Biopharma Facility Design Execution & Design Aspects - Austin Lock

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Biopharma Facility Design Execution & Design AspectsAustin Lock

BioPharma India Convention

December 2010

V20.3


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Agenda Biopharma Facility Design Execution & Design Approaches

1. Facility Statement of Requirements (Design Brief)

2. Facility Design Aspects3. Advances / Trends in Facility Design

4. Summary


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1. Facility Statement of Requirements (Design Brief)


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Facility

Statement ofRequirements(Design Brief)Specific

BusinessRequirements

Processes &Production

Business CaseProject Drivers Facility

Integrationinto Site

Operations

1.


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Business Case, Project Drivers, Project Definition

Before SOR Approval, the need to understand and define

the reasons for a project / investment is essential

Business Case & Objectives:

Debottleneck / Capacity Increase / GMP / New Product /Cost of Goods

Project Drivers:

Cost Driven / Schedule Driven / Phasing of CapitalInvestment

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Type of Facility: Production (Bulk, formulation & filling), packaging,R&D, Teaching

Scale of Production: Clinical Trials / Market Entry / Production

Proposed Markets and Regulatory Framework: National / Regional / Global

WHO / CDSCO/ EU / FDA Specific Organisation Requirements:

Attract Clients

Attract & Retain Staff

Centre of Excellence

Low Cost of Production

Flexibility or Not!

Corporate Image e.g. green credentials Future requirements define what is to be designed for

Specific Business Requirements1.


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Processes & Production Drive the Facility Design

Identify scope: single or multiproduct (campaign based / concurrent based)

Identification of Type of Products - Impact facility design

Expression systems & associated technology (Cell Culture, Microbial, Yeast, Viruses)

Biosafety Level

Scale of Operation (MABs cf. Viral Vectors)

Requirement for viral segregation

Identification of the Processes, Unit Operations, and associated Technologies

Identification of critical process parameters and quality attributes Definition of Open and Closed Operations: Impact on Area Classifications

Definition of all Process Support Operations: Material Prep, Washing, IPC etc

The Processes and Production1.


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Working shift pattern

Level of automation

Key Operational Philosophies (which impact layout andprocess design):

CIP Philosophy

Storage Philosophy Waste Handling

Logistics Handling

Maintenance Access & ergonomics

Operations1.


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Facility Integration into Site1.


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FacilityStatement of

Requirements(Design Brief)Specific

BusinessRequirements

Processes &Production

Business CaseProject Drivers

ProjectDefinition

FacilityIntegration

into Site

Operations

1.

Initiated at the start of

Feasibility / Concept

Approved for the start of Basic

Design Important to maintain

consistency with SOR

throughout Design Phases


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2. Facility Design Aspects


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Process Design2.

Culture InoculationInoculation

100L Primary Ferm.

800L Secondary Ferm.

Fermentation / ExtractionFermentation / Extraction

800L Production Ferm.

2500L Harvest Vessel

3000L FlocculationVessel

Centrifuge

1200L CentrifugeReceiving Vessel

HA Chromatography

X2

X6X2

X2

X2

X1

X2

X2

Be aware of over design!


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Segregation & Flow Concepts

Identify the Segregation Concepts:

Physical, procedural, environmental, and

chronological (time)

Primary Segregation addresses directenvironmental contamination threat (e.g.

use of closed processing, segregation

between different products or lots)

Secondary Segregation - addressmanagement of the facility rather than

intrinsic product protection (e.g. number

of corridors, clean to dirty flow)

Identify the Flow Philosophies:

Personnel (Gowning Philosophy)

Materials (Handling Philosophy)

1 CORRIDOR

2 CORRIDORS

3 CORRIDORS

2.


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Vertical Concepts2.


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Layout Development Process

Operating

Definitions

Adjacency Diagrams

Equipment Building Blocks

Accommodation Schedule

Segregation

Concepts, Personnel

/ Material Handling

Philosophies

Flows,

Constructability

Fire Safety

Concept

Layouts, HVACDesign &

Environmental

Classification

Facility

Layout

Process

Definition

2.

HVAC Design &

Environmental

Classification


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Building Architecture

External Internal

2.

Blend

Functional

Image

Labs

Offices

Finishes


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3. Advances / Trends in Biopharma Facility Design


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Use disposable technologies to reducecapital investment, support closed

processingGreater use of closed processing,

lower environmental classifications

Increased use of modular constructiontechnologies:

Skids / Superskids

Construction Modules

More sustainable design features

Advances / Trends in Facility Design

3.


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4. Summary


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Essential to understand and define Business Case and Drivers

Important to maintain consistency with SOR throughout Design Phases

The Processes & Production Drive the Facility Design

Recognise that projects may fail in early design stages through over

design

Building architecture can promote company image and create an

enhanced working environment

Disposables and modular technologies are becoming more common

place, but recognise impact on the design process

Summary

4.


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Consultants, Engineers & Architects to

the Biopharma Industry

Thank You

PM GroupFF-1, Alpine Arch

#19/3, Langford Road

Bangalore 560 027

India

Tel: +91 8040624062

E-mail: [email protected]

Documents

Biopharma Facility Design Execution & Design Aspects - Austin Lock