October 9-12, 2017 Huntington Convention Center
Brought to you by: Rubber Division | American Chemical Society
October 9-12, 2017 Huntington Convention Center

Educational Symposium

Material Considerations for Medical Devices and Pharmaceutical Products 
October 10, 2017; 8:00 a.m. – 12:30 p.m.

This course is designed for engineers, chemists, material designers and supply chain specialists that are interested in learning more about
materials that are used in pharmaceutical applications. There is a variety of regulations and expectations for these materials. After this overview is presented, in-depth training will focus on the selection, qualification and control of materials. 

Appropriate material selection is the first step to ensure that materials will be appropriate for their intended use in a medical device or
pharmaceutical delivery system. The selection process will be discussed in the context of technical, business, and regulatory needs. Examples of systematic approaches to material selection will be presented to illustrate how stakeholder needs can be translated into material requirements. The next step to ensure that materials are appropriate for their intended use involves a variety of activities to ensure the materials meet the requirements (qualification). The focus of the discussion in this workshop will be on safety qualification, which involves evaluation of biological endpoints, physicochemical characterization and toxicological assessment. Depending on the pharmaceutical application different qualification strategies may be adopted. The participants will be introduced to various types of testing (e.g., ISO 10993, USP) and guided through the process of developing an appropriate testing strategy. The use of risk analysis and other tools will be demonstrated. Relevant examples will be given to illustrate interpretation of test results combined with other relevant information to determine qualification status. After a material is qualified it is essential that appropriate controls are established throughout the supply chain. Examples of the development and implementation of control strategies will be presented and discussed. Approaches to
managing material changes during the product lifecycle will also be addressed.

Learning objectives for this workshop include:

  • Developing an understanding of regulatory and industry expectations for materials used in pharmaceutical applications
  • Learning how to use various tools to effectively select and test materials
  • Becoming familiar approaches to meet regulatory and industry expectations throughout the product lifecycle.

CEUs:  0.4
Instructors: Cheryl Stults, C & M Technical Consulting, LLC

Member: $250 
Non-member: $395
Student: $50
- Pricing increases $100 after September 1, 2017

Essentials of Rubber Technology
October 10, 2017; 8:00 a.m.- 12:00 p.m.

The training is designed for those individuals who are seeking an increased degree of knowledge related to the science behind the design and creation of rubber parts.  The course is designed to give practical assistance in answering day-to-day questions related to shop floor issues and customer questions.  By applying the principles outlined in this training, the participant should expect to be able to improve the quality of their rubber fabrications.
Couse content includes:
• What is rubber
• Why do engineers use it
• Differences between rubber and plastic
• Types of rubber; how are they different
• How to select the type of rubber for the application
• How rubber compounds are formulated basic overview of constituents
• How rubber compounds are mixed; overview of mixers and mixing methods
• Rubber curing and its relationship to properties
• How to test rubber
• Rubber bonding
• Rubber molding
• Improving rubber part quality

Instructor: Joe Walker, Elastomer Technologies
CEUs: 0.4

Member $250
Non-Member $395
Student Member $50
- Pricing increases $100 after September 1, 2017

Chemistry and Technology of Polymeric Materials Used in Medical Devices
October 10, 2017; 1:00 p.m. – 5:00 p.m.
The course begins with an overview of the FDA systems, terminology and guidance documents for:  classifications of devices, for obtaining FDA approvals, and for pre-clinical testing including biocompatibility and bio durability testing.  Included by example in the foregoing and throughout the course are a broad range of medical devices which are manufactured wholly or substantially from elastomeric and plastic polymeric materials.  These include medical latex items such as: gloves, catheters, condoms; urethane, silicone, polyamide, and polyolefin catheters; thermoplastic elastomeric blood tubing; syringes and associated accessories; UHMW and polyurethane orthopedic implants; plastic bottles, packaging and closures; and others.  
Key properties, chemical characteristics, and testing and analytical methods related to requisite performance characteristics of materials used in a range of products are discussed.  Finally, the course reviews methods of material modification through chemical backbone modifications, surface treatments, incorporation of nano materials to achieve properties such as: anti-microbial properties, electrical conductivity, improved blood compatibility, and/ or improved bio durability.  
Those who should attend include:
This is intended as an introductory course for Materials, Quality and Engineering personnel who have limited knowledge of rubber and plastic materials used in medical devices.  The course may also be useful to management or sales professionals new to the medical device field.  There are no suggested technical pre-requisites for this course, one should need only have a general knowledge of rubber and plastics terminology to benefit to derive a significant benefit.
Instructor: Dave Russell, PU Prospect
CEUs: 0.4
Member $250
Non-Member $395
Student Member $50
- Pricing increases $100 after September 1, 2017

Silicone Rubber Chemistry and Technology
October 10, 2017; 1:00 p.m. – 5:00 p.m.

