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Fundamentals of

Biopharmaceutical
Facility 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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12-Feb-09

Introduction  Traditional: Single product facilities  1990’s: Multi- product facilities introduced  GMP evolves to permit multi- product operations with shared equipment 3 of 20 12-Feb-09 .

Key Design Parameters  Process Flows / Unit Operations  Process Volumes  Biosafety  Viral Segregation  Multi-product V/s Single Product  Regulatory Requirements 4 of 20 12-Feb-09 .

Process Flows  “Biopharma facilities are built around the process” 5 of 20 12-Feb-09 .

difficult to clean  Pre viral & post viral steps in DSP  Column packing areas: open. aerosol generating. Process Flows  Segregation  Inoculum prep  Centrifugation: noisy. manual operations  Solvent use areas: flame-proof zone  Product changeovers: Segregation in overlapping batches 6 of 20 12-Feb-09 .

corridors  Long pipe runs  Space for clean staging  Multistoried units  CNC spaces for less critical operations. mobile  CIP hardpiping preferred  Hard piped  COP/SOP possible  CIP/SIP  Multiple CIP units  Centralized CIP  Large MALs. Process Volumes  Large (~ >1500L)  Small  Stationary systems  Mix of stationary. closed operations 7 of 20 12-Feb-09 .

 Exponential rise in capital cost with higher Biosafety levels 8 of 20 12-Feb-09 . Biosafety  BL1 preferred.

 Extended to segregation in area. washing.  Separate AHUs and washing areas 9 of 20 12-Feb-09 . airlocks. Viral Segregation  Detection of potentially harmful viruses in DS (Porcine parvovirus in Factor VIII)  Principle concern: “Segregation of post-viral material from pre-viral”.

volumes & process directional transfer paths schedules  Larger quantum of extra  Defined operating range space provision  Fixed equipment preferred  More disposables used over disposables  No additional space provisions required. accommodating processes defined process  Equipment more flexible in  Sizing. multi. flows operating ranges straightforward  Utilities oversized  Utilities sized to batch  Pre-determined. Multi Product /Single product  Multi Product Facility  Single Product Facility  Need flexibility for  One/two batch sizes. 10 of 20 12-Feb-09 .

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.  India does not specify viral segregation.  EU needs Class A in B for inoculum prep. 11 of 20 12-Feb-09 . V.  PICS & others like Indonesia require separate PAL MAL  USFDA open to considering V+.process steps in the same room.

Emerging Trends in Facility Design  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 12 of 20 12-Feb-09 .

tank movement …  Reduced Size of Utilities and Piping – both Central Utilities and within a process room  Easily validatable closed systems allow use of lower air classification  Rapid deployment – less planning due to low cost of capital 13 of 20 12-Feb-09 . Staging. Single Use Products: Influence on Facility Design  Reducing requirement of cleaning spaces – SIP/CIP/SOP/COP.

Use of CNC Areas 14 of 20 12-Feb-09 .

Multi-product facilities with parallel operations  Historically: Multiproduct Operation = Campaign mode  Newer technologies for closed operations and risk based approach  Manufacturers pushing for simultaneous multi-product operations  Regulators more open to concept – Ok if segregation and cross contamination issues are addressed 15 of 20 12-Feb-09 .

constructed. integrated offsite  Reduce sitework  Condense Construction Timelines  Pre-tested & integrated. Suited for midsized plants. offsite Qualification  Modular plants: Designed. infrastructural constraints 16 of 20 12-Feb-09 . shrink timelines. Modular Plants and Superskids  Superskids: Reduce sitework.no last minute surprises  Higher Cost.

key drivers: To attract potential customers  Influence Design – room placements. adjacencies 17 of 20 12-Feb-09 . Workplaces not Factories  To provide better working environment  Moving away from windowsless artificially lighted rooms  Contract manufacturers.

add functional areas around the process  Flexibility comes at a price  Design only for more expected variables Ex. lay down operational requirements  Build the facility around the process. Designing a Facility  Start with defining the process. 85% process coverage of LAMP 18 of 20 12-Feb-09 .

1000s of drawings. equipment URSs.Room sizing. detailed layout. P & IDs and cost (+ 10%)  Detailed Design (8-12 months): Full/detailed designing of all elements. The Facility Design Process  Facility URS  Conceptual Design (3-4 months) Basic layouts. building sizing. line diagrams. overall philosophies & budget cost (+ 25%)  Basic Design (3-4 months). utility sizing. 2D and 3 D designing 19 of 20 12-Feb-09 . site plan. utilities-basic plan and sizing. equipment lists.

If you are lucky…. for which you designed the facility! 20 of 20 12-Feb-09 . You will end up making THAT product.

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