Handbook on Medical and Surgical Disposable Products (Blood Bags, Plastic Gloves, I.V. Cannula, Infusion Set, Gowns, Masks, Catheter, Cotton and Bandage, Surgical Wear, Syringes) ( ) ( ) ( ) ( ) ( )
Author NPCS Board of Consultants & Engineers ISBN 9789381039281
Code NI257 Format Paperback
Price: Rs 1775   1775 US$ 48   48
Pages: 384 Published 2014
Publisher Niir Project Consultancy Services
Usually Ships within 5


Handbook on Medical and Surgical Disposable Products

(Blood Bags, Plastic Gloves, I.V. Cannula, Infusion Set, Gowns, Masks, Catheter, Cotton and Bandage, Surgical Wear, Syringes)


Medical and surgical device manufacturers worldwide produce a multitude of items that are intended for one use only. The primary reason is infection control; when an item is used only once it cannot transmit infectious agents to subsequent patients. Like medicines and other health technologies, they are essential for patient care – at the bedside, at the rural health clinic or at the large, specialized hospital. The demand of these goods is not only because of their “one time use” property but also due to the hygienic methods adopted to produce them. From manufacturing to Marking, production of disposable goods is stacked with numerous standards and regulations. This book includes the basic manufacturing method and labeling requirements, required for the bulk production of such life saving devices. General medical disposables that are being in demand in domestic as well as in international market includes: medical gloves, syringes, gowns, catheters, blood transfusion units and so on.

The information provided is not only confined to the different methods involved in the manufacturing of medical disposables but also describes the raw material used and other information related to product, which are necessary for the manufacturers knowledge. The details given will be very good for an individual/entrepreneur who is willing to invest in the field of medical disposables.

The main demand of medical disposables are, nowadays not limited to the super specialty hospitals but is also continuously increasing in rural hospitals and clinics. The work provides an idea to reader about the final product, hygiene, safety, packaging, uses, manufacturers and suppliers of the machinery, raw material involved in the processes etc.

The book covers various aspects concerned with the disposable medical devices and presents an overview of the processes involved with their machineries and specifications. The work provides the complete details of the suppliers and manufacturers with machinery photographs for better understanding of the reader.


Design, Prototyping and Product Development
Importance of Testing

Medical Devices
Active Implantable Medical Devices
In Vitro Diagnostic Medical Devices
Competent Authority
Notified Body
Guide to CE Marking
Reproduce the CE Marking
Steps for Class I Medical Devices Compliance
Class I Medical Devices: Conformity Assessment Routes

Humans in Cleanrooms
Contamination Process
Sources of Contamination
1. Facilities
2. People
3. Tool Generated
4. Fluids
5. Product Generated
Key Elements of Contamination Control
List of Some of Equipment and Supplies Needed to Clean the Cleanroom
Classification of Cleanrooms
Conventionally Ventilated Cleanrooms
Unidirectional Airflow Cleanrooms
Mixed Flow Cleanrooms
Isolator or Minienvironment
International Standards
Cleanroom Garment System
Testing of Cleanroom Clothing
Effect of the Garment Design on Dispersion
Comparison of Clothing made from Different Fabrics
General Cleanroom Regulations
Personal Actions Typically Prohibited in Cleanrooms
Layout of Cleanroom Suite
Cleaning Methods and the Physics of Cleaning Surfaces
How Should a Cleanroom be cleaned?
Cleaning Methods with Respect to Area Type
Choice of Materials
Test Methods
Cleanroom Equipments

Packaging Design Controls
User Preference
Packaging Materials
Package Validation
Procurement, Acceptance and Storage
Packaging Process
Product Specification: Pouch
Header Bag (Specification Form)
Mandatory Label Information
Product Identity Declaration
Net Quantity Declaration
Manner of Declaring
Different Stages of Packaging
Primary Packaging
Chevron Peel Pouch
Corner Peel Pouch
Chevron Peel Pouch
Squared Sealed (No-peel, Tear) Pouch
Standard Method of Dimensioning Pouches
Standard Tray with Undercuts
Tray with Molded Lid
Tray with Heat Sealed Lid
Dual Sterile Barrier – Inner & Outer Tray
Die Cut Backer Cards
Secondary Packaging
Folding Cartons
Corrugated Shipping Containers
Packaging Standards
Packaging for Terminally Sterilized Medical Devices
ASTM D Standards
ASTM International Standards Fall into Six Categories
ASTM F Standards
Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
Current Good Manufacturing Guidelines for Finished Pharmaceutical Goods
Materials Examination and Usage Criteria
Labeling Issuance
Packaging and Labeling Operations
Drug Product Inspection
Expiration Dating