The focus of this training session it to provide the attendee an increased level of insight into the silicone rubber family of polymers.  The course will take the participant through the process of making silicone polymer, selecting the polymer architecture, cure systems, formulating and fabrication.  
Course content includes:
• How silicones are made
• What makes silicone a specialty polymer; when to use it over other polymers
• The influence of polymerization on suitability of manufacturing process
• Essential differences between high consistency (millable), RTV and liquid silicone rubber
• Influence of filler types
• Cure systems
• Mixing/manufacturing compounds
• Fabrication technologies; how to set up the process
• Adhesion
• Troubleshooting guide

Instructor: Joe Walker, Elastomer Technologies
CEUs: 0.4

Member $250
Non-Member $395
Student Member $50
- Pricing increases $100 after September 1, 2017

Chemistry & Technology of Polyurethane Elastomers
October 11, 2017; 8:30 a.m. – 4:30 p.m. 
The course focuses on the fundamentals of elastomeric polyurethanes such as those used in coatings adhesives, sealants or elastomers (“CASE”). The course includes identification of major raw materials, an introduction to polymer chemistry and chemical structure-property relationships in elastomeric polyurethanes. Testing and analysis techniques, typical formulary and key processing methods are discussed in the context key markets such as medical device, oil field, materials handling, architectural, and materials handling applications.

Those Who Should Attend:
Product engineers, managers, quality professionals and Jr. or 
Sr. level chemists. Suggested pre-requisites include general 
technical aptitude and general familiarity of technical terminology 
related to chemistry and rubber or plastic materials.

Course Outline:
1. Introduction: CASE market overview
2. Polymer and functional group chemistry of polyurethanes
3. Structure-property relationships and key raw materials
4. Testing and analytical methods
5. Processing Methods
6. Case examples of typical polyurethane formulary

Instructor: Dave Russell, PU Prospect
CEUs:  0.7
Member $500
Non-Member $645
Student Member $75
- Pricing increases $100 after September 1, 2017

Compound Mixing and Consistency
October 11, 2017; 8:00 a.m. – 12:00 p.m.
This course is designed to provide the attendee an in depth understanding of the influence of the mixing process and the characteristics of the mixed compound.  The focus of the training will be on reducing the batch to batch variation commonly associated with batch mixed rubber compounds.   The use the Association of Rubber Products Manufactures Compound Consistency Guideline will be used to walk each aspect of rubber compound manufacture.
Course content includes:
• Raw material specifications
• Storage of raw materials
• Error proofing
• Weigh-up controls
• Batch sizing
• Integrated power mixing
• In process mixer data and analysis
• Two roll mill controls
• Compound properties vs. the mix fingerprint
• Testing the compound

Instructor: Joe Walker, Elastomer Technologies
CEUs: 0.4

Member $250
Non-Member $395
Student Member $50
- Pricing increases $100 after September 1, 2017

Establishing a Rubber Molding Process
October 11, 2017; 1:00 p.m. – 5:00 p.m.

This program is designed to show how to establish a rubber molding process based on cross link density.  The course is designed to show the influence of cross link density on mechanical properties as well as its influence on de-molding.  The overall focus is the design of a rubber molding process that yields the most consistent properties.
Course content includes:
• Selection of the correct polymer characteristics to match the molding process
• Understanding curing of rubber
• How to measure cure state
• Relationship between cure state and physio-mechanical properties
• Role of mold temperature and it variation reduction
• Heat transfer models in predicting cure time
• Insert molding
• Selecting mold release
• Post mold curing
• Verification of the molding process

Instructor: Joe Walker, Elastomer Technologies
CEUs: 0.4

Member $250
Non-Member $395
Student Member $50
- Pricing increases $100 after September 1, 2017

Failure Analysis of Rubber & Plastics by Physical and Chemical Analysis 
October 12, 2017; 8:30 a.m. – 12:30 p.m. 

