Plastics currently form one of the most important components of the medical industry. Medical device designers and engineers increasingly prefer plastics to conventional packaging materials such as metals owing to superior flexibility offered by plastics in fabrication process. Advancements in sterilization techniques shift towards disposable devices, development of enhanced plastic materials, and technological innovations are factors driving the overall market growth and expansion. The development of novel materials such as biocompatible polymers for use in medical implants will furthermore provide the required impetus for the global medical plastics market. Every day, plastics are involved in critical surgeries, life saving efforts, and routine medical procedures. Plastic materials can be sterilized hundreds of times without degradation. Lightweight plastics are used to form replacement joints, non surgical supports, and therapy equipment. Clear plastics provide visibility for transfusions, surgeries, and diagnostic equipment of all kinds and plastics can be machined, molded, or formed into almost any shape imaginable. The use of plastics in health care field encompasses several distinct markets. Plastic is used on a large scale as medical devices like disposable syringes, optical and dental products, heart valves, contact lenses and many more medical products. This way plastic has very importance in making medical devices. The medical plastics industry is set to expand rapidly over the next decade taking up increasing proportions of GDP, as countries provide healthcare to an ageing population, access to medicine expands in developing regions and new technology is developed.
This book basically deals with significance of packaging for pharmaceuticals & medical industry, tablets & capsules liquids, creams and ointments, OPVC, OPP and oriented and non oriented pet containers, blister trays for ampoules, cartridge tubes etc., shrink packaging and stretch wrapping, conducting health based risk assessments of medical materials, performance properties of metallocene polyethylene, EVA, and flexible PVC films, polyurethane thin film welding for medical device applications, polyurethane film as an alternative to PVC and latex, opportunities for PVC replacement in medical solution containers, thermoplastic silicone urethane copolymers : a new class of biomedical elastomers, selecting materials for medical products : from PVC to metallocene polyolefins, injection molding engineering plastics, assessing the performance and suitability of parylene coating etc.
The present book contains the important information of plastics in medical field and their uses in various ways. This is very useful book for entrepreneurs, researchers, technocrats and technical institutions.
The Complete Book on Medical Plastics
Author: NIIR Board of Consultants & Engineers
Published: 2006
Format: paperback
ISBN: 8178330008
Code: NI172
Pages: 368
$ 25.95
975
Publisher: NIIR PROJECT CONSULTANCY SERVICES
Usually ships within 5 days
Contents
1. SIGNIFICANCE OF PACKAGING FOR PHARMA & MEDICAL INDUSTRY
Tablets & Capsules
Liquids
Creams and Ointments
Labels
Caps & Closures
Wadding Materials
Specific New Systems
Opvc, Opp and Oriented and Non-oriented Pet Containers
Blister Trays For Ampoules, Cartridge Tubes Etc.
Single-serve/Unit Dose Packages (Laminates of PPR, Plastics and Foil)
The Delcap Metered-dose
Form, Fill, Sealing of Plastic Bottles Under Aseptic Condition
Radiation Resistant PP Bottles
Double Derker Spray-aerosol
Single Dose Blister-break Open Packs
Capped Gabletop Cartons
Refillable, Reusable and Recycliable Aerosols
Shrink Packaging and Stretch Wraping
Bulk Drug and Fine Chemicals
Packaging of Medical Devices
Materials & Technologies
Tyvek
Dot Coat Advantages
Tyvak vs. Paper
Peelable Paper Lidding Materials
Advantages
Applications
Medical Grade Pressure Sensitive Materials
Advantages
Applications
Evoh in Health Care Packaging (HCP)
Packaging Requirements For Health Care Products
Structure, Props & Uses
Barrier Bottles/Vials
Evoth
Other Important Area of Use
Packaging & Sterility
Plastics and Their Biomedical Applications
Pharmaceutical & Medical Packaging
New Development
Packaging Waste Directive
The Directive
Conclusion
2. TESTING
Conducting Health-Based Risk Assessments of Medical Materials
