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Tim Wortley, Global Product Mgr, Kaye Products GE Sensing Tim.Wortley@ge Chip Bennett

Tim Wortley, Global Product Mgr, Kaye Products GE Sensing Tim.Wortley@ge.com Chip Bennett KV Pharmaceuticals. A Case Study at KV Pharmaceuticals, St Louis MO. Overview. Background: Why Wireless The Technology Wireless in Action. Why Wireless. Why Wireless – Wired Systems.

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Tim Wortley, Global Product Mgr, Kaye Products GE Sensing Tim.Wortley@ge Chip Bennett

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  1. Tim Wortley, Global Product Mgr, Kaye Products GE Sensing Tim.Wortley@ge.com Chip Bennett KV Pharmaceuticals A Case Study at KV Pharmaceuticals, St Louis MO

  2. Overview • Background: Why Wireless • The Technology • Wireless in Action

  3. Why Wireless

  4. Why Wireless – Wired Systems • Validation, Monitoring and Thermal Mapping since 1970’s

  5. Why Wireless – Wireless Loggers • Appeared late 1990’s from Food Industry • Harsh Environment possible • No wiring • No process visibility • Can Loose study data e.g. battery failure. • Needed to repeat studies

  6. Why Wireless – True Realtime Wireless • No Wiring / Feedthru’s • Realtime data during • Validation / Mapping • Devices can stay in place • for 3 runs • Estimate save 30-50% on Validation / Mapping costs

  7. The Business Case – Chamber Mapping

  8. Why Now? • Industrial wireless is not new • Wireless has been used in industry for decades • Legacy wireless fits niche applications but has not reached broad adoption • Two recent developments have ignited interest in industrial wireless • Standardization and availability of low-cost, low-power radios • Introduction of self-organizing, self-healing wireless networking software Standard radios and self-organizing networks change the economics of monitoring and control

  9. Why Now in Pharma? • Reliability • RF Mesh can provide 99.9% transmission reliability • Data storage/redundancy eliminate risk of repeated runs • Security • Immune to RF Interference, snooping, insertion of invalid data • Useability • No RF Site surveys required. System works out of box • Fully Validatable The right wireless infrastructure can be Validated

  10. Key Wireless Features • Low Power (12+ months battery life) • Simply works • Self Forming / Correcting Networks • Interference Free • Secure data transfer, tamperproof (Part 11)

  11. Implementing Wireless

  12. Corporate LAN/Intranet Area/Floor 1 Area/Floor 2 Area/Floor 3 Building Lan/WiFi

  13. Why, What, How • Why should I do this • Easy of wiring, existing sensor interface • What is wired, what does a system comprise • How would I roll out • How would I validate

  14. Installing Wireless • Neither data nor power wiring is required • Battery Life 1 to 5 years • Change Battery on Annual Cal if required • Site Surveys not required • Reliably works within 150-300’ • Each node is a “repeater”, daisy chain for distance • Mesh network self-configures and periodically self-optimizes • Traditional model – over-design & over-built wireless infrastructure to cope with worst case

  15. Automatic Joining and Formation • Network is self forming and self-optimizing • Each Node can • Discovers Neighbours • Measures RF Signal Strength • Optimizes signal paths • Dynamically optimize signal routing • route signal traffic from neighours • A node may • join as an end node, • become a routing node due to changing RF conditions, • revert back to an end node Auto-Configuration  Best Signal Path at all Times

  16. Fully Redundant Mesh Routing • Redundant routing is a must have in the real world • Conditions change dramatically over time • due to weather, • new/unknown RF systems, • moving equipment and population density • A full mesh topology with automatic node joining and healing lets the network maintain long-term reliability and predictability in spite of these challenges

  17. Fully Redundant Mesh Routing • Spatial Diversity • Normally multiple antenna’s fractions of wavelength apart • Enabling each node to discover multiple possible parent nodes and then establish links with two or more • A full mesh network • No special-purpose routers, base stations, or aggregators • Buy the sensors you need, that’s all • Low wireless expertise and installation skills • Can be installed by users, low installation costs • No site surveys, no over-engineering and over-building of point-to-point connections • None of “It may work”

  18. Reliability

  19. Validating Wireless

  20. Principles of Validation • Standard Validation Instruments • SOP, IQ, OQ, DQ Package • GAMP Cat 3 • Monitoring Systems • Software Validation: GAMP Cat 4(Configurable Software Packages) • End to End I/O Check & Calibration • Wireless Issues

