Abstract

Cleanrooms consume large amounts of energy and it is common for power requirements to be
specified based on norms without a clear understanding of the dynamics. Alexander Fedotov, Invarproject, considers steps to reduce energy consumption based on real examples and figures

Cleanrooms consume large amounts of energy anything from 2 to 50 times more than is consumed
by non-classified areas, depending on each specific application. In the past, little attention was paid
to energy consumption and over-specification and over-designing of facilities, often based on
normative documents or a poor interpretation of them, was common.
Existing international standards tend to be general and do not reflect the specific features of
cleanrooms
Existing international standards tend to be general and do not reflect the specific features of
cleanrooms. Detailed guidance on how to save energy in cleanrooms can be found in two national
standards the British standard BS 8568:2013 1 and the German VDI 2083 standard2 but the issue is
complex and not thoroughly investigated, therefore further efforts to understand energy consumption
are required.
Special attention needs to be given to reducing air change rates (ACRs) and to considering real
particle generation in cleanrooms to determine the actual ACRs needed once in operation. Energy
consumption grows rapidly with an increase in cleanliness levels. It is difficult to make a general
estimation, but practical examples show that power required for cleanrooms can be orders of
magnitude greater than for non-classified rooms, depending on the class of cleanliness (see Table 1).

Table 1: Examples of energy consumption for different facilities

Class

Power, kW/m2

% Increase in consumption
Semiconductor facility

Non-classified

0.05

100% (1)

8 ISO

0.10

200% (2)

7 ISO

0.22

440% (4.4)

6 ISO

1.15

2300% (23)

4/5 ISO

2.40

4800% (48)
Non-sterile ointments production

Non-classified

0.06

100% (1)

0.60

1000% (10)

C (laboratory)

1.20

2000% (20)
Aseptic production

Non-classified

0.06

100% (1)

0.41

680% (6.8)

0.50

830% (8.3)

1.52

2530% (25.3)

Of course, ACR depends also on heat load, local exhausts, personnel present, etc., which vary for
different processes. But the trend is clear: energy consumption grows dramatically from one
cleanliness class to another, and it can vary depending on ACR, recovery time and other factors that
are discussed later in this article.

Energy saving methods

Energy saving methods can be both general (as applied to all kinds of premises and buildings) or
specific to cleanrooms. General methods focus on:

minimising heat gain/losses and providing heat isolation of buildings

air recirculation with as little outdoor air as possible on safety grounds

siting plants in climate zones where high power in winter/summer is not needed

use of high efficiency ventilators, AHUs and chillers

use of equipment (HVAC units, filters, etc.) with reserve power, (as bigger nominal power
consumes less energy)

avoiding unnecessary narrow tolerances for temperature and humidity

removal of excess heat load from process equipment by local in-built means.

Specific methods consider cleanroom features and include:

reducing cleanroom size to a minimum

avoiding over-specification of cleanliness class

use of HEPA filters with reduced pressure drop

sealing all leaks

local protection where higher cleanliness class is maintained in a limited area as required by a
process

minimising number of personnel and using technologies that dont require people (closed
systems, RABS, isolators)

careful attention to operation, garments, hygiene, training, etc

reducing air flow rate when at rest

avoiding over-specification of ACRs and recovery time

determining actual required air flow rates during testing and operation and setting ACR based
on these data

Energy consumption factors differ for unidirectional and non-unidirectional flows. For unidirectional
air flow the key factor is air velocity. The GMP guidance specifies 0.360.54m/s (0.45 20%) now.
But where did 0.45m/s come from and what is the rationale behind it?
Metric 0.45m/s are equal to 90ft/min. This number was included in an early version of US Federal
Standard 209B (1973). It was very approximate and reflected the level of knowledge at that time.
Later on, it was discussed in many publications that 0.45m/s was over-specifying and 0.3m/s was
considered enough; as a result, the 0.45m/s norm was excluded from the next revision of Fed. Std.
209C (1987). Non-GMP areas of cleanroom application follow this rule successfully but the figure of
0.45m/s carried over into the GMP guides and has remained there ever since.
For cleanrooms with non-unidirectional air flow ACR is the key factor, but as the picture is more
complicated, it requires a more detailed analysis. High air flow in HVAC systems that provide rooms

