Plastics Injection Molding and Extrusion - Medmarc

1 Plastics Injection Molding and ExtrusionCritical Manufacturing Processes for the Medical Device IndustryDave Rittenhouse, MedAccredCurrently Manufacturing and Supply Chain ConsultantRetired from Plastics and Healthcare IndustryVP Global Supply Chain Management Bayer Healthcare Diagnostics (Terrytown, NY)Director of Manufacturing Bayer (now Covestro) MakrolonPolycarbonate Plant (Baytown, TX)Plant Manager Bayer Graphic Arts Quality Films (Berlin, CT)Betriebsleiter(Production Superintendent) Bayer MakrolonMarket Scale-Up Plant (Krefeld, Germany)Led Bayer European Plastics Manufacturing Implementation of then newly rolled out ISO 9001:1987 derived from BS57501 Sasha Brishkovski, Johnson & JohnsonSupplier Quality Engineer, DePuy Synthes, Johnson and JohnsonLead Quality Engineer, Texas Instruments20 + Years of experienceCertified Black BeltCertified Senior Technology Manager (ATMAE)Lead Auditor ISO 13485 Background in Design, NPD, Mfg.

2 Process, Process Validation, QSR, Electronics, assembly and testMachining, Special Processes2 Advanced Sourcing Engineer, Stryker10+ Years of Experience8 Years of Plastic Part Design2 Years Sourcing/Plastic Part ProcessingLicensed Professional EngineerISO 13485 Certified Lead AuditorExperience in DFM, NPD, Special Process Validation, and FDA QSR Roy Holmberg, Stryker3 AgendaScopeTargeting Manufacturing ProcessesExamples of Product Issues & ChallengesKey Process Audit Elements - PlasticsTechnical Standards ComplianceTop Non-ConformancesTypical Root CauseWhat is the Medical Device industry doing to improve Plastics Injection Molding and Extrusion Quality and Supply Chain Oversight?

3 4 MedAccred Plastics Injection Molding AuditSource: MTD Micro MoldingScopeMedical Device Plastics Injection MoldingInsert Molding , Overmolding, Injection blow Molding , Transfer Molding , Compression MoldingMedical Device Plastics ExtrusionTubing/Profile, Sheet, Film, Blown Film, Over-Jacketing, Co Extrusion Ram ExtrusionMaterialsThermoplasticsThermose tsElastomers/Silicones5 Targeting Manufacturing ProcessesConsistent and comprehensive practices for ensuring QualityProcess/Product Consistency Machine/Tool ReliabilityHealth, Safety, and Environment 6 Examples of Product Issues & Challenges - PlasticsProductReasonFusion Oxygenator w/ Arterial Filter, cardiotomy/Venous Reservoir, perfusion tubing packsIdentified an out-of-specification condition exhibiting additional plastic (flash)

4 In the arterial sampling port adjacent to the arterial outlet port of the tipsFilter Tips molded incorrectly and may not seal to the tip adaptor properly causing inaccurate aspiration and dispensingElectric Homecare BedThe failure mode is directly related to contaminated material in the plastic housing used to produce the motor. Contaminated motor housings may crack resulting in a motor that will no longer actuate the head section per the intended the head section were to fall it is unlikely but possible an injury could occur. No injuries have been (Fluidics Management System) PackThe possible presence of a Molding irregularity found within the aspiration luerwhich may result in a reduction of vacuum within the aspiration.

5 Process Audit Elements -PlasticsEnd to End Manufacturing Supply ChainMaterial Receipt, Acceptance and StorageCompounding (as required)Material PreparationPrimary Plastics ProcessingInjection MoldingExtrusionCuring/Annealing (as required)Secondary Processing OperationsMaterial/Product TraceabilityPackaging, Storage and Delivery8 Key Process Audit Elements -PlasticsQuality System Certification is RequiredAudit Basics:ExistenceComprehensivenessComplia ncePersonnelTrainingQualification9 Source: MTD Micro MoldingKey Process Audit Elements -PlasticsTooling StorageCleaning Process ChemicalsMaintenanceAssembly10 Source.

6 MTD Micro MoldingKey Process Audit Elements -PlasticsProcess ValidationMaster Validation planIQ, OQ, PQStatistical BasisMeasurement System AnalysisCapabilityProcess Planning DocumentsSoftwareOngoing MonitoringCustomer Approval11 Key Process Audit Elements -PlasticsQuality ControlRaw MaterialsIn Process ( Dimensional/Visual)Final InspectionSupport FunctionsFacilitiesCapital ProgramMaintenanceSpares ProgramClean/White RoomsProcess segregationCleaning process12 Technical Standards Compliance CleanroomsISO 14644-1 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentrationOr equivalent ( US FED STD 209E, BS 5295, and GMP EU)Medical IndustryQMS Certification.

7 ISO 13485, ISO 9001, AC8004, IATF/ISO 1694921 CFR Part 820 GHTF Process Validation Guidance edition 2 - January 200413 Top Non-conformancesComprehensive documentation of processes various gaps within existing proceduresClean room/white room proceduresSoftware controlled equipment proceduresMaster Validation Plan14 Typical Root Cause Tribal Knowledge Misunderstanding the requirement or unaware of requirementLack of procedure, procedure was not well defined, or not in-depth15 What is the Medical Device industry doing to improve Plastics Injection Molding & Extrusion Quality and Supply Chain Oversight?

8 MedAccred Plastics Task GroupBaxter; Becton, Dickinson Johnson Philips; StrykerOpen to Subject Matter Experts from OEMs, CMs and SuppliersDevelop Audit CriteriaApprove SME auditorsGrant Supplier accreditationsOEMs/CMs use MedAccred Accreditation a criteria to award new business and oversee their critical process supply chain qualitySuppliers use MedAccred Accreditation to ensure final product quality and improved manufacturing operations16 Questions?17 Justin McCabeSr. Specialist, Business