  21. Principles of Validation: Wireless • Data Reliability & Integrity • Storage of data • Interferences • Can anything in my plant interfere with the wireless system • Does this new system interfere with anything pre-existing in my plant

  22. Principles of Validation: Wireless • Wireless Audit • Know what’s installed (Internal and External) • Frequency bands/types • Industrial Wireless, Legacy PalmNet • WiFi, Cell Repeaters, walkie-talkie • “Interferee” • Monitor data reliability numbers during validation phase • Expect 99.99% + Data reliability • Frequency hopping & Smart Mesh technology Key • “Interferor” • Low power transmissions, 2.4GHz ISM band • Data transmission time in milliseconds • Data rate < 100 bytes for packet = “on” time few milliseconds

  23. Principles of Validation: Wireless • Mesh Configuration • Due to TDMA, mesh topology impacts data time skew • But TDMA requires precision (millisecond) network time synchronization • All nodes know the time, all the time. • Timestamped data, better than most instruments on the market. • EN 285 specifies 0.5% • Instruments typically 5-15 seconds/day • Validateable

  24. Principles of Validation: Wireless • Data Validation • Data Delivery • Data timestamped, and stored both in nodes and routers for recovery later • Data can never be wrong (e.g. corrupted) but can be late • Data Integrity • As with wired systems • From point of measure to display/report

  25. KV PharmaceuticalsSt Louis, Mo

  26. KV • Centralized manufacturing under KV Pharma • 6 Locations around St Louis, MO • Three go-to Market Subsidiaries • ETHEX Corporation (Generics) • Ther-Rx Corporation (Branded) • Specializing in Women's Health around Infection, Prenatal Supplements and Iron supplement • Particle Dynamics, Inc (Specialty Ingredients) Missouri – the “Show Me” state

  27. KV • Showcase Facility • Build-Out and Retro Fit • Highly Configurable Suites • Stability Chambers, Portable Incubators • Hot/Cold Chambers / Walk-Ins • 24/7 Monitoring, Validation and Mapping

  28. KV • Long Time Kaye User • Wired Labwatch 24/7 GMP Monitoring Systems • Validation / Mapping Systems • Digi, Validator Thermcouple wired Systems

  29. KV • Wanted to expand monitoring to showcase facility • With no Thermocouples • With no Steel power conduit (Local Code Regulations) • AND Wireless battery powered technology newly available (Jan 2006)

  30. KV • Corporate IT • RF Security & Reliability Issues • Interoperability (or insure none could occur… ) • Heavy Wireless user already • WiFi, Wireless Process Control • Mobile, cellular, pager, Blackberry etc Key Decision maker and enabler. Got IT on board almost on Day 1

  31. Issues • 4 Buildings within 1-15 miles of each other • Expanding System to all facilities as built-out • 1 to 3 floors per building • 1-3 “corridors” per floor, 5-10 chambers/areas per “corridor” • Users • Building/Floor Supervisors (See only local info) • Central Monitoring & Validation People (See system wide) • Remote IT People (Manage Desktops remotely) • Locked down Computers in GMP Area’s • Active IT Management for Patching

  32. Systems Installed: Mobile Incubator, Stability (ICH) Rooms

  33. Monitoring Systems • Expanding to All locations • Corporate Intranet Backbone – WiFi & T1/3 • Addition of Points • Very Easy – Lick & Stick, Velcro • Portable equipment - sensors go with equipment provided within Antenna range • If move building, simply software configuration (minimal validation) • No Interference from older to newer technology

  34. Maintenance • SOP states Annual Calibration requires Battery Change • Calibration in Place • Calibration in Adjacent Cal lab • Wireless still active, same node, same Base Station, Same PC, Same Infrastructure • Maintain end-to-end measurement chain

  35. Experience with Wireless Monitoring Purchased Wireless Validation Systems sight unseen Received Wireless Validation Systems for Temperature Mapping (& RH) Validation

  36. Summary • KV Good Example • In 18 months wireless is now >50% of Monitoring Applications for Kaye • In 3 Months, Wireless Validation is now quoted 30-50% of Time Thanks to Chip Bennett and staff at KV Pharmaceuticals Pharma and Biopharma rapid adopters on Wireless Technology, even in GMP areas

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