BAib12017-02 Guideline On Conceptual Design and Engineering Requirements For CSSU PDF

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)
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Tel: 603-8000 8000 | Fax: 603-8892 4855/4872 E E
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Website: http://engineering.moh.gov.my IDE UIDE
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GUIDELINE
ON CONCEPTUAL DESIGN AND
ENGINEERING REQUIREMENTS FOR
CENTRAL STERILE SUPPLY UNIT
(CSSU)
MINISTRY OF HEALTH
MALAYSIA
MOH/ESD/2017-02
Disclaimer: Any pictures of equipment, brand and model of equipment depicted in this guideline shall
not be considered as an acceptance or approval from the Ministry of Health Malaysia. It shall only serve
as an example or illustration for the relevant issues and matter of interest.
3
TABLE OF CONTENTS
Message from The Director General of Health 6

Preface by The Director of Engineering Services Division 7
Acknowledgements 8
List of Abbreviations 10
Glossary 11
Executive Summary 14
1.0 Introduction 15
2.0 Central Sterile Supply Unit (CSSU) 16

2.1 Primary Function 16
2.2 Location 17
2.3 Sterilization 18
2.3.1 Classification
2.3.2 Types of Sterilization
3.0 General Function and Layout 22

3.1 Basic CSSU Layout 22
3.2 Staff Movement 24
3.3 Material Movement 25
3.3.1 Soiled Zone
3.3.2 Clean Zone
3.3.3 Sterile Zone
4.0 Service Area within Zone 27

4.1 Soiled Zone 27
4.1.1 Receiving Area
4.1.2 Cleaning Area
4.1.2.1 Decontamination Area
4.1.2.2 Manual Cleaning Area
4.1.2.3 Ultrasonic Cleaners
4.1.2.4 Washer Disinfectors
4.1.2.5 Cart Washer
4.1.2.6 Transfer Hatch
4.1.2.7 Medical Drying Cabinet
GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING
4 REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)
4.2 Clear Zone 36

4.2.1 IAP Area
4.2.2 Documentation and Label Printing Area
4.2.3 Clean Stores
4.2.4 Sterilizer Loading Area
4.2.5 Sterilizer Room
4.3 Sterilization Zone 44
4.3.1 Sterilizers
4.3.1.1 Steam Sterilizer
4.3.1.2 Ethylene Oxide Sterilizer
4.3.1.2 Hydrogen Peroxide Sterilizer
4.3.2 Cooling Area
4.3.3 Sterilized Product Storage Area
4.3.4 Sterile Item Issuing Area
4.4 Administrative and Staff Facilities 50
4.4.1 Administrative (Matron/Sister) Office
4.4.2 Meeting Room
4.4.3 Change Room
4.4.4 Staff Room
4.4.5 Prayer Room
4.4.6 Personnel Protective Equipment (PPE) Store
4.4.7 Chemical Store
4.4.8 Disposal Room
4.4.9 Receive and Break Pack Room
5.0 General information 57

5.1 Calculating the size of CSSU 57
5.2 Information required in determining number of Sterilizers 57
6.0 Architectural and Engineering Services 59

6.1 Architectural Finishes 59
6.1.1 Wall
6.1.2 Ceiling
6.1.3 Flooring
6.1.4 Doors
6.1.5 Windows
6.1.6 Worktops and Sinks
6.1.7 Painting
5
6.2 Mechanical Services 62

6.2.1 Air Conditioning and Ventilation
6.2.2 Fire System
6.2.3 Noise
6.2.4 Water
6.2.5 Steam
6.2.6 Compressed Air
6.2.7 Drainage
6.3 Electrical Services 66
6.3.1 Electrical Installation
6.3.2 Lighting
6.3.3 Switch Socket Outlets
6.3.4 Emergency Supply
6.4 Communication 67
6.4.1 Internal Communication
6.4.2 External Communication
6.5 IT Link 68
6.6 Security 68
7.0 Acquiring and Installing of Major CSSU Equipment 69

7.1 Elements to consider prior to acquiring of equipment 69
7.2 Roles and responsibilities of user during planning, installation,
testing and commissioning of upgraded facilities or equipment 70
replacement
8.0 Upgrading of Existing CSSU 71
9.0 References 72
MESSAGE
THE DIRECTOR GENERAL OF HEALTH
The Central Sterile Supply Unit (CSSU) is the hub where contaminated re-usable med-
ical devices are decontaminated, cleaned, disinfected, washed, packed, sterilized and
stored before being delivered to the respective departments in a hospital to be used
onto the next patient.
In view of the emergence of many new viruses, the sterility of those medical devices
must be assured at the highest level. To achieve this, the CSSU is designed and op-
erated with the principle of stringent infection control measures in handling those
medical devices from the receiving to the operation table.
Good engineering practice in construction, selection of appropriate material and

equipment, installation of suitable engineering systems and effective maintenance of
the entire facility partly contribute to the achievement. Therefore, the formulation of
this document is timely and serves as a practical guidance to whoever involved in the
planning, constructing and maintaining of the CSSU.
This guideline, hopefully, can be benefited by various interested parties within or out-
side the Ministry of Health to further enhance the sustainability of CSSU in continu-
ously producing the highest sterility of re-usable medical devices.
Datuk Dr. Noor Hisham Bin Abdullah

Director General of Health
Ministry of Health Malaysia
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PREFACE
THE DIRECTOR OF ENGINEERING SERVICES DIVISION
Central Sterile Supply Unit (CSSU) is an integral part of the hospital and plays the
role of processing re-usable medical devices and consumables that are used in op-
erating theatres, emergency department and wards where surgical and non-surgical
procedures are carried out.
Properly designed, installed, operated and maintained CSSU facility and equipment
will ensure that reprocessed medical devices and other sterilized products achieve
high assurance levels of sterility, and eliminate any source of contaminant/infection
for the personnel and patient.
These guidelines are developed to ensure that CSSU at the hospitals comply to inter-
national requirements with a greater emphasize put on the engineering aspects as
to address the issues and concerns raised during the construction and operation
phases.
These guidelines are also prepared to serve as a guiding document in establish-

ing some basic requirements in the construction of a new CSSU and upgrading or
converting an existing area in a CSSU. Apart from complying with the functionality
requirements, the design should allow flexibility and creativity to cope with the min-
imum space of utilization as the way forward.
These guidelines are intended for Ministry of Health personnel (the owners), the
hospital administrators, health care workers, designers, maintenance personnel, and
others concerning the CSSU in the healthcare facilities.
Haji Md. Jalal Bin Bongkik

