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23rd Jan 2018
BIOPHARMACEUTICAL-PROJECT FLOW
SHEETING & LAYOUT
AGENDA OVERVIEW
Presentation 1 Process Flow-sheeting & Equipment Layout: 10.00 to 10.30 (30 mins)
Group/Individual Exercise Block Flowsheet & Layout 45 mins
Presentation 2 Capital Cost Estimating 11.15 to 11.30 (15 mins)
Group/Individual Exercise Capital Cost estimating for flowsheet & Layout 45 mins
Presentation 3 Economic Evaluation 12.15 to 12.45 (30 mins)
INTRODUCTION & OVERVIEW
CV
▪ Gary McRobbie Chemical Engineer – Graduated in 1991
▪ Life Science Consultant with BPE www.bpe-ds.com
▪ BPE are a process led consultancy of about 25 people
▪ Predominantly worked in the Pharma & Bio Pharma Business Sector for over 25 years
▪ Worked for Pfizer for 12 years, Fermentation Technologist, Pilot Plant Supervisor, Capital Projects & Production Manager
▪ Worked for a Biotechnology equipment supplier (OEM) Pall Life Science Division for 4 years, European Sales Engineering Support Manager
▪ Last 10 years worked for various Engineering Consultancies, Kvaerner John Brown, Jacobs & PMG
▪ Clients: GSK, AstraZeneca, Novartis, BMS, Merck Serono, Pfizer
WHO ARE THE PROCESS ENGINEERING DESIGN
COMPANIES IN UKTOP TIER
Company
Fluor Engineering (Farnborough)
AMEC Foster Wheeler – Wood
Group (Reading & Manchester)
Jacobs Engineering (Manchester
& Glasgow)
Bechtel (London)
Worley Parsons ( London &
Teeside)
Company
Mott Macdonald (Croydon)
DPS (Ireland)
WSP CEL (Coventry)
Project Management Group
(Ireland & Birmingham)
MIDDLE TIER THIRD TIER
Company
Scitek (Guildford)
Manrochem (Huddersfield)
IPS- Integrated Services
(Birmingham)
BPE (Winchester)
WHO ARE THE BIO-PHARMACEUTICAL COMPANIES
Company Company
1. Johnson & Johnson 9. Abbvie
2. Pfizer 10. Bayer
3. Roche 11.Astra Zeneca*
4. Novartis 12. Amgen
5. Merck & Co 13. TEVA
6. Sanofi 14. Eli Lilly
7. GSK * 15. Bristol-Myers Squibb (BMS)
8. Gilead Sciences
Top 15 Pharma & Biotech Companies by 2016 revenue
BPE SERVICES
BPE SERVICES
PROCESS FLOW-SHEETING, FACILITY LAYOUTS AND CAPITAL COST ESTIMATING
BIOPHARMACEUTICAL TYPICAL PROCESSING STAGES
Filling & Finishing
Upstream Processing (USP)
Downstream Processing (DSP)
UPSTREAM BLOCK FLOW DIAGRAM
Cell Bank Freezer
Seed Cell Growth
& Expansion #1
Seed Cell Growth
& Expansion #2
Production
Bioreactor
Primary
Separation
Cell
Disruption
Media from
tank
Filtration &
Collection
Production
Solution to
DSP
Buffer from
tank
TYPICAL UPSTREAM PROCESS FLOW BIOREACTORS
Bioreactor 1 Bioreactor 2 Bioreactor 3
Media
ProductionMedia
Filtration
Seed Production
Media Hold
Cell Production
UPSTREAM UNIT OPERATIONS
Cell Bank
Freezer
Rotary Incubator
Wave Bag Incubator
UPSTREAM UNIT OPERATIONS – BIOREACTORS
Typical
Bioreactors
UPSTREAM UNIT OPERATIONS – BIOREACTORS
CELL CENTRIFUGATION & CELL DISRUPTION
SUPPORT VESSELS
DOWNSTREAM & FILL & FINISH BLOCK FLOW DIAGRAM
Product Capture -
Chromatography
Impurity Removal
- Chromatography
Concentrate –
TFF
(Ultrafiltration)
Virus
Filtration
Filtration
Formulation
& Filling
Product vials
Buffer from tank
Buffer from
tank
UF 1
Buffer
Production
Buffer
Filtration Buffer Hold
Chrom. USP Collection Chrom.
