Date post: | 08-Apr-2018 |
Category: |
Documents |
Upload: | austinlock |
View: | 216 times |
Download: | 0 times |
of 21
8/6/2019 Biopharma Facility Design Execution & Design Aspects - Austin Lock
1/21
Biopharma Facility Design Execution & Design AspectsAustin Lock
BioPharma India Convention
December 2010
V20.3
8/6/2019 Biopharma Facility Design Execution & Design Aspects - Austin Lock
2/21
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
8/6/2019 Biopharma Facility Design Execution & Design Aspects - Austin Lock
3/21
1. Facility Statement of Requirements (Design Brief)
8/6/2019 Biopharma Facility Design Execution & Design Aspects - Austin Lock
4/21
Facility
Statement ofRequirements(Design Brief)Specific
BusinessRequirements
Processes &Production
Business CaseProject Drivers Facility
Integrationinto Site
Operations
1.
8/6/2019 Biopharma Facility Design Execution & Design Aspects - Austin Lock
5/21
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
1.
8/6/2019 Biopharma Facility Design Execution & Design Aspects - Austin Lock
6/21
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.
8/6/2019 Biopharma Facility Design Execution & Design Aspects - Austin Lock
7/21
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.
8/6/2019 Biopharma Facility Design Execution & Design Aspects - Austin Lock
8/21
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.
8/6/2019 Biopharma Facility Design Execution & Design Aspects - Austin Lock
9/21
Facility Integration into Site1.
8/6/2019 Biopharma Facility Design Execution & Design Aspects - Austin Lock
10/21
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
8/6/2019 Biopharma Facility Design Execution & Design Aspects - Austin Lock
11/21
2. Facility Design Aspects
8/6/2019 Biopharma Facility Design Execution & Design Aspects - Austin Lock
12/21
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!
8/6/2019 Biopharma Facility Design Execution & Design Aspects - Austin Lock
13/21
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.
8/6/2019 Biopharma Facility Design Execution & Design Aspects - Austin Lock
14/21
Vertical Concepts2.
8/6/2019 Biopharma Facility Design Execution & Design Aspects - Austin Lock
15/21
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
8/6/2019 Biopharma Facility Design Execution & Design Aspects - Austin Lock
16/21
Building Architecture
External Internal
2.
Blend
Functional
Image
Labs
Offices
Finishes
8/6/2019 Biopharma Facility Design Execution & Design Aspects - Austin Lock
17/21
3. Advances / Trends in Biopharma Facility Design
8/6/2019 Biopharma Facility Design Execution & Design Aspects - Austin Lock
18/21
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.
8/6/2019 Biopharma Facility Design Execution & Design Aspects - Austin Lock
19/21
4. Summary
8/6/2019 Biopharma Facility Design Execution & Design Aspects - Austin Lock
20/21
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.
8/6/2019 Biopharma Facility Design Execution & Design Aspects - Austin Lock
21/21
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]