Biopharma Facility – Design Execution & Design Aspects

Austin Lock

V20.3

BioPharma India Convention

December 2010
Agenda – Biopharma Facility Design Execution & Design Approaches

1. Facility Statement of Requirements (Design Brief)

2. Facility Design Aspects
3. Advances / Trends in Facility Design
4. Summary
1. Facility Statement of Requirements (Design Brief)
1.

Business Case
Project Drivers Facility
Integration
Facility into Site
Statement of
Requirements
Specific (Design Brief)
Business
Requirements

Operations
Processes &
Production
1.
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 Capital

Investment
1.
Specific Business Requirements

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
1.
The Processes and Production

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
1.
Operations

Working shift pattern

Level of automation

Key Operational Philosophies (which impact layout and
process design):
 CIP Philosophy

 Storage Philosophy

 Waste Handling

 Logistics Handling

 Maintenance Access & ergonomics

1.
Facility Integration into Site
1.

Business Case
Project Drivers Facility
Project Facility Integration
into Site
Definition
Statement of
Requirements
Specific
Business
(Design Brief)
Requirements
Operations
Processes &
• Initiated at the start of Production
Feasibility / Concept
• Approved for the start of Basic
Design
• Important to maintain
consistency with SOR
throughout Design Phases
2. Facility Design Aspects
 Culture X2 Inoculation

2.
Process Design X2
Fermentation / Extraction
100L Primary Ferm.
800L Secondary Ferm.
X6
X2
800L Production Ferm. 3000L Flocculation
Vessel
X2 X1
2500L Harvest Vessel Centrifuge

X2 X2
1200L Centrifuge
HA Chromatography
Receiving Vessel

Be aware of over design!

2.
Segregation & Flow Concepts

Identify the Segregation Concepts: 3 CORRIDORS

 Physical, procedural, environmental, and

chronological (time)
 Primary Segregation – addresses direct

environmental contamination threat (e.g.

use of closed processing, segregation
between different products or lots)
 Secondary Segregation - address
2 CORRIDORS
management of the facility rather than
intrinsic product protection (e.g. number
of corridors, clean to dirty flow)

Identify the Flow Philosophies:
 Personnel (Gowning Philosophy)
1 CORRIDOR
 Materials (Handling Philosophy)
2.
Vertical Concepts
 2.
Layout Development Process

Flows,
Constructability Process
Fire Safety Definition

HVAC Design &

Facility
Environmental Operating
Classification Layout
Definitions

Concept
Layouts, HVAC Segregation
Design & Adjacency Diagrams Concepts, Personnel
Environmental / Material Handling
Equipment Building Blocks
Classification Philosophies
Accommodation Schedule
2.
Building Architecture

External Labs Internal

Functional

Finishes

Image

Blend Offices
3. Advances / Trends in Biopharma Facility Design
 Advances / Trends in Facility Design
3.

Use disposable technologies to reduce

capital investment, support closed
processing

Greater use of closed processing,
lower environmental classifications

Increased use of modular construction
technologies:
 Skids / Superskids

 Construction Modules

More sustainable design features

4. Summary
 Summary

4.

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
 Thank You
Consultants, Engineers & Architects to
the Biopharma Industry

PM Group
FF-1, Alpine Arch
#19/3, Langford Road
Bangalore 560 027
India
Tel: +91 8040624062
E-mail: bangalore@pmgroup.asia