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Enhancing medical devices; Improving reliability and safety through parylene conformal coatings

Enhancing medical devices; Improving reliability and safety through parylene conformal coatings

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Dick Molin, Senior Medical Market Specialist, Specialty Coating Systems

Dick Molin, Senior Medical Market Specialist, Specialty Coating Systems

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  • 1. MedicalMedicalMedicalMedical Devices; Improving ReliabilityDevices; Improving ReliabilityDevices; Improving ReliabilityDevices; Improving Reliability and Safetyand Safetyand Safetyand Safety through Parylenethrough Parylenethrough Parylenethrough Parylene Conformal CoatingsConformal CoatingsConformal CoatingsConformal Coatings Dick Molin, Sr. Medical Market Specialist MD&M Texas 2014
  • 2. • Device Coatings Requirements • Parylene Conformal Coatings • New Advances in Parylene • Conclusion • Questions & Answers AgendaAgendaAgendaAgenda
  • 3. Coating RequirementsCoating RequirementsCoating RequirementsCoating Requirements What is the most common reason to use a conformal coating? Barrier Protection of the device – application specific – Moisture – Chemical – Electrical (insulation, as well as diel. const. and diss. factor) Barrier Protection of the patient – Biocompatibility – Adhesion: no delamination, blistering, flaking or chem. decomp. – Low outgassing, leaching or extractions – Non-nutrient and resistant to microorganisms
  • 4. • A name that refers to a polymer series based on p-Xylylene POLY(PARA-XYLYLENE) • Non-line-of-sight, applied in a vacuum chamber, molecular level deposition • A truly conformal, thin, optically clear, inert • Chemically pure coating; no catalysts or leachables; no cure forces • No liquid properties, including edge effects, flowing, bridging, and pooling ParyleneParyleneParyleneParylene Conformal CoatingsConformal CoatingsConformal CoatingsConformal Coatings
  • 5. Parylene N • High dielectric strength … 7,000 V@ 25 µm Parylene C • Lowest permeability to moisture and gases Parylene HT® • UV stable • Highest service temperature = 350°C • Short term (≤24 hrs.) temperature = 450°C Parylene VariantsParylene VariantsParylene VariantsParylene Variants
  • 6. Parylene N • High dielectric strength … 7,000 V@ 25 µm Parylene C • Lowest permeability to moisture and gases Parylene HT® • UV stable • Highest service temperature = 350°C • Short term (≤24 hrs.) temperature = 450°C Parylene VariantsParylene VariantsParylene VariantsParylene Variants
  • 7. Parylene N • High dielectric strength … 7,000 V@ 25 µm Parylene C • Lowest permeability to moisture and gases Parylene HT® • UV stable • Highest service temperature = 350°C • Short term (≤24 hrs.) temperature = 450°C Parylene VariantsParylene VariantsParylene VariantsParylene Variants
  • 8. Parylene Deposition ProcessParylene Deposition ProcessParylene Deposition ProcessParylene Deposition Process
  • 9. Parylene Thickness UniformityParylene Thickness UniformityParylene Thickness UniformityParylene Thickness Uniformity SEMs courtesy of E.E. Hui, UC Berkeley.
  • 10. Parylene AttributesParylene AttributesParylene AttributesParylene Attributes • Biocompatible and biostable • Barrier properties and chemical inertness • Corrosion control • Electrical resistance • Thermal & humidity aging resistance • Fungus resistant • Dry film lubricity • Radiation resistance • Sterilizable • No catalysts, plasticizers, solvents • No outgassing, leaching • Excellent crevice penetration ability • RoHS compliant
  • 11. Parylene Electrical PropertiesParylene Electrical PropertiesParylene Electrical PropertiesParylene Electrical Properties Properties Parylene N Parylene C Parylene HT Dieletric Constant 6 GHz 2.46 - 2.54 3.06 - 3.10 2.10 - 2.15 Dissipation Factor 6 GHz 0.0002 - 0.0010 0.0021 - 0.0028 0.0015 - 0.0020 Additional Data
  • 12. Parylene Electrical PropertiesParylene Electrical PropertiesParylene Electrical PropertiesParylene Electrical Properties Properties Parylene N Parylene C Parylene HT Dieletric Constant 6 GHz 2.46 - 2.54 3.06 - 3.10 2.10 - 2.15 Dissipation Factor 6 GHz 0.0002 - 0.0010 0.0021 - 0.0028 0.0015 - 0.0020 Additional Data
  • 13. Parylene Barrier PropertiesParylene Barrier PropertiesParylene Barrier PropertiesParylene Barrier Properties Water Vapor Transmission Rate Gas Permeability
  • 14. USP Class VI • Intracutaneous Reactivity • Systemic Toxicity • 120 hour (5 day) Implantation ISO 10993-1/FDA •Cytotoxicity •Sensitization • Intracutaneous Reactivity •Systemic Toxicity • 2, 12, 26 Week Implantation •Hemocompatibility − Hemolysis − PTT (clotting) (Includes USP Class VI) BiocompatibilityBiocompatibilityBiocompatibilityBiocompatibility Evaluation TestsEvaluation TestsEvaluation TestsEvaluation Tests
  • 15. Medical Coating ApplicationsMedical Coating ApplicationsMedical Coating ApplicationsMedical Coating Applications Short-term • Mandrels, molds, core pins • Seals: O-rings, endoscopic port seals, valves • Guide wires • Catheters: CV, IV, urology, biliary, etc. • Surgical tools - Barrier and/or dielectric – Electrocautery Devices – Energized Surgical Tools • Turbine Motors • Jaws • Needles: Hypodermic, acupuncture, epidural • Pharmaceutical containers: − Syringe components, stoppers, caps − Capsules, containers
