AP15 - Nephron: Doubles Capacity, Eases Validation with Integrated Control and Information

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 )


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


HMI Displays ( 2 ) FactoryTalk View

( Lines 27 – 28 )


( Lines 25 – 26 )


( 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


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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NEPHRON PHARMACEUTICALS

CORPORATION