Director of Engineering Services Division
ACKNOWLEDGEMENTS
The guidelines were prepared by the Engineering Services Division of the Ministry
of Health Malaysia (MOH) and assisted by Healthcare Facilities Consultant, Sistem
Hospital Awasan Taraf Sdn Bhd (SIHAT), who was appointed by the Government of
Malaysia.
We thank and acknowledge the following personnel who contributed to the prepara-
tion of this document, by taking part in discussions, reviews, providing feedbacks and
being members in the committee meetings.
Engineering Services Division, Ministry of Health Malaysia (MOH)
1. Tn. Haji Md. Jalal Bin Bongkik

2. Tn. Haji Tauran Zaidi Bin Ahmad Zaidi
3. En. Mohd Azizi Bin Ibrahim
4. Ir. Haji Suhaimi Bin Rashid
5. Ir. Mohd Hisam Bin Sa’at
6. En. Mohd Kamalluddin Bin Hashim
7. En. Mohd Fairuz Bin Mohd
8. En. Abu Bakar Bin Abdullah
9. Ir. Rasyidi Bin Mohd Tahir
10. En. Amir Ikram Bin Muhammad
11. En. Adli Faiz Bin Ramli
12. En. Mohd Haisa Bin Hafiz Ariffin
13. Ir. Haji Rosmahadi Bin Ali (Editor)
14. En. Alif Riduan Bin Khalid@Othman (Member of Editorial Board)
15. En. Mohd Amirul Fahmi Bin Mohd Lazim (Member of Editorial Board)
Planning Division, Ministry of Health

1. Dr. Siti Sarah Binti Mohd Shukor
2. Pn. Katijah Binti Karim
3. Pn. Shaliza Binti Abd. Rahman
Medical Development Division, Ministry of Health

1. Dr. Suraya Binti Amir Husin
2. Dr. Suriana Aishah Binti Zainal
9
Tengku Ampuan Rahimah Hospital

1. Pn. Jamilah Binti Jaafar
2. Pn. Ong Siew Wang
3. Pn. Nor Saffia Binti Badron
Sungai Buloh Hospital

1. Pn. Khaslina Binti Kasbon
Malaysian Sterile Service Association

1. Pn. Kamariah Binti Jusoh
2. Pn. Hjh. Mek Binti Jusoh
3. Pn. Rahijah Binti Abd. Rahman
LIST OF ABBREVIATIONS
ORGANIZATIONS
ASHRAE American Society of Heating, Refrigerating and Air-Conditioning
Engineers
JKKP Jabatan Keselamatan dan Kesihatan Pekerjaan (Department of
Occupational Safety and Health)
MOH Ministry of Health, Malaysia
TERMS
ACMV Air Conditioning and Mechanical Ventilation
AHU Air Handling Unit
CSSU Central Sterile Supply Unit
ICU Intensive Care Unit
MD Medical Device
UPS Uninterruptible Power Supply
11
GLOSSARY
Air- A form of air treatment whereby temperature humidity and air
Conditioning cleanliness are all controlled within limits determined by the
requirements of the air-conditioned enclosure.
Air Handling AHU is a device that is used to filter, condition and circulate the air as
Unit (AHU) part of a heating, ventilating, and air-conditioning (HVAC) system.
Carrier A device that carries or transports the load through the decontamination
process.
Class 8 Class 8 is a classification number in the ISO 14644 clean-room standard

on the classification of the air cleanliness.
ISO Maximum concentration limits (particles/m3 of air) for particles equal to and
Classification larger than the considered sizes shown below
number
= 0.1μm =0.2 μm = 0.3 μm = 0.5 μm = 1 μm = 5.0 μm
ISO Class 1 10 2
ISO Class 2 100 24 10 4
ISO Class 3 1000 237 102 35 8
ISO Class 4 10,000 2370 1020 352 83
ISO Class 5 100,000 23,700 10,200 3520 832 29
ISO Class 6 1,000,000 237,000 102,000 35,200 8320 293
ISO Class 7 352,000 83,200 2930
ISO Class 8 3,520,000 832,000 29,300
ISO Class 9 35,200,000 8,320,000 293,000
HEPA filter High Efficiency Particulate Air filters capable of removing 99.97%
of particles 0.3 µm in diameter and may assist in controlling the
transmission of airborne disease agents.
LAeq, Leq It is the Total Sound Energy measured over a given period of time with
an A weight-age measurement.
Load Collectively, all the goods, equipment and materials that are put into
a sterilizer or washer-disinfector at any one time for the purpose of
processing it.
Medical device Any instrument, apparatus, appliance, material or other article, whether
used alone or in combination, including the software necessary for
its proper application intended by the manufacturer, to be used for
human beings for the purpose of: diagnosis, prevention, monitoring,
treatment or alleviation of disease; diagnosis, monitoring, treatment,
alleviation of or compensation for an injury or handicap; investigation,
replacement or modification of the anatomy or of a physiological
process; and control of conception: and which does not achieve its
principal intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its
function by such means.
Microbial Deposition of viable or potentially viable elements of bacteria, fungi or

contamination viruses onto or within articles previously rendered free of them.
Porous-load A clinical sterilizer designed to process, by exposure to high temperature

steam sterilizer steam under pressure, porous items such as towels, gowns and dressings,
and also medical devices that are wrapped in porous materials such as
paper or fabrics.
Pressure The difference in air pressure of the room with respect to the
Differential surrounding. The surrounding here refers to the corridor or adjacent
area where applicable.
Room Units Room units here refer to the local air conditioning units that are used
primarily for the cooling of air, and not disinfection of air.
Spore A small, usually single cell that is dormant and resistant to adverse
environmental conditions, chemical and enzymes.
Sterile Free from viable micro-organisms, including bacterial spores and

viruses.
Sterilization A process undertaken to render a load sterile.
Sterilizer An apparatus designed to achieve sterilization. (See also Porous-load

sterilizer.)
13
Sterilization BS EN 285 specifies that a sterilizing module is a rectangular shape

module measuring 300 x 300 x 600 mm, of volume 54 L. A large sterilizer can
accommodate one or more modules.
Tray A container, usually with a flat base and upturned edges, used for
containing an assembly of surgical instruments for packing to be used
in an aseptic procedure.
Ultrasonic A mechanical cleaner that generates sound waves that creates cavitation
cleaner and is used to clean instruments.
Uninterrupt- UPS is a battery back power supply that provides emergency power for
ible Power a specified duration during a power failure.
Supply (UPS)
User User is the person who uses the equipment or services e.g. nursing
staff.
Washer- Machine intended to clean and disinfect medical devices and other
disinfector articles used in the context of medical, dental, pharmaceutical and
veterinary practices.
EXECUTIVE SUMMARY
The guidelines were prepared by the Engineering Services Division, Ministry of Health
Malaysia and have eight (8) sections.
Section 1 : Introduction
This section explains the importance of CSSU in the hospital and the need for proper
planning in design, build and maintain of the department.
Section 2 : Central Sterile Supply Unit (CSSU)