Flexible PVC Blood Bags
Uses of Blood Bags
Properties of Disposable Blood Bags
Raw Material
Quality of the Raw Materials
1. Translucency so can Check it Full, and See Layers in Centrifuged Bags
2. Flexibility (Low Bending Stiffness) so can Process by Squeezing the Bag
3. Heat Resistance, so can Steam Sterilize Prior to Use
4. Materials Property-Melting Temperature
5. Must Not Burst in the Centrifuge, or Tear on Handling
6. Permeable to Oxygen, but not too Permeable to Water
7. Moderate Cost
8. Processing and Welding
9. PVC Plasticized Blood Bag sizes: 350 ml & 450 ml
Manufacturing Process
Flow Sheet Diagram
Bag Making
Tube Making
Blood Bag Forming Machine
Suppliers of Plant & Machinery
Raw Materials Addresses

Manufacturing Process
Raw Material
Basic Plant and Machineries Required
1. Washing
2. Coagulation
3. Application
4. Dripping
5. Gelling
6. Leaching
7. Beading
8. Slurry
9. Stripping
10. Testing
11. Packaging
Process Flow Diagram
Glove Manufacturing Machines
PE Glove Machine
Disposable Glove Making Machine
Non-Woven Glove Sewing Machine
Non woven Glove Making Machine
Suppliers of Raw Material
Suppliers of Plant Machineries

Uses & Applications
Manufacturing Process of Disposable Surgical Masks
Flow Diagram for Disposable Surgical Mask
Machinery Images for Masks
Mask Making Machine
Surgical Mask Sewing Machine
Mask Blank Machine
Plant & Machinery Suppliers

Uses & Applications
Common Features of Central Venous Catheter (CVC)
Manufacturing Process of Catheters
Process Flow Diagram of Catheter
Catheter Production Equipments
Plant & Machinery Suppliers
Suppliers of Raw Materials

(Surgical Gowns, Bed sheets, Pillow cover, Caps)
Disposable Bed Sheets
Disposable Pillow Cover
General Construction for Disposable Gowns
Sizing Analysis of Disposable Gowns
The General Requirements for Manufacturers, Processors and Products – EN 13795-1
Products: Description
Medical & Sanitary Articles
Nonwoven Medical Gown
CPE Shoe Covers
Face Masks
Non Woven Face Mask
Dust Mask
Description of Surgeon Gowns
Description of Patient Gown
Description of Surgeon Suits
Raw Material
Protective Materials
Spun Bond Polypropylene
DuPont T Isolation Wear T Medical Fabrics
Coated Polypropylene
Breathable Laminate
Manufacturing Process
Machinery Images & Details
Surgical Gown Sewing Machine
Non-Woven Gown making Machine
Disposable Surgical Cap Making Machine
Process Flow Diagram
Surgical Disposable Products Photograph
Surgical Gowns
Disposable Apron
Disposable Gown
Disposable Surgeon Gown
Disposable Coverall
Disposable Surgical Cap
Disposable Bouffant Cap
Disposable Mob Cap
Disposable Surgical Bed Sheets
Plant & Machinery Suppliers
Raw Materials Suppliers

Necessity of Disposable Syringes
Parts of a Disposable Syringe
Raw Material Used for Manufacturing Disposable Syringes
Polyolefin - (Polyethylene and Polypropylene)
Natural Rubber
Synthetic Polymeric Material
Silicone Oil
Leakage Test
Outer Container
Marking of Outer Containers
Manufacturing Process
Process Description
1st Stage of Process
2nd Stage of Production
3rd Stage of Process
4th Stage of Production
Process Flow Diagram
Assembling Operation and Packing
Machinery Images
Single Barrel Moulds
Syringe Plunger Moulds
Injection Moulding Machine
Disposable Syringe Packaging Machine
Storage of Sterilized Articles
Test for Detection of Aerobic and Anaerobic Organism
Medium for Anaerobic Organism
Medium for Aerobic Organism
A. Benzathine Penicillin, Benzyl Penicillin
B. Other Antibiotic
C. Test for Detection of Fungi Medium
Suppliers of Raw Material

