2019 johannesburg expo medicinal cannabis
TRANSCRIPT
Slide 1 © PharmOut 2018
2019 JohannesburgExpo – Medicinal Cannabis
Facility Design Considerations
Trevor Schoerie - Managing DirectorNovember 2019
Slide 2 © PharmOut 2018
Slide 3 © PharmOut 2018
Medicinal Cannabis
Software – Paperwork
Control Strategy
- Drives the Design
- Basis of design
Validation Lifecycle
- 3 stages of validation
Pharmaceutical Quality System
- 200 documents
Hardware FSE
Facility
- fabric, logical layout, mix up
Services
- power, water, laboratories
Equipment
- non reactive, cleanable
Slide 4 © PharmOut 2018
54 PIC/S member authorities (1 January 2019)
4 Partners
EDQMEMA
UNICEFWHO
New Zealand
Iceland
Canada
USA
Argentina
South Africa
Australia
Malaysia
Taiwan
Switzerland
Norway
Indonesia
Ukraine
Singapore
Israel
Liechtenstein
EUROPEAN UNION Member States Agencies (29)
Japan
South Korea
Hong Kong
Thailand
Mexico
Iran
Turkey
Newest members 1 Jan 2018All slides © PharmOut Pty Ltd
Slide 5 © PharmOut 2018
Six (EU – PIC/S) GMP requirements
Front End
Engineering
Study
(FEED)
Functional
and
Detailed
Design
Facility User
Requirement
Specification
(URS)
Tender Construction Installation CommisioningFacility
Handover
Validation
Master
Plan
(VMP)
Factory
Acceptance
Testing
(FAT)
Design
Qualification
(DQ)
Qualification
Protocol
Development
Pre-delivery
Inspection
(PDI)
Execute Installation
Qualification (IQ)
and Operational
Qualification (OQ)
Execute
Performance
Qualification
(PQ)
Facility/
Equipment
approved for
Manufacture
Supplier
Assessment
Process
Validation
Summary
Report
GMP /
Quality Risk
Assessment
Project
plannning/
scoping (includes org
structure)
System
Implem-
entation
Project Plan
and Schedule
Monitor
system for
effectiveness
System
development
and approval
Training and
assessment
Quality
Manual /
Policies
User
Requirement
Specification
Functional
Specification
(FS)
GMP Risk
Assessment
Design
Qualification
(DQ)
Factory
Acceptance
Testing (FAT)
Operational
Qualification
(OQ)
Performance
Qualification
(PQ)
Quality and
Project Plan
(QPP)
Pre-delivery
Inspection
(PDI)
Design
Specification
(DS)
Installation
Qualification
(IQ)
Qualification
Protocol
Development
Validation
Summary
Report (VSR)
ConstructionSupplier
Assessment
Site
Master
File
Rectify any
identified
deficiencies
GMP
license
application
Pre-GMP
licensing
audit
Lodge
application
with TGA
Requirement 1
GMP Facility Design, Construction and Validation
Obtain GMP
license
Requirement 3
GMP Quality System Development and Implementation
Requirement 2
Equipment / Lab Method / IT Validation
Requirement 5
TGA Good Manufacturing Practice (GMP) License
Requirement 6
Regulatory Product Registration
Common
Technical
Document
Product
Registration
TGA GMP Requirements for Pharmaceutical Drugs
Commercial
Manufacturing
Raw Material
Specifications
In-process
Specifications
Finished
Product
Specification
Requirement 4
Product Characterisation/Specification
Purchase
Purchase
Validation
Master
Plan
(VMP)
Most requirements are concurrent
Quality System Elements- Product Realisation + Raw Material procurement & assurance
+ Manufacture
+Testing
+ Batch Release
+Storage & Distribution
Supporting sub-systems- Document Control
- Vendor Assurance
- Training
- Validation
- Calibration
- Preventative Maintenance
- Deviation Management (CAPA)
- Change Control
- Self Inspection
A typical GMP compliant quality
system would include SOPs and
sub-systems as defined above.
Slide 6 © PharmOut 2018
• Site, Context
• Access, Security
• Location, Town Planning
• Proximity to Labour, Transport
• Services, supply
• Weather, climate
It is critical to design facilities from an understanding of site context
Slide 7 © PharmOut 2018
EnvironmentBOM data: 133 million data points
• Weather data used to assess appropriateness of the climate to the intended crop that is to be raised
• Weather data informs the design of buildings, location of (any) greenhouses and the type of greenhouses
(e.g.)