Nancy Stark
Standards and Guidances
Method
Hazard Identification
Dose-Response Assessment
Exposure Assessment
Risk Characterization
Nitinol Implant
Wound-Dressing Formulation
Perchloroethylene Solvent
Ligature Material
Sources of Data
Uncertainty Factors
Safety Margins
Conclusion
Pharmaceutical
Pharmaceutical Market Focuses on Cutting Costs, Not Value
Some Segments Promising
Regulatory Requirements
Packaging Machinery
Other Trends
The Future
3. STERILIZATION
Traditional Processes
New Processes
Chemical Processes (Gas/Liquid)
Peracetic Acid
Hydrogen Peroxide
Ozone
Chlorine Dioxide
Physicochemical Processes
Plasmas
Steam
Synergetic Processes
Psoralens and UVA (PUVA)
Microwave and Bactericide
Low-Temperature Steam and Formaldehyde
Physical Processes
Microwaves
Pulsed-Light Systems
Validation of Sterilizer Processes
4. HIGH PERFORMANCE PVC COMPOUNDS & TPE’S FOR MEDICAL APPLICATION
Long Term Contribution of PVC in Health Care
Pvc’s Dominance in the Growing Market
Challenges by Environmentalist to PVC
Key Barriers to PVC Replacement
The Major Factors Which Continue to Favour the Use of PVC are
PVC Innovation
ABC of Innovation
Features of Hi-performance PVC Compounds
The Use of Hi-performance PVC in Medical Devices
TPE Based on Pvc Replaces Silicone
TPE Based on PVC Outflexes Silicone Rubber
5. INNOVATIONS REMAKE PLASTIC INJECTION MOLDING
Useful Properties
Parts on a Diet
Equipment and Processes
Automating for Success
Conclusion
6. POLYVINYL CHLORIDE IN CRITICAL HEALTHCARE PRODUCTS
Factors Which Made Polyvinyl Chloride the Material of Choice for the Fabrication of Medical Devices
Typical Medical Applications of PVC
Choice of Plasticisers
Containers for the Collection and Storage of Blood and Blood Products
Storage of Platelets
Containers for Intravenous Fluids and for Parenteral Nutrition
Containers for Constant Ambulatory Peritoneal Dialysis Solutions (Capd Bags)
Containers for the Collection and Storage of Cord Blood
Reported Deleterious Effects of Dehp Plasticised PVC and the Present Position
Trends in the Development of Newer Materials
7. ADVANCES IN MEDICAL PLASTICS
Microtagging
Thermosets
Antithrombogenic Coatings
Dryfilm Lubricant
Curing Process for Synthetic Polyisoprene Latex
Topas Cyclic Olefin Copolymer
8. MEDICAL APPLICATIONS OF POLYCARBONATE
Processing
Sterilization
Typical Applications
Renal Dialysis
Cardiac Surgery Products
Surgical Instruments
IV Connection Components
Polycarbonate Developments for the Medical Market
Radiation Grades
High-Temperature Grades
Polycarbonate Blends
Enhanced-Productivity Grades for Cleanroom Molding
Lipid-Resistant Grades
Conclusion
9. RADIO-FREQUENCY SEALING FOR DISPOSABLE MEDICAL PRODUCTS
Steve Myers
What is RF Sealing?
How RF Works
Sizing RF Sealers
Tooling
Efficient RF Sealing Techniques
Maximum Throughput With Automation
Double-cycle Sealing
Comparing RF With Other Sealing Technologies
Conclusion
10. PET BOTTLES AND APET SHEET FOR BLISTER PACKING FOR PHARMA APPLICATION
Pet Conversion Processes
Pet – A Pure Polymer
Pet Bottles for Pharma
Filling Lines for Pet Bottles
Case Study for Use of Pet Bottles in Pharma Industry
Conclusion
Generic Drugs That Can Be Packed in Pet Bottles
Ayurvedic Products That Can Be Packed In Pet
Cost-Competitiveness of Pet Bottle for Pharma Industry
Pet Bottles for Pharma Products – Useful Tips
Apet Sheet – Material, Processing & Applications
Apet Sheets – Total Consumption
Apet Thin Sheet
What is Apet Sheet
Factors For Growing Interest in Apet Sheet
Advantages of Apet Sheet
Blister Packing
Apet Sheet vs. PVC Sheet
Apet Sheet vs. PP Sheet
Gas/Moisture Barrier Properties Pet vs. Other Polymers
Salient Points of Apet Thin Sheet
Pet – Ecofriendly and Recyclable
Pet Converters – Expectations of Pharmaceutical Industry
Development Trials for Pharma Industry By RIL
Other Applications of Apet Thin Sheet
Conclusion
11. BREATHABLE TPE FILMS FOR MEDICAL APPLICATIONS
Barrier Films
Microclimate Dynamics
TPE Resin Chemistry
Soft Segments
Hard Segments
Film Manufacture
Lamination
Hot-Melt Screen Printing
Melt Printing
Porous Coating
Spray Coating
Medical Applications
Conclusion
12. THE CHANGING ROLE OF THE MEDICAL DEVICE CONTRACT MANUFACTURER
Growth, Growth & Growth
Outsourcing and Consolidation
Meeting the Challenge
13. MEDICAL PACKAGING
Rising Demand Predicted
Drug/Device Products Lead The Way
