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8/8/2019 Funda Bio Facility Design
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Fundamentals of
BiopharmaceuticalFacility Design
INTAS BIOPHARMACEUTICALS LIMITED
S. BALLAL & M. KODILKAR
Dec 29, 2010
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Program Introduction
Key Design Parameters
Emerging Trends
Design Process
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Introduction Traditional: Single
product facilities 1990s: Multi-
product facilities
introduced GMP evolves to
permit multi-product operationswith sharedequipment
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Key Design Parameters Process Flows / Unit Operations
Process Volumes
Biosafety
Viral Segregation Multi-product V/s Single Product
Regulatory Requirements
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Process Flows Biopharma facilities are built around the process
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Process Flows Segregation
Inoculum prep
Centrifugation: noisy, aerosol generating, difficult toclean
Pre viral & post viral steps in DSP Column packing areas: open, manual operations
Solvent use areas: flame-proof zone
Product changeovers: Segregation in overlapping
batches
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Process Volumes Large (~ >1500L)
Stationary systems
Hard piped
CIP/SIP
Centralized CIP Long pipe runs
Multistoried units
Small Mix of stationary, mobile
CIP hardpiping preferred
COP/SOP possible
Multiple CIP units
Large MALs, corridors Space for clean staging
CNC spaces for less critical operations, closed operations
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Biosafety BL1 preferred.
Exponential rise in capital cost with higher Biosafetylevels
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Viral Segregation Detection of potentially harmful viruses in DS (Porcine
parvovirus in Factor VIII)
Principle concern: Segregation of post-viral material frompre-viral.
Extended to segregation in area, airlocks, washing. Separate AHUs and washing areas
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Multi Product /Singleproduct Multi Product Facility
Need flexibility foraccommodating processes
Equipment more flexible inoperating ranges
Utilities oversized
Pre-determined, multi-directional transfer paths
Larger quantum of extraspace provision
More disposables used
Single Product Facility One/two batch sizes,
defined process
Sizing, flowsstraightforward
Utilities sized to batchvolumes & processschedules
Defined operating range
Fixed equipment preferred
over disposables No additional space
provisions required.
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Regulatory requirements Which regulator will approve the facility? What do they
require?
Are there any key flags to look for?
Talk to the regulators & get a feel of their opinion prior to
basic/detail design.
EU needs Class A in B for inoculum prep.
India does not specify viral segregation.
PICS & others like Indonesia require separate PAL MAL
USFDA open to considering V+, V- process steps in thesame room.
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Emerging Trends in FacilityDesign Disposable/ Single use systems
Use of Controlled Non Classified (CNC) areas
Multi-product facilities with parallel operations
Modular Plants & Superskids
Visual Factories and Open Space concepts
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Single Use Products: Influenceon Facility Design Reducing requirement of
cleaning spaces SIP/CIP/SOP/COP, Staging,tank movement
Reduced Size of Utilities andPiping both Central Utilitiesand within a process room
Easily validatable closedsystems allow use of lower airclassification
Rapid deployment lessplanning due to low cost ofcapital
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Use of CNC Areas
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Multi-product facilities withparallel operations Historically:
Multiproduct Operation = Campaign mode
Newer technologies for closed operations and riskbased approach
Manufacturers pushing for simultaneous multi-productoperations
Regulators more open to concept Ok if segregationand cross contamination issues are addressed
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Modular Plants andSuperskids
Superskids: Reduce sitework, shrinktimelines, offsite Qualification
Modular plants: Designed, constructed,integrated offsite
Reduce sitework Condense Construction Timelines Pre-tested & integrated- no last minute
surprises Higher Cost, Suited for midsized plants,
infrastructural constraints
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Workplaces not Factories To provide better working environment
Moving away from windowsless artificially lighted rooms
Contract manufacturers- key drivers: To attract potentialcustomers
Influence Design room placements, adjacencies
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Designing a Facility Start with defining the process, lay down operational
requirements
Build the facility around the process- add functional areasaround the process
Flexibility comes at a price
Design only for more expected variables Ex. 85% processcoverage of LAMP
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The Facility Design Process
Facility URS
Conceptual Design (3-4 months) Basic layouts, site plan, buildingsizing, utilities-basic plan and sizing, line diagrams, equipment
lists, overall philosophies & budget cost (+ 25%) Basic Design (3-4 months)- Room sizing, utility sizing, detailed
layout, equipment URSs, P & IDs and cost (+ 10%)
Detailed Design (8-12 months): Full/detailed designing of allelements. 1000s of drawings, 2D and 3 D designing
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If you are lucky.
You will end up making THAT product, forwhich you designed the facility!