Types of IV Catheters
Midline Peripheral Catheter
Peripherally Inserted Central Catheter
Central Venous Catheter
Uses and Application
Application of Cannula
Nasal Cannula
Veterinary Use
Body Piercing
Butterfly Needle
Application of Butterfly Needle
Needle Gauge
I.V. Cannula: General Features
Needle Hub
Needle Protector
Flash Back Chamber
Threaded Stopper
Blister Packing
Raw Material
Polymers Used in Plastic Moulding
1. Nylons
2. Polyamides, PA
3. Polyethylene
LDPE Properties
HDPE Properties
4. Polypropylene
Polypropene, PP
5. Polyvinyl Chloride (PVC)
Medical Grade Plastic
Manufacturing Process of IV Cannula
Plastic Moulding
Plastic Moulding Techniques
Rotational Moulding Technique
1. Preparing the Mould
2. Heating and Fusion
3. Cooling the Mould
4. Unloading/Demoulding
Plastic Injection Moulding
1. Preparing the Mould
2. Injection of Polymer Melt into the Mould
3. Cooling the Mould
4. Unloading/Demoulding
The Blow Moulding Process
A. Injection Blow Moulding
B. Extrusion Blow Moulding
C. Stretch Blow Moulding
The Compression Moulding Process
Plastic Extrusions
Manufacturing Process Assembly Line
Silicon Valve
Safe Blood Stopper
Catheter Material as per USP standards Class VI
Process Description of the Assembly Line
Automatic Cup Forming Machine
Semi Automatic Body Assembly/Wing Assembly Machine
Semi Automatic Tip Forming Machine
Automatic Silicon Tube Cutting Machine
Automatic Needle Assembly Machine
Automatic Luer Lock & Flash Back Chamber Assembly Machine
Automatic Catheter Cutting Machine
Automatic Blister Packing Machine
Ethylene Oxide (ETO) Sterilization Process
Pre-Conditioning Stage
Sterilizer Stage
Degasser Stage
Process Flow Diagram
Machinery for IV Cannula Production Line
Automatic Needle Assembly Machine
Automatic Luer Lock & Flash Back Chamber Assembly Machine
Cannula Assembly Machine
Body Assembly Machine
Tip Forming Machine
Cup Forming Machine
Catheter Cutting Machine
Suppliers of Raw Material

Blood Transfusion
Before the Blood Transfusion
During the Blood Transfusion
After the Blood Transfusion
Blood Transfusion Process Protocol
Product Description
Blood Transfusion Sets
Disposable Infusion Set
Infusion & Transfusion Sets
Micro Flo Air Micro Drip Set
Micro Flo Eco Micro Drip Set
Blood Transfusion Set (Double Chamber)
Blood Transfusion Set Haemodrip (Double Chamber)
Blood Transfusion Set-Easy (Single Chamber)
Blood Donor Set
Infusion Set
Infusion Therapy
Manufacturing Process
Plastic Injection Moulding
1. Preparing the Mould
2. Injection of Polymer Melt into the Mould
3. Cooling the Mould
4. Unloading/Demoulding
The Blow Moulding Process
1. Injection Blow Moulding
2. Extrusion Blow Moulding
3. Stretch Blow Moulding
Stretch Blow Moulding
The Compression Moulding Process
Plastic Extrusions
Assembly Processes
Process Flow Diagram
Description of Machinery
Tubing Cutter
Pneumatic Angled Tube Cutter
Tubing Cutter - Pneumatic Operated
Molded Tubing - Cutting Machine
Plastic Tube Bending Oven
Double Ended Hose Assembly Machine
10 Vibratory Bowl Feeders for Hose Assembly Machine
Tape Dispenser
Floor Standing Coiling Machine
Tubing Taping Machinery
Suppliers of Plant and Machinery
Suppliers of Raw Material

(a) Surgical Bandage
(b) Surgical Cotton
Process of Manufacture of Surgical Cotton
1. Mechanical Cleaning of Raw Cotton
2. Boiling
3. Bleaching
4. Hydro-extraction
5. Drying
6. Carding
7. Sterilization
8. Packing
Flow Sheet for the Manufacture of Surgical Cotton
Process of Manufacture for Bandage
1. Mechanical Cleaning
2. Drawing
3. Combing
4. Spinning
5. Weaving
6. Washing and Bleaching
7. Starching & Natural Drying
8. Cutting the Bandages Cloth into Bandage
9. Packing
Flow Sheet for the Manufacture of Surgical Bandage
Machinery Images & Specifications
1. Surgical Cotton Machinery
2. Bandages Making Machines
Plant & Machinery Suppliers



NIIR PROJECT CONSULTANCY SERVICES (NPCS) is a reliable name in the industrial world for offering integrated technical consultancy services. NPCS is manned by engineers, planners, specialists, financial experts, economic analysts and design specialists with extensive experience in the related industries.

