Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Download Silicones for Long Term Implant Applications Medical Silicone Conference
Document related concepts
no text concepts found
Transcript
Silicones for Long Term Implant Applications Medical Silicone Conference 2010 !! Founded – 1979 !! Early beginnings supplying the Aerospace Industry, and later transitioned into providing materials into the Healthcare arena !! Largest US silicone supplier withdrawal from the market in 1993. •! Developed many equivalents to products being taken off market •! Meetings with Industry reps, HIMA, FDA •! Origins of Master File (MAF) protocol !! 300+ Master Files & Drug Master Files !! Long-term implant line (UNR) expanded exponentially !! Today, largest supplier of silicones for long-term implantable medical devices !! From 1 gallon to 2,000 gallon mixers !! ! cc syringes to ocean-going freight containers •! No MOQ !! 3 unique manufacturing sites •! Disaster Recovery Plan !! Duplicity in manufacturing !! 2,500 formulations in our database !! Formulator, not a compounder !! Long history with implantable device applications !! First used in healthcare applications in the early 1950’s !! Characterized as biologically inert •! The most researched biomaterial to date !! Other characteristics: •! •! •! •! •! Hydrophobic Permeable Stable under various environmental conditions Tolerant to most sterilizing techniques Elastomeric !! Additives •! Electrical / Thermal Conductivity !! Colors !! Radio Opacity •! Barium Sulfate •! Tungsten !! API’s •! Steroids •! Hormones •! Antimicrobials !! Working relationship with regulatory agencies •! MAF / DMF !! Support with Testing Compendium •! •! •! •! Bulk Material Properties Mechanical / Physical Properties Chemical Properties Confirmatory Biological Testing !! 4750 or 4850 most current !! Work with agencies worldwide to accommodate unique testing requirements •! Europe •! Canada •! South America •! Asia / Japan !! Development and expansion of Healthcare line !! Customer / Industry demands !! Drug Delivery / Combination Products •! 20 years experience •! Regulatory support •! Testing support !! Purity !! Identity •! Drug Master File (DMF) !! Drug Delivery Silicones !! Effects of API’s on silicone system •! Steroids •! Hormones •! Antimicrobials !! !! !! !! !! !! !! !! Temperature limitations Inhibition concerns Rheology control Preserving mechanical properties Compatibility of silicone cure chemistry and API stability Achieving prescribed dose delivery rate and end point Maintaining process-ability Verifying content uniformity of API in silicone !! Capable of formulating, validating, manufacturing, testing and providing regulatory support for a custom product designed to achieve customer-defined, application-specific physical, mechanical and elution properties. !! Material Design •! Chemistry •! Custom Formulation •! Compounding !! Testing !! Controlled Manufacturing Facilities !! Regulatory Support !! Custom formulation’s influence on elution properties •! •! •! •! Optimization of elastomer chemistry Filler content Crosslink density Additives to facilitate release !! The following graph models two distinctively different API release rates !! Formulation A and Formulation B use the same base silicone:API but have modified chemistries to facilitate the targeted release profile !! Lot-to-lot in-house testing •! Identity Testing •! Mechanical & Chemical •! Elution Rate !! Qualification testing •! Content uniformity •! API degradation •! Shelf life stability !! Elution testing may need to be customized for a particular application giving consideration to: •! •! •! •! •! Elution media simulating in vivo conditions Temperature Conditioning Dose curve identification Configuration of test sample to simulate end-use application API degradation analysis and stability profiling !! All testing performed per FDA GLP and/or ICH guidelines. !! ISO 9001 certification •! Consistent processes and standards !! FDA Registered/Audited Facility !! Quality System compliant with: •! 21 CFR Part 210/211 cGMP for Finished Pharmaceuticals •! ICH Q7 GMP for Active Pharmaceutical Ingredients •! IPEC GMP for Pharmaceutical Excipients !! !! !! !! !! !! !! !! !! Adhesives and Sealants Primers and Coatings Fluids and Greases Foams Resins Gels Fluorosilicones High Consistency Elastomers Liquid Silicone Rubber Thank You, Brian T. Reilly Product Director, Healthcare Materials (805) 566-4119 [email protected]
