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CLEANROOM ENERGY REDUCTION: POSSIBILITIES FOR NOW & IN THE
NEAR FUTURE
Keith Beattie of EECO2
ISPE Boston Area Chapter Product Show
18th September 2019
Connecting Pharmaceutical Knowledge ispe.org
1. Introduction
2. Cleanroom development history vs What we know
today
3. 3 great energy reduction strategies – guaranteed to
work in cleanrooms
4. Future opportunities
5. Summary
AGENDA
Connecting Pharmaceutical Knowledge ispe.org
The standard industry model for cleanroom design & operation has not changed for around 50 years.
3
A BRIEF HISTORY
1867 Joseph
Lister uses
Carbolic acid
as antiseptic
1940’s good
ventilation
hinders
infections
1961 Laminar
airflow used in
surgery (Charnley
& Howorth)
WW2 Cleanrooms developed
to aid production of precision
mechanical parts
1985 FFU
developed
1999 ISO
standards
published
1962 Whitfield
creates ultra-
clean room
2000 ULPA
filters
introduced
1978
Multi-zone
cleanroom
concept
First commercial
application of adaptive
cleanroom control in
pharma manufacturing?
2000 1980 1960 1940 2019
Connecting Pharmaceutical Knowledge ispe.org
• Critical for product protection
• Performance (cleanliness) is dependent on many factors influencing:
• Contamination infiltration – from less clean areas
• Contamination generation – people, process & equipment
• Contamination removal effectiveness – design, filtration
• Air Change Rates are not a reliable indicator of cleanroom performance.
• HVAC systems are designed, constructed, commissioned & validated for “worst case” scenarios.
• Very energy intensive spaces (up to 80% of energy consumption is HVAC) – no correlation to production output/volume
4
WHAT WE KNOW ABOUT CLEANROOMS TODAY
Connecting Pharmaceutical Knowledge ispe.org
0
500
1,000
1,500
2,000
2,500
3,000
Semicoductorfacility
Non-sterileOintments
Asepticproduction
OfficeBuilding(Typical)
Energy Intensity by Class, W/m2
NC ISO 8 ISO 7 ISO 6 ISO 5
5
ENERGY INTENSITY VS AREA
Typical % Area
NC ISO 8 ISO 7 ISO 6
Data Source: Cleanroom Technology article “Saving energy in cleanrooms” by
Alexander Fedotov (Invar-project), published 04 Aug 2014.
Data Source: eeco2 approximation
Connecting Pharmaceutical Knowledge ispe.org 6
PHARMACEUTICAL HVAC ENERGY REDUCTION STRATEGIES:
Reduce quantity of air
Reduce amount of conditioning
Condition efficiently
Maintain efficiency
Improve
robustness &
compliance
ENERGY REDUCTION:
TODAY WHAT YOU CAN DO TODAY IN YOUR FACILITIES:
• AIR CHANGE RATE REDUCTION
• SETBACK
• CONTROLS OPTIMISATION
Connecting Pharmaceutical Knowledge ispe.org
• From the fan affinity laws, fan power is related to airflow by a “cube” law.
• A small reduction of airflow (10% in this case), gives a 28% reduction in the fan power consumed.
• That’s why air change rate reduction is such an effective energy reduction strategy.
8
FAN AFFINITY LAWS: WHY AIRFLOW IS SIGNIFICANT FOR ENERGY REDUCTION
10%
28%
Connecting Pharmaceutical Knowledge ispe.org 9
1. HOW MUCH AIR DO WE NEED?
24
18
22
2
5
7 6
0
5
10
15
20
25
30
Original Design Site Data BaselineMeasured
New Design(Particle
ConcentrationControl)
New Design (HeatGain Removal)
New Design(Pressurisation)
New FinalBalancing
Site Standard
(Min ACPH)
Connecting Pharmaceutical Knowledge ispe.org 10
1. HOW MUCH AIR DO WE NEED?
24
18
22
2
5
7 6
0
5
10
15
20
25
30
Original Design Site Data BaselineMeasured
New Design(Particle
ConcentrationControl)
New Design (HeatGain Removal)
New Design(Pressurisation)
New FinalBalancing
New Site
Standard (Min
ACPH)
Site Standard
(Min ACPH)
Supply Air -72%
Fan Energy -81%
Connecting Pharmaceutical Knowledge ispe.org
≥0.5 micron shows very small increase
≥5.0 micron shows larger increase but greatly under compliance limits
Improved diffusers selected for revised airflow and improved mixing will mitigate the 5.0 micron increases
Trial demonstrates ACPH’s can be reduced… …without impact on quality compliance
11
1. HOW MUCH AIR DO WE NEED?
0.5μm 5.0μm
5% 9%
2% 4% 4% <1%
1% 7%
6% 19% 1% 5%
1% 4%
% of class limit
Connecting Pharmaceutical Knowledge ispe.org
• No people = no contamination source
• No production = no risk to product
• When no production turn down air supply rate (+ relax temp/humidity setpoints)
It’s a good idea to:
• Keep people out of area whilst in setback mode
• Provide visual indication for setback mode – to alert operators
• Qualify return to normal operation (particles + micro)
• Might require CV boxes on fresh air to maintain pressure
12
2. SET BACK (TURN-DOWN) – NON PRODUCTION TIME
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19°C
23°C
21°C
27°C
3. BAS CONTROLS – FOR EFFICIENCY
Connecting Pharmaceutical Knowledge ispe.org
19°C
23°C
21°C
27°C
3. BAS CONTROLS – FOR EFFICIENCY
Cooling valve is shown closed,
and heating valve is 100% open,
yet temperature decrease
observed from 23°C to 19 °C OA damper
shown as closed.
