Lighthouse Worldwide Solutions Master Presentation
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1 Lighthouse Worldwide Solutions Master Presentation
2 R&D / Headquarters / Manufacturing Medford, OR Manufacturing Service & Repair Center Central Calibration Lab RMA Center Medford, OR Fremont, CA R&D Engineering Pilot Production Executive Management Fremont, CA
3 New Headquarters: Silicon Valley
4 Lighthouse Focus on Quality ISO 9001:2000 Facilities United States: Medford, OR San Jose, CA The Netherlands: Alphen Singapore Thailand 5 Lighthouse Locations are ISO 9000 Registered
5 Lighthouse Worldwide Solutions Pharmaceutical Capabilities: Particle counters and facility monitoring systems for meeting cgmp monitoring regulations 21 CFR Part 210 & CFR Part 11 EU GMP Annex 1 PIC/S Annex 1 WHO Guidelines USP 788/797 Systems designed for compliance Project management services Installation services Validation services Service, repair, retrofit of monitoring systems Calibration per ISO standards Contamination control consulting and training
6 Monitoring Solutions General Monitoring Air Particle Liquid Particle Temperature Humidity Differential Pressure Electrostatic Charge Air Velocity TOC Specific Applications Current on FFU s Chillers/Refrigerators Door Switches Oven Temp Dry Box Humidity Gas Purity Incubators Large LCD Displays
7 Lighthouse Systems Experience Lighthouse experience in FMS system installation, particle counter integration and software Over 200 FMS system installations worldwide Lighthouse is the number one shipper of remote particle counters (numbers exceeding 900 units / month)
8 Pharmaceutical Customers Boston Scientific
9 Lighthouse Pharma Customers (System) Large multi-building Pharma system which consists of particles counters and environmental sensors. These sensors are integrated to the FMS software with alarm beacons. Baxter System ROCHE Sandoz Bimagen Beta Plus Pharma Budelpack NV Galapagos NV Helvoet Pharma Belgium NV Mediline NV Salvamed Novo Nordisk Styker Howmedica system West Pharmaceuticals Hospira / Abbott GE Healthcare system Kabi Fresenius Biogalenica Favea Vericore Jugoremedia Octapharma Q- Med Alcomed BV
10 Lighthouse Pharma Customers (System) Cont d Crucell Dutch Veterian Institute Fresenius Hemocare BV Mallinckodt Medical/ Tyco Microclean B.V Nelipak / Seal Air Sandoz Schenker International TNO Dimes ACE Pharmaceuticals Allergy Therapeutics system Aston University (Mayne-Parma) Astra Zeneca system Baxter system Glan Clywdd Hospital Medtronic Glaxo Smith Kline system NIBSC Stem Cell Bank Pfizer-system University College London system Vericore (Novartis) system Astra Zeneca system Bassaire IBA Molecular Amgen Chiron Organogenisis Pharmaforce Cell Genesys McGuff Pharma MDS Nordion
11 Products
12 Lighthouse Family of Products World s Number One Particle Counters!
13 Remote Particle Counters
14 Remote Particle Counters Largest selection of remote particles counters available Variety of outputs Modbus ASCII 4-20mA RS-485 (Met One Protocol) Ethernet Sensitivity from 0.1µM Flow-rates 0.1 CFM, 1.0 CFM (4) Series includes flow sensor Remote vacuum or self-contained pump units Temp / RH probe options Hydrogen peroxide resistant
15 ELITE Sensor Technology Accelerated Tests at 75 Degrees Celsius and Full Power Extreme Lifetime Infrared Technology Emitter (ELITE) higher power Laser Diode Optical communications grade Laser Diode Packaged and tested for Lighthouse products Accelerated tests performed to verify lifetime Extends lifetime of Laser Diode based products to an estimated years based upon accelerated test results on all products Slide 28
16 REMOTE X104 ELITE Sensor (Optional) Temperature and Humidity Probe >20 Year Laser Life Power LED Flow LED Sampling LED Service LED Status Output: * Flow Status * Sensor Serial # * Calibration Date * Laser Voltage * Background Voltage True Flow Detection & Status From 0.2µm Detection 2-4 Channel Industry Standard MODBUS or Ethernet Protocol Intelligent Alarm Relay for Tool Shut Down
17 REMOTE X104 ELITE Sensor Self-diagnostics The Lighthouse Remote 4 Series particle counter has the most complete self diagnostics of any sensor on the market today. Self-diagnostics help to ensure data accuracy and reliability. Self-diagnostics include: * Laser voltage * Laser background voltage * Laser Diode failure * Photo amp failure * Photo Diode failure * Flow status
18 Remote 5104V VHP, IPA, LpH, Vesphene and Spor-Klenz compatible Class 1 Division 2 Rating Built-in flow monitoring μm 1.0 cfm (28.3 LPM) flow rate Designed for ISO compliance Small size Stainless steel, wash down resistant / splash-tight enclosure 20 year laser life
19 Remote 5104V Wipedownable Case Sealed Inlet VHP Compatible 316L Stainless Steel Sealed Connectors Mounting Tabs Smoothed Surface VHP, IPA, LpH, Vesphene and Spor-Klenz Compatible
