Tim Wortley,
Download
1 / 41

Tim Wortley, Global Product Mgr, Kaye Products GE Sensing Tim.Wortley@ge Chip Bennett - PowerPoint PPT Presentation


  • 78 Views
  • Uploaded on
  • Presentation posted in: General

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.

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha

Download Presentation

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

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -

Presentation Transcript


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

  • Validation, Monitoring and Thermal Mapping since 1970’s


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

  • 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


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?

  • 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

  • Low Power (12+ months battery life)

  • Simply works

  • Self Forming / Correcting Networks

  • Interference Free

  • Secure data transfer, tamperproof (Part 11)


Implementing Wireless


Corporate LAN/Intranet

Area/Floor 1

Area/Floor 2

Area/Floor 3

Building Lan/WiFi


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

  • 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

    • 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

    • 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 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


    Validating Wireless


    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

    • 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: 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: 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: 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 PharmaceuticalsSt Louis, Mo


    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


    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


    KV

    • Long Time Kaye User

    • Wired Labwatch 24/7 GMP Monitoring Systems

    • Validation / Mapping Systems

      • Digi, Validator Thermcouple wired Systems


    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)


    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

    • 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


    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

    • 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)

    Validation


    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


    ad
  • Login