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Tim Wortley, Global Product Mgr, Kaye Products GE Sensing [email protected] 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 [email protected] Chip Bennett

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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

[email protected]

Chip Bennett

KV Pharmaceuticals

A Case Study at KV Pharmaceuticals, St Louis MO


Overview

Overview

  • Background: Why Wireless

  • The Technology

  • Wireless in Action


Why wireless

Why Wireless


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% onValidation / Mapping costs


The business case chamber mapping

The Business Case – Chamber Mapping


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)


Implementing wireless

Implementing Wireless


Tim wortley global product mgr kaye products ge sensing tim wortley ge chip bennett

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 routing1

    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”


    Reliability

    Reliability


    Validating wireless

    Validating Wireless


    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 wireless1

    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 wireless2

    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 wireless3

    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


    Kv pharmaceuticals st louis mo

    KV PharmaceuticalsSt Louis, Mo


    Tim wortley global product mgr kaye products ge sensing tim wortley ge chip bennett

    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


    Tim wortley global product mgr kaye products ge sensing tim wortley ge chip bennett

    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


    Tim wortley global product mgr kaye products ge sensing tim wortley ge chip bennett

    KV

    • Long Time Kaye User

    • Wired Labwatch 24/7 GMP Monitoring Systems

    • Validation / Mapping Systems

      • Digi, Validator Thermcouple wired Systems


    Tim wortley global product mgr kaye products ge sensing tim wortley ge chip bennett

    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)


    Tim wortley global product mgr kaye products ge sensing tim wortley ge chip bennett

    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


    Issues

    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


  • Systems installed mobile incubator stability ich rooms

    Systems Installed: Mobile Incubator, Stability (ICH) Rooms


    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


    Maintenance

    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


    Validation

    Experience with Wireless Monitoring

    Purchased Wireless Validation Systems sight unseen

    Received Wireless Validation Systems for Temperature Mapping (& RH)

    Validation


    Summary

    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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