20 Remote 5104PN & 5102PN Remote 5104PN: Modbus Remote 5102PN: 4-20mA 1.0 CFM (28.3 LPM) flow rate Built-in pump Filter pump exhaust Pump start / stop via software (5104PN) Stainless steel construction Wipe-down enclosure VAC Power (50/60Hz)
21 Remote 5104PN Channel sizes: μm 1.0 cfm (28.3 LPM) flow rate Internal vacuum pump with flow control Designed for ISO compliance NEMA style stainless steel enclosure LED status indicators VHP, IPA, LpH, Vesphene and Spor-Klenz compatible 20 year laser life
22 Remote 5104PN Wipedownable Case Sealed Inlet 316L Stainless Steel Built in Pump Sealed Connectors 0.2 micron Filtered Exhaust VHP, IPA, LpH, Vesphene and Spor-Klenz Compatible
23 Remote 5104P & 3104P Remote particle counter w/pump Supports remote display Interface: USB, RS-485 or Ethernet HEPA filter cooling fan exhaust and pump exhaust Interface with manifold 32 Port 6 Port Reduced cost for manifold systems
24 Remote 50104H (Remote Boulder Counter) Remote 50104H (remote Boulder Counter for hazardous environments Class 1 Division 2) (Five-Zero-One-Zero-Four H) 5 to 100µm remote particle counter 1.0 CFM with flow monitoring 4 channels For use in Auto Manufacturing, Aerospace and other industrial applications
25 Portable Cart System Real time monitoring of multiple locations Troubleshoot the process Identify particle sources quickly Characterize the process Qualify the equipment
26 Portable Cart System
27 Manifolds Universal Manifold 32 sample locations 1.0 cfm Works with Lighthouse and Met One particle counters Mini-Manifold 6 sample locations 0.1 cfm 4 analog inputs Mini-Manifold+ 6 sample locations 1.0 cfm Fan Mini-Manifold & 0.2 Micron Particle Counter HEPA / ULPA Filter Particle Shedding / Generation Mini-Environment Monitoring With Mini-Manifold & Single Particle Counter
28 Online Remote Viable Sampling
29 Active Air Samplers Similar to sieve impactor; cover contains uniformly spaced orifices; vacuum draws in air which is impacted on agar plate
30 Principle of Operation Similar to sieve impactor; cover contains uniformly spaced orifices; vacuum draws in air which is impacted on agar plate
31 Impaction on Media Plate
32 Remote Viable Sampling Systems Remote SMA Allows for not violating Grade A conditions for sampling SMA is in Grade B environment: with tube to Isokinetic probe for Grade A sampling
33 Active Air Samplers Provides for starting and sampling from inside the room
34 Active Air Samplers
35 Lighthouse Installation Pictures
36 Lighthouse Installation Pictures Viable Sampling
37 Lighthouse Installation Pictures Viable Sampling
38 Remote Viable Sampling Systems Remote microbial sampling system Utilizing microbial agar impactors Controlled via FMS monitoring computer system Internal pump or external
39 Combined Online Viable and Non-Viable Sampling
40 Remote Viable / Non Viable Sampling Systems Combined viable and non-viable sampling 1.0 cfm flow rate Particle sampling at 0.5 and 5.0 micron Controlled locally or via software Internal or external vacuum
41 Remote Viable/Non Viable Sampling Systems Individually Controlled Non-Viable Viable Regulated Flow
42 Installation Viable Particle Combined Viable / Non- Viable Sampling
43 SMA Control Interface: Example Duration will allow the user to click on the text box and select one of the preset sample times for the individual SMA. Time remaining will show how much time is left for the sample. Air flow will show the flow rate of the sample taking place. Start will start the sampling process. Reset will reset the time remaining to the preset sample time selected. Start / stop require password entry
44 SMA Control Interface: Example Manual data can be integrated into an existing record. Input Date Start/Stop Time Description Flow Rate Volume CFU
45 Online Monitoring Systems
46 Vacuum Systems
47 Online Systems Star Configuration 6 Real Time Particle Counters with External Vacuum Pump Real Time Software Data Hub - Ethernet or Modbus Output - Supplies Power to Remotes RS-485 MODBUS Power From Data Hub Vacuum Gauge Optional Items Vacuum pump Vacuum Manifold Alarm Light TRH Sensor DP Sensor
48 Online Systems- Network Configuration 4 Real Time Particle Counters with Built in Vacuum Pump Over Ethernet Real Time Software Built in Vacuum Pumps ps Power and Ethernet ethernet ps Power and Ethernet ethernet ps Power and Ethernet ethernet ps Power and Ethernet ethernet LAN Optional Items Alarm Light TRH Sensor DP Sensor View Station View Station
49 Online Systems- Network Configuration
50 Online Systems- Network Configuration
51 Online Systems- Network Configuration
52 Plug and Play
53 Online Manifold Systems Manifold Sampling System Real Time Software Up to 32 Sample Ports Data Hub - Ethernet or Modbus Output Particle Counter and Sequential Sampling Manifold RS-485 MODBUS Optional Items Alarm Light TRH Sensor DP Sensor
54
55 Online System with Server
56 Thank You
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