Case Study: New High Purity Water System Technologies Deliver Reliability & Sustainability
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Transcript of Case Study: New High Purity Water System Technologies Deliver Reliability & Sustainability
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PRESENTERS
BRIAN LIPKO, PE Senior Project Manager Hargrove Life Sciences
BRIAN TERMINE, PE Maintenance Engineering Manager GlaxoSmithKline
STEVE WALTER, CPIP Process Systems Technology Hargrove Life Sciences
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ACKNOWLEDGMENTS
RANDY MINTO, PE, Program Manager, GlaxoSmithKline
DAN D’AQUILA, PE, Director of Engineering & Validation, GlaxoSmithKline
ED STEVENS, Engineering Manager, GlaxoSmithKline
ALEX TANJUTCO, Validation Project Manager, GlaxoSmithKline
TED DOMBROWSKI, Senior Project Engineer, Arcadis (on behalf of GSK)
ROBERT HOEPPNER, Project Executive, Henderson Constructors, Inc.
MIKE BILLUPS, Project Manager, Henderson Constructors, Inc.
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Introduction
AGENDA
Execution Results
Background Objectives Challenges
Benefits Lessons Learned
Summary
Design Construction Qualification
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Introduction
INTRODUCTION
Execution Results
Background Objectives Challenges
Benefits Lessons Learned
Summary
Design Construction Qualification
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CTM (Clinical Trial Materials)
Facility
Manufactures purified drug substances for
clinical trials worldwide
INTRODUCTION: BACKGROUND
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INTRODUCTION: BACKGROUND
Existing HPW & WFI systems obsolete
Parts no longer available
Insufficient capacity for future expansion or production increase
Costly systems not energy efficient
Increased plant downtime risk due
to insufficient equipment reliability
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INTRODUCTION: BACKGROUND
Project Scope
REPLACE 2 OBSOLETE WATER SYSTEMS
HPW High Purity Water
WFI Water for Injection
New Reliable System Design
Supply HPW to Biopharm Development Pilot Plant
Change System Configuration from 3 to 2 Pumps
Replace WFI Control Panel Install Redundant VC Stills
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INTRODUCTION: OBJECTIVES
DELIVER SUSTAINABILITY
REDUCE WATER & ENERGY USAGE
REPLACE OBSOLETE EQUIPMENT
PROVIDE RELIABILITY THROUGH REDUNDANCY
NO IMPACT TO ON-GOING OPERATIONS
INCREASE SUPPLY &
STORAGE CAPACITY
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INTRODUCTION: OBJECTIVES RELIABILITY THROUGH REDUNDANCY
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re·dun·dant serving as a
duplicate for preventing
failure of an entire system
HPW WFI Multi-Media Filters Softeners Carbon Filters RO/CDI Skid Tank Nitrogen
Filters Distribution Pumps
Vapor Compression Stills
Tank Vent Filters Distribution
Pumps
No Unplanned Downtime
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INTRODUCTION: OBJECTIVES
Generation and Storage Capacity
Insufficient during Maintenance Activities
Need to be Adept & Flexible
Accommodate Emerging Technologies in Manufacturing
Generation Capacity Bottlenecked
Required Daily Water Usage Planning Activities
CLINICAL TRIALS
HPW
WFI
INCREASE SUPPLY & STORAGE CAPACITY
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Reverse Osmosis Pre-Treatment System
(Built c.1987)
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FRP High Purity Water Storage Tank
2000 Gallon (Built c.1987)
INTRODUCTION: OBJECTIVES OBSOLETE EQUIPMENT
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Multi-Effect WFI Still (5 MEF)
(Built c. 1987)
(3) WFI Distribution Pumps One pump on each floor (Spares in Warehouse)
INTRODUCTION: OBJECTIVES OBSOLETE EQUIPMENT
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Softener Regeneration
Brine Tank
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Softener Regeneration Salt Pellets Palletized 40 lb bags
Consumed 400-800 lb/day
INTRODUCTION: OBJECTIVES OBSOLETE EQUIPMENT
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INTRODUCTION: OBJECTIVES
SC Microbial Microbial Fermentation Media Prep Microbial Purification Buffer Prep
Building 5 Building 38
Biopharm GMP Clinical Trial Production
Manufacturing
Building 4
Biopharm Development
Pilot Plant
NO IMPACT TO ON-GOING OPERATIONS
Safety Assessment
Manufacturing
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INTRODUCTION: CHALLENGES
WFI CONTROL
PANEL CHANGE
OUT
IMPACT TO ON-GOING
OPERATIONS: PHASED
APPROACH
VENDOR COMMITMENT
FOR EQUIPMENT DELIVERY
INSTALL WINDOW
& AVAILABLE DOWNTIME LIMITED
SPACE
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INTRODUCTION: CHALLENGES
Generation Equipment
Access
Utilities
BUILDING 38
EXISTING MECHANICAL
ROOM
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Introduction
INTRODUCTION
Execution Results
Background Objectives Challenges
Benefits Lessons Learned
Summary
Design Construction Qualification
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SUSTAINABILITY EVALUATION
