Tim Wortley Global Product Mgr Kaye Products GE

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

Tim Wortley, Global Product Mgr, Kaye Products GE Sensing Tim. [email protected] com Chip Bennett KV Pharmaceuticals A Case Study at KV Pharmaceuticals, St Louis

Overview - Background: Why Wireless - The Technology - Wireless in Action 2/ GE

Overview - Background: Why Wireless - The Technology - Wireless in Action 2/ GE / 12 March 2021

Why Wireless 3/ GE / 12 March 2021

Why Wireless 3/ GE / 12 March 2021

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

Why Wireless – Wired Systems Validation, Monitoring and Thermal Mapping since 1970’s 4/ GE / 12 March 2021

Why Wireless – Wireless Loggers Appeared late 1990’s from Food Industry - Harsh Environment

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 5/ GE / 12 March 2021

Why Wireless – True Realtime Wireless - No Wiring / Feedthru’s - Realtime data

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 6/ GE / 12 March 2021

The Business Case – Chamber Mapping 7/ GE / 12 March 2021

The Business Case – Chamber Mapping 7/ GE / 12 March 2021

Why Now? Industrial wireless is not new - Wireless has been used in industry

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 8/ GE / 12 March 2021

Why Now in Pharma? Reliability - RF Mesh can provide 99. 9% transmission reliability

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 9/ GE / 12 March 2021

Key Wireless Features - Low Power (12+ months battery life) - Simply works -

Key Wireless Features - Low Power (12+ months battery life) - Simply works - Self Forming / Correcting Networks - Interference Free - Secure data transfer, tamperproof (Part 11) 10 / GE / 12 March 2021

Implementing Wireless 11 / GE / 12 March 2021

Implementing Wireless 11 / GE / 12 March 2021

Corporate LAN/Intranet Area/Floor 1 Area/Floor 2 Area/Floor 3 Building Lan/Wi. Fi 12 / GE

Corporate LAN/Intranet Area/Floor 1 Area/Floor 2 Area/Floor 3 Building Lan/Wi. Fi 12 / GE / 12 March 2021

Why, What, How Why should I do this Easy of wiring, existing sensor interface

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 13 / GE / 12 March 2021

Installing Wireless - Neither data nor power wiring is required - Battery Life 1

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 14 / GE / 12 March 2021

Automatic Joining and Formation -Network is self forming and self-optimizing -Each Node can -

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 15 / GE / 12 March 2021

Fully Redundant Mesh Routing Redundant routing is a must have in the real world

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 16 / GE / 12 March 2021

Fully Redundant Mesh Routing Spatial Diversity - Normally multiple antenna’s fractions of wavelength apart

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” 17 / GE / 12 March 2021

Reliability 18 / GE / 12 March 2021

Reliability 18 / GE / 12 March 2021

Validating Wireless 19 / GE / 12 March 2021

Validating Wireless 19 / GE / 12 March 2021

Principles of Validation -Standard Validation Instruments - SOP, IQ, OQ, DQ Package - GAMP

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 20 / GE / 12 March 2021

Principles of Validation: Wireless - Data Reliability & Integrity - Storage of data -

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 21 / GE / 12 March 2021

Principles of Validation: Wireless - Wireless Audit - Know what’s installed (Internal and External)

Principles of Validation: Wireless - Wireless Audit - Know what’s installed (Internal and External) - Frequency bands/types - Industrial Wireless, Legacy Palm. Net - Wi. Fi, 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. 4 GHz ISM band - Data transmission time in milliseconds - Data rate < 100 bytes for packet = “on” time few milliseconds 22 / GE / 12 March 2021

Principles of Validation: Wireless Mesh Configuration - Due to TDMA, mesh topology impacts data

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 23 / GE / 12 March 2021

Principles of Validation: Wireless - Data Validation - Data Delivery - Data timestamped, and

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 24 / GE / 12 March 2021

KV Pharmaceuticals St Louis, Mo 25 / GE / 12 March 2021

KV Pharmaceuticals St Louis, Mo 25 / GE / 12 March 2021

KV - Centralized manufacturing under KV Pharma - 6 Locations around St 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 26 / GE / 12 March 2021

KV Showcase Facility Build-Out and Retro Fit Highly Configurable Suites Stability Chambers, Portable Incubators

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 27 / GE / 12 March 2021

KV Long Time Kaye User -Wired Labwatch 24/7 GMP Monitoring Systems - Validation /

KV Long Time Kaye User -Wired Labwatch 24/7 GMP Monitoring Systems - Validation / Mapping Systems - Digi, Validator Thermcouple wired Systems 28 / GE / 12 March 2021

KV -Wanted to expand monitoring to showcase facility - With no Thermocouples - With

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) 29 / GE / 12 March 2021

KV - Corporate IT - RF Security & Reliability Issues - Interoperability (or insure

KV - Corporate IT - RF Security & Reliability Issues - Interoperability (or insure none could occur… ) - Heavy Wireless user already - Wi. Fi, Wireless Process Control - Mobile, cellular, pager, Blackberry etc Key Decision maker and enabler. Got IT on board almost on Day 1 30 / GE / 12 March 2021

Issues - 4 Buildings within 1 -15 miles of each other - Expanding System

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 31 / GE / 12 March 2021

Systems Installed: Mobile Incubator, Stability (ICH) Rooms 32 / GE / 12 March 2021

Systems Installed: Mobile Incubator, Stability (ICH) Rooms 32 / GE / 12 March 2021

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Monitoring Systems -Expanding to All locations - Corporate Intranet Backbone – Wi. Fi &

Monitoring Systems -Expanding to All locations - Corporate Intranet Backbone – Wi. Fi & T 1/3 - 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 36 / GE / 12 March 2021

Maintenance -SOP states Annual Calibration requires Battery Change - Calibration in Place - Calibration

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 37 / GE / 12 March 2021

Validation -Experience with Wireless Monitoring - Purchased Wireless Validation Systems sight unseen - Received

Validation -Experience with Wireless Monitoring - Purchased Wireless Validation Systems sight unseen - Received Wireless Validation Systems for Temperature Mapping (& RH) 38 / GE / 12 March 2021

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Summary KV Good Example - In 18 months wireless is now >50% of Monitoring

Summary KV Good Example - In 18 months wireless is now >50% of Monitoring Applications for Kaye - In 3 Months, Wireless Validation is now quoted 3050% of Time Thanks to Chip Bennett and staff at KV Pharmaceuticals Pharma and Biopharma rapid adopters on Wireless Technology, even in GMP areas 41 / GE / 12 March 2021