with the required ACRs are the main cause of the huge energy consumption. Cleanrooms with nonunidirectional (turbulent) air flow make large demands on air ventilation, heating, cooling,
humidification and drying.
It is not really possible to give one formula because energy consumption depends on too many
variables
Different sources of information present different figures for how ACRs affect energy consumption.
BS 8568:2013 (item B.15)1 says: Air volume is proportional to the cube of the fan power, i.e. a
halving of the air volume reduces the fan power to one eighth or a 50% reduction on flow gives an
88% reduction in power. Other publications give less difference.
In fact, it is not really possible to give one formula because energy consumption depends on too
many variables. Therefore, it is worth making a short analysis for a facility at the design stage to
estimate how ACR influences the power required. Table 2 shows an example for a facility in the
Moscow region. For this real facility halving the air flow reduces the energy consumption by 25
30%.
Table 2: Power consumption for cleanrooms in non-sterile ointments facility
Energy consumer

Power, kW for air flow

22,250m3/h

11,000m3/h

30

15

hot water (1st stage)

80

151

electric heater (2nd stage)

240

20

3 Cooler (electric power)

53

14

4 Steam humidification

133

45

winter: hot water

240

151

electric power

243

70

summer: electric power

163

49

1 Ventilators in HVAC system

2 Air heating:

5 Total consumption:

The ACR required can depend on many factors: the volume of outdoor air required for hygiene
reasons (breathing); compensation of local exhausts; maintaining pressure difference; removal of
heat loads; and providing necessary cleanliness (cleanroom class). All these factors should be taken
into consideration at the design stage. ACR should be chosen for the worst case scenario or the
largest value (see Figure 1).

Figure 1: Typical factors that affect air change rates in cleanrooms

It is important to pay attention to cases where the ACR for heat load removal or compensation of
local exhausts exceeds the demands for the cleanliness class. It indicates over-specifying of heat load
(see below) or justifies the application of closed systems (isolators, RABS) with much reduced
exhausts.
Example of poorly specified heat load
Energy wastage because of poorly specifying equipment heat load can be large. There was a case of
a supplier of nanotech equipment that indicated a 24kW heat load from a process machine in the
specification for cleanroom design. The HVAC engineer took it as a basis and calculated huge energy
consumption and sizes of HVAC unit. An AHU supplier made an offer and the civil engineers
constructed a large technical room.
When the project manager examined the spec and looked for unusually high numbers he found that
the 24kW referred to start-up or changing operation mode, which might happen once every six
months when process and personal are absent. Heat load during normal operation was about 2kW.
This correction dramatically changed the HVAC design and reduced energy consumption.
The moral pay attention to unusual values and find out what is the reason for them. Dont hesitate
to ask why if something looks unusual or is unclear.

What ACR is needed?

Today most normative documents do not specify exact numbers for ACR, leaving it to designers. But
some documents do give a figure. The most common requirement is 20 changes per hour (20h -1).
The development of the norms for ACR has its history: in the late 1950s, the US set requirements for
ACRs in surgical suites at a minimum of 20h-1 in existing facilities and a minimum 25h-1 in new ones.
Probably the first mention of 20h-1 was in the early version of Federal Std. 209B. It reflected the
practice in the 1960s. Later this norm was withdrawn from Fed. Std. 209 because it was understood