Our various services are: Detailed Project Report,  Business Plan for Manufacturing Plant, Start-up Ideas, Business Ideas for Entrepreneurs, Start up Business Opportunities, entrepreneurship projects, Successful Business Plan, Industry Trends, Market Research, Manufacturing Process, Machinery, Raw Materials, project report, Cost and Revenue, Pre-feasibility study for Profitable Manufacturing Business, Project Identification, Project Feasibility and Market Study, Identification of Profitable Industrial Project Opportunities, Business Opportunities, Investment Opportunities for Most Profitable Business in India, Manufacturing Business Ideas, Preparation of Project Profile, Pre-Investment and Pre-Feasibility Study, Market Research Study, Preparation of Techno-Economic Feasibility Report, Identification and Section of Plant, Process, Equipment, General Guidance, Startup Help, Technical and Commercial Counseling for setting up new industrial project and Most Profitable Small Scale Business.

NPCS also publishes varies process technology, technical, reference, self employment and startup books, directory, business and industry database, bankable detailed project report, market research report on various industries, small scale industry and profit making business. Besides being used by manufacturers, industrialists and entrepreneurs, our publications are also used by professionals including project engineers, information services bureau, consultants and project consultancy firms as one of the input in their research.

Our Detailed Project report aims at providing all the critical data required by any entrepreneur vying to venture into Project. While expanding a current business or while venturing into new business, entrepreneurs are often faced with the dilemma of zeroing in on a suitable product/line.


And before diversifying/venturing into any product, wish to study the following aspects of the identified product:

• Good Present/Future Demand
• Export-Import Market Potential
• Raw Material & Manpower Availability
• Project Costs and Payback Period

We at NPCS, through our reliable expertise in the project consultancy and market research field, Provides exhaustive information about the project, which satisfies all the above mentioned requirements and has high growth potential in the markets. And through our report we aim to help you make sound and informed business decision.


The report contains all the data which will help an entrepreneur find answers to questions like:

• Why I should invest in this project?
• What will drive the growth of the product?
• What are the costs involved?
• What will be the market potential?

The report first focuses on enhancing the basic knowledge of the entrepreneur about the main product, by elucidating details like product definition, its uses and applications, industry segmentation as well as an overall overview of the industry sector in India. The report then helps an entrepreneur identify the target customer group of its product. It further helps in making sound investment decision by listing and then elaborating on factors that will contribute to the growth of product consumption in India and also talks about the foreign trade of the product along with the list of top importing and top exporting countries. Report includes graphical representation and forecasts of key data discussed in the above mentioned segment. It further explicates the growth potential of the product.

The report includes other market data like key players in the Industry segment along with their contact information and recent developments. It includes crucial information like raw material requirements, list of machinery and manufacturing process for the plant. Core project financials like plant capacity, costs involved in setting up of project, working capital requirements, projected revenue and profit are further listed in the report.

Reasons for buying the report:

• This report helps you to identify a profitable project for investing or diversifying into by throwing light to crucial areas like industry size, demand of the product and reasons for investing in the product.

• This report provides vital information on the product like its definition, characteristics and segmentation.

• This report helps you market and place the product correctly by identifying the target customer group of the product.

• This report helps you understand the viability of the project by disclosing details like raw materials required, manufacturing process, project costs and snapshot of other project financials.

• The report provides forecasts of key parameters which helps to anticipate the industry performance and make sound business decision.


Our Approach:

• Our research reports broadly cover Indian markets, present analysis, outlook and forecast.

• The market forecasts are developed on the basis of secondary research and are cross-validated through interactions with the industry players. 

• We use reliable sources of information and databases.  And information from such sources is processed by us and included in the report.


Our Market Survey cum Detailed Techno Economic Feasibility Report Contains following information:



Ø  Introduction

·         Project Introduction

·         Project Objective and Strategy

·         Concise History of the Product

·         Properties

·         BIS (Bureau of Indian Standards) Provision & Specification

·         Uses & Applications


Ø  Market Study and Assessment

·         Current Indian Market Scenario

·         Present Market Demand and Supply

·         Estimated Future Market Demand and Forecast

·         Statistics of Import & Export

·         Names & Addresses of Existing Units (Present Players)

·         Market Opportunity


Ø  Raw Material

·         List of Raw Materials

·         Properties of Raw Materials

·         Prescribed Quality of Raw Materials

·         List of Suppliers and Manufacturers


Ø  Personnel (Manpower) Requirements

·         Requirement of Staff & Labor (Skilled and Unskilled) Managerial, Technical, Office Staff and Marketing Personnel


Ø  Plant and Machinery

·         List of Plant & Machinery

·         Miscellaneous Items

·         Appliances & Equipments

·         Laboratory Equipments & Accessories

·         Electrification

·         Electric Load & Water

·         Maintenance Cost

·         Sources of Plant & Machinery (Suppliers and Manufacturers)