Is it really?
Whenever we see valve positions at
100%, then this is often an indication
something is not right. Most likely is
cooling valve has failed or is in manual
bypass.
Connecting Pharmaceutical Knowledge ispe.org
Part 16 – currently at final review stage (FDIS)
• Expected publication around Q4 2019
• What’s in it?
• Process to follow
• Debunks air change rate myth
• Lots of examples of what to do
• Helpful calculations
• Benchmarking techniques
15
……AND FINALLY: ISO 14644-16
Design cleanroom with efficiency in mind & use performance data in
use to ‘tune’ cleanroom HVAC to the real need.
ENERGY REDUCTION:
FUTURE
ADAPTIVE (DEMAND BASED) CONTROL -
FUTURE CLEANROOM OPERATIONS WILL
BE SUPER-EFFICIENT
16
Connecting Pharmaceutical Knowledge ispe.org
PARTICLE CONCENTRATION
Time – duration 1 production day
Limit: Grade C (in operation) / ISO 8
Limit: Grade B (in operation) / ISO 7
Connecting Pharmaceutical Knowledge ispe.org
PARTICLE CONCENTRATION
Log Scale
Count (no of
particles / m3)
Limit: Grade B (in operation) / ISO 7
Limit: Grade C (in operation) / ISO 8
Time – duration 1 production day
Connecting Pharmaceutical Knowledge ispe.org
CURRENT PRACTICE
Fixed Air Supply
Rate (ACR) Variable
Contamination
Levels
(#particles/m3)
ACR Classification Limit
Connecting Pharmaceutical Knowledge ispe.org
• We don’t know the actual contamination level at any particular
time or location
• Most of the time particle generation rates are low, therefore air
flow is much higher than needed
• Fan energy accounts for 35-50% of the annual energy
consumption of a cleanroom
• As energy costs increase, cost of production increases
WHAT DOES IT MEAN?
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HYPOTHESIS: CAN WE CONTROL TO A FIXED CONTAMINATION LEVEL?
Variable Air Supply
Rate (ACR) Fixed
Contamination
Levels
(#particles/m3)
New ACR
Classification Limit
Connecting Pharmaceutical Knowledge ispe.org 22
Connecting Pharmaceutical Knowledge ispe.org
• Static air change rate (without ICCS): PI controllers implemented in the BMS maintain the ACR for cleanrooms to steady state
• Dynamic particulate control (with ICCS): particle counter based MPC implemented in the PLC platform control the particle concentration dynamically.
• ICCS control setpoint: 20% of classification limit
• People with cleanroom gowning
23
RESULTS – STATIC VS. DYNAMIC CONTROL
0.2% 4.3%
0.1% 1.3% 0.7%
12.9%
0.8%
11.3%
0.0%
20.0%
40.0%
60.0%
80.0%
100.0%
120.0%
0.5um 5um 0.5um 5um
Grade C room Grade B room
Without ICCS With ICCS
Classification limit ICCS control setpoint
GMP EU Classification limit
Maximum particle concentration with and without ICCS (Grade C)
Percentage of
classification limit
Connecting Pharmaceutical Knowledge ispe.org
RESULTS – ACR IN TEST CLEANROOMS
0
2
4
6
8
10
12
14
16
18
1 4 7
10
13
16
19
22
25
28
31
34
37
40
43
46
49
52
55
58
61
64
67
70
73
76
79
82
85
88
91
94
97
100
103
106
109
112
115
118
121
124
127
130
133
136
AC
R (
/hour)
Time (min)
Air Change Rate (ACR) with and without ICCS (Grade C)
Without ICCS With ICCS
Grade C room
Connecting Pharmaceutical Knowledge ispe.org
• Particulate count maintained
under 20% of class limit
• 67% energy reduction
compared with static system.
RESULTS - ENERGY
32,938
10,906
-
5,000
10,000
15,000
20,000
25,000
30,000
35,000
Without ICCS With ICCSE
nerg
y (k
Wh)
Energy consumption per year
67% reduction
Static Dynamic
Connecting Pharmaceutical Knowledge ispe.org
1. Cleanroom energy consumption can be reduced with no
significant impact to performance;
2. Higher classes are more energy intensive – but lower classes
consume more energy;
3. Performance of the cleanroom is critical - Air Change Rate is not;
4. Applicable reduction strategies should be considered on a case
by case basis;
5. Adaptive (demand based) control of cleanroom HVAC has huge
potential for cleanroom energy reduction globally.
SUMMARY
THANK YOU Any Questions?
Find out more at:
www.eeco2.com