, the proportion of the world’s population over 60 will increase from 12% to 22%, almost double. However, the high cost of pre-filled syringes and the availability of alternative drug delivery methods are some of the factors limiting the growth of the global syringe market. Compared to existing disposable syringes, industry participants are investing more and more in the research and development of new, more powerful chemicals, which could increase market opportunities over the forecast period

  Asia pacific is expected to Witness a Fastest Growth in the Global Disposable Syringes Market

  North America has been the market leader so far and is expected to remain dominant in future in the global disposable syringes market majorly due to rise in occurrence of infections which needs to be treated with the help of a therapeutic injection, the growing prevalence of various chronic conditions, which requires immunization and rising cases of diabetes. According to American Diabetes Association (ADA), approximately 34.2 million American citizens, which is nearly 10.5% of the population, had diabetes in 2017 and is expected to increase by about 54% to more between 2015 and 2030. Major manufacturers of disposable syringes also contributed by introducing new products and technologies to improve patient comfort and safety. Asia-Pacific is expected to witness the fastest growth during the forecast period, owing to the increase in awareness regarding the use of disposable syringes in the region. Due to the high population density and increased health spending in China and India, it is expected that in the near future they will become two main profitable channels for manufacturers of disposable syringes. Much of the increase in demand for disposable syringes is due to the growing number of government and private programs conducting nationwide immunization campaigns.

  Key Benefits for Global Disposable Syringes Market Report–

  Global market report covers in depth historical and forecast analysis.

  Global market research report provides detail information about Market Introduction, Market Summary, Global market Revenue (Revenue USD), Market Drivers, Market Restraints, Market opportunities, Competitive Analysis, Regional and Country Level.

  Global market report helps to identify opportunities in market place.

  Global market report covers extensive analysis of emerging trends and competitive landscape.

  Complete Report Details @ https://industrystatsreport.com/Medical-Devices-and-Consumables/Disposable-Syringes-Market-Top-Manufactures/Summary

  Global Disposable Syringes Market Segmentation:–

  By product Type:
  Conventional Disposable Syringes
  Safety Disposable Syringes

  By syringe tip:
  Luer-Lock Tip
  Slip-Tip
  Eccentric Tips
  Catheter Syringe Tips

  By Application:
  Immunization Injections
  Therapeutic Injections

  By Regional & Country Analysis: (North America, U.S., Canada, Europe, U.K., France, Germany, Italy,Asia Pacific, China, Japan, India, Southeast Asia, Latin America, Brazil, Mexico, Middle East and Africa, GCC, Africa, Rest of Middle East and Africa)

  Table of Content

  1 Study Coverage
  1.1 Disposable Syringes Product
  1.2 Key Market Segments in This Study
  1.3 Key Manufacturers Covered
  1.4 Market by Type
  1.5 Market by Application
  1.6 Study Objectives
  1.7 Years Considered

  2 Executive Summary
  2.1 Global Disposable Syringes Market Size
  2.2 Disposable Syringes Growth Rate (CAGR) 2020-2025
  2.3 Analysis of Competitive Landscape
  2.4 Key Trends for Disposable Syringes Markets & Products

  3 Market Size by Manufacturers
  3.1 Disposable Syringes Production by Manufacturers
  3.2 Disposable Syringes Revenue by Manufacturers
  3.3 Disposable Syringes Price by Manufacturers
  3.4 Mergers & Acquisitions, Expansion Plans

  4 Disposable Syringes Production by Regions

  5 Disposable Syringes Consumption by Regions

  6 Market Size by Type

  7 Market Size by Application

  Figure-8 & figure-9 shows that the product roadmap.

  You need few different specification in plant layout in manufacturing of disposable syringe. Disposable syringe is manufactured with plastic material and has to make them sterilized, so you require machinery according to it. Disposable syringes are mostly injection molded from polypropylene. Syringes are available in different sizes like 1 ml, 2 ml, 5 ml and 10 ml, 50ml. To manufacture variety of designs, the number and size of injection moulding machine should be fixed as per need.

  Production of disposable syringe requires following steps:

  • Raw Material 
  • Moulding machine 
  • Automatic Sterilization Plant 

  Raw material used is polypropylene. This is fed into special moulding machine and special moulds. Then moulded it in chilled conditioned to get better clarity. When it has been converted into disposable syringe. It is sent into sterilization plant where it is being sterilized by using ethylene oxide. Disposable syringe is then assembled with sterilized needle. This process is totally sterilized to prevent any contamination because it is ready to use disposable syringe.

  Needles could be out sourced. Then complete syringe is packed in blister by using blister packing machine This is simple process to manufacture disposable syringes. But you have to get manufacturing license from drug control department. If you don’t have idea about syringe manufacturing, you should visit any existing plant that are manufacturing disposal syringe in India. That is very good to understand the process. Visiting local drug control office will also be beneficial for you to understand documentation and formalities. Adequate space is required for starting manufacturing.

  Land & Building Area

  An area of 30 square meters for moulding and 15 square metres for assembling are recommended for basic installation. The assembling area shall be air-conditioned provided with HEPA filters. The moulding section shall, if necessary, have proper exhaust system.

