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NA-04-7-4

Controlled Clean Operating Room Area

J. Shen, Ph.D.
Member ASHRAE

ABSTRACT
New China standards, the Construction Standard for
Clean Operating Room in Hospital and the Architectural
Code for Clean Operating Room in Hospital have been
published. These standards make a breakthrough in the
technical approaches for industrial cleanrooms and
emphasize that a clean operating department serves as a
biocleanroom and a controlled environment. This paper
introduces the general principles and recommended practice
that the new standards require.
INTRODUCTION
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With the medical development in China, the level of

medical technology has been greatly raised and medical
requirements have been largely changed. Thus, the requirements for hospitals to be constructed and extended has become
all the more severe. Surgical technology is increasingly delicate. Accordingto the statistics, by the end of 1998,China had
16,468 hospitals, including 1,527 county-level or above
county-level hospitals, 7,498 hospitals with over 100 beds,
788 hospitals with over 500 beds. However, there are only over
a hundred hospitals with converted clean operating departments to date, which account for 1.25% of the total number of
hospitals. Therefore, some medical units strive for conversion
into clean operating departments. The construction of a clean
operating department has been a priority for many hospitals.
The operating departments become a key link for infection
control in hospitals.
In the past, China did not understand clean operating
rooms very well. The design of operating rooms in our country
is influenced greatly by cleanroom industry techniques. This
only emphasizes the cleanlincss level, the air change rates, or

the widespread usage of unidirectional flow, and so on, but

ignores the establishment of the systemic and synthetic safeguard. This is the main cause of the high construction and
operating cost of clean operating rooms, while the potential
for contamination problems is not effectively resolved in our
country. Nevertheless, there have been no construction standards and codes for clean hospital operating rooms in China.
Although, the Construction Technical Norm of Military
Hospital Clean Operating Room Area was enacted in 1995,
the hospitals in most places did not have to follow.
Standards for Construction of Hospital Clean Operation
Room (referred to as Standard herein) was published in
October 2000, and the Architectural Technical Code for
Hospital Clean Operating Room (referred to as Code
herein) was published in December 2002. This could be a
landmark in China because it means that the design of hospital
clean air-conditioning in China has stepped away from use of
cleanroom industry techniques, and some new ideology and
principles were employed to construct operating rooms in an
economical and effective way.
THE GUIDING IDEOLOGY AND BASIC PRINCIPLE IN
WORKING OUT THE STANDARD
A lot of thought went into controlling clean operating
room areas as the practice was developed. It was understood
that not only the does the clean air conditioningsystem play an
important role in controlling the environmentin the operating
room, but it also must maintain control throughout the operating process. The goal of the system should be to maintain a
high indoor sterility level. In other words, the clean operating
room should always be controlled in any case so as to lower
any potential risk of infection.

Jinming Shen is a professor at the HVAC Institute, Tongji University, Shanghai, China.

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BIOCLEANROOM CHARACTERISTICS AND
PROTECTION OF KEY AREAS
The clean operating room is classified as a biological
cleanroom, with the intention of controlling living particles.
Therefore, the concentrationof microbials should be used for
the classification. Cleanroom systems could also be flexible in
terms of air purifying treatment, so people would be more
wary of comprehensive measures taken for complete and allencompassing control, and they would not view air purifying
as an unity measure. Meanwhile, it could be said that clean
operating room areas differ from common operating rooms
only by the need to maintain sterilization. Without measures to
purifi the air, the space would not be called a clean operating
room. Hence, the essence of the clean operating room area is
clearly defined.
The Standard defined four grades for operating room
areas. It employed the concept of protecting key areas and
defined the central space and neighboring space in these clean
operating room areas. Take Grade 2 Clean operating room area
as a standard, Grade 1 is a more stringent requirement and is
called a Super clean operating room, and Grade 3 is less
stringent, and is called a Common clean operating room. To
let ordinary hospitals all use a clean operating room, Grade 4
is given, which is significant for the popularization of the clean
operating room. The Standard states that a ceiling supply
should be used in Grade 1, Grade 2, and Grade 3 operating
rooms and the size of the ceiling supply should be appropriate
to its grade. Both the area and velocity of supply air could be
decreased compared with prior practices. The scheme of local
ventilation and operating room protection is more systematic.
It is beneficial to the control of biocontamination and easy to
operate.
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The Special Demand for Air Conditioning

Compared to air-conditioning systems for general buildings, the system used in clean operating room areas satisfies
the requirements for operations, which provides for control of
infections while operating on wounds during surgical procedures and thus improves the success rate of operations.
Therefore this type of system should have the following
characteristics.
I . Indoor environment control requirements
1. Maintain sterilization through indoor air cleaning
in the operating room area.
2. Control airflow pattern and air velocity.
3 . Maintain desired airflow direction and pressure
distribution between different areas.
4. Ensure special required temperature and humidity
for medical procedure.
5 . Exhaust pollutants such as noxious gas to ensure
indoor air quality and exclude the external environment (for any infective operating).

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2.