Ø  Manufacturing Process and Formulations

·         Detailed Process of Manufacture with Formulation

·         Packaging Required

·         Process Flow Sheet Diagram


Ø  Infrastructure and Utilities

·         Project Location

·         Requirement of Land Area

·         Rates of the Land

·         Built Up Area

·         Construction Schedule

·         Plant Layout and Requirement of Utilities


Project at a Glance

Along with financial details as under:


  •     Assumptions for Profitability workings

  •    Plant Economics

  •    Production Schedule

  •    Land & Building

            Factory Land & Building

            Site Development Expenses

  •    Plant & Machinery

             Indigenous Machineries

            Other Machineries (Miscellaneous, Laboratory etc.)

  •    Other Fixed Assets

            Furniture & Fixtures

            Pre-operative and Preliminary Expenses

            Technical Knowhow

            Provision of Contingencies

  •   Working Capital Requirement Per Month

             Raw Material

            Packing Material

            Lab & ETP Chemical Cost

           Consumable Store

  •   Overheads Required Per Month And Per Annum

         Utilities & Overheads (Power, Water and Fuel Expenses etc.)

             Royalty and Other Charges

            Selling and Distribution Expenses

  •    Salary and Wages

  •    Turnover Per Annum

  •   Share Capital

            Equity Capital

            Preference Share Capital


  •    Annexure 1:: Cost of Project and Means of Finance

  •    Annexure 2::  Profitability and Net Cash Accruals


                Expenses/Cost of Products/Services/Items

                Gross Profit

                Financial Charges     

                Total Cost of Sales

                Net Profit After Taxes

                Net Cash Accruals

  •   Annexure 3 :: Assessment of Working Capital requirements

                Current Assets

                Gross Working. Capital

                Current Liabilities

                Net Working Capital

                Working Note for Calculation of Work-in-process

  •    Annexure 4 :: Sources and Disposition of Funds

  •    Annexure 5 :: Projected Balance Sheets

                ROI (Average of Fixed Assets)

                RONW (Average of Share Capital)

                ROI (Average of Total Assets)

  •    Annexure 6 :: Profitability ratios


                Earnings Per Share (EPS)


             Debt Equity Ratio

        Annexure 7   :: Break-Even Analysis

                Variable Cost & Expenses

                Semi-Var./Semi-Fixed Exp.

                Profit Volume Ratio (PVR)

                Fixed Expenses / Cost 


  •   Annexure 8 to 11:: Sensitivity Analysis-Price/Volume

            Resultant N.P.B.T

            Resultant D.S.C.R

   Resultant PV Ratio

   Resultant DER

  Resultant ROI

          Resultant BEP

  •    Annexure 12 :: Shareholding Pattern and Stake Status

        Equity Capital

        Preference Share Capital

  •   Annexure 13 :: Quantitative Details-Output/Sales/Stocks

        Determined Capacity P.A of Products/Services

        Achievable Efficiency/Yield % of Products/Services/Items 

        Net Usable Load/Capacity of Products/Services/Items   

       Expected Sales/ Revenue/ Income of Products/ Services/ Items   

  •    Annexure 14 :: Product wise domestic Sales Realisation

  •    Annexure 15 :: Total Raw Material Cost

  •    Annexure 16 :: Raw Material Cost per unit

  •    Annexure 17 :: Total Lab & ETP Chemical Cost

  •    Annexure 18  :: Consumables, Store etc.,

  •    Annexure 19  :: Packing Material Cost

  •    Annexure 20  :: Packing Material Cost Per Unit

  •    Annexure 21 :: Employees Expenses

  •    Annexure 22 :: Fuel Expenses

  •    Annexure 23 :: Power/Electricity Expenses

  •    Annexure 24 :: Royalty & Other Charges

  •    Annexure 25 :: Repairs & Maintenance Exp.

  •    Annexure 26 :: Other Mfg. Expenses

  •    Annexure 27 :: Administration Expenses

  •    Annexure 28 :: Selling Expenses

  •    Annexure 29 :: Depreciation Charges – as per Books (Total)

  •   Annexure 30   :: Depreciation Charges – as per Books (P & M)

  •   Annexure 31   :: Depreciation Charges - As per IT Act WDV (Total)

  •   Annexure 32   :: Depreciation Charges - As per IT Act WDV (P & M)

  •   Annexure 33   :: Interest and Repayment - Term Loans

  •   Annexure 34   :: Tax on Profits

  •   Annexure 35   ::Projected Pay-Back Period And IRR