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    Presentation 2012

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    Le Vy
    ETC Sterilization Systems is an ISO 9001:2000 Certified company with 510k employees worldwide. Current projects include: Boston Scientific, RI One (1) 12 Pallet chamber Two (2) 28 Pallet chambers complete mezzanine mounted mechanical systems. Covidien, north Haven CT Three (3) Six Pallet Chambers 7,000 SCFM Catalytic Oxidizer with Peak Shaver Automated Unloading Systems to aeration rooms, gas chromatograph, material handling, IQ / OQ

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    Presentation 2012

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    Le Vy
    99 views38 pages
    ETC Sterilization Systems is an ISO 9001:2000 Certified company with 510k employees worldwide. Current projects include: Boston Scientific, RI One (1) 12 Pallet chamber Two (2) 28 Pallet chambers complete mezzanine mounted mechanical systems. Covidien, north Haven CT Three (3) Six Pallet Chambers 7,000 SCFM Catalytic Oxidizer with Peak Shaver Automated Unloading Systems to aeration rooms, gas chromatograph, material handling, IQ / OQ

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    ETC Sterilization Systems is an ISO 9001:2000 Certified company with 510k employees worldwide. Current projects include: Boston Scientific, RI One (1) 12 Pallet chamber Two (2) 28 Pallet chambers complete mezzanine mounted mechanical systems. Covidien, north Haven CT Three (3) Six Pallet Chambers 7,000 SCFM Catalytic Oxidizer with Peak Shaver Automated Unloading Systems to aeration rooms, gas chromatograph, material handling, IQ / OQ

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    99 views38 pages

    Presentation 2012

    Uploaded by

    Le Vy
    ETC Sterilization Systems is an ISO 9001:2000 Certified company with 510k employees worldwide. Current projects include: Boston Scientific, RI One (1) 12 Pallet chamber Two (2) 28 Pallet chambers complete mezzanine mounted mechanical systems. Covidien, north Haven CT Three (3) Six Pallet Chambers 7,000 SCFM Catalytic Oxidizer with Peak Shaver Automated Unloading Systems to aeration rooms, gas chromatograph, material handling, IQ / OQ

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    of 38

    ETC Sterilization Systems

    Presented by:

    David Mitchell, VP & Business Unit Manager


    Email: [email protected] Mobile: 215.359.7441

    COMPANY FACTS
    Incorporated in 1969 ISO 9001:2000 Certified Headquarters & Main Manufacturing Facility in Southampton, PA since 1972 Subsidiaries in Poland and Turkey Installations in 60+ countries worldwide FDA Registered Manufacturer with 510k 400+ employees

    Corporate Overview

    Business Units

    Training Systems Group


    Military Flight Simulators Incident Command Pilot/Astronaut Training

    Control Systems Group


    Sterilization Systems Group Biomedical Systems Group Automotive Test Chambers

    STERILIZER DIVISION

    STERILIZER CUSTOMERS
    (Partial)

    Teleflex Medical/Arrow International B.Braun Becton Dickinson Terumo Cook, Inc. Ethicon Isomedix (STERIS) Boston Scientific

    Johnson & Johnson King Pharmaceutical Medline Medical NASA The Smithsonian Institute Covidien Wilson-Cook ITL Healthcare Steritech

    Current EtO Projects Boston Scientific, RI


    One (1) 12 Pallet chamber Two (2) 28 Pallet Chambers Complete Mezzanine Mounted Mechanical Systems Advanced Predictive Maintenance functions 5 Preconditioning and Aeration Rooms Automated Unloading Systems Interface to wet scrubber

    Covidien, Dominican Republic


    Three (3) Six Pallet Chambers 7,000 SCFM Catalytic Oxidizer with Peak Shaver Automated Unloading Systems to Aeration Rooms Gas Chromatograph, Employee Monitoring, LEL/O2 Monitoring Boiler IQ/OQ Services

    Current EtO Projects (cont.) Covidien, North Haven CT


    Identical configuration to the Dominican Republic project (e.g. 3 chambers, emissions control, monitoring, material handling, IQ/OQ)

    Company Confidential
    Research Vessel Control System upgrade

    Why choose ETC?


    39 Years Building EtO Systems Hot Air Jacketing Standard Most Advanced Control Superior Gas Recirculation Technology Unblemished Safety Record Free Remote Diagnostics Non-Proprietary Components Superior Validation Documentation (and executed STP) Complete In-house design, construction and test facilities Facility Design Assistance Turnkey Services

    CAPABILITIES
    ASME Pressure Vessel Technology Design and Manufacturing Flexibility Process Control Standard and Custom PLC or PC Control Systems Non-proprietary Components Facility Design & Construction Documentation In-House Testing Rigging, Installation, Start-Up, and Training IQ/OQ Services Field Refurbishment/Retrofits After Sales Service & Preventive Maintenance Plans Control Upgrades & Rebuilding

    SYSTEM INCLUSIONS
    ETC standard construction 304 Stainless Steel chamber and doors Gas Concentration Sensor Humidity Sensors Aluminum Sheathed Rigid Insulation Complete door systems Air Heated/Cooled Jacket and doors Chamber Internal Recirculation Assemblies EtO gas cylinder handling system (2 scales per chamber) PC/PLC SCADA based control system (e.g. ETC Advantage Control System) Motor Control Center Installation and Operational Qualification Services Documentation & Drawings Warranty Complete piping skids