This section discusses the primary function, location, interaction between CSSU and other
departments, and the internal processes. There is also a brief explanation of sterilization
and the types of common sterilization processes in a hospital.
Section 3 : General Function and Layout

This section focuses on the basic layout, staff and material movement in CSSU to promote
infection control protocol as well as to prevent cross contamination during processes.
Section 4 : Service Area within Zone

This section elaborates the various areas within the department and specifies the
intended function, activities, requirements, fixtures, fittings, equipment, and engineering
service requirements.
Section 5 : General Information

This section briefly describes the planning of the department in terms of sizing and
selecting the major equipment.
Section 6 : Architectural and Engineering Services

This section explains the detailed requirements of architectural, mechanical, electrical,
and communication aspects of the department.
Section 7 : Acquiring and Installation of Major CSSU Equipment

This section discusses the planning for acquiring and installation of a new major CSSU
equipment. It also stresses the roles and responsibilities of the owner of the hospital
during the planning, execution, testing & commissioning of the equipment.
Section 8 : Upgrading of Existing CSSU

The last section of the guideline discusses the elements to be closely considered and
thought by the owner before embarking on a major upgrading of the CSSU.
15
1. Introduction
Centralized Sterile Supply Unit (CSSU) in hospitals play an important role in providing sterile
products to the various end users e.g. the operation theatres, emergency department,
maternity, wards etc. through a series of strictly monitored cleaning, disinfecting, packing
and sterilizing processes.
Building the CSSU requires an in-depth knowledge of the operational of the department,
relationship between the supplying and receiving departments in the hospital, compliance
to the infection control protocol, cross contamination containment, the necessity of
major processing and supporting working equipment, and the ability of the department
to sustain the current and near future demands.
As the design of the department becomes more complicated to address all the above
mentioned requirements within the allowable space, the engineering systems installed in
this department shall be relooked. Based on the experience from the construction of new
or upgrading the existing of such department in hospitals as well as the operation and
maintenance of the facility, there is the need to establish a quick reference on the various
engineering issues concerning this department.
This document is developed based on numerous established guidelines plus the input from
the local CSSU practitioner and medical planners with the noble intention of reducing any
operational and maintenance problems with regards to engineering systems and design.
It covers the basic planning of the department, space and equipment requirements, and
utilities requirements to support the equipment and department.
Last but not least, the document also provides the basic roles of the hospital and
instructions to be followed in planning and upgrading the process of existing facility and
major equipment replacement in the department. Coupled with the inclusion of the
latest construction and new policy requirements, this document shall be handy for all
relevant parties.
2. Central Sterile Supply Unit (CSSU)
Central Sterile Supply Unit (CSSU) is the center for processing reused medical devices and
supplying sterilized products to various departments such as operation theatres, critical
care departments, emergency department and wards.
2.1 Primary Functions
1) To receive, decontaminate, clean, dry, pack and sterilize contaminated re-

usable Medical Device (MD) to a level that provides an assurance of sterility.
2) To sterilize soft goods before distributing to the relevant departments.
3) To ensure that all decontamination and sterilization processes are carried
out, monitored and adhered to the acceptable international standard.
4) To manage all raw materials and sterilized MDs that are received/issued
through CSSU to be continuously tracked, to ensure accountability and loss
reduction in the most cost effective manner.
2.2 Location
The location of the CSSU is dependent on the primary function i.e. to sterilize
consumables and contaminated re-usable MDs.
1) CSSU shall be located near the main source of generation i.e. the operation
theaters. It shall preferably be adjacent to and on the same floor of the
operation theatres. CSSU shall also be close to critical care units and the
emergency department.
2) The potential risk of contamination of the sterile products shall be minimized
by the shorter distance and travel time possible.
3) There shall be a direct and easy access from the medical supplies store to
the CSSU or from the CSSU to other users of departments via designated
route(s).
4) The routes for transporting dirty and sterile products shall, in any way or
point, not be crossing each other. A designated route for maintenance
activities shall be preferable.
5) The CSSU shall not be placed in the inner part of the building to avoid
complexity in the engineering system design and maintenance.
6) Proper accessibility to the department and supporting engineering facilities
shall be considered for maintenance and future equipment replacement
activities.
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Operation Theatres/
Critical Care
Units/Wards/ ED
Receiving
Distribution
Decontamination
Storing
CSSU
Washing
Cooling
Inspection
Sterilization
Packing
Raw Material/
Linen/ MDs
Figure 1- Primary Functions

2.3 Sterilization
2.3.1 Classification
Reusable medical devices1 are classified based on device usage and their
contact with body i.e. non-critical, semi-critical and critical. The classification
is shown in the table below;
Table 1
Spaulding Contact Level Disinfection/ Sterilization
Classification
Non-Critical Skin, non-secretion membranes (e.g. Low or Intermediate Level
bed pans, cuffs etc.) Disinfectant
Semi-Critical Mucous membrane or non-intact High Level Disinfectant
skin (some endoscopes, medical
instrument blades etc.)
Critical Tissue or the vascular system (e.g. Sterilization
implants, invasive catheter etc.)
Medical devices that have contact with sterile body tissues or fluids are
considered critical items. These items shall be sterile when used because
any microbial contamination could result in disease transmission.
2.3.2 Type of Sterilization
Sterilization describes a process that destroys or eliminates all forms

of microbial life and spores, and is carried out in health-care facilities by
physical or chemical methods2. A product is said to be sterile when it is free
from any viable microorganism present after it is sterilized.
The level of sterility is referred as Sterility Assurance Level (SAL). SAL is

expressed as 10-n. SAL of 10-6 is the probability of not more than one in a
million microorganisms surviving after sterilization.
There are three main parameters to be considered during sterilization i.e.

temperature, pressure and time. Any change in one of the parameters
affects the SAL. SAL (10-6) can still be achieved by manipulating the other
two parameters within allowable limits i.e. increasing/decreasing the time,
temperature or pressure.
1 Chemical disinfection of medical and surgical materials, Spaulding E.H. (Guideline for Disinfection and
Sterilization in Healthcare Facilities, 2008, Page 10)
2 Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, Page 8
19
There are mainly two types of sterilization i.e. steam sterilization and low
temperature sterilization used in hospitals.
a. High temperature (Steam) Sterilization
The steam sterilization process shall be applied for heat resistant medical
devices because it has the largest margin of safety due to its reliability,
consistency and lethality.
There are two types of steam sterilizers i.e. gravity displacement type and pre-
vacuum (dynamic-air-removal) type. The gravity displacement autoclaves
are primarily used to process laboratory media, water, pharmaceutical
products, regulated medical waste, and nonporous articles whose surfaces
have direct steam contact.
The high-speed pre-vacuum sterilizers, on the other hand, are fitted with a
vacuum pump (or ejector) to ensure air removal from the sterilizing chamber
and load before the steam is admitted. The advantage of using a vacuum
pump is that there is a nearly instantaneous steam penetration, even into
porous loads.
Another design in steam sterilization is a steam flush-pressure pulsing

