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Tim Wortley, Global Product Mgr, Kaye Products GE Sensing Chip Bennett KV Pharmaceuticals PowerPoint Presentation
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Tim Wortley, Global Product Mgr, Kaye Products GE Sensing 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 Chip Bennett KV Pharmaceuticals

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Presentation Transcript

Tim Wortley,

Global Product Mgr, Kaye Products

GE Sensing

Chip Bennett

KV Pharmaceuticals

A Case Study at KV Pharmaceuticals, St Louis MO

  • Background: Why Wireless
  • The Technology
  • Wireless in Action
why wireless wired systems
Why Wireless – Wired Systems
  • Validation, Monitoring and Thermal Mapping since 1970’s
why wireless wireless loggers
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
why wireless true realtime wireless
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
why now
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

why now in pharma
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

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

Corporate LAN/Intranet

Area/Floor 1

Area/Floor 2

Area/Floor 3

Building Lan/WiFi

why what how
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
installing wireless
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
automatic joining and formation
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

fully redundant mesh routing
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
fully redundant mesh routing17
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”
principles of validation
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
principles of validation wireless
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
principles of validation wireless22
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
principles of validation wireless23
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
principles of validation wireless24
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
  • 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

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

  • 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
monitoring systems
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
  • 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
Experience with Wireless Monitoring

Purchased Wireless Validation Systems sight unseen

Received Wireless Validation Systems for Temperature Mapping (& RH)

  • 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