Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. Rockwell Automation TechED 2015 @ROKTechED #ROKTechED
PUBLIC INFORMATION
Nephron Doubles Capacity, Eases Validation with Integrated Control and Information
Chad Owens
Senior R&D Engineer
Nephron Pharmaceuticals Corporation
NEPHRON PHARMACEUTICALS
CORPORATION
COMPANY OVERVIEW Leading specialized manufacturer of Blow-Fill-Seal (BFS)
pharmaceutical manufacturing. Founded in 1991, NPC is a private woman owned business. Existing products include
generic respiratory medications: Albuterol Sulfate, Ipratropium
Bromide, a combined Albuterol/Ipratropium dose, Racepinephrine and Saline.
Distributed approximately 1 billion doses of sterile respiratory
medicine in each of the last five calendar years
Nephron products can be found in any pharmacy, hospital, or
long-term care facility in the US
SC Plant built and set-up for new contract manufacturing opportunities.
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BFS TECHNOLOGY – ROTARY MACHINES
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Elimination of Risk:
• Continuous process - no parison
cut or particle generation
• Containers are formed, filled and
sealed with downward motion of
mold
• Critical area (Point of fill) is Class
100 and completely
encapsulated
• Inner surface of parison and fill
needles are never exposed to
outer environment
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AUTOMATED PARTICLE INSPECTION
• Integrated Batch Reporting • Ability to review rejected products and images
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100% IN LINE LEAK DETECTION PUCK SYSTEM FOR INJECTABLE PRODUCTS
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TRAY LOADING AND SSCC PALLET TRACKING
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WAREHOUSING AND LOGISTICS • Real time tracking of all plant
inventory.
• All pallets stored with SSCC
Information
• Delivered to Packaging in LIFO
• Stages Shipment orders
managed by our PIMS System
• Interface with E80 using real
time WEB-API with JSON
Objects. (Real Time)
• Inducts all components using
Barcode and RFID Technology
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AUTOMATED PACKAGING
• LSS User Interface
• Batch Data
• Complete Tray Verification
State of the art
singulation and
ultrasonic
wrapping
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AUTOMATED PACKAGING CUSTOMIZED SEPARATION AND PUCK LOADING SYSTEM FOR INJECTABLE BOTTLES
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TRACK AND TRACE
GS1 Standard
Compliant
Labeling
GS1 Data Matrix 2D
Barcode Imbedded with
Serial Number and Lot
Information
DISTRABUTION & MARKETING
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Transportation: Servicing the continental U.S. through an affiliated trucking company via four distribution centers:
Orlando, FL; Phoenix, AZ; Murray, KY and Columbia, SC
Distribution: Contracts with all major drug wholesalers such as Cardinal and McKesson, Long Term Care, Homecare
companies and Hospitals
Sales: Current pricing contracts with GPOs and drug distribution agreements with wholesalers
Marketing: National sales force of 50+ people calling on
doctors, pharmacies, hospitals
BUSINESS NEED - SCOPE
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• Provide automated control for the formulation process at the filling lines • Automate valves
• Tank Pressure control
• Tank Level monitoring
• WFI Additions
• API and Excipient Additions
• Control mixing
• Monitor Temperatures and Pressures Throughout the system
• Collect Plant Data including: • Plant Utilities
• Room Monitoring Data
• Machine Data for Manufacturing and Packaging
• Electronic Batch Record (EBR) • Ability to combine all relevant data into a single electronic report
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VENDOR SELECTION • Entered project with Wonderware as the main contender
• Wonderware had already been selected to provide the HMI and
historical data for our WFI Pump-skid application and was in the lead to
be used plant wide.
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VENDOR SELECTION • DeltaV enters the conversation
• Thoughts behind DeltaV
• Provided more reliable data
• More real time Monitoring
• New Management was from the polymere industry and the
utilized DeltaV – Higher level of comfort.
• PI Historian – DeltaV utilizes PI Historian
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VENDOR SELECTION • Allen-Bradley® Sneaks in with integrated PI Historian
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COST AND EASE OF INSTALLATION EVALUATION
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PATH FORWARD
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Formulation / BFS Panel # 2 ( Lines 25 – 26 )
Printer ( s ) Scale ( s ) Label Printer ( s )
Formulation / BFS Panel # 1 ( Lines 27 – 28 )
WFI Pretreatment
PLC BFS PLCs
( 4 )
Leak Detector PLCs ( 4 )
BFS PLCs ( 4 )
Leak Detector PLCs ( 4 )
Packaging PLC
Elettric 80 PLC
FTH LIVE FT Historian Live Data
Collector OPC Interface
Trayloader PLCs ( 4 )
Delta Robot PLCs ( 4 )
Trayloader PLCs ( 4 )
Delta Robot PLCs ( 4 )
Johnson Controls MetaSys
ALL EM DATA VALIDATED SYSTEM
Enterprise Network
IPT PLC ( WFI Storage WFI Stills ( 2 ) Pure Steam )
Resins
Formulation / BFS Panel # 3 ( Lines 21 – 22 )
HMI Displays ( 2 ) FactoryTalk View
( Lines 27 – 28 )
HMI Displays ( 2 ) FactoryTalk View
( Lines 25 – 26 )
HMI Displays ( 2 ) FactoryTalk View
( Lines 21 – 22 )
HMI Displays ( 2 ) FactoryTalk ViewPoint
Industrial Waste & Nitrogen
FTH - SERVER FT Historian Server
( 50 , 000 Points )
- FTV - SERVER
FT View ( HMI Server ) ( 250 displays – 6 Clients )
FTAC -SERVER FT AssetCentre
Software Repository and Disaster Recovery
HMI Displays ( 2 ) FactoryTalk ViewPoint
HMI Display ( 2 ) FactoryTalk ViewPoint
Process Tank Level Display
HMI Displays ( 1 ) FactoryTalk View
Industrial Waste & Nitrogen HMI
PLATFORM - FACTORYTALK® ASSETCENTRE
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• Validated Automation Software Repository
• Store all PLC, HMI, Parameter, and Config. Files
• Separate Access for Engineers and Quality
• Gives full file History with comments (Use to track PR’s)
• Logs all activity in our FactoryTalk® System.
• Logins to HMI’s
• Parameter Changes
• PLC File Changes (For AB Devices)
PLATFORM - FACTORYTALK® VIEW SE NETWORK DISTRIBUTED
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• Network Distributed HMI Functionality
• Ability to manage HMI Changes and User
Access from a centralized server
• PlantPAx® HMI/PLC Integration allowed for DCS
like Rollout
• Log-in’s and changes are tracked with Alarms
and Events monitoring
PLATFORM – FACTORYTALK® HISTORIAN SE
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• Validated Plant wide Historical Database • 50,000 tag System
• Collects all plant data from Multiple sources • Manufacturing equipment • Plant Utility Systems
• Automated Formulation
• Data Reporting • Process Book • DataLink Excel Add-in • FactoryTalk® VantagePoint®
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PROCESS CONTROL OF PLANT SYSTEMS WATER FOR INJECTION
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ENVIRONMENTAL MONITORING JCI METASYS SYSTEM INTEGRATION
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FORMULATION CONTROL
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FORMULATION CONTROL
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Confidential Property of Nephron Pharmaceuticals Corp.
VALIDATION APPROACH Validated for storage and retrieval of all automation software
View SE:
Historian SE:
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Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
PUBLIC INFORMATION
Rockwell Automation TechED 2015 @ROKTechED #ROKTechED
Questions?
NEPHRON PHARMACEUTICALS
CORPORATION