  Machinery & Equipment’s

  • 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

  Raw Material

  • Polypropylene 
  • Rubber Gaskets 
  • Needles
  • Packing Material
  • Printing ink 

  Disposable syringe manufacturing small plant estimated cost (Including Machinery & Equipment)

  Fixed Financial Aspects:

  Rates are in Indian Rupees (Approximate)

  • Rent: Approx. 20000/-
  • Injection Moulding Machine cap- Approximately 10-12 lakh
  • Sterilization Plant (Ethylene Oxide)-Approx. 4-6 lakh
  • Bilster Packing Machine-Approx. 4-6 Lakh
  • Air Compressor-Approx. 1-1.5 lakh
  • Water Pump -Approx. 20000/-
  • Chilling Plant-Approx. 1-1.5 lakh
  • Others -5-7 Lakh

  Disposable Syringe Manufacturing Process-

  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.

  Firstly all the disposable syringes & needle production line is manufactured with the use of Polypropylene. You have to make a decision about which type of sizes you want to make. The normal standard charges are 1ml, 2ml, 5ml and 10ml. because of health awareness and health consciousness, you can get a lot of profit from the needle and disposable syringe manufacturing business.

  Already most syringes & needle production line was made of glasses. Because of their accessibility in sanitized condition, prepared to utilize, and cost adequacy, expendable syringes are quick supplanting the glass syringes. The progression of AIDS and related lethal ailments worldwide has included of not utilizing reuse of syringes and the interest for dispensable syringe has expanded incredibly.

  Machinery Used for Needles and Disposable Syringe Manufacturing:

  • Sterilization Plant
  • Blister Packaging machinen
  • Automatic packaging machine
  • Scrap Guiding machine
  • Zigma injection molding machine
  • Weighing scale
  • Water Pump

  • Air Compressor
  • Chilling Plant
  • Testing Equipment
  • Electrical Fittings & Socket
  • Set of molds for barrels
  • Set of molds for syringes body 16 cavities for barrel & 16 cavity for plungers.

  Raw Materials Used for Needles and Disposable Syringe Manufacturing and Other Requirements

  There are generally two types of raw materials, required to manufacture syringes. The first thing is polypropylene and the other is the needle. Land requirement is generally decided according to your business size.

  Required Manpower:

  If you are planning to start an average size business of syringe manufacturing things you may need for your plant

  1. Skilled workers/Unskilled workers
  2. Supervisors
  3. Security
  4. Account assistant
  5. Marketing executive

  Raw materials which are used in this business

  1. Polypropylene
  2. Ethylene Oxide
  3.  Packing paper
  4.  Rubber gaskets
  5. Needles
  6.  Printing Ink

  Some Basic Information About What Type of Machinery you will Require for a Disposable Syringe Manufacturing Business

  • Injection Molding Machine

  Injection molding machine also known as an injection press is a kind of a machine used for manufacturing plastic products with the Injection molding production. Types of injection molding machines,

  Also, Read – Why follow safe injection syringes & standard?

  Mechanical

  This type of machine is used to toggle the system for building up the tonnage on the side of the machine, that does not open due to injection pressure.

  Hydraulic

  This machines despite are not that nearly precise, and are the predominant type in most of the world.

  Electric

  The electric press also known as electric machine technology, reduces the cost by cutting the consumption of energy. Electric press is said to be quieter, faster, and have the highest accuracy.

  • Screen printing machine

  After the completion of the first step, the next thing is to print the injections appropriate to their standard level marking. You have to make sure about the alternative machine for manufacturing companies for price variation.

  • Sterilization plant

  For the sterilization process here they have to use the ethylene oxide. Ethylene oxide (ETO) known as the gas used for low-temperature sterilization. It is generally used to sterilize the instruments or devices and all those products that have to be sterilized but cannot stand high temperature.

  • Syringe packing machine

  The syringe packing machine is used for the automatic syringes mass packing. For this, you have to check all types of machines sizes and prices at every different industrial machine store.

  • Syringe assembly machine

  For the syringe Assembly machine, a hopper and a bowl feed the syringe plungers with the help of an inline track to a dead track where they are picked and placed 2 up into a double nest onto a 24 position on an indexed dial plate. In Disposable Syringe assembly machine hopper and bowl feed needle-in-hubs and 2 up places needles on barrels.

  • Injection Molding Machine

  Injection molding machine also known as an injection press is a kind of a machine used for manufacturing plastic products with the Injection molding production. Types of injection molding machines,

  Also, Read – Why follow safe injection syringes & standard?

  Mechanical

  This type of machine is used to toggle the system for building up the tonnage on the side of the machine, that does not open due to injection pressure.

  Hydraulic

  This machines despite are not that nearly precise, and are the predominant type in most of the world.

  Electric

  The electric press also known as electric machine technology, reduces the cost by cutting the consumption of energy. Electric press is said to be quieter, faster, and have the highest accuracy.

  • Screen printing machine

  After the completion of the first step, the next thing is to print the injections appropriate to their standard level marking. You have to make sure about the alternative machine for manufacturing companies for price variation.

  • Sterilization plant

  For the sterilization process here they have to use the ethylene oxide. Ethylene oxide (ETO) known as the gas used for low-temperature sterilization. It is generally used to sterilize the instruments or devices and all those products that have to be sterilized but cannot stand high temperature.

  • Syringe packing machine

  The syringe packing machine is used for the automatic syringes mass packing. For this, you have to check all types of machines sizes and prices at every different industrial machine store.

  • Syringe assembly machine

  For the syringe Assembly machine, a hopper and a bowl feed the syringe plungers with the help of an inline track to a dead track where they are picked and placed 2 up into a double nest onto a 24 position on an indexed dial plate. In Disposable Syringe assembly machine hopper and bowl feed needle-in-hubs and 2 up places needles on barrels.