process, which removes air rapidly by repeatedly alternating a steam flush
and a pressure pulse above the atmospheric pressure. Typical sterilization
temperatures and times are 132°C to 135°C with 3 to 4 minutes of exposure
time for porous loads and instruments.
The typical operating temperature and exposure times for the category of
items sterilized in a gravity displacement and pre dynamic air removal (pre-
vacuum) sterilizers are based on acceptable international standards.
The medical devices shall be exposed to direct steam contact at the

appropriate temperature and pressure for the specified time in order
to accomplish sterilization. The ideal steam for sterilization shall be dry
saturated steam and entrained water (dryness fraction ≥97%).
The Bowie-Dick test shall be used to detect air leaks and inadequate air
removal and consists of folded 100% cotton surgical towels that are clean
and preconditioned. A commercially available Bowie-Dick-type test sheet
shall be placed in the center of the pack.
Portable (table-top) steam sterilizers shall be used in outpatient, dental, and

rural clinics. These sterilizers are designed for small instruments, such as
hypodermic syringes and needles and dental instruments. The ability of the
sterilizer to reach physical parameters necessary to achieve sterilization shall
be monitored by mechanical, chemical, and biological indicators.
Similarity, the steam cycle shall be monitored by mechanical, chemical,

and biological monitors. Steam sterilizers shall have a printout (or shown
graphically) by measuring the temperature, the time at the temperature,
and pressure. Typically, chemical indicators shall be affixed to the outside
and incorporated into the pack to monitor the temperature or time and
temperature.
b. Low temperature sterilization
There are a few types of low temperature sterilization i.e. Hydrogen Peroxide
Gas Plasma, Ethylene Oxide Gas and Peracetic Acid. These low temperature
sterilizers are used for MDs that are susceptible to heat and moisture e.g.
plastic and electrical devices.
Some of the common types are briefly described in the following paragraphs.
1) Hydrogen Peroxide Gas Plasma
The sterilant used in this sterilizer is Hydrogen Peroxide solution which

vaporizes and comes in contact with the surface of the load. Electrical
field created using radio frequency is applied to the vapor which
generates microbicidal free radicals (hydroxyl and hydroperoxyl).
These radicals inactivate the microorganisms.
The advantage of this sterilizer is that the by-products of this type of

sterilization are water vapor and oxygen. The process operates in the
range of 37-44oC and has a cycle time of about 75 minutes.
2) Ethylene Oxide (EtO) Gas Sterilizer
The sterilant used in this sterilizer is EtO gas which is colorless,

flammable and explosive.
The distinct disadvantage of this sterilizer is the long processing time

(1-6 hours) and aeration time (8-12 hours at 50-60oC).
21
Since EtO poses a potential health hazard to the staff and patient, a
proper installation to prevent exposure and personnel monitoring
mechanisms shall be applied. Local exhaust ventilation system shall
be installed at this sterilizer.
3) Peracetic Acid
Peracetic acid is a highly biocidal oxidizer that maintains its efficacy

in the presence of organic soil. Peracetic acid removes surface
contaminants (primarily protein) on endoscopic tubing.
The sterilant, 35% peracetic acid, and an anticorrosive agent are

supplied in a single-dose container. The concentrated peracetic acid
is diluted to 0.2% with filtered water (0.2 μm) at a temperature of
approximately 50oC. The container is punctured at the time of use,
immediately prior to closing the lid and initiating the cycle.
The sterilant is pumped through the channels of the endoscope for

12 minutes, decontaminating the exterior surfaces, lumens, and
accessories.
3. General Function and Layout
The general function of the department shall be addressed by specifying the right flow of
materials and personnel, proper areas zoning, sufficiently sized equipment, and provision
for future expansion.
The details of the departmental layout such as type of rooms, size, orientation, and
location shall be strictly adhered to the guideline produced by the Planning Division,
Ministry of Health.
The provision of proper air movement, environmental parameters controlled and

pressurization scheme shall be strictly adhered to in order to eliminate the potential risk
of cross contamination.
The actual details of rooms, size and orientation shall be finalized prior to the construction
of the department involving all relevant parties subjected to the actual project area and
complying with the requirements of standard.
The use of newly advanced washing and sterilizing equipment utilizing energy/water
efficient mechanisms shall be encouraged. Based on the available space area, the double
doors version of equipment shall be preferable.
The use of information technology in the process of registration, verification, validation,

stock circulation and tracking mechanism shall be promoted for efficient management of
CSSU.
Proper intra route and adequate space between equipment or nearby installation/wall
for maintenance access or activities shall be provided.
3.1 Basic CSSU Layout
The basic layout shall be designed to meet the principle function of CSSU and be
equipped with the proper supporting facilities in resulting infection-free sterilized
medical devices.
The design shall allow flexibility and creativity in space utilization and equipment
sizing without compromising the principle of infection control and cross
contamination prevention.
A CSSU shall be made up of three clearly indicated zones namely the soiled zone,
clean zone and sterile zone.
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Figure 2: The Basic Zoning and Pressurization Trends in CSSU
For the double doors equipment arrangement, the washer disinfectors and
sterilizers shall act as the primary and secondary physical barriers.
For the single door equipment set up, the soiled area shall be clearly separated
from the clean or sterile area.
The movement of personnel and material within the CSSU shall be properly
designed to ensure no or minimum contamination of the sterile products.
The layout and proposed workflow in CSSU shall comply with the latest safety
requirements by Fire Department. Dedicated escape route for staff shall be
established to accommodate safe evacuation in the event of fire or any other
emergency incidents.
The layout shall preferably allow adequate space for the future expansion of
services by the department.
The following chart shall serve as a basic guide for area distribution in the new CSSU.
The actual percentage may differ at the site based on the specific requirement at
a particular hospital.
15% 20%
15%
20%
30%
Auxilliary zone
Cleaning area
Preparation zone
Steriled products storage
Storage room
Figure 3: Proposed Area Distribution in CSSU
3.2 Staff Movement
Staff safety and wellbeing is crucial as they constantly come in contact with
contaminated re-usable medical devices. The safety aspects involve administrative
controls i.e. controlling the staff movement and the donning of personnel protective
gears.
The staff movement shall be restricted within zones so as to minimize any cross
contamination within the zones. The staff movement shall abide to the CSSU
operational policies and/or by use of dedicated security passes.
Staff entering the soiled zone shall go through a dedicated change room where
they wear the appropriate clothing and Personnel Protective Equipment (PPE) e.g.
gloves, face mask, wet boots etc.
Staff working in clean zone shall enter the clean zone through a dedicated change
room where they wear appropriate clothing and PPE, while staffs working in the
sterile zone shall then proceed through a door between the clean and sterile zones.
25
3.3 Material Movement
There are various types of material moving within the CSSU i.e. contaminated re-
usable medical devices, clean medical devices, linen and consumables.
Contaminated re-usable medical devices arriving from various locations shall be