    DOOR CONFIGURATIONS
    Single/Versus Double Manual or Power Driven Horizontal Sliding, Hinged, or Vertical Rising

    DOOR GASKETS & SEALING TECHNIQUES

    Silicone Rubber Material Static (RLD) Mechanical


    Compression Blown Forward (HSD & VRD) Compressed Air Nitrogen

    AIR JACKETING SYSTEM


    BENEFITS: Faster Heat up/Cool Down Times Minimum Upkeep w/ No Corrosion No Pumps No Water Leaks 15 Year chamber warranty

    Air vs. Water


    Much lower utility consumption Lighter chamber (shipping, rigging, facility) Does not require a hot water heater AND a steam boiler Far more flexible in temperature profiles (ramp up/down) Greater temperature uniformity
    $30.00 $25.00 $20.00 Cost per Cycle $15.00 $10.00 $5.00 $0.00 Water/Jackets Air/I-Beams

    Air vs. Water Cost

    Water/Jackets Air/I-Beams

    Heating $23.20 $4.40

    Setpoint $5.41 $5.41

    Cooling $26.30 $4.16

    *Based on specified cycle parameters

    3 Pallet example only

    CHAMBER RECIRCULATION
    Staggered for superior mixing and temperature uniformity Incorporated within jacketing (e.g. no heat loss) Does not impede on internal chamber volume Validated with one or more off

    Motors are explosion-proof, with rotation sensors as per ISO 11135

    GAS DISPENSING SYSTEM

    EtO Volatizer

    EtO Gas Dispensing Panel

    Material Handling
    Hands-off hot product

    DOCUMENT SUBMITTALS
    ETC submits front end documents of varying degrees for comment and approval for each sterilizer project. Submitted 2-4 weeks after receipt of order (autoclaves)

    Production Schedule Preliminary Drawing Package Installation Arrangement (for approval) P&I Diagrams (for approval) Equipment Weights Utility Consumption (Peak and Nominal) Ventilation Requirements and Heat Loss Specs. Noise Levels

    ADVANTAGE STERILIZER CONTROL SYSTEM


    The following control elements will be included as a minimum:
    PLC-/PAC Allen-Bradley ControlLogix Desktop or Panel PC w/Printer Database Server to serve all three units Door status and control for each door Flex EX Chamber I/O Air solenoid Manifold Gas Room Interface EtO tank scale controls Emission Control Interface Material Transport Interface Uninterruptible Power Supply (UPS)

    PRO GENESIS ADVANTAGE CHARACTERISTICS

    Sterilization process control with advanced cycle programming Clear Cycle Status indications Alarm handling Access security Cycle data storage Printer Active P&ID screen Electronic records respective of 21 CFR Part 11 Maintenance & Calibration areas

    FLEXIBLE PHASE PROGRESSION

    IN-HOUSE TESTING
    All sterilizers are subjected to Quality Control and FAT procedures which include the following:
    ASME Hydro Testing Vacuum/Pressure Leak Testing Point to Point Wiring Check Software Bench Testing Vacuum Performance Test Door Operational Test Operational System Testing Chamber and Wall Temp. Mapping Actual Cycle Runs (sans EtO) Factory Acceptance (FAT)

    DOCUMENTATION
    Equipment Specific Operations and Maintenance Manuals are custom tailored to include:
    Manufacturers U-1 Data Sheet (pressure vessel cert) Operational Description Troubleshooting & Preventive Maintenance Procedures Critical Drawings such as electrical schematics and P&I D Bills of material (B/Ms) Component cut sheets (Vendor Data) Spare Parts List Calibration Procedures & certifications

    VALIDATION SUPPORT DOCUMENTATION


    Software Process Description (SPD) Software Requirements Specification (SRS) Software Design Specification (SDS) Software Test Plan (STP) Factory Acceptance Test Procedures (FAT) Site Acceptance Test Procedures (SAT) Installation & Operational Qualification Services

    Teleflex Medical/Arrow International


    Double door 8-pallet EtO Sterilizers (five total) Manually Loaded onto passive rollers Indexing station at unload end Ante-room at unload end for isolation Heated Aeration rooms at unload end

    Conventional Automated

    J&J Medical
    Fully automated Four Chambers

    Preconditioning Exposure Aeration Secondary Aeration

    Tunnel Special S/S Pallets Nitrogen Ante-Rooms

    Terumo
    Single Door Manually loaded/unloaded Fork-truck Reinforced Floor Sophisticated Robotic Aeration Material Handling System

    ITL Healthcare (and Steritech)


    10 Pallet Chambers Double Door Double Wide Pre/Post Staging Drag Chain Conveyors standard pallets

    STERIS/Isomedix Minneapolis
    Five chambers 3 to 12 pallet in length Single door Passive rollers Loaded/Unloaded Manually

    STERIS/Isomedix El Paso, TX (building #2)


    Four (4) 6,000 cubic foot sterilizers (two more in production) Vertical Rising Doors Automated Unloading Systems Mezzanine Mounted Piping EtO Snubbers

    114x126x698 (5,802 cu. ft.) During Welding

    114x126x698 (5,802 cu. ft.) Prior To Final Assembly

    ETC Sterilizer Division Meeting our customers expectations

    County line Industrial Park Southampton, PA 18966-3877 Tel. 215-355-9100 Fax 215-357-4000

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