  The syringe assembly process is done by the Hypodermic syringe also known as the hypodermic needle is a type of device used by medical experts to transfer liquids into or out of our bodies. It is made from a hollow needle that is attached to a tube and a plunger. When the handle of the plunger is pulled back the fluid is then drawn into the tube. The fluids are then forced through the needle when the handle is pushed down.  There is various syringe assembly machine supplier who assists in procuring the machines and provide a demonstration of the running machines in various facilities.

  Already most of the syringes were made of glasses. Because of their accessibility in disinfected or as we call in a sterilized condition, prepared to utilize, and cost viability, expendable syringes is quick replacing the glass syringes. The progression of AIDS and related lethal illnesses worldwide has included not utilizing reused syringes and the demand for disposable syringe has expanded phenomenally. Most importantly disposable syringes have huge market potential. Beyond the growing market for the products, there’s also a great scope for this to the nearby countries.

  Task-3>

  1>

  Disposable syringe manufacturing is perfect for people who have years of experience in the medical product market. Disposable Syringes are primarily made of plastic material. They are used in the field of medical and veterinary science. They are used for intramuscular and intravenous injections and are disposed of immediately after usage.

Previously most syringes were made of glasses. Due to their availability in sterilized condition, ready-to-use, and cost-effectiveness, disposable syringes are fast replacing the glass syringes. The advancement of AIDS and related fatal diseases worldwide has added of not using reuse of syringes and the demand for disposable syringes has increased phenomenally. Disposable syringes are mainly injection molded from polypropylene.

Syringes are available in sizes of 1 ml, 2ml, 5 ml, and 10 ml, in a variety of designs and consist of either two or three components construction. The number and size of injection molding machines required to depend upon syringe construction, number of mold cavities, annual production. The major advantages of using disposable plastic syringes are that no infection is transmitted since the injection is disposed of immediately after use

Market Potential of Disposable Syringe

Firstly, the disposable plastic syringe has big market potential. Besides the growing domestic market for the product, there is also great potential for export to nearby countries. For sustained exports on a durable basis, accreditation under ISO:14000 or ISP 9000 is mandatory.

The glass syringes are very fast becoming redundant. There are many manufacturers of disposable plastic syringes in the country. Out of which about 5-6 units are under the small-scale sector. The total installed capacity is to be about 400 million and the actual production is about 350 million.

Read: Naphthalene Ball Manufacturing Business

Only one unit in Haryana with a capacity of 50 million disposable plastic syringes. Production in the small-scale industry has not been considered because it is quite insignificant as compared to organized units and may eventually of cheaper and quality products from the organized sector.  Some of these units are 100% export-oriented units. At present, there is no manufacturing unit in Eastern India.

Equipment Required to Manufacture Disposable Syringes

Some of the basic machines and equipment needed to make disposable syringes are the following:

• Injection Moulding Machine
• Sterilization Plant
• Scrap Grinding Machine
• Air Compressor
• Bilster Packing Machine
• Water Pump
• Chilling Plant
• Different types of Moulds
• Vacuum Dust Cleaner
• Rubber-tip Washing Machine.
• Foil stamping or screen printing equipment.
• Lab Equipment
• Weighing Devices
• Granulator
• Packing Materials

Manufacturing Process and Source of Technology of Disposable Syringe

Step 1.

The cylinder and pistons are produced by injection molding machines. They are fed by individual granule feeding systems in different parts to be molded. This determines the relevant types and Quantities of raw material to be supplied by the feeding lines. Clamping force, Temperature, Dosing and injection pressure of raw material, and clamping time of the machine are automatically controlled so that disturbance or faults in production should occur very rarely and wastes are kept at the lowest possible rate.

Step 2.

The Scrapes are then separated from the molded parts, which are then transported, to a control channel. A conveyor belt situated below the machine removes the scrapes. For shrinking to their required dimensions. The molded parts are packed into plastic containers or bags and are deposited in an air-conditioned interim storage room for at least one or two days.

Step 3.

After the shrinking is completed, the scales and the product logo are printed on the syringe cylinders by a semi-automatic embossing machine. The feeding is performed manually while printing and discharging are done automatically. The cylinders and the pistons are conveyed to the assembling by means of vibrating feeders. The piston is automatically fitted into the cylinder and is immediately tested for tightness.

Step 4.

The complete syringe is placed by hand into the deep drawing cavities of the blister packing machine for sealing up the single units automatically with the plastic foil. Between 50-250 sealed units (according to delivery demands) are packed into a cardboard box by hand. The boxes are closed, labeled, and subsequently pelletized. After in-process storage over a few days, sterilization is carried out. The autoclave sterilization with ethylene oxide allows the previous packing of the final products ready to be delivered ex-works.

Step 5.

Therefore the cardboard boxes can be placed into the autoclave on pallets but only after being stored under normal conditions for two to three days in order to insured the sterilization effect. This minimum period is a presupposition for the bacteria to reach with the blister foil a certain to reach within the blister foil a certain degree of growth necessary for rendering them innocuous. It is recommended to design the autoclave chamber for one daily production in order to minimize quality controls because bacteriological tests are done batch-wise.

Step 6.

Due to the fact that ethylene oxide is inflammable, the sterilization equipment must be explosion-proof and installed in a separate room. Sterilization of one batch takes about 8 hours. Syringe shall be manufactured in accordance with recognized codes of good manufacturing practice for medical devices and shall be substantially free from defects affecting appearance, safety, and serviceability for the intended use.