processed from the most soiled (dirtiest) part of the CSSU to the cleanest part of
the CSSU.
3.3.1 Soiled Zone
The Soiled Zone is where soiled items are received from the user locations.
Here, the items are decontaminated, cleaned and disinfected.
Soiled Zone is made up of the following areas;
1) Receiving Area
Stainless steel tables counter
2) Cleaning Area
a. Decontaminating Area
b. Manual Washing
c. Ultrasonic cleaning area
3) Disinfection
a. Automated Washing Area
b. Automated Cart Washer
4) Hand washing facilities
5) Bins or other containers for the disposal of waste
6) Detergent Room
- Stainless cabinet
- Exhaust fan
7) Cleaning equipment room / area
3.3.2 Clean Zone
The Clean Zone is where items that have been cleaned are inspected,
assembled and packed before they are sent for sterilization. Clean Zone is
made up of the following areas;
1) Inspection, Assembly and Packing

- Stainless packing table with wheels and locking system
- Magnifying glass on each table
- Heat seal machine
- Digital weighing scale ( place on table)
2) Documentation and Label Printing Area
3) Clean Stores
4) Sterilizer Loading Area
5) Linen Room
- Inspection table with lamp
- Exhaust fan
6) Soft Dressing Room
- Packing table and adjustable chair with back rest
- Exhaust fan
3.3.3 Sterile Zone
The Sterile Zone is where the loads are sterilized, cooled, stored and
prepared for dispatch to the end-user. The Sterile Zone is made up of the
following areas;
1) Sterilizer
2) Cooling Area
3) Sterilized Products Storage Area and
4) Sterile Item Issuing Area
27
4. Service Area within Zone
4.1 Soiled Zone
4.1.1 Receiving Area
This area is the entrance to the Soiled Zone.
A. Function
1) This area is where contaminated re-usable medical devices
from various user locations are deposited for processing.
2) All items received shall be recorded.
Stainless steel tables Computer and bar code scanner
B. Activities carried out

1) Contaminated items are received at the counter where they are
sorted out, scanned and logged.
2) The items are forwarded to the decontamination area and the
trolleys are sent to the Cart Washer.
C. Requirements
1) It shall be at the entrance to the CSSU.
2) The entrances shall be secured to prevent access by
unauthorized people.
3) A “red-line” is to be drawn out on the floor to designate the
beginning of the area, where soiled trolleys and materials are
to enter.
D. Fixtures, Fittings and Equipment

1) Computer with CSSU management software
2) Uninterruptable Power Supply for computer
3) Bar code scanner
4) Stainless steel tables
5) Moveable stools with back support
E. Engineering Services Required

1) For general requirements, refer to Section 6
2) Switch socket outlets for computer, and scanner
3) Data ports for network connections
4) Door access control
5) Intercom and telephone connection
4.1.2 Cleaning Area
Cleaning of MDs is the first step towards sterilizing re-usable MDs. The
purpose is to clean and rinse the MDs so as to remove all visible debris
and reduce the number of particulates, micro-organisms and potential
pathogens. Thorough cleaning and rinsing are vital for the effectiveness
of subsequent processes used for decontamination, disinfection and / or
sterilization.
Ineffective cleaning and rinsing of the MDs may result in foreign material on
the device to interfere with the effectiveness of subsequent disinfection and
/ or sterilization.
4.1.2.1 Decontamination Area
A. Function
1) Some of the soiled MDs that are deemed unsafe to
handle shall be decontaminated before they are further
cleaned and processed.
2) Decontamination is carried out by immersing the soiled
MDs in chemicals that will inactivate or destroy blood-
borne pathogens on a surface or difficult to access
locations on the MDs e.g. the joints; so that they are
no longer capable of transmitting infections and are
rendered safe for handling.
29
Stainless steel table tops with deep sink Signage identify the area

1) Highly contaminated MDs are immersed in special
stainless steel bowls with covers.
C. Requirements
1) Area is identified and labeled as “BIOHAZARD
INSTRUMENTS”.
2) There shall be space for foot operated clinical waste bins.

1) Double Bowl Stainless Steel Deep Sink
2) Stainless steel table tops
3) Moveable stools

2) Cold water supply to the hand wash basin
4.1.2.2 Manual Cleaning Area
A. Function
1) Soiled MDs that are deemed unsuitable for automated
cleaning are manually cleaned. Manual cleaning is
recommended for MDs that are delicate or complex,
such as micro-surgical devices, instruments having lenses
(scopes) and air-powered drills.

1) Soiled MDs are sorted, cleaned and rinsed.
C. Requirements
1) Adjacent to the decontamination area.

1) Double Bowl Stainless Steel Deep Sink
2) Stainless steel tables
3) Moveable stools
4) Spray gun at sink to facilitate the cleaning of lumens
(hollow, tubular instruments)

2) Cold water supply to deep sink
3) Medical air
4) Laparoscopic Insulation Tester
Laparoscopic Insulation Tester
4.1.2.3 Ultrasonic Cleaner
A. Function
1) Ultrasonic cleaner is the most effective and efficient
way to clean instruments with small crevices, cavities,
lumens, and between tightly spaced parts, where it is
hard to reach during manual cleaning. It is able to remove
debris from challenging areas of the instrument e.g. the
box lock, jaw, ratchets, hinges, serrations, reamers and
drills. To maximize its effectiveness, the instruments shall
first be cleaned of all visible debris.
31
Ultrasonic Cleaners Ultrasonic Cleaner with de-ionized

water treatment system, hot water
boiler and detergent dispenser

1) Cleaning is done using de-ionized water with detergents.
C. Requirements
1) The ultrasonic cleaner shall have an interlocking lid and
thermostatically controlled heaters/ hot water boiler.

1) Rack with baskets

2) De-ionized water
3) Switch socket outlets
4) Water outlet
5) Hot water boiler
4.1.2.4 Washer Disinfector (WD)
There are two types of WD i.e. single chamber and multi-chamber

(tunnel washers).
A. Function
1) The WD’s primary function is to wash, disinfect and
lubricate the instruments.
2) A typical wash cycle in a WD is pre-rinsing, cleaning
(with detergent), post rinsing (with lubrication), thermal
disinfectant, final rinse and the drying phase.
3) The whole cycle is automatically validated.
4) The WD forms a part of the primary physical barrier

between the Soiled Zone and the IAP Zone.
5) These washers form the primary physical barrier between
the soiled and clean zones.
Washer disinfectors Transfer trolley in front of washer

disinfector

1) Disassembled and washed items are placed in wire mesh
baskets which are then placed into the appropriate
carriers that are loaded into the WD.
2) Cleaning detergent (enzymatic and non-enzymatic) and
lubricant are loaded into the WD prior to the switching
on the cycle.
C. Requirements
1) Dedicated floor mounted conveyor line (to suit WDs).
2) The WDs shall be sufficiently ventilated to remove heat
and smell from disinfecting agents.