that the required cleanliness level can be achieved with a lower ACR. The task of determining ACR
was left to the facility designer.
FDA Aseptic Guidance copied 20h-1 in 1987 for supporting rooms, even though it was excluded from
the original Fed. Std. 209, and this was not corrected in 2004 when this guidance was re-edited. 3
Today, FDA requirement for 20h-1 for supporting rooms (8 ISO in operation) is still in force: For
Class 100,000 (ISO 8) supporting rooms, air flow sufficient to achieve at least 20 air changes per
hour is typically acceptable. Significantly higher air change rates are normally needed for Class
10,000 and Class 100 areas. So for ISO Class 7, this Guidance requests an ACR even greater than
20h-1.
The early GMP EU Guide had this norm but it was cancelled in 1997. It is worth saying that this did
not change matters much because the conservative requirement for recovery time of 1520 minutes
remained (see Tables 3 and 4).4
Many practitioners follow the ISPE Guidelines that recommend 20h -1 for sterile processes (both
aseptic and terminal sterilisation): Generally, air changes of at least 20h -1 are expected in Grade 7
and Grade 8 rooms (ISO 7 and ISO 8 respectively) item 5.5.3. 5
The recent World Health Organisation (WHO) report No. 961, Annex 5 also specifies ACRs for nonsterile dosage forms: 4.1.6 Air change rates are normally determined by the following considerations
(could normally vary between 6 and 20 air changes per hour) ... 6, which could be regarded as a step
forward, but the same report specifies strict values for recovery time: 20min (item 4.1.10) and even
15min (item 8.2.14, see Table 3). The WHO report gives 620h -1 as a general idea but does not
explain what to choose when.
Table 3: Requirements for air change rates in different guides
Sterile production
Aseptic
FDA Aseptic Guidance
GMP EU
ISPE
WHO

Non-sterile products

Terminal sterilisation

20

20

20

620

The old conservative value of 20h is therefore still present in documents (Table 3). The 20h -1 ACR
refers mostly to sterile production, but some designers opt to use it in non-sterile cases too.
-1

Sometimes 20h-1 travels from the in operation requirement (ISO Class 8) of FDA Aseptic Guidance
to zone D where ISO Class 8 is specified for at rest condition only and no requirements exist for in
operation at all!

GMP EU talks about a 1520 minute recovery time for sterile production and does not differentiate
between aseptic processes and those with terminal sterilisation, setting 1520 minutes recovery time
for both. But these cases are different in principle and it is obvious that norms for aseptic and
terminal sterilisation processes should not be equal. The same is true for different stages of aseptic
processes: the stages before sterilising filtration can have lower requirements than the aseptic core.
Figure 2 shows curves of reducing particle concentration following the start-up of operation. The
required cleanliness class can be maintained easily for different values of ACR, even for a rate of 5h -1.
All curves tend to a constant value, which is quite good for this cleanroom. However, what is
important is that the ACR depends not only on the cleanliness class but also on the recovery time.

Figure 2: Reducing of particles concentration in zone C after start-up

Graph a) shows at rest, particles generation 100 particles/s, no personnel present; graph b) shows
in operation, particles from process 10,000 particles/s with four persons (10,000 particles/s from
each human)

Recovery time
ISO 14644-3:20057 says that recovery time is the time required to decrease the initial concentration
of particles by a factor of 100 (100:1 recovery time). Some other guides describe it as the time taken
to achieve cleanliness level for the at rest state after a short clean-up period after completion of
operation.
Normally, it is deemed that recovery time should be 1520 minutes (Table 4). The strictness of these
requirements depends on the risk to the products. This risk is dramatically different for preparation
stages (sterilising filtration, dry-heating of glassware) and the final operations (filling, stoppering
etc.).

Table 4: Requirements for recovery times in different guides

Sterile production
Aseptic, before or after sterilising
Before

Terminal sterilisation

After

GMP EU

1520

ISPE

1520

WHO, TR 961

Non-sterile products

15 or 20

Just as 20h-1 were in Fed. Std. 209 and moved to FDA Guidance for aseptic only, and then spread, the
same situation applies for the recovery time of 1520 minutes, creating one of the main reasons for
the over-design and unnecessarily high energy consumption of cleanrooms. Increasing recovery time
to 2040min allows one to reduce the ACR from 20h -1 to 10h-1 or to reduce energy consumption by
25% (Figure 3).

