Handbook on Medical and Surgical Disposable Products

Non-Woven Gown making Machine NIIR Project Consultancy Services (NPCS) ... Plastic Injection Moulding 1. ... Pneumatic Angled Tube Cutter...

15 downloads 271 Views 15KB Size
Handbook on Medical and Surgical Disposable Products Author: NPCS Board of Consultants & Engineers Format: Paperback ISBN: 9789381039281 Code: NI257 Pages: 384 Price: Rs. 1,775.00 US$ 150.00 Publisher: NIIR PROJECT CONSULTANCY SERVICES Usually ships within 5 days

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.

Contents 1. INTRODUCTION Design, Prototyping and Product Development Importance of Testing

NIIR Project Consultancy Services (NPCS) 1/10

2. CE MARKING 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

3. CLEANROOM TECHNOLOGY Introduction 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 Regulations 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 Furniture Electrical Cleanroom Equipments

4. MEDICAL DEVICE PACKAGING Packaging Packaging Design Controls User Preference

NIIR Project Consultancy Services (NPCS) 2/10

Packaging Materials Package Validation Procurement, Acceptance and Storage Packaging Process Exhibits Product Specification: Pouch Header Bag (Specification Form) Mandatory Label Information Product Identity Declaration Language Location 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 ISO ISO-11607 Packaging for Terminally Sterilized Medical Devices ASTM ASTM D Standards ASTM International Standards Fall into Six Categories ASTM F Standards ASTM-F1929 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

5. DISPOSABLE BLOOD BAGS Introduction Flexible PVC Blood Bags Uses of Blood Bags Properties of Disposable Blood Bags Raw Material Quality of the Raw Materials

NIIR Project Consultancy Services (NPCS) 3/10

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

6. DISPOSABLE PLASTIC GLOVES Introduction Properties Uses Manufacturing Process Raw Material Basic Plant and Machineries Required Steps 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

7. DISPOSABLE MASKS Introduction Uses & Applications Properties Manufacturing Process of Disposable Surgical Masks Sterilization

NIIR Project Consultancy Services (NPCS) 4/10

Flow Diagram for Disposable Surgical Mask Machinery Images for Masks Mask Making Machine Surgical Mask Sewing Machine Mask Blank Machine Plant & Machinery Suppliers

8. DISPOSABLE SURGICAL CATHETERS Introduction 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

9. DISPOSABLE SURGICAL WEAR (Surgical Gowns, Bed sheets, Pillow cover, Caps) Introduction Disposable Bed Sheets Disposable Pillow Cover General Construction for Disposable Gowns Closures Sizing Analysis of Disposable Gowns Standards 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 Advantages Dust Mask Advantages Description of Surgeon Gowns Description of Patient Gown Description of Surgeon Suits Raw Material Protective Materials Spun Bond Polypropylene SMMS DuPont T Isolation Wear T Medical Fabrics Coated Polypropylene Breathable Laminate Characteristic Manufacturing Process Machinery Images & Details Surgical Gown Sewing Machine Non-Woven Gown making Machine

NIIR Project Consultancy Services (NPCS) 5/10

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

10 DISPOSABLE PLASTIC SYRINGES Introduction Uses Necessity of Disposable Syringes Parts of a Disposable Syringe Nozzle Piston Raw Material Used for Manufacturing Disposable Syringes Polyolefin - (Polyethylene and Polypropylene) Polyethylene Polypropylene Polystyrene Natural Rubber Synthetic Polymeric Material Silicone Oil Leakage Test Sterility Packing 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 Media Medium for Anaerobic Organism

NIIR Project Consultancy Services (NPCS) 6/10

Medium for Aerobic Organism A. Benzathine Penicillin, Benzyl Penicillin B. Other Antibiotic C. Test for Detection of Fungi Medium Suppliers of Raw Material

11. I.V. (INTRA-VENOUS) CANNULA Introduction Types of IV Catheters Peripheral 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 Needle Hub Needle Protector Catheter Flash Back Chamber Threaded Stopper Blister Packing Raw Material Polymers Used in Plastic Moulding 1. Nylons 2. Polyamides, PA Properties 3. Polyethylene Properties LDPE Properties HDPE Properties 4. Polypropylene Polypropene, PP Properties 5. Polyvinyl Chloride (PVC) Properties 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

NIIR Project Consultancy Services (NPCS) 7/10

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 Wings Needle Tubing Silicon Valve Safe Blood Stopper Packing 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

12. INFUSION SET & BLOOD TRANSFUSION SET Introduction Blood Transfusion Before the Blood Transfusion During the Blood Transfusion After the Blood Transfusion Blood Transfusion Process Protocol Product Description Blood Transfusion Sets

NIIR Project Consultancy Services (NPCS) 8/10

Features 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

13. SURGICAL COTTON & BANDAGES Introduction Properties (a) Surgical Bandage (b) Surgical Cotton Uses Process of Manufacture of Surgical Cotton 1. Mechanical Cleaning of Raw Cotton 2. Boiling 3. Bleaching 4. Hydro-extraction 5. Drying

NIIR Project Consultancy Services (NPCS) 9/10

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

About NIIR 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.

NIIR PROJECT CONSULTANCY SERVICES , 106-E, Kamla Nagar, New Delhi-110007, India. Email: [email protected] Website: NIIR.org

Thu, 09 Aug 2018 23:14:07 +0530

NIIR Project Consultancy Services (NPCS) 10/10