1) Transfer trolleys
2) Conveyor lines

2) Domestic hot and cold water supply
3) De-ionized water
5) Water outlet
6) Intercom
33
4.1.2.5 Cart Washer
A. Function
1) The main functions of the washer are to wash, disinfect
and dry the soiled carts (trolleys).
2) The wash cycle may consist of pre-rinsing, cleaning
(with detergent), post rinsing (with lubrication), thermal
disinfectant, final rinse and the drying phase. The whole
process of the washing cycle is automatic.
Cart Washer

1) Trolleys are placed into the Cart Washer and the washing
process is initiated.
2) Disinfectants need to be replenished.
C. Requirements
1) There shall be a dedicated room adjoining the cart
washer to accommodate the boiler and air compressor.
This room can either come as part of the cart washer
package or is dedicated to the facility.
2) There shall be sufficient space provided around the
equipment for inspection and repairs, while the access
doors shall be sized appropriately to allow a complete
replacement of the equipment.
3) There shall be a water jet facility to be used to clean the
washer disinfector.

1) Dedicated steam boiler
2) Dedicated compressed air

2) Domestic hot and cold water supply
4) Waste water outlet
5) Water jet facility
6) Compressed air to dry the trolley
Water jet facility
4.1.2.6 Transfer Hatch
A. Function
1) The transfer hatch is used to transfer large, manually
cleaned and disinfected MDs and none-MDs to the next
Zone (IAP Zone). The none-MDs that are transferred are
baskets and instrument trays.
2) This hatch forms a part of the primary physical barrier
between the Soiled Zone and the Clean Zone.
3) The transfer hatch door facing the Soiled Zoned and the
one facing the IAP Zone shall be interlocked, allowing
only one door to be opened at one time.
35
Transfer hatch

1) Large, cleaned and disinfected MDs and non-MDs are
passed through this hatch.
C. Requirements
1) The hatches shall be able to close so as to create an airlock
to minimize the air movement between the Soiled Zone
and the Clean Zone.
2) Dedicated floor mounted conveyor lines shall be placed
at the Transfer Hatch.

1) Stainless steel conveyor lines

1) For general requirements, refer to Section 6.
2) Intercom shall be installed for staff to communicate
between the two zones.
4.1.2.7 Medical Drying Cabinet
A. Function
1) This cabinet generates hot air that is used to dry MDs
such as anesthetic hoses, breathing bags, hollow ware
and tubing.
Drying cabinets with utensils on rack Drying cabinets with tube rack

1) MDs are placed in the drying cabinets for a period of
time under fixed temperatures.
C. Requirements
1) There shall be sufficient space at the back of the dryer for
proper air circulation.

Not Applicable

2) Switch Socket Outlet
4.2 Clean Zone
4.2.1 Inspection, Assembly and Packing Area (IAP Area)
A. Function
1) In this area, MDs are Inspected, Assembled and Packed prior to
sending them for sterilization.
37
Worktable at IAP Rack with pouches
Worktable with bins

1) Here, the MDs are placed on a stainless steel table laid with
wrapping sheets where they are inspected, assembled and
packed. Stainless steel storage racks are also made available in
this area to store paper wrapping sheets.
2) MDs are inspected to ensure that they are clean and not
damaged. The instruments are also inspected for their
functionality and are lubricated when required.
3) The MDs and consumables are assembled in sets or in trays
based on the standard checklist for their final use (surgical
procedures).
4) The assembled packages are then packed in proper wrappers/

pouches, sealed, and labeled. Biological indicators are placed in
the middle of the load and chemical indicators are placed inside
and outside of the packing to validate the sterilization process.
C. Requirements
1) IAP area shall be sufficiently sized and suitably arranged.
2) Minimum distance from the machine & working table shall be
allowed for material and staff maneuverability.
3) Windows to the outside shall be encouraged; however, when
installing, the windows need to be sealed.
4) Internal walls and doors shall have vision panels.
5) The area shall be under positive pressure differential with
respect to adjacent areas.

1) Adjustable height, stainless steel packing tables
2) Adjustable height, stools
3) Stainless steel storage racks
4) Stainless steel, wrapper racks
5) Stainless steel “wire” containers or plastic/polypropylene
baskets.
6) Table lamp with light and magnifier
7) Mobile, high adjustable stools
8) Stainless steel trolleys
9) Rotary Heat Sealing Machine (2 different types)
a. for sealing both types of high temperature and high
pressure pouches and bags; and
b. for sealing low temperature pouches and bags.

2) IAP area shall be air conditioned and designed for appropriate
class of clean room.
3) The area shall be under positive differential pressure with
4) Natural lighting from windows is encouraged. Task lighting shall
be in place where items are inspected at IAP tables.
5) Switch socket outlets shall be required for the task lighting.
39
4.2.2 Documentation and Label Printing Area
A. Function
1) In this area, all the different packing checklists are printed so
that the nursing staff can use this checklist to assemble the
MDs sets based on the operation requirement.
2) Bar code labels are also printed and scanned to capture all
relevant information.
Computer with printer

Scanner with label printer
B. Activities Carried Out

1) Checklist for the assembly of sets are printed out
2) Labels are printed out
3) Labels are placed on the scanner and packed
C. Requirements
1) Propriety software for CSSU management

1) Computer
2) Printer for checklist
3) Label printer and scanner
4) Uninterruptible Power supply (UPS)
5) Stainless Steel Table
6) Movable stool

2) Switch socket outlets for computer, printer, scanner.
3) Data line for network.

4) Intercom and telephone connection.
4.2.3 Clean Stores
There are basically four different types of clean stores i.e. “Stor Pukal (bulk
store), “Stor Peralatan” (instrument store), “Stor Kain Kasa” (soft goods
store) and “Stor Kain” (linen store).
A. Function
1) The bulk store is used to store items purchased in bulk, especially
the bulky items e.g. sterilization wrapping paper, pouches and
autoclave tape, etc.
The instrument store is used to store medical devices to stock
up on any deficiency in the packing or faulty device.
The swab/gauze store is where gauze is repackaged into the
desired packing e.g. gauze pad, gauze bandages, gauze sponge,
swabs etc.
The linen store is where clean linen is stored and packed as a
part of the procedural accessories e.g. surgical towel, mayo
stand cover, drape sheet etc.
2) These stores are used to store clean items (consumables)
before there are sent to the packing area or directly to the
sterile loading area for sterilization.
Rack in bulk store Rack in soft goods store

41
B. Activities Carried Out

1) Items are stored in these stores and in some cases, packed prior
to sending them for sterilization.
C. Requirements
1) The swab/gauze cutting table in the store shall have a Local
Exhaust Ventilation system.
2) Linen packing area shall be properly lit so that the user can
clearly see and pick any frayed linen (loose thread).