2>

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 upto lesser extent. In this project, we are manufacturing the disposable syringes with the sizes are 3 ml, 5 ml, 10 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, antidysentery 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 moulded 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 (15000 sq.ft)     Rs. 5.28 Cr
Plant & Machinery                    Rs. 2.85 Cr
Working Capital for 1 Month    Rs. 47 Lac
Total Capital Investment          Rs. 8.75 Cr
Rate of Return                         12%
Break Even Point                     68%



INTRODUCTION                                            
CHARACTERISTICS OF SYRINGES                                
TYPES OF SYRINGE TIPS                                    
TYPES OF SYRINGES                                        
TYPES OF HYPODERMIC NEEDLES                                
USES AND APPLICATION                                    
B.I.S. SPECIFICATION                                        
PROCESS FLOW CHART FOR DISPOSABLE SYRINGE                    
MANUFACTURING PROCESS OF DISPOSABLE SYRINGE                
LIST OF RAW MATERIAL                                    
INSPECTION AND TESTING                                    
LIMIT FOR EXTRACTABLE MATTER                                
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 TESTING                                        
MARKING OF UNIT CONTAINER                                
OUTER CONTAINER                                        
OVERVIEW OF DISPOSABLE PLASTIC SYRINGE IN NEPAL                
HEALTH CARE SERVICE IN NEPAL IS MOVING IN THE RIGHT DIRECTION    
ARRIERS TO EQUITABLE HEALTHCARE                            
DETAILED EXPORT DATA OF DISPOSABLE SYRINGE 5ML NEEDLE        
MARKET POSITION                                        
EXPORT DATA OF DISPOSABLE SYRINGE                            
EXPORT DATA OF DISPOSABLE SYRINGE 5ML NEEDLE                
IMPORT DATA OF DISPOSABLE SYRINGE                            
IMPORT DATA OF DISPOSABLE SYRINGE 5ML NEEDLE                
GCC SYRINGES AND NEEDLES MARKET                            
PLANT LAYOUT                                            
MANUFACTURERS/SUPPLIERS 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                                
EOT CRANE                                                          
SUPPLIERS OF POWER TRANSFORMER                                           
SUPPLIERS OF ELECTRICAL PANEL                                               
SUPPLIERS OF COOLING TOWER                                                                   
SUPPLIERS OF EFFLUENT TREATMENT PLANT (ETP PLANT)                   
AIR POLLUTION CONTROL EQUIPMENTS                                                          
AIR CONDITIONING EQUIPMENTS                                                                   
AIR COMPRESSORS                                                                                     
PLATFORM WEIGHING MACHINE                                                                   
MATERIAL HANDLING EQUIPMENTS                                                         
FIRE FIGHTING EQUIPMENTS                                                                  
SUPPLIERS OF SUBMERSIBLE WATER PUMP                                                


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) 

3>

Disposable Plastic 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 moulded from polypropylene. Syringes are available in sizes of 1 ml, 2 ml, 5ml and 10ml, 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. These are made of plastic material have been successfully used in the 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 the hospitals and physicians. At the same time they offer the best possible technique of applications to the physician and highest possible degree of safety to the patient. Disposable needle is widely used by doctors for injection purpose with the help of syringes. With the increase in population in our country, requirement of medicine and injections has increased. For more strength of people more number of needles are required with syringes. Tablets or capsules also pay a great role in the life of human beings but injections are also a must to some extent. For quick relief, needles are used by surgeons, dental surgeons, Veterinary Surgeons and by the breeders in the poultry farm, where the farm birds are periodically injected against epidemics. During epidemics for better control, disposable needles are of much use. Veterinary Surgeons and doctors find it more useful to use needles as tablets or syrup shall not be helpful. To avoid wastage and to reduce cost by quantity of syrup, needles find a wide scope with the veterinary surgeons/doctors. With the development of pharmaceutical industries the use of syringes and disposable needles will also develop. About 70% pharmaceutical industries are in small scale sector. The output of small scale sector covers a wide spectrum, anti T.B. Drugs, ant dysentery drugs, unit rhenemsties, haematirines, hormonal preparations, tranquilizers, analagesties and anti-Ryrities. Disposable needles are becoming more popular in the medical world due to its lower cost and higher accuracy. Plastic can be used in place of metal without any problem. The procedure is also relatively easy and cheaper. Only one disadvantage is that there is not so much heat resistance as compared to hypodermic needle. Even then the disposable needle has widely replaced hypodermic needle because of lower cost, easy compatibility and higher sterilizations. Whenever a suture is required to close a wound. needles to arm the suture material are necessary. The number of sizes and the variety of different shapes of needles run into many thousands. The range supplied by manufacturers is usually classified into types for specific surgery, as for example. arterial. general purpose. intestinal. obstetric ophthalmic. plastic. retention. Shapes are designated as straight, curved, 1/2 circle, 5/8 circle etc. and the sections as round bodied, triangular cutting edge, triangular reverse cutting point, tracer point. In addition the length of the needle from point to hilt is specified in millimeters and the hilts are designed to take the various diameters of suture material employed. Needles are chosen by the surgeon to suit his operating technique and it is largely because of the surgeons interest in improving suture efficiency that the development of surgical needles has taken place. In very many cases the surgeon himself has caused needles to be made to his own design and a large number of commonly used needles are referred to by the name of the inventing surgeon. Surgical needles are of two types : those which have an eye through which the suture is threaded and eyeless needles where the suture is inserted into the hollow hilt and held in position by swaging the metal around it. The first patent on an eyeless needle was obtained by the late Sir Henry Souttar in 1921. but in the U.K. their use has only increased appreciably in the past few years. In the U.S.A. 70 percent of the suture needles are of the cycle’s type. The needles themselves are made either of stainless steel or of carbon steel, the latter usually being plated to resist corrosion. At one time the carbon steel needle had a better resistance to bending than its counterpart in stainless steel but recent technological advance hare is proved stainless steel needles and they now compete in strength with carbon steel and have added advantage that they will not corrode and do not present the surgeon with the dreaded emergency of having to locate and extract the broken point of a needle embedded somewhere in the tissues of an unfortunate patient.