This is a materials testing and analysis course which covers a wide range of thermoset and thermoplastic elastomeric materials as well as engineering plastic materials. The course is divided into four sections:  Section 1 begins the course with a brief overview of polymeric materials based on typical properties as relate to intended end uses.  Next in section 1 in order to provide a basis for chemical analysis discussions the basic chemical functional group concepts as relate to the polymer backbone are presented.  Sections 2 and 3 give a basic introduction to physical testing and chemical analysis methods respectively.  Physical testing including: tensile and tear testing, abrasion testing, ozone and other environmental resistance test, stress crack testing, and a range of predictive testing methods.  Analytical and instrumental methods covered includes:  polymer identification by simple wet chemistry methods as well as more advanced methods such as FT-IR, NMR, state of cure analysis, microscopic and X-ray analysis methods, and chromatographic methods for identification of additive.  Finally, section four presents a series of case studies related to a broad range of actual failure analyses including tires, cast polyurethane parts, medical devices, automotive parts, hose and tubing, sporting goods, and the like.

Those who should attend:
Materials and quality technicians and Jr level chemists looking to expand their knowledge and skill set related to testing and analysis.  Product engineers, managers, quality professionals desiring to expand their knowledge of what tests or analyses to request and/or desiring better understanding of the significance and interpretation of laboratory results.  Pre-requisites; general technical aptitude and general familiarity of technical terminology related to rubber and plastic materials.

Instructor: Dave Russell, PU Prospect 
CEUs: 0.4

Member $250
Non-Member $395
Student Member $50
- Pricing increases $100 after September 1, 2017

Chemical Structures and Viscoelasticity of Rubber 
October 12, 2017; 8:30 a.m. – 12:30 p.m. 

This course is designed to focus on the chemistry of rubber and the other compound ingredients and their effects on viscoelasticity rather than the mathematical models and laboratory methods of measuring rubber viscoelasticity.  The viscoelastic models, theories and definitions are covered but the main focus is on the rubber compounding side.  The viscoelastic properties of non-tire mechanical goods and tires are discussed versus their performance properties.

Outline of Course:

1. Viscoelastic Theory – Elastic and Viscous Behavior
  a. Hooke’s Law
  b. Newton Dashpot Model
  c. Brownian Motion
  d. Maxwell Model
  e. Kelvin-Voigt Model
2. Elastomer Phases with Temperature Change
  a. Glassy region
  b. Glass transition region (Tg)
  c. Rubber region
  d. Flow region
  e. Time-Temperature Superposition Theory
3. Viscoelastic Properties Definitions
  a. Elastic modulus
  b. Viscous modulus
  c. Tan delta
  d. Complex Modulus
  e. Loss compliance
4. Laboratory Measurement of Viscoelastic Properties
5. Laboratory Viscoelastic Properties for Non-tire Rubber Applications
6. Laboratory Viscoelastic Properties for Tire Applications
7. Elastomer Chemical Structure and Viscoelastic Properties
  a. Elastomer backbone flexibility
  b. Bulkiness of the side groups
  c. Steric hindrance
  d. Flexibility of side groups
  e. Symmetry of side groups
  f. Homogeneous versus heterogeneous elastomers
  g. Molecular weight
  h. Elastomer branching
  i. Polymer chemical modification
8. Common rubber chemical structures and glass transition temperatures
  a. SBR, styrene butadiene rubber
  b. BR, butadiene rubber
  c. EPDM, ethylene propylene diene rubber
  d. IIR, CIIR, CIIR, butyl, bromobutyl and chlorobutyl rubbers
  e. NBR, HNBR, XNBR, butadiene acrylonitrile rubbers
  f. CR, polychloroprene rubber
  g. CSM, chlorosulfonated polyethylene rubber
  h. ECO, epichlorohydrin rubber
  i. ACM, polyacrylic rubber
  j. MQ, VMQ, PMQ, PVMQ, FVMQ, silicone rubbers
  k. AEM, ethylene acrylic rubber
  l. FKM, fluorocarbon rubber
9. Non-rubber Rubber Compound Ingredients and Viscoelastic Properties
  a. Carbon black
  b. Mineral fillers
  c. Plasticizers, oils and process aids
10. Vulcanization System and Viscoelastic Properties

Instructor: Bonnie Stuck, ARDL
CEUs: 0.4

Member $250
Non-Member $395
Student Member $50
- Pricing increases $100 after September 1, 2017