Cost Considerations
Test Methods
Regulatory Picture
Conclusion
14. PERFORMANCE PROPERTIES OF METALLOCENE POLYETHYLENE, EVA, AND FLEXIBLE PVC FILMS
Experimental Procedure
Results
Conclusion
15. POLYURETHANE THIN-FILM WELDING FOR MEDICAL DEVICE APPLICATIONS
Weldability of Thermoplastics
Film-joining Methods
RF Welding
Ultrasonic Welding
Direct Thermal Sealing
Induction Welding
Solvent Bonding
Conclusion
16. POLYURETHANE FILM AS AN ALTERNATIVE TO PVC AND LATEX
PVC
Natural Rubber Latex (NRL)
Thermoplastic Polyurethanes
Concerns About PVC
17. GAS PERMEABILITY AND MEDICAL FILM PRODUCTS
Materials and Experimental Methodology
Results and Discussion
Conclusion
18. OPPORTUNITIES FOR PVC REPLACEMENT IN MEDICAL SOLUTION CONTAINERS
Ethylene-vinyl Acetate
Polyester
Polyolefin Blends
Polyolefin Laminates
Functionalized Polyolefins
Conclusion
19. PRODUCING BUBBLE/TAPER TUBING FOR MEDICAL APPLICATIONS
Extrusion-line Design
Forming Considerations
Cooling and Sizing
Pulling and Cutting Systems
Conclusion
20. THERMOPLASTIC SILICONE-URETHANE COPOLYMERS : A NEW CLASS OF BIOMEDICAL ELASTOMERS
Silicones
Thermoplastic Polyurethanes
Silicone-modified Polyurethanes
Silicone-urethane Copolymers
Conclusion
21. SELECTING MATERIALS FOR MEDICAL PRODUCTS : FROM PVC TO METALLOCENE POLYOLEFINS
Fundamental Considerations
Selecting Materials
Material Performance Versus Product Performance
PVC Versus Metallocenes
Advantages of PVC
Disadvantages of PVC
Advantages of Metallocenes
Potential Metallocene Disadvantages
Challenges for Metallocene Materials
Safety and Quality
Product Design and Processing
Product Performance
Conclusion
22. COATING AND SURFACE TREATMENT TECHNOLOGIES
Ion-Beam Processing—Spire Corp. (Bedford, MA).
Light-Activated Surface Modification—BSI Corp. (Eden Prairie, MN).
Plasma Surface Engineering—Talison Research (Sunnyvale, CA).
Antimicrobial/Antibiotic Coatings—STS Biopolymers, Inc. (Henrietta, NY).
Thromboresistant (Heparin) Coatings—Baxter Healthcare Corp. (Irvine, CA).
23. INJECTION MOLDING ENGINEERING PLASTICS
How It Works
Balancing Variables
Tool Design
Design Aids
Conclusion
24. GROWTH AND NEW CHALLENGES FOR DEVICE MARKET
Cost Concerns
Steady Growth
Regulatory Issues
Technology Issues
The Future
25. ASSESSING THE PERFORMANCE AND SUITABILITY OF PARYLENE COATING
Medical Coating Characteristics
Medical Coating Applications
Parylene Review
Parylene N
Parylene C
Parylene D
The Parylene Process
Conclusion
26. PAPER OR PLASTIC? MEDICAL NONWOVEN COMBINES BEST PROPERTIES OF BOTH TAPES
Thin-Film Coater Improves Process Control
Susan Wallace
Chips Propel Advances in Medical Imaging Equipment
Susan Wallace
27. PRODUCTS & SERVICES
Dispensing units
Slot-die system
Packaging system
Tube cutter
Automation equipment
Injection moulding machines
Catheter processing equipment
Benchtop moulder
28. REPROCESSING DISPOSABLE (SINGLE-USE) ITEMS
Background
How Safe Is Reprocessing
Benefits of Reprocessing
Definitions
Recycling
Reprocessing
Reprocessing Disposable (Single-use) Items
Reprocessing Disposable Surgical Gloves
Recycling or Reprocessing Disposable (Plastic) Syringes Andhypodermic Needles
Recycling Disposable Syringes
Reprocessing Disposable Syringes (and Needles)
Reprocessing Versus Disposal of Needles and Syringes
29. PLASTICS MEDICAL DISPOSABLES & AMPULE TRAYS WITH G.N. PRESSURE-FORMING TECHNOLOGY
Introduction
Ampule Package
Current Technology
Contact Heat, Cut-in-place, Pressure Thermoforming Technology
Quality Control
Flexibility
Efficiency
Simplicity
Applications of Contact Heat, Cut-in-place, Pressure Thermoformers
Design of Parts
Material
Production Volume
Cost
30. PVC IN MEDICAL APPLICATION
Introduction
Topic of Discussion
Medical Application For PVC
Benefits of PVC
Safety
Chemical Stability
Biocompatibility
Clarity & Transparency
Flexibility, Durability & Dependability
Sterilizability
Compatibility
Resistance to Chemical Stress Cracking
Low Cost
Additives Used for PVC Compounding
Plasticisers
Stabilisers
PVC In Medical Products – An Environmental Perspective
Regulation and Product Standards
Good Manufacturing Practice (GMP)
Important Aspects Of GMP
Plastic Processing in Clean Rooms
I.V. Fluid Containers: Why PVC?
Cost Effectiveness
Reliability
Simplicity in the Filling Process
Safety in the Hospital
Conclusion
Sample Chapters
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