PROJECT LOCATIONS & CONSTRAINTS EQUIPMENT
EVALUATION
VISIT OTHER GSK SITES
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EXECUTION: DESIGN
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Site 1: Christ System
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Site 2: Siemens: PreVUE®
Other Site Tours (Gemba)
EXECUTION: DESIGN
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Options Decision
HPW
Single Pass vs. Double Pass RO Single Pass
Polisher vs. None Install Polisher
Carbon vs. Bi-sulfite vs. UV Light Filtration Carbon Filtration
Service Type vs. Back Washable Carbon Filters Back Washable
Hot Water vs. Chemical Sanitization Hot Water Sanitization
FRP vs. SS HPW Storage Tank SS Tank
High Recovery RO vs. None High Recovery RO
Nitrogen Blanket on Storage Tank vs. None Nitrogen Blanket
Bulk Brine vs. Day Tank Both
Redundant vs. Single Storage Tank Filters Redundant Filters
EQUIPMENT EVALUATION
EXECUTION: DESIGN
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Options Decision
WFI
Vapor Compression vs. Multi Effect Vapor Compression
Separate Pump per Floor vs. Redundant Pumps Redundant Pumps
Redundant vs. Single Storage Tank Filters Redundant Filters
EQUIPMENT EVALUATION
EXECUTION: DESIGN
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SUSTAINABILITY EVALUATION
Systems Design
Evaluations
Operating Cost
Comparisons
Wastewater Volume
Reduction
EXECUTION: DESIGN
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Only Feasible Solution:
Utilize existing Courtyard between B5 & B38 (14’ W x 110’ L)
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Project Locations Limited
PROJECT LOCATIONS & CONSTRAINTS
EXECUTION: DESIGN
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Top of Courtyard Looking NORTH
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Bottom of Courtyard Looking SOUTH
EXECUTION: DESIGN PROJECT LOCATIONS & CONSTRAINTS
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2-STORY MECHANICAL ROOM DESIGN
EXECUTION: DESIGN
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EXECUTION: DESIGN 2-STORY MECHANICAL ROOM DESIGN
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Construct Addition
& Install
HPW System
Install WFI Pumps
& Control Panel
Demo Old HPW System
Install WFI VC
Stills
Demo Old Still
Phased Construction/ Qualification
Approach
PHASE 1 PHASE 1A PHASE 2
NO IMPACT TO ON-GOING OPERATIONS
EXECUTION: DESIGN
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Construct 2-Story Addition for HPW
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Between 2 Buildings Limited Access Adjacent GMP Operations
EXECUTION: DESIGN PHASE 1
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EXECUTION: DESIGN PHASE 1
Construct 2-Story Addition for HPW
Between 2 Buildings Limited Access Adjacent GMP Operations
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EXECUTION: DESIGN SYSTEM CONSIDERATIONS
Choose Vendor that Supplies Customizable PLC Controllers: Normalized Differential Pressure to determine cleaning interval Softener Regeneration is based on Hardness Softener Regeneration Rinse is based on Conductivity
Bulk Brine Tank System
Energy Efficiency
S3 Technology & Pump VFDs
Reduce Water Usage
S3 Technology & High Recovery RO
WFI: Pump Schemes
Fathom Software Complexity of Flows – Multiple Floors
Online TOC, Conductivity &
Microbial Detection
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EXECUTION: DESIGN PHASE 1A - WFI
No Redundancy
Difficult to Control Flow
Maintenance requires
Shutdown
Single Pump affected Tank Temp and other
Floor Availability
OLD SYSTEM
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EXECUTION: DESIGN PHASE 1A - WFI
Generated from Fathom Modeling
NEW SYSTEM
Redundancy
Control From Worst Case
Pump Maintenance = No downtime
VFD’s to manage fluctuations
Individual Loops can be Isolated
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EXECUTION: DESIGN WFI CONTROL PANEL
Desktop Simulation
Only
20 Year Old
System
No ‘Plan B’
Instruments = 86 I/O Points = 106 GREATEST RISK
Extensive Pre-planning
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EXECUTION: DESIGN HPW GENERATION SUMMARY
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EXECUTION: CONSTRUCTION TIMELINE
Week 1 25 33 41 49 57 65 73 81 89 97
Phase 2 Begins Shut Down & Phase 1 End
4/21/14
Shut Down Begins
12/16/13
Construction Begins
4/1/13
PHASE 2
PHASE 1A 7 WK
CONSTRUCTION AWARD
DESIGN 24 WEEKS
PHASE 1
9 105 17
Construction Complete
6/16/14 Design KO 6/4/12
CM Award 11/5/12
8 WKS
PROCUREMENT & DOCUMENTS 29 WEEKS
44 WEEKS
CONSTRUCTION
9/3/12 POs
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EXECUTION: CONSTRUCTION Existing
Courtyard
Stone & Soil Excavation
1st Floor Slab Installation
PHASE 1
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Maintain Building Integrity during Removal of Building Façade
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EXECUTION: CONSTRUCTION TEMPORARY PROTECTION
Removal of the façade exposed Utilities above occupied space inside
