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Tim Wortley, Global Product Mgr, Kaye Products GE Sensing [email protected] Chip Bennett KV Pharmaceuticals se Study at KV Pharmaceuticals, St Loui
Tim Wortley, Global Product Mgr, Kaye ProductsGE [email protected]
Chip BennettKV Pharmaceuticals
A Case Study at KV Pharmaceuticals, St Louis MO
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April 22, 2023
Overview
- Background: Why Wireless- The Technology- Wireless in Action
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April 22, 2023
Why Wireless
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April 22, 2023
Why Wireless – Wired Systems
Validation, Monitoring and Thermal Mapping since 1970’s
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April 22, 2023
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
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April 22, 2023
Why Wireless – True Realtime Wireless- No Wiring / Feedthru’s
- Realtime data duringValidation / Mapping
- Devices can stay in place for 3 runs
- Estimate save 30-50% onValidation / Mapping
costs
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April 22, 2023
The Business Case – Chamber MappingCategory Wired Solution Logger Solution Wireless
Hardware Capital Costs 20,000$ 30,000$ 23,000$ Depreciation 5 years 3 years 5 yearsCalibration Capital Costs 10,000$ 12,000$ 12,000$ Depreciation 5 years 5 years 5 yearsAnnual Depreciation Total 6,000$ 12,400$ 7,000$
Consumables (Batteries) 0 1000 100Consumables (Thermocouples) 1000 0 0Recalibration 1500 5500 4500Repair / Out of Warrentee 1000 2000 500Annual Cost of Ownership 3,500$ 8,500$ 5,100$
Wiring/Placement Hours 4 1.5 0.5Programming/Reading 0.5 2 0.5Wiring/Placement Costs 1,800$ 1,400$ 400$
Calibration Hours 4 4 2Calibration Costs 1,600$ 1,600$ 800$
Validation Downtime (400/hr) 400 400 400Time to Failure determination 0.5 24 0.5% chance of failure 2% 10% 2%$$ to restart validation 4 960 4Cost to Validate 3,404$ 3,960$ 1,204$
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April 22, 2023
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
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April 22, 2023
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
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April 22, 2023
Key Wireless Features
- Low Power (12+ months battery life)- Simply works - Self Forming / Correcting Networks- Interference Free- Secure data transfer, tamperproof (Part 11)
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April 22, 2023
Implementing Wireless
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April 22, 2023
Building Lan/WiFi
Corp
ora
te L
AN
/In
tran
et
Area/Floor 1
Area/Floor 2
Area/Floor 3
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April 22, 2023
Why, What, How
Why should I do thisEasy of wiring, existing sensor
interfaceWhat is wired, what does a system compriseHow would I roll outHow would I validate
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April 22, 2023
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
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April 22, 2023
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
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April 22, 2023
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
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April 22, 2023
Fully Redundant Mesh RoutingSpatial 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”
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April 22, 2023
Reliability
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April 22, 2023
Validating Wireless
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April 22, 2023
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
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April 22, 2023
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
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April 22, 2023
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
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April 22, 2023
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
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April 22, 2023
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
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April 22, 2023
KV PharmaceuticalsSt Louis, Mo
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April 22, 2023
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
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April 22, 2023
KV
Showcase Facility Build-Out and Retro FitHighly Configurable SuitesStability Chambers, Portable IncubatorsHot/Cold Chambers / Walk-Ins24/7 Monitoring, Validation and Mapping
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April 22, 2023
KV
Long Time Kaye User-Wired Labwatch 24/7 GMP Monitoring Systems- Validation / Mapping Systems
- Digi, Validator Thermcouple wired Systems
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April 22, 2023
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)
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April 22, 2023
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
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April 22, 2023
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
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April 22, 2023
Systems Installed: Mobile Incubator, Stability (ICH) Rooms
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April 22, 2023
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April 22, 2023
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April 22, 2023
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April 22, 2023
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
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April 22, 2023
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
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April 22, 2023
Validation
-Experience with Wireless Monitoring- Purchased Wireless
Validation Systems sight unseen
- Received Wireless Validation Systems for Temperature Mapping (& RH)
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April 22, 2023
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April 22, 2023
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April 22, 2023
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
