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Medical Polymers and Processing Technology SeminarThursday 16th February 201710.00am to 3.00pmVenue:First Polymer Training,7 Centre Court,Blyry Business and Commercial Park,Athlone,Co. WestmeathThis event is most suited for those involved in R&D, new product development and technical roles; that would like to increase their knowledge of how medical regulatory requirements influence material selection and processing of medical polymers. Information and Booking:There is no charge to attend but places are limited so booking is essential. Please contact:Catherine Collins at First Polymer Training SkillnetTelephone: 090 6471223Email: c.collins@firstpolymer.com

9.30am- 10.00am

RegistrationMaterial Suppliers

10.00am-10.30am

Katie Heydon from NCC presents: “Polymers in Medical Devices - An Introduction to Regulations for Raw Materials”As the medical device field grows and devices become more complex, manufacturers look to medical grade polymers for their processes to ensure optimal material safety, approvals and support. But what does it mean to refer to a polymer as “medical grade”? NCC will give an introduction into the history of medical polymers, where and when they came into use and explore the rationale behind raw material regulation. This talk will cover what USP Class VI and ISO10993 testing covers and will give an under-standing of the practicalities in selecting and purchasing medical grade material, what questions to expect from your supplier and what regulatory support and assistance a customer should expect.

10.30am – 11.00am

Carl Mendonca from Ultra Polymers presents: “Meeting the challenges of using Polymers in Healthcare Applications”In addition to discussing the correct polymer selection process to meet the functional & regulatory requirements of medtech, this presentation will also focus on how to optimize processing for efficient production by considering part design, testing, validations, and risk assessment. We will highlight the tools available to help the process of product development in order that the manufacturer can arrive at a well-designed functional part that meets the demand of its end use application.

11.00am - 11.15am Tea/Coffee

12.45pm -1.45pm Lunch

Final Q & A 2.45-3.00 then Finish

11.15am – 11.45am

David Howard from IPC presents: “Medical Polymer Compounding at IPC – A Case Study”Polymer Materials & Additives used. The Impact of final component design and use on compounding parameters. The importance of material dispersion. The Compounding process at IPC. Material Testing. COA & COC standards for medical compounds. Packaging of Medical Compounds.

11.45am -12.15pm

Mr Chris Smith; Senior Market Manager, Teknor Apex BV on behalf of JL Goor Materials presents: “Medalist Medical Elastomers – an alternative to PVC, Latex, Thermoset Rubber & Silicone in Medical devices”Positioning of Medalist grades in the medical sector. A Breakdown of the Medalist family products; SBC, TPV, TPO and Blends, including those for bonding or multi-shot injection. Identification of target products and applications, using the appropriate thermoplastic manufacturing process. Touching the Regulatory compliance of Medalist, noting it’s performance in the end product including sterilisation capability. Comparison to PVC, noting applications and key performance criteria – physical & chemically properties compared, as well as post component manufacture assembly operations. Latex applications compared to Medalist – pros and cons discussed, and benefits of Medalist. Comparison of manufacturing processes for similar application. Summary of rubber replacement in medical devices with Medalist – the benefits from manufacturing capability, design freedom and cleanliness. Review of silicone replacement in diverse applications from moulded & extruded components. Includes a comparison of the key performance criteria. Many case studies referred to during the presentation on all topics.

12.15pm - 12.45pm

John Hanamy from Delta Q presents: “Masterbatch Influence in Medical Device Design – More than a Regulatory Consideration”

1.45pm- 2.15pm

Padraic Lunn from Precision Extrusion Technologies presents: “Challenges for the Medical Micro Extrusion Process - extrusion equipment” As the need to provide smaller and smaller medical devices for minimally invasive procedures, the challenges for the Medical tubing manufacturer are constantly increasing. The extrusion equipment specification and design are critical to maximise the dimensional stability of the process and also to achieve the physical characteristics of the final tube produced, this presentation looks at some of the important equipment details.

2.15pm- 2.45pm

Trevor Thornton from Trend Technologies presents: “Understanding Melt & Part Temperature Measurement, past & present” Material manufacturers and injection moulding simulation companies invest a lot of time and effort trying to create the perfect part. Past methods have provided results but they are never repeatable and can change based on the user. The most important requirement is the actual melt temperature. Infrared (IR) thermography has really taken off in the past 7 to 10 years. Trevor will discuss the usage of IR cameras in Scientific Injection Moulding (SIM) studies, and their importance on a daily basis as a vital piece of equipment for both fault finding and as part of the part validation process.

Colouring of Polymers: Masterbatch composition; Compounds; Pigments and other additives; Compatibility considerationsEffect of colour and other additives on: Regulatory approvals; Appearance; Dimensional stability; Mechanical properties; ProcessabilityCase studies