System design

The type of clean air-conditioning system in an operating room could play a very important roll in maintaining
different concentrations of airborne microbial contamination
in different rooms. Several different methods were adopted to
prevent cross-infection. The Standard regulates clean airconditioning systems for clean operating rooms and requires
that systems with unique characteristics be installed for
subsidiary rooms. An independent clean air-handling unit
should be installed in each clean operating room area for
Grade 1 and Grade 2; however, two or three clean operation
rooms of Grade 3 or Grade 4 can share the same system, and
a centralized fresh air (or makeup) supply system could be
adopted.
3.

Positive tressure control

The control of positive pressure is a more important

aspect in a clean operating room area to attempt to guarantee
system performance. Pressure control in order to keep the
operating room area sterile depends upon the airtightness of
the space envelope. Contamination is prevented when the
pressure in the sterile area is higher than the external area.
Because the control concept in the clean operating room is
based upon maintaining separate sterile areas instead of a
single clean operating room, the different levels of spaces
within a department needed distinct control of differential
pressure. The ordered gradient pressure can ensure the directional flow of clean air so that the air can only flow from the
sterile spaces of a higher level to a lower level, including from
the sterile areas to the areas ofnonsterility. With the assurance
that the ordered pressure gradient distribution in the clean
operating room area could be maintained in any situation, the
risks of infection in the operating area can indeed be reduced
effectively.
4.

Clean operating mom turndown

The clean air-conditioning system was expected to be

turned on or off promptly, if required, because continuous
usage is infrequent. The Standard simply states that a whole
operating room area should be always under control regardless
whenever one system is on or off. It is not permitted that the
whole operating room area could be influenced by shutting
down a portion of it.
5.

Prevent secondary contamination in the system

Biocontamination control in an air-conditioning system

should receive higher attention. A clean operating room area
using a traditional ventilation and air-conditioning system is
not in conformance with the Standard because it might bring
in dust, virus, and moisture to any area in the system, where
microbial growth, particularly in the coil, filter, condensation
pan, etc., could occur. Accumulated dust and moisture was
called primary contamination, and microbial growth was
generally called secondary contamination. So a traditional
air-conditioning system could be a hotbed for microbial

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Figure I

A new type of clean air conditioning.

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contamination because it cannot keep the potential sources of

biocontamination out of its system.

A New Type of Clean Air-Conditioning System

As stated before, it was a baffling problem that the entire
operating room area should always be under control in line
with the ventilation regulation in the Standard. When a
traditional air-conditioning system was employed in a clean
operating room area, the desired airflow directions in the
whole area, along with positive pressures in different rooms,
could not always be maintained. If one air-handling unit would
stop, the distribution of positive differential pressure in the
area could change. Then the indoor operating room
environment would be polluted and cross-infection could
occur as a result. It was not reasonable to only depend on an
automatic system in the past. Therefore, a primary task is to
cautiously choose the design of a clean operating room airconditioning system.
A new type of system has now been developed (shown in
Figure 1) in China, which could keep the whole operating
department always under control regardless of whether a clean
air-handling unit is on or off.
In the new type of system for clean operating room areas,
there are individual air-handling units (AHU) and an independent unit supplying makeup air (MUAH). The AHU controls
each area to achieve the temperature, humidity, and the degree
of clean air in these separate areas. Every operating room has
its own exhaust air unit. Constant air volume devices (CAV)
with two positions were adopted in each branch duct. In the
first-position, a larger fresh airflow rate was supplied during
normal operating conditions, and in the second-position, a
lower fresh air flow rate was supplied only to maintain positive
pressure.
A reasonable method of preventing secondary contamination is to remove the sources of biocontamination, espe778
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cially particulates and moisture. According to the

requirements of the Standard, three-stage filtration should be
set up in the independent fresh air unit, and the terminal filter
must be greater than an F-10 filter. This requirement is based
on removing most of the particles in the fresh air supply. The
MUAH could be designed to remove all (or most) of the latent
cooling load. It is possible for this system to eliminate
secondary contamination in every AHU after it.
1.

Control concept
Figure 1 illustrates the following.
This system is called a semi-central air system and consists of an independent fresh air-handling unit with an
individual AHU for every clean operating room. The
branches of the fresh air system, on which the CAV
devices with two-position control are mounted, are
directly connected to the supply air ducts for the individual units on which a one-way damper is mounted to prevent makeup air from returning.
With the use of CAV devices having two-position control, the independent fresh air-handling unit provides
both the air volume to maintain positive pressure in each
clean operating room and the normal fresh air. Then the
individual AHU for each operating room t u n i s into a
recirculating unit. The indoor contaminants and odors
are removed by their own exhaust unit.
When an operating room is normally in use, the CAV
device is adjusted to the first position, allowing a larger
volume of fresh air to enter the room. The exhaust air
volume is the difference in volume between the fresh air
and the pressurization losses. When this operating room
is unused, the CAV device with two-position control on
the branch of the fresh air unit was adjusted to the lower
level, allowing a relatively small volume of fresh air (or
positive pressure air) to enter the room. With the exhaust
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