1) Stainless steel storage racks
2) Stainless steel table and movable stool
3) Rotary heat sealing machine
4) Illuminated linen inspection table
5) Gauze cutting machine

2) Switch socket outlets for rotary heat sealing machines and
gauze cutting machine.
3) There shall be a Local Exhaust Ventilation (LEV) system in the
swab/gauze store. This LEV is used to exhaust out any debris
generated during the cutting and repackaging process. The LEV
shall be so designed to take into account the fire hazard posed
by lint and dust.
4) Data line for network
4.2.4 Sterilizer Loading Area
A. Function
1) Packed sets shall flow from the IAP area to the Sterilizer Loading
Area.
2) Sterilizer Loading Area is where packed sets and trays are placed
in baskets and mounted on trolleys, parked and awaiting to be
loaded into sterilizers.
3) The loads entering this area are sorted based on the type of
sterilization e.g. high pressure steam sterilization or those
requiring low heat (plasma) sterilization. (Plasma sterilization is
discussed as a separate topic).
4) In case of high pressure single-door sterilizers, this area is used
to load and un-load packed items into and out of the sterilizers.
5) In case of double-door sterilizers, the loading is done in this

area while the un-loading is done in a separate area (cooling
area) on the other end of the sterilizer (sterile zone).
6) There shall be a dedicated area to hold visibly defective packs
before the sterilization process.
7) Proper extraction mechanism above the opening of sterilizer
shall be provided.
Trolley parking bay

Demarcated loading area

1) Loads are received and held in this area before they are
loaded into the sterilizer for sterilization and unloaded after
sterilization.
C. Requirements
1) Space requirement shall be based on the three elements i.e.
number of trolleys used, the space required for the trolleys
to move around and space for loading and unloading.
Space requirements shall comply with the manufacturer’s
requirements. A minimum of 2m3 space is required in front the
sterilizers. This area shall be demarcated by a colored line.
2) The area shall be under positive differential pressure with

Not Applicable.

3 IUSS Health Facility Guides, Central Sterile Service Department (Proposal V.1) 21st March 2014, Page 60
43
4.2.5 Sterilizer Room
A. Function
1) This room is used to accommodate sterilizers and its associated
plant and equipment e.g. steam generator (boilers), compressor,
water pump, test points for water etc.
Steam generator

1) Maintenance and repair works are carried out in this area.
2) Water quality is checked in this area at the test points.
C. Requirements
1) There shall be sufficient space within the plant room to
accommodate the sterilizers, its associated plants and
equipment. Space requirement shall be based on the number
of sterilizer and associated equipment.
2) Sufficient space shall also be provided to allow the maintenance
personnel to carry out their maintenance works.
3) Manufacturer’s requirement shall be adopted.
4) The plant room shall be ventilated to remove heat released
during the sterilization process and discharge from safety
valves. An exhaust system shall be installed.

Not Applicable

2) High pressure steam sterilizers from a central boiler or localized
steam generator.
3) Any autoclaves, steam generators and air compressors shall

require the JKKP certificates.
4) Exhaust system
4.3 Sterilization Zone
4.3.1 Sterilizers
4.3.1.1 Steam Sterilizers
A. Function
1) These steam sterilizers are also known as free standing
autoclaves and are used to sterilize items that are able to
withstand high temperature.
2) These sterilizers form the secondary physical barrier
between the clean and sterilized zones.
Steam sterilizer-loading end Steam sterilizer- unloading end

1) Packed sets and trays are placed onto carriers that are
loaded into the sterilizer.
2) The autoclave operators need to ensure that the desired
sterilizer program is initiated and that the sterilizer
completes it sterilization cycle.
3) The autoclave operators will unload the sterilized
products and validate that the sterilization cycle has
been completed.
45
C. Requirements
1) There shall be sufficient numbers of sterilizers to meet
the demand of the hospital.
2) There shall be sufficient space for future expansions
(additional sterilizers).

1) Steam sterilizers
2) Steam generators
3) Air compressors

2) There shall be sufficient numbers of switch socket outlets.
3) There shall be a drainage system to facilitate the discharge
of condensate and dirty water arising from cleaning the
sterilizer.
4) There shall be a dedicated or shared Local Exhaust
Ventilation (LEV) hood just in front and at the other end
of the sterilizer to exhaust the gush of steam whenever
the sterilizer door is opened for loading and unloading.
Exhaust system shall also be installed above the sterilizers.
This exhaust system can be a part of the sterilizer plant
room’s LEV system.
4.3.1.2 Ethylene Oxide (EtO) Sterilizers
A. Function
1) Heat sensitive loads are sterilized in these low
temperature sterilizers.
Ethylene Oxide Sterilizer


1) Packed sets are placed into the sterilizing chamber.
completes its sterilization cycle.
been completed.
C. Requirements

1) Ethylene Oxide Sterilizers (Low temperature sterilizer)
2) Aerator (new sterilizers may not have a separate aerator)

3) There shall be a dedicated Local Exhaust Ventilation (LEV)
system to exhaust the residual Ethylene Oxide.
4.3.1.3 Hydrogen Peroxide (Plasma) Sterilizers
A. Function
1) Heat sensitive loads are sterilized in these low
temperature sterilizers.
Plasma Sterilizer (Low Temperature Sterilizer or

Hydrogen Peroxide (Plasma) Sterilizers )
47

1) Packed sets are placed into the sterilizing chamber.
completes it sterilization cycle.
been completed.
C. Requirements

Not Applicable.

4.3.2 Cooling Area
A. Function
1) This area is located on the unloading side of the double-door
sterilizer. Here, items that have been sterilized are removed
from the autoclaves and placed onto trolleys, where they are
allowed to cool to room temperature.
Sterilized load in cooling area


1) Sterilized item are unloaded from the sterilizer onto trolleys,
where they are allowed to cool to room temperature.
C. Requirements
Not Applicable.

1) Sufficient number of trolleys are available.

4.3.3 Sterilized Product Storage Area
A. Function
1) Once the items have been sterilized and cooled in the Cooling
Area, they are transferred to the sterile store. The sterile store
is the cleanest area in the CSSU.
2) Items are stored on open shelf stainless steel racks.
Sterilized products on racks in sterile store

1) Items are loaded and un-loaded onto or from the open shelf
stainless steel racks.
49
C. Requirements
1) There shall be no source of contamination e.g. wash areas,
trash bins.
2) The store shall be in an area with minimum traffic flow.

1) There shall be sufficient space around the racks for proper
storing of the sterilized items.
2) The lowest shelf of the rack shall be 250mm above the floor;
while the top part of the rack shall be 440mm from the ceiling4.
3) Air-conditioned.