TYPICAL DOWNSTREAM PROCESS FLOW BIOREACTORS
CHROMATOGRAPHY
CHROMATOGRAPHY - BINDING & ELUTION
Step 1 Step 2 Step 3
CHROMATOGRAPHY
TANGENTIAL FLOW FILTRATION
FILTRATION
SUPPORT VESSELS
STERILE FILLING
FACILITY DESIGN
Process
Designs
HVAC
Systems
Facility
Layouts
…..Take all
aspects of
design into
account
FACILITY DESIGN - ADJACENCIES
PRODUCTION
FACILITY
1 - Personnel
2 - Bulk Product
4 - Liquid Waste
Kill Tanks
Visitors View
3 - Solid Waste
5 - Distribution
Media
Buffer
Equipment
Return Equip.
Fermenter Media
Live
AreaAu
ROOM LAYOUT –PRODUCTION FLOOR
EU Grade A/B
EU Grade C
EU Grade D
Technical Areas
Unclassified
CleanroomClassifications(Design Standards)
malelockerroom
femalelockerroom
male w.c.
female w.c.
autoclave
clean &sterileequipmentstore
changeroom
washroom
preparation & wrap
generalpurposearea(e.g. packing)
store
cleaner'sstore
autoclave
in-processcontrol lab.
ch. 1
ch. 2
inoculum
operators'roomharvest &
extraction
fermentation
m.a.l.
m.a.l.
ch. 1
ch. 2
m.a.l.
media & bufferpreparation
weighing
purificationroom
centrifugation/purification
+4 deg.flame-proofpurification
technical
w.i.p.store
tec
hn
ica
l
passbox
freezedryer
Finalfiltration &freezedrying
ch. 1
ch. 2
ch. 3
m.a.l.m.a.l.
main distribution corridor
ch. 1
ch. 2
m.a.l.
purification corridor
technical
250 l.fermenter
30 l.fermenter
seedfermenters
inc.
biosafetycabinet
inc.
l.a.f. unit
w.m.
operators'room
operators'room
l.a.f. unit
m.a.l.(f-p)
ch. 3
ch.4A
sh.
tec
hn
ica
l
tec
hn
ica
l
tech.
goodslift
up
stairs
lobby
wash &prep.
h.o.
a.c.
viewing corridor
l.a.f. unit
fr.
generalpurposearea(e.g. storage)
sto
re
break room
up
ch.5A
sh.
ch.4B
ch.5B
ch. 1
parts &cleanstore
technical
tech.
s
s
s
s
s
t tech.riser
tec
hn
ica
l ri
se
r
kitchen
t.
s
sh.lockers with bench
lockers with bench
lockers with bench
lockers with bench
w.c.
w.c. w.c.
w.c.
w.b. w.b.
w.b.w.b.
w.b.
w.b.
w.b.
w.b.
w.b.
w.b. w.b.
w.b.
w.b.
future link bridge
flame-proofpurification
t.m.a.l.
step
ste
p
step
step
sh.
area ofraisedceiling
t.
elec.
m.a.l.
t.
dust filters
accessstairs
t.
technical
w.b.
bench
window cleaning access only
ele
c.
fireexit
t.
fire
fire
elec.
technical
fr.
bench
s
t. bench
t.
t.
t.
biosafetycabinet
lin
e t.
tech.
t.
t. t.
floorscale
benchscale
t.
w.m.