Figure 3: It is possible to reduce air change rates if recovery time is increased

One further curious thing: GMP or cleanroom regulations do not differentiate between start-up
period and stabilised at work periods. As a general rule, energy consumption for a start-up period is

much greater than for a steady period. Why then, are cleanrooms required to work with a large ACR
after reaching a stabilised period? Why not switch a cleanroom on 4060 minutes before the start of
process to reach a stabilised period and use less energy?
There may be a concern that an explosion of particles could happen during this process and thus 15
20 minutes are necessary. But monitoring and frequency control of fans are now widely in use; a
quick check for sudden particle emission can easily be achieved, and switching the AHU on to full
capacity can remove the contamination. Monitoring can be arranged even for classes ISO 86 to keep
the process under control.

Clothing
Clothes have great impact on ACR. Dr B Reinmller and Prof B Ljungqvist made detailed
investigations of particle generation by personnel dressed in different types of clothing. Figure 4
illustrates (in numbers rounded to simplify the illustration) the difference between ordinary
cleanroom clothes (jacket and trousers) with the generation of 10,000 particles/s; and good
cleanroom clothing (overalls) with particle generation of 1,000 particles/s. This shows the great
improvement in air cleanliness when using good cleanroom gowns. It is possible to reduce the ACR
from 20h-1 to 10h-1 by improving the quality of garments, without other expense.

Figure 4: Reducing particle concentration for different types of clothing: a) air change rate 20h -1; b)
air change rate 10h-1

The gap between cleanliness classes during design

and in operation

Cleanroom class depends on many factors during the design, construction and operation stages. It is
not good practice to compensate for particle generation from poor clothes and badly trained or
controlled personal by increasing ACRs. On the contrary, it is worth using high quality clothes and
maintaining good hygiene, even for ISO Classes 7 and 8.
Particle concentration has a statistical nature that is difficult to consider at the design stage. Real
particle generation is normally unknown at the design stage, therefore cleanroom designers prefer to
guarantee cleanroom class through over-design. In fact, this is seen to help compensate for poor
operation. As a result a cleanroom normally has a reserve of cleanliness. Existing practice of
cleanroom testing and operation does not take into account this reserve. Over-use and, thus, a waste
of energy is the result.
This article puts forward a different approach: a cleanroom should be tested to determine reserves;
these reserves should be considered at operation and the cleanroom should work at minimum
capacity. Routine testing and good operational practice should help this work. Because bad
operational practice exists in some cleanrooms, people contaminate the cleanroom more than
necessary then try to clean the air by increasing the ACR.
Therefore a flexible approach for defining cleanroom parameters is required. An estimation of energy
consumption should be carried out at three stages:
Design to take into account necessary hygiene and safety issues, local exhausts, heat loads and to
estimate ACR with reasonable margin;
Testing to determine real particle generation and to learn how big the margin is without making
process worse;
Operation to consider the margin and to operate the cleanroom at reduced capacity; to follow good
operational practice; to monitor air cleanliness and to make a trend analysis. It is also worth
estimating real particle generation during operation with trend analysis and monitoring in zones C
and D (ISO 7/8 classes) and not only A and B. These data can be provided as the proof for
maintaining low ACRs.

References
1. BS 8568:2013 Cleanroom energy Code of practice for improving energy efficiency in
cleanrooms and clean air devices
2. VDI 2083 Blatt 4.2 Reinraumtechnik Energieeffizienz. Beuth Verlag, Berlin (April 2011)
3. Guidance for Industry. Sterile Drug Products Produced by Aseptic Processing Current Good
Manufacturing Practice. FDA, USA. 2004

4. EU Guidelines to Good Manufacturing Practice. Medicinal Products for Human and Veterinary
Use (GMP EC). 2010
5. ISPE Baseline Guide: Sterile Product Manufacturing Facilities, Second Edition, September 2011
6. WHO Technical Report Series, No. 961, 2011

7. ISO 14644-3:2005 Cleanrooms and associated controlled environments - Part 3. Test methods
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