  • 16. Medical Coating ApplicationsMedical Coating ApplicationsMedical Coating ApplicationsMedical Coating Applications Long-term • Pacemakers, ICDs, neurostimulators • Coronary and cerebral stents • MDI technology • Cochlear and ocular implants • Catheters • Gastric balloons and cuffs • Endotracheal tubes • Laboratory devices • Pharmaceutical containers: − Including pre-filled syringes and components • Electronics circuit boards and components
  • 17. Electronic Coating ApplicationsElectronic Coating ApplicationsElectronic Coating ApplicationsElectronic Coating Applications • PCBs & Flex Circuits • MEMS wafers • Probes / pins • Rotors / stators • Components – Metal – Brackets • Cables • Ferrite cores • Telecommunication devices
  • 18. Cleanroom Operations-ISO 14644 • Class 7 (10,000) • Class 6 (1,000) • Class 5 (100) Regulatory Support • SCS Parylene Certifications ‒ ISO 10993 and USP Class VI; SCS FDA Drug and Device Master Files ‒ Mil-I-46058C, IPC-CC-830, QPL & UL Listing • SCS Operations Certifications ‒ ISO 9001:2008, AS9100 Rev C ‒ Accredited Third Parties (USA) and Notified Bodies (EU) • RoHS, REACH programs SCS ResourcesSCS ResourcesSCS ResourcesSCS Resources
  • 19. Latest Developments inLatest Developments inLatest Developments inLatest Developments in Adhesion Promotion TechnologiesAdhesion Promotion TechnologiesAdhesion Promotion TechnologiesAdhesion Promotion Technologies • AdPro Plus® … solves adhesion challenges for difficult metallic and plastic substrates • AdPro Poly ® … solves adhesion challenges for most remaining polymeric substrates, including Polyimide • Both enhance the reliability of miniaturized and advanced components in all markets
  • 20. Biological Evaluations per ISOBiological Evaluations per ISOBiological Evaluations per ISOBiological Evaluations per ISO----10993109931099310993
  • 21. WhyWhyWhyWhy AntimicrobialAntimicrobialAntimicrobialAntimicrobial Parylene Technology?Parylene Technology?Parylene Technology?Parylene Technology? • Increase in Healthcare-Associated Infections (HAIs) require manufacturers to address antimicrobial properties of their devices • microRESIST™ introduces antimicrobial attributes in Parylene coatings • microRESIST Antimicrobial Parylene Technology can protect: – Medical electronics – Catheters – Endotracheal tubes – Urological tools – Other devices in contact with the body • Chemistry that is non-toxic, safe and environment friendly
  • 22. EffectivenessEffectivenessEffectivenessEffectiveness • Evaluated effectiveness of microRESIST Antimicrobial Parylene Technology against commonly encountered microorganisms – Most Common HAI Pathogens (CDC) – Other Relevant Microorganisms • Offers > log 5 (99.999%) reduction against 14 microbes after 24 h of inoculation (in accordance with JIS Z 2801) • E. coli • S. aureus • S. aureus (MRSA) • K. pneumoniae • K. oxytoca • A. baumannii • P. aeruginosa • C. albicans • E. faecium • E. faecalis (VRE) • S. enterica • B. subtilis • P. vulgaris • L. monocytogenes
  • 23. EffectivenessEffectivenessEffectivenessEffectiveness ---- Test ResultsTest ResultsTest ResultsTest Results
  • 24. Antimicrobial Parylene TechnologyAntimicrobial Parylene TechnologyAntimicrobial Parylene TechnologyAntimicrobial Parylene Technology LongLongLongLong----Term EffectivenessTerm EffectivenessTerm EffectivenessTerm Effectiveness Detection limit = 5CFU/ml. Non-detects presented as zero on this chart E.E.E.E. ccccoli Testoli Testoli Testoli Test Results After 7 & 15 Day Exposure to PBSResults After 7 & 15 Day Exposure to PBSResults After 7 & 15 Day Exposure to PBSResults After 7 & 15 Day Exposure to PBS
  • 25. Antimicrobial Parylene TechnologyAntimicrobial Parylene TechnologyAntimicrobial Parylene TechnologyAntimicrobial Parylene Technology Additional Test Data • Completed ISO 10993 Tests – Cytotoxicity – Sensitization • No difference in the COF of Parylene surfaces with or without microRESIST™ technology
  • 26. ConclusionConclusionConclusionConclusion Parylene ultra-thin conformal coatings • Used more than ever to protect devices and components • Enhance the reliability of today’s and tomorrow’s innovative technologies. Ultra-thin and conformal offering complete encapsulation No liquid phase or cure forces Excellent moisture, chemical and electrical properties Biocompatible and biostable Enhanced capabilities on difficult surfaces with AdPro Plus and AdPro Poly
  • 27. ConclusionConclusionConclusionConclusion Successful development offers > log 5 (99.999%) reduction against 14 microbes after 24 hr of inoculation Demonstrated antimicrobial effectiveness against E.coli (> log 5) is maintained after 7 & 15 day exposures to phosphate buffer saline (PBS) Passes the cytotoxicity test per ISO 10993 SCS microRESIST™ Antimicrobial Parylene Technology
  • 28. Thank You!Thank You!Thank You!Thank You! Dick MolinDick MolinDick MolinDick Molin Sr. Medical Market Specialist E: dmolin@scscoatings.com Specialty Coating Systems, Inc.Specialty Coating Systems, Inc.Specialty Coating Systems, Inc.Specialty Coating Systems, Inc. 7645 Woodland Drive Indianapolis, IN USA 46278 P 317.244.1200 :: www.scscoatings.com