Installed Temporary Partition Walls in Active Areas & Issued Change Control
Updated Qualified Flow Drawings Continually During Construction
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EXECUTION: CONSTRUCTION
Large Crane due to Limited Access
Building Structure Construction
PHASE 1
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EXECUTION: CONSTRUCTION
Installation of HPW Equipment
PHASE 1
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EXECUTION: CONSTRUCTION
Outdoor Bulk Brine Tank 2nd Floor HPW
PHASE 1
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EXECUTION: CONSTRUCTION
2nd Floor Dual Softeners & Multi-Media Filters
2nd Floor Dual Carbon Filters
PHASE 1
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EXECUTION: CONSTRUCTION
1st Floor Dual RO Skids
1st Floor HPW Tanks & Pumps
PHASE 1
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EXECUTION: CONSTRUCTION
B38 Mechanical Room New WFI Pumps
B38 Mechanical Room Existing WFI Pumps to Demo
PHASE 1A
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EXECUTION: CONSTRUCTION
B38 Mechanical Room HPW System to Demo
Access Doors to B38 Mechanical Room
PHASE 2
6’6”
8’8”
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EXECUTION: CONSTRUCTION
New WFI Stills in B38 Mechanical Room
New WFI Stills at FAT Sugarland, TX
PHASE 2
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EXECUTION: CONSTRUCTION LEVERAGED QUALIFICATION APPROACH
Vendor Qualification Documents Reformatted to GSK Standards PRIOR to Factory Acceptance Test (FAT)
PEOPLE
Qualification Team: Validation Engineering Facilities QA
EQUIPMENT CHECK
Resolve issues prior to shipment Equipment Still at Factory
DURATION
Reduced Document Development Time by 3 weeks Duplicated FAT during SAT
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EXECUTION: CHALLENGES CONSTRUCTION
Constrained Area within the Middle of Operating Buildings
Delivery of High Purity Equipment
S3 Design Not Turn-Key
Polisher Tank Delivery
Sartorius Filter Housings
Installation of High Purity Equipment
DI Tank Filters
Failure of PQ1 Testing (Plan B)
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EXECUTION: QUALIFICATION VALIDATION DOCUMENTATION
1 Validation Master Plan (HPW/WFI) including 3 Validation Interim Reports
5 User Requirement Specs
14 Change Controls
27 Installation Operation Qualification Documents
10 Standard Operating Procedure Updates
22 Functional Design Specifications
3 Factory Acceptance Test / Site Acceptance Test
2 Design Qualifications
EXT
EN
SIV
E D
OC
UM
EN
T M
AN
AG
EM
EN
T
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Introduction
INTRODUCTION
Execution Results
Background Objectives Challenges
Benefits Lessons Learned
Summary
Design Construction Qualification
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RESULTS: BENEFITS
INCREASED SUPPLY
& CAPACITY
IMPROVED RELIABILITY
& DELIVERED
SUSTAINABILITY
LOWER OPERATING
EXPENSE
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IMPROVED SUPPLY TO CLINICAL OPERATIONS
RESULTS: BENEFITS
Increased Capacity & Reliability
Redundant HPW & WFI B38 B5 B4
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RESULTS: BENEFITS Reduced ~11,000 gallons per day / ~4,050,000 gallons per year Cost savings of ~$32K per year (Water & Sewer) Supports GSK’s strategic goal to reduce Water Consumption
Annual carbon emissions reduction of 348 TONNES CO2 Supports GSK’s strategic goal to reduce Carbon Footprint
New System supplying HPW to Biopharm Development Pilot Plant Eliminated Building 5 Resin Bed Train Service New Bulk Brine & Online Microbial Detection Systems Cost Savings of ~$170,000 per year
Water Consumption
Electrical Energy
Carbon Emissions
Operations
Pumping operations reduced by 88% Cost Savings of ~$28k per year
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OPERATING SAVINGS
RESULTS: BENEFITS Online Microbial Detection System
Synchronized Optical
Monitoring
Particulate Size
Microbial Fluorescence
Reduces Regulatory Sampling
Doesn’t Eliminate
Bioburden/Endotoxin 20%
(96) samples/yr
4th System Installed in US
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RESULTS: LESSONS LEARNED
Full Control
Replacement: Demo Simulation of Functionality
Integration of
Automation Contractor
Selection of Construction Contractor
WHAT WENT WELL
Procurement Management
WFI Batcher Orifices
WFI Still & Clean
Steam Supply Pressure
PQ1 Failure / ‘Plan B’
COULD HAVE DONE BETTER
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SUCCESS!
RESULTS: SUMMARY
CONSTRUCTED & VALIDATED IN LESS THAN 1
YEAR
TWO VALIDATED SYSTEMS
& NEW GENERATION EQUIPMENT
MINIMAL IMPACT TO ON-GOING OPERATIONS
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RESULTS: SUMMARY
MINIMIZED DOWNTIME
DELIVERED SUSTAINABILITY
LOWER OPERATING
EXPENSE
INCREASED RELIABILITY
OBJECTIVES EXCEEDED!
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RESULTS: SUMMARY OBJECTIVES EXCEEDED!
We kept the Trains on the Tracks
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QUESTIONS