ETC Sterilization Systems

Presented by:

David Mitchell, VP & Business Unit Manager

Email: dmitchell@etcusa.com 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