4.3.4 Sterile Item Issuing Area
A. Function
1) Sterilized items are issued from this sterile issue area to the
users.
Computer with scanner Issuing area

1) Sterilized items are issued at this area.
C. Requirements
Not Applicable
4 Guideline Storage Design for Sterile and Non-Sterile Stock for New and Refurbished Healthcare Facilities,
Centre for Healthcare Related Infection Surveillance and Prevention & Tuberculosis Control, Queensland
Government

1) Counter top or table.
2) Computer with dedicated CSSU module
3) Printer
4) Uninterrupted Power Supply (UPS)
5) Label scanner.
6) Stainless shelves to store empty wire basket

2) Switch socket outlets for computer, printer and label scanner
4.4 Administrative and Staff Facilities
4.4.1 Administrative Office
A. Function
1) This office is to be used by the person in-charge of the CSSU.
The setup shall be consistent with the setup of any office in the
hospital.

1) Administrative works are carried by the person in-charge.
C. Requirements
1) The office shall be located in the clean zone so as to allow the
person in-charge to observe the various activities at this area.
2) The internal walls and doors shall have vision panels.

1) Office furniture e.g. table, chairs, cupboards and filing cabinets.
2) Whiteboard
3) Computer and printer
5) Waste bins

2) Switch Socket Outlets for computer and printer
51
3) Data ports for network connection

4.4.2 Meeting Room
A. Function
1) The meeting room can either be used specifically for the purpose
of conducting a meeting or can also be used as a training room.
The meeting room can also be used for departmental activities.

1) Meeting or trainings are conducted in this facility.
C. Requirements
1) The meeting room shall be located in the clean zone and away
from the all the work areas.
2) The internal walls and doors shall have vision panels.

1) Meeting table and chairs
2) Whiteboard
3) Computer
4) Overhead/LCD projector cum with screen
5) Waste bins

2) Switch socket outlets for computer, printer and overhead/ LCD
projector
4.4.3 Change Room
Change Rooms shall be made available for staff to change their clothing to
hospital gowns and wear Personnel Protective Equipment. There shall be
a set of male and female change rooms with wash room facilities. These
change rooms shall be located at the soiled zone and clean zone.
A. Function
1) This facility is for staff to change into or out of the protective
clothing or gowning.

1) All staffs and visitors entering or leaving the CSSU are required
to change into appropriate clothing.
C. Requirements
1) There shall be separate change rooms for male and for female
staff.
2) The facility shall have washrooms preferably with shower
facilities.
3) There shall be a step-over-barrier to demarcate the clean and
dirty areas within the change room.
4) There shall be sufficient lockers for the staff and spares for
visitors.
5) There shall be shelves for clean gowns and PPE storage.
6) There shall be space for soiled linen bins and foot operated
clinical waste bins.

1) Shelves and lockers
2) Hand wash basin with no plug and overflow
3) Hands-free tap that do not discharge directly into the drain
aperture
4) Footwear storage facility
5) Wall mounted mirror in the wash room for staff

2) Cold water supply to the hand wash basin, shower and
washrooms
3) Intercom
4.4.4 Rest/Staff Room
A. Function
1) The rest room is used specifically by the staff to have a break,
refreshing oneself, rest or have a meal

1) A place where staff discuss about work and socialize during
breaks
53
C. Requirements
1) Shall be away from processing area

1) Table and chairs
2) Cabinets for storage
3) Lockers
4) Sinks
5) Refrigerator
6) Microwave oven

2) Cold water supply to the hand wash basin
4.4.5 Prayer Room
A. Function
1) The prayer room is a room where staff can perform their
religious obligations

1) Staff can perform their prayer activities within this facility
C. Requirements
1) There shall be separate prayer rooms for male and female staff
with ablution facilities

1) Prayer mats

2) Ablution facilities
3) Cold water supply for ablution
4.4.6 Personnel Protective Equipment (PPE) store
A. Function
1) Personnel Protective Equipment store is a store where safety
attires such as gowns, boots, face masks etc. are stored

1) PPE are kept on racks and are withdrawn for use as and when
required.
C. Requirements
1) The PPE store shall be located in the clean zone.
2) This store shall be secured and only assigned staff shall have
access to it.

1) Stainless steel racks

4.4.7 Detergent and Disinfectant Store (Chemical Store)
A. Function
1) The store is used to store detergents and disinfectants used for
decontamination, cleaning and washer disinfector processes
2) Housekeeping cleaning chemicals shall not be stored in this
area

1) Detergents and disinfectants are stored on racks and are
withdrawn based on the CSSU usage.
2) The detergents and disinfectants are topped-up based on their
re-order level.
C. Requirements
Not Applicable

1) Stainless steel shelves
55

2) Local exhaust ventilation will be required where chemicals
are subjected to an occupational exposure limit as per
OCCUPATIONAL SAFETY AND HEALTH (USE AND STANDARDS
OF EXPOSURE OF CHEMICALS HAZARDOUS TO HEALTH)
REGULATIONS 2000.
4.4.8 Disposal Room/Soiled Utility Room
A. Function
1) This room is used to hold clinical and non-clinical waste for
collection and disposal

1) Clinical waste and non-clinical waste bags and bins are stored in
this room and are collected by the Clinical Waste (CW) Disposal
personnel for disposal and the consumables are replaced
C. Requirements
Not Applicable

1) Stainless steel racking

4.4.9 Receive and Break Pack Room
A. Function
1) It is a room where all clean consumables and new MDs are
received for further processing
2) Bulk items are also received here and unpacked before sending
them to the clean rooms

1) Items are received and unpacked into small packs
C. Requirements
1) The store shall be secured and only assigned staff shall have
access to this store
2) Dedicated CSSU module

1) Stainless steel racks
2) Counter top or table
3) Computer
4) Printer
6) Label scanner

2) Switch socket outlets for computer, printer and label scanner
57
5. General Information
5.1 Calculating the size of the CSSU
The size of a CSSU shall be generally determined by;
1) The workload demand of sterile products from various departments within

or outside the hospital.
2) The footprint requirement for the placement of sterilizing and
decontaminating equipment, supporting built-up (benches, cabinet etc.),
administrative spaces, routes for achieving material and personnel flow,
storage areas and so on.
3) The circulation area for the handling of materials and sterilized goods to
promote safe and effective working environment.
4) The appropriate space for trolley and personnel maneuverability during
operation. Proper clearance between the equipment and the working bench.
5) The space for maintenance activities and for future expansion to cater to
additional load demand.
The size of the CSSU shall be based on the maximum simultaneous demand.
5.2 Information required in determining the number and size of major equipment
(sterilizers and washers)
Sterilizers and washer disinfector are amongst the costly equipment in the CSSU.
Due to the high initial capital cost, a proper decision making needs to be made
during the