• Circle colour represents daily solar radiation
• Circle size represents % of temperatures within the desired range (during growing hours selected)
Slide 8 © PharmOut 2018
SurroundsData : Solar Exposure And Rainfall
0
20
40
60
80
100
120
0
5
10
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20
25
30JA
N
FE
B
MA
R
AP
R
MA
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JU
N
JU
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AU
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SE
P
OC
T
NO
V
DE
C
MEAN
SO
LAR
EXPO
SU
RE (
MJ/
SQ
M//
MO
NTH
UQ Gatton Mean daily solar exposure (MJ/(m*m)) for years 1990 to 2019
Applethorp Mean daily solar exposure (MJ/(m*m)) for years 1990 to 2019
UQ Gatton Mean rainfall (mm) for years 1897 to 2019
Applethorp Mean rainfall (mm) for years 1966 to 2019
Slide 9 © PharmOut 2018
SurroundsData : Relative Humidity
0
10
20
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40
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60
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90
JA
N
FE
B
MA
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AP
R
MA
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JU
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JU
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AU
G
SE
P
OC
T
NO
V
DE
C
RELATIV
E H
UM
IDIT
Y (
%)
UQ Gatton Mean 9am relative humidity (%) for years 1938 to 2010 UQ Gatton Mean 3pm relative humidity (%) for years 1995 to 2010
Applethorp Mean 9am relative humidity (%) for years 1966 to 2010 Applethorp Mean 3pm relative humidity (%) for years 1966 to 2010
Slide 10 © PharmOut 2018
SurroundsData : Maximum Temperature
0
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40
45
50
JAN
FE
B
MA
R
AP
R
MA
Y
JUN
JUL
AU
G
SE
P
OC
T
NO
V
DE
C
TEM
PER
ATU
RE
(°C
)
UQ Gatton Mean maximum temperature (Degrees C) for years 1913 to 2018
UQ Gatton Highest temperature (Degrees C) for years 1965 to 2018
Applethorp Mean maximum temperature (Degrees C) for years 1913 to 2018
Applethorp Highest temperature (Degrees C) for years 1966 to 2018
Slide 11 © PharmOut 2018
SurroundsData : Minimum Temperature
-10
-5
0
5
10
15
20
25
JA
N
FE
B
MA
R
AP
R
MA
Y
JU
N
JU
L
AU
G
SE
P
OC
T
NO
V
DE
C
TEM
PERATU
RE (°C
)
UQ Gatton Mean minimum temperature (Degrees C) for years 1913 to 2018
UQ Gatton Lowest temperature (Degrees C) for years 1965 to 2018
Applethorp Mean minimum temperature (Degrees C) for years 1966 to 2018
Applethorp Lowest temperature (Degrees C) for years 1966 to 2018
Slide 12 © PharmOut 2018
Planning
• Planning factors externally driven by the municipality
• Planning zones are critical in site assessments - they stipulate what the site can and cannot be used for - and any further requirements
• The purpose of zones and overlays is to regulate and inform the use of land.
• The site may also have an ‘overlay’ - informs on a specific requirement of the land.
Slide 13 © PharmOut 2018
Site Master Plan
• Single point of entry• Natural site features• Concentric layering• Vehicle/pedestrian
controls• Carparking requirements• Perimeter site access• Solar orientation• Common loading• Services considerations• Central building services
Slide 14 © PharmOut 2018
Site Security
• Natural site features• Secure perimeter• Site monitoring• Staff within boundary• Minimum 2 layers• Single point of entry• Concentric gradient• Security access levels 1-5• Product categorisation• Common services
Slide 15 © PharmOut 2018
The cultivation and subsequent processing of medicinal cannabis has a significant demand on site services and other resources.
Due diligence on the availability and capacity of site services is required to confirm that this demand can be met.
Design driven by systems.
Slide 16 © PharmOut 2018
• Design not derived through a listing of square metre areas, but through the ‘process lens’:
• Product specification,
• Product capacity,
• Production schedule,
• Production technology,
• Process utilities/services.
Slide 17 © PharmOut 2018
Slide 18 © PharmOut 2018
Wheel Of Fortune
• Step-wise process• Form follows function• Functional adjacencies• ‘Lean Manufacturing’• Collective set definitions• Increasing GMP
downstream• Common support core• Within security envelope
Slide 19 © PharmOut 2018
Facility layout
• ‘Step-wise’ design• Reflects process flow• ‘Lean’ manufacturing• Ratio of functional areas• Central services at
height• Common point of entry• Common warehouse• Public exterior ‘layers’• Secure interior ‘layers’• North facing (SH) GH• South facing (SH) HH
Slide 20 © PharmOut 2018
Systems
Process
design
Slide 21 © PharmOut 2018
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Slide 24 © PharmOut 2018
Modularity, Scalability
and Flexibility
Common observations in cannabis cultivation:
• High capital cost• Environment of reducing sales prices• Seeking competitive advantage
Key cost factors requiring reduction:
• Energy• Infrastructure• Labour
Slide 25 © PharmOut 2018
Our estimator –Quick planning and cost estimator
• Single brief for the design team
• Captures scope of work on day one
• Quickly shows high level costs and scales to verify clients intent and budget
• Output consistent ratios across projects
• Co-located knowledge base of all our findings
• Self learning
• Verify concept designs
• Can be used to review external designs
Slide 26 © PharmOut 2018
Architectural and Engineering
•
Slide 27 © PharmOut 2018
Six Project Steps
Slide 28 © PharmOut 2018
Slide 29 © PharmOut 2018
Manufacturing Design – Lean Manufacturing
Medicinal Cannabis Cultivation
and Manufacturing
conceived as a pharmaceutical
manufacturing facility.
Facility design is derived from
understanding the material,
personnel and waste flows
Slide 30 © PharmOut 2018
Thank you
Trevor Schoerie
Managing Director
www.pharmout.net