equipmentaccesspanel
229
227
226
225
231
230
238
228
223
232233 234 237
235
239
241
242
240 243
244
249
250
248
251
245
246
247252
253
258
260
254
255
256
257
259
267
266
262
264
265
261
224
201
202
203
204
205
208
206
207
209
213
212
211
210
268
222
214215221
220
219
216218
217
236
Scale 1:100 @ A3
0 1 2 3 4 5m
City of OuluGMP Pilot Plant
PlanProductionRoom LayoutLevel +0.00m
Cleanrooms
Drawing No:440045- SK-002Issue: L
Drawn by:R.E.LinnellDate:13th Oct. 2000
ROOM LAYOUT –SERVICE FLOOR TECH SPACE
materials & equipmententrance with canopy over
personnelentrance
electricalswitchroom
electricaltranformerroom
goodslift
stairs
up
delivery &despatchdocumentation
storage areano solid wallsto be installedsub-division asrequired usingframed weld-meshscreens and doors
su
pe
rvis
or
&G
MP
do
cu
men
tati
on
m.a.l.& ch.
killtankroom
building services &process utilities plant room
store 2.
bomb shelterand store 1.
entrancelobby
circulation area
wastedilution
tank
bundwall
materialscollationarea
lobby
w.c.
receipt &despatcharea
instrumentworkshop
electricalstandbygeneratorroom
workshop
yellow hatching shows area ofhigh-level kill tank extending asa sealed zone over other rooms
securestore
water systems
shutter door
tech
. ri
ser
telecom.
solid wall at high level aroundextended kill-tank area (yellow)with support columns below wallat nominal boundary betweenstorage area and corridor.
co
rrid
or
zon
e
s
shutter door
pack
ag
eg
en
erato
r set
c.i.p./s.i.p.area
samplingarea
w.b.
sh
+0
-30
RelativePressuresin Pascals
Positive
Negative
+10
-15
-30
+0
+0
+0
+0
+0
+0
+0
+0
+0
+10
+0-10
+10
Scale 1:100 @ A3
0 1 2 3 4 5m
City of Oulu
GMP Pilot Plant
PlanBasementLevel -4.50mRelative AirPressures
Drawing No:440045- SK-014Issue: K
Drawn by:R.E.LinnellDate:4th May. 2000
ROOM SECTION
+6.90m.
+3.90m.
+0.00m.
-4.50m.
hydraulicgoodslift
liftshaft
air
in
let
ple
nu
m
malew.c.
femalew.c.
kill tank room
viewarea
fermenter room
walk-on ceiling
ch.4A
ch.5A
ch.1
technical area -services distribution
HVAC plant room
store 2
airexhausts
maincorridor
workshop store 1 & shelterm.a.l. &change
sh.
+3.00m.
utilitystation
utilitystation
raised section approx. 6.1 x 1.8m.
+4.20m.
delivery &despatchdocumentation
services zone
fire wall
contained pipework zone
w.c. w.c.shower shower
bund wall
Scale 1:100 @ A3
0 1 2 3 4 5m
City of OuluGMP Pilot Plant
SchematicSection A - A
Drawing No:440045- SK- 91Issue F
Drawn by:R.E.LinnellDate:29th Jun. 2000
HVAC & MECHANICAL SERVICES OVERVIEW
HVAC & PLANT ROOM
FACILITY GMP CLASSIFICATION
Air cleanliness
Considering Annex 14, Annex 1 and existing facility classification; EU GMP grade C / ISO 8 / Class 100,000 is considered appropriate.
Pressure regime
At this stage, 15Pa minimum DP is considered necessary cascading from product manufacturing areas through critical barriers to the background CNC corridor. Please refer to pressure regime drawing (709-GA-100).
Room temperature & relative humidity
This is not considered a GMP requirement – only provided for comfort. Any product or GMP critical temperature or relative humidity will be provided by the equipment package and suitably integrated into the room.
Viable Particle control
Surface and people cleanliness, microbial controls are deemed as current procedures
Environmental Monitoring System
We understand CMR provide a international cGMP compliant side-wide environmental monitoring system which is proposed to be utilised on the new manufacturing facility.
HVAC CLASSIFICATION OF AREAS
HVAC AHU ZONING
GROUP /INDIVIDUAL EXERCISE
Develop a Process Flow Block and Pictorial Flow for new scale up project.
Guess equipment dimensions. ASK
Develop a simple facility layout that includes equipment and their associated
room layout with some preliminary dimensions.
Think about what utilities and services may be required for both HVAC &
Process. Clue Water, Steam etc. Show on facility layout.