Task-4>

 Disposable syringe model.

Task-5>

 1>

FMEA TABLE.

2>

FTA

Task-6>

1>

Safety syringe is a syringe which has safety features. It is designed to overcome two main problems of using a normal syringe. First is to reduce the use of syringe which may lead to cross-infection of disease and the second is to avoid needle stick and sharp injuries. The need of single-use safety syringe arise due to these concerns. There are a lot of patents found in modern application today. Although many single-use safety syringes have achieved public acceptance and commercial success in the marketplace, many single-use syringes present a variety of problems. To begin with, it is found that some syringes which claim to be "single-use" in actuality can be reused with user intervention. Some syringes are designated as "single-use" solely because they are supposed to be discarded after use by following their instruction; however, nothing prevents their reuse. Some syringe designs expose the drug or bodily fluid contained therein to reactive components of the syringe, e.g. a spring used to retract the plunger. Moreover, some syringes, although cannot be reused, present health risks to the medical personnel handling them. In addition, there are some factors which may need to be considered such as their complex design, and high cost of contemporary components. According to a market survey in Malaysia, safety syringe has to maintain the same procedure to operate as the normal syringe. Eventhough there are a variety of safety syringes available in the market, they do not fulfill the basic requirements of the medical practices. Due to this concern, a new design improvement of safety syringe is proposed to enhance the design of an existing safety syringe. The objectives of this research are to develop the design of safety syringe, to fabricate the prototype of safety syringe and to test the functionality of the prototype safety syringe. The research starts by identifying the needs and goals. This includes recognizing the client needs, modifying existing product, defining the method to achieve the goals, and clarifying the objectives. Then it proceeds to the next processes which are concept generation, synthesis, and analysis. For these processes, the focus includes the morphological chart, product component decomposition diagram, and combining idea concept. Next stage is the preliminary design which includes the product geometry design, configuration design, and parametric design. And after that comes the detail design which consists of drawing development and modelling. The product can only proceed to this stage if the preliminary design satisfies all of the objectives, otherwise the design process will go back to the original concept which are the generation stage, synthesis, and analysis until the design meets the requirements. Then the design can move to the next stage, which is prototype development. The design product is also analysed by using engineering software such as SOLIDWORKS before fabricating a new prototype. The experimental test is carried out in order to validate the prototype. The result of this study is a new design of safety syringe which meets the main characteristics as stated before. The newly designed system will allow the user to use it single-handedly and easy to be disabled after use.

2>

Implementation Schedule

Project implementation will take a period of 8 months from the date of approval of the scheme. Break-up of activities will relative time for each activity is shown below:

Task-7>

1>

Re-use of injection equipment to administer injections to more than one patient, including reintroduction of injection equipment into multi-dose vials, re-use of syringe barrels or of the whole syringe, informal cleaning with re-use and other practices. These practices are often ingrained and believed to be safe, but in reality they lead to the transmission of bloodborne viruses such as HIV, HBV, and HCV, as well as bacterial infections and abscesses at the injection site. In 2000, at the start of the WHO Injection Safety Programme and of the Safe Injection Global Network (SIGN), WHO estimated that 40% of the 16 billion injections were given with re-used injection equipment, leading to 21 million new HBV cases (32% of all new cases), 2 million new HCV cases (40% of all new cases) and around 260 000 HIV cases (5% of all new HIV cases)(2). Other diseases can also be transmitted through the re-use of injection equipment e.g. viral haemorrhagic fevers, such as Ebola and Marburg. 2. Accidental needle-stick injuries (NSIs) in health care workers (HCWs) which occur while giving an injection or after the injection, including handling infected sharps before and after disposal. Certain practices considered high risk for HCWs, such as recapping contaminated needles, are associated with NSIs and have frequently been observed during surveys on injection practices using WHO’s Injection Safety Assessment Tool C (http://www.who.int/injection_safety/ toolbox/techtools/en/). In 2003, WHO published the burden of diseases from NSIs in HCWs which showed that there were 3 million accidental needle-stick injuries leading to 37% of all new HBV cases in HCWs, 39% of new HCV cases and around 5.5% of new HIV cases (3). 3. Over-use of injections for health conditions where oral formulations are available and recommended as the first line treatment. Demand for and prescriptions of injectable medicines that are inappropriate include overuse of antibiotics, use of unnecessary injectable products such as certain vitamins, moving directly to second-line injectable treatments and others. Some of these issues are addressed through other WHO interventions to promote a rational and responsible use of medicines, and specific initiatives to combat overuse of antibiotics. Such initiatives use information and communication campaigns to target both HCWs and communities to decrease inappropriate demands for medicines, including injectable medicines. Similarly and in support of the guidance in this document, WHO will embark on an injection safety global campaign targeting both HCWs and communities as a means of decreasing demand for and over-prescription of injections. WHO guideline on the use of safety-engineered syringes in health care settings 8 Executive summary 4. Unsafe sharps waste management putting HCWs, waste management workers and the community at large at risk of needle-stick injuries and subsequent bloodborne infections. Unsafe management of sharps waste includes incomplete incineration, disposal in open pits or dumping sites, leaving used injection equipment in hospital laundry and other practices that fail to secure infected sharps waste. In some cases, used injection equipment is removed from open waste pits by people who scavenge through waste and then wash, repackage and resell the equipment as new. These issues will be covered by the recommendations made in this document to procure sufficient safety boxes for the containment of all safety-engineered devices, as well as through the global injection safety campaign to implement and adapt the recommendations to each country context. RUP and SIP syringes, especially in curative services, are the focus of the recommendations contained in this document, along with the provision of sharps waste management equipment. As above, reducing inappropriate demand will be addressed separately through other WHO initiatives. As part of a comprehensive package of interventions to ensure safe and rational use of injections – including communication and behaviour change strategies, supportive policies and provision of sufficient quantities of the appropriate injection equipment – WHO has analysed the potential contribution of safety-engineered syringes in reducing the problem of re-use and preventing needle-stick injuries. Safety syringes are well established and available in global markets. Official performance requirements and definitions have been added and developed over time, beginning with AD syringes for immunization in 1990 and progressing to models with re-use prevention in 2006 and sharps injury protection features in 2012. The International Organization for Standardization (ISO) has well defined requirements for producers of these products related to performance and fitness for purpose of safety syringes. This document references safety syringes according to their ISO definition to provide an exact definition of the safety mechanism of each type of syringe and allow a common understanding between all guideline readers. The ISO definitions also provide guidance for procurers in determining the specifications and minimum standards for performance of safety-engineered devices for the selection of appropriate devices. The three main ISO definitions are below, along with additional clarifying descriptions. • ISO 7886 – Part 3: “sterile hypodermic syringes for single use – Part 3: autodisable syringes for fixed-dose immunization (AD).” This definition includes syringes that deliver fixed doses, most have non-removable needles and all have a feature that blocks the syringe from being used a second time. This definition is limited to equipment for immunization services, and are typically 0.1 – 0.5 and 1.0 ml in size. WHO guideline on the use of safety-engineered syringes in health care settings 9 Executive summary • ISO 7886 – Part 4: “sterile hypodermic syringes for single use with a re-use prevention feature (RUP).” This definition includes syringes that can measure flexible dosing amounts, have removable needles and a feature that blocks the syringe from being used a second time. The RUP feature is activated following a single aspiration and injection in RUP syringes Type A while in syringes Type B the mechanism allows multiple plunger aspirations if reconstitution of the medication or the vaccine is required, or if multiple drugs need to be mixed in the same syringe before being administered to the patient. This definition is provided for syringes used in curative services where a broad range of injection procedures are performed and are typically 2.0 – 10.0 ml in size. • ISO 23908: “sterile hypodermic syringes with a sharps injury protection feature (SIP)”. Some SIPs also have a built-in RUP feature. SIPs cover AD and RUP syringes that have an additional feature to prevent sharps injury, such as a means to contain the infected sharp after use. The evidence-based policy guidance contained in this document will be the first WHO policy document that specifically addresses the use of safety-engineered injection devices for therapeutic injections. It complements and expands previously issued WHO guidance, including the following: • WHO-UNICEF-UNFPA Joint Policy Statement issued in 1999 (http://www.who. int/injection_safety/toolbox/resources/en/). The 1999 policy recommends the exclusive use of AD syringes for all immunization injections; • “Guiding principles to ensure injection device security” (4) issued by SIGN in 2003, which states: “syringes with a RUP feature offer the highest level of safety for injection recipients. They should be considered for use for therapeutic injections where local data indicate that unsafe practices are particularly common.”; • WHO best practices for injections and related procedures toolkit, published by WHO in 2010 (5), which notes the importance of sufficient supply of qualityassured syringes and matching quantities of safety boxes. It is expected that the evidence-based policy guidance in this document will additionally contribute to preventing the re-use of syringes on patients and to a decrease in the rate of needle-stick injuries in HCWs related to injection procedures, thus contributing to the prevention of injection-transmitted infections. Based on the findings of the systematic review, out of every 1000 HCWs in settings where SIP devices are introduced, nine fewer (from six fewer to 11 fewer) are likely to suffer a needle-stick injury in a one year period. There are no expected harms. Greater benefits can be expected in settings with higher HIV, HBV and HCV disease prevalence, higher sharps injury frequency and higher rate of re-use of injection equipment. WHO has developed the policy recommendations in this document using the procedures from the WHO handbook for guideline development. The steps in this process include: (i) identification of priority questions and outcomes; (ii) retrieval of the evidence; (iii) assessment and synthesis of the evidence; (iv) formulation of WHO guideline on the use of safety-engineered syringes in health care settings 10 Executive summary recommendations, including research priorities; and (v) planning for dissemination, implementation, impact evaluation and updating of the guideline when new evidence is available. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was followed to prepare evidence profiles related to preselected topics, based on up-to-date systematic reviews. The Guideline Development Group (GDG) and the Guideline External Expert Group comprised content experts, methodologists, representatives of professional associations, key NGOs and organizations working on injection safety and representatives of patients’ associations. The GDG met at a WHO technical consultation held in Geneva in March 2014. Members of the External Experts Group were identified through previous collaborative work in injection safety, from the Safe Injection Global Network (SIGN) members and through a public call for comment published in SIGN Post, an electronic weekly newsletter which has 1500 subscribers interested in injection safety. The SIGN Post members were involved in an external peer review once the recommendations had been developed by the GDG. The GDG agreed, by consensus among its members, on the strength of recommendations, taking into consideration: (i) the benefits and possible harms of this intervention; (ii) the quality of the available evidence; (iii) the values and preferences related to the intervention in different settings; and (iv) the cost of different devices available in the international market. To ensure there were no conflicts of interest, all members of the GDG completed a Declaration of Interests form prior to the meeting and the development of the policy recommendations. The GDG made the following recommendations: 1. “We recommend the use of injection devices with a sharps injury protection feature (SIP), as opposed to devices without a sharps injury protection feature, by HCWs delivering intramuscular, subcutaneous or intradermal injectable medications to patients (conditional recommendation, moderate quality evidence)”. 2. “We recommend the use of injection devices with a re-use prevention feature (RUP), as opposed to devices without re-use prevention features, by HCWs delivering intramuscular, subcutaneous or intradermal injectable medications to patients (conditional recommendation, very low quality evidence)”. The conditional nature of the recommendations is consistent with the quality of the level of evidence on the impact of introducing safety-engineered devices. The current prevalence of the problem, however, suggests that doing nothing is not an acceptable course of action (13).

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PERT Chart.

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1. Accelerate early. You know you are going to face delays at some time on your project. Therefore, if at all possible, try to get ahead of schedule early. This might be done by starting the project earlier than planned, or adding resources earlier than planned. You need to have a mindset that you are not going to start out late, and you are not even happy to be on-schedule. You want to get ahead of schedule to build an early buffer to protect against future delays.

2. Fast-track dependent activities. Most of the activities in your schedule are linked to others with a finish-to-start relationship. Think about whether you really need to wait until the first task finishes, or if there is an opportunity to move forward with the second task early. For example, you may have two activities called "write requirements" and "design solution" that are linked in your schedule. You might ask whether you really have to wait until 100% of the requirements are written before you can begin designing the solution? Maybe you can start the overall design when the requirements are 80% finished. If that's the case then the overall elapsed time for the project will be shorter. There is some risk with this approach, but it may be worthwhile to you.

3. Remove activities that are no longer needed

When you first write your schedule, you are assuming all of the activities are necessary and achievable. However as the project progresses, things change.  You need to review the remaining activities and remove anything that isn't absolutely necessary. Some activities may no longer be needed. Perhaps some can be pushed to post implementation.

4. Add resources to the critical path

Check if you have flexibility to add resources. These may be specialists, or perhaps there are some general activities that anyone can do. This technique is also called "crashing"

5. Optimize your processes

Look for process improvement opportunities that will save time. For example, an approval process might normally take two weeks. Is there a way it can be done in one week, or one day? Or perhaps you realize a process that takes four activities can actually be done with three activities.

Task-8>

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If you wish to protect an idea, there are certain important things that you must know before filing a patent. How can your idea qualify as an invention? First, you cannot patent a mere idea as an idea is usually theoretical in nature. Many people have great ideas, but cannot obtain patents for them as they are not inventions.

An invention must fulfil certain patentability criteria, which can vary across jurisdictions. In general, the term 'invention' means a unique product or process. The invention must:

• be novel – it must have at least one feature which is not present in single prior art;
• be non-obvious – it must have at least one feature which is novel and should not be obvious to a person skilled in the field of the invention in view of a combination of multiple prior arts or a single prior art and common general knowledge; and
• have industrial application – most jurisdictions proscribe patenting in certain areas (eg, scientific theory, new animal or plant varieties, methods of treatment, algorithms, mathematical formulas, business methods and software).

The process of obtaining a patent can be expensive as a number of fees must be paid (eg, a filing fee, an examination fee and attorney fees). While discounted official fees apply to individual inventors and small enterprises in most jurisdictions, the overall cost of protecting the invention can be high, particularly if the inventor wishes to protect his or her invention in multiple jurisdictions.

It is generally advisable to carry out a prior art search yourself or engage a professional to do so before beginning the patenting process. Based on the findings of the prior art search, the novel and inventive features of the invention can be identified clearly, and a decision can be made regarding in which jurisdictions to file. There are multiple advantages of conducting a prior art search:

• It can avoid wasting money and resources in patent filings and prosecution proceedings if the invention is not unique, allowing R&D centres to use their IP budgets wisely.
• The prior art search helps to identify the closest prior arts and thus can define the scope of protection in patent claims. This can even lead to a reduction in the prosecution time due to the need for fewer office actions and claim amendments. The prior art search is like a due diligence exercise that can reduce the risk of rejection of the patent application.

In order to conduct a prior art search, it must first be understood what can act as prior art against the patent application. Prior art is any publicly available evidence that proves that an invention is already known or obvious. Any granted patent, published patent application, article, research paper, web page, book or video can be potential prior art for the patent application. The prior art search is simple and can be carried out by anyone. Sometimes an inventor may not be as familiar with the prior art search process as a professional searcher; however, there are many patent databases and search engines for novice users.

A typical prior art search process requires a search strategy to be formulated at the beginning using a keyword search, name search, classification search or a citation search, or a combination thereof. In the keyword search, all of the key features of the invention are identified and then keywords and their contextual synonyms are ascertained from the key features of the invention to formulate search strings to be run on patent and non-patent databases. In addition, patent classes, applicants and inventors relevant to the field of invention may be identified and used in the search strings to refine the search strategy. All of the search results must be manually analysed to shortlist the most relevant prior arts. For this purpose, only the title and abstract of the search results can be read for the first level of screening, and then other sections of the search results can be seen at the second level of screening, if required. Once most of the relevant prior arts have been shortlisted, their citations can be checked to discover more results around the shortlisted ones.

It is always better to try several search strings to ensure that all permutations and combinations are covered. However, a prior art search can never be complete. It can never be said with certainty that no prior art exists as the search requires skills, training and practice. Nevertheless, an inventor should attempt to carry out a comprehensive prior art search in order to minimise the risk of rejection of the patent application or invalidation of the granted patent at a later stage.

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Patentable subject matter in India

Invention must

• relates to a process or a product or both
• be new (Novel)
• involves an inventive step
• be capable of industrial application
• not fall under Section 3 and 4

Patentability requirements of an invention

• Newness or novelty
• Inventive step or non-obviousness requirement
• Capable of Industrial application
• Enabling

What we can learn from it:

If your innovative idea is a product or a process that has novelty, has an inventive step, and is capable of the industrial application then the invention said to be a patentable invention.

Now let’s look at each patentability criteria one by one so that we can see if our innovative idea satisfies them and whether we should proceed with the patent application.

Newness or novelty requirement

Sections 2(1)(l) and 2(1)(j) of the Patents Act highlight the difference between a new invention and an invention.  A ‘new invention’ is defined as:

any invention or technology which has not been anticipated by publication in any document or used in the country or elsewhere in the world before the date of filing of a patent application with complete specification, i.e., the subject matter has not fallen in the public domain or that it does not form part of the state of the art.

An invention is said to be novel if all elements of a claim of the invention are not anticipated by a single prior art that is published, or used or known to the public.

Refer our section on “working with patent agent or attorney” on patent drafting for understanding importance of claim and the role they play in patent.

Inventive step or non-obviousness

Now let’s talk about the inventive step, also known as the non-obviousness test for your innovative idea.

An inventive step is said to be present in your invention when it has a technical advance as compared to the existing knowledge (that is state of the art of your field of the invention) or it has economic significance or you invention has both such that it makes your invention non-obvious to a person skilled in the art.

So, we need to identify a feature of our invention that is either technically advance or it is economically significant or both, when it is compared to state of the art or existing knowledge such that our invention becomes non-obvious to a person skilled in the art.

Technical advance means some feature of the invention is having advancement which is technical in nature as compared to the existing knowledge.

A person skilled in the art is a person who has average skills from your domain. For example, if your invention is related to a mechanical device, the person skilled in the art would be from a mechanical background. If there are multiple technologies used in the invention then a person skilled in the art is assumed to have all the knowledge (that is available and known to the public) from the technologies involved. This is to assess the inventiveness of the invention.

The idea here is our invention should not be obvious to a person skilled in the art (that is an average person from a background of the field of the invention).

In other words, considering the state of the art (things are already known to the public) and assuming the person skilled in the art does not have any knowledge about our invention, if that person skilled in the art was asked to solve the problem (that our invention solves), then our invention should not come as a natural suggestion by that person skilled in the art. Which ultimately means invention should not be obvious. This is in essence known as the non-obviousness test.

Few approches to achieve Inventive step

few approches to achieve Inventive step are:

• Inventions is solveting a long-standing technical problem which is tried to be solved by prior arts but could not.
• If invention is showing unexpected technical effect of a new combination of known elements
• The digree of difficulty to a person to combine known prior arts to arrive at solution, etc..
• The “problem/solution” approach is usually used for evaluating inventive step, wherein the solution presented by the patent application is checked if it is obvious to a person skilled in the art.

And one of the ways to qualify for the non-obviousness test of patentability is mentioning and proving to the examiner that our invention is solving a long-standing problem in the industry. Pointing out that the problem existed for a long time and there was a need to solve the problem, also mentioning existing prior arts and patent references who tried before but could not solve up to a certain extent   (stating problems with the prior arts in the background of the invention while drafting patent) and since the problem has not solved till now it ultimately means the solution to the problem that is our invention was Not obvious.

Now, this is not your job as an inventor to do all this, in fact, this is the responsibility of a patent agent or patent attorney working on your invention.  an experienced patent professional would be asking you for the required details and technicality of your invention and using such information while drafting patent application for your invention which gives a very good chance for your patent application to stand through the examination stage till the grant of patent.

This is explained in detail in the section “preparing patent application (patent drafting)”

Industrial application or utility

Section2(1)(ac) capable of industrial application”, in relation to an invention, means that the invention is capable of being made or used in an industry;

Industrial application means invention is capable of being made or used in any kind of industry. This is also known as usefulness, a patented invention should be able to be produced on a large scale that is it could be created, used and repeated.

Now if you observe the word in the definition is Capable of industrial application, which means it need not be mass-produced right now, but has the capability of industrial application in the future.  In general, this patentability requirement of usefulness or industrial application is not much of a problem to prove.

Who can apply for a patent in India?

An application for a Patent for an invention may be made by any of the following persons either alone or jointly with any other person:

• The true and first inventor
• True and first inventor‘s assignee
• The legal representative of the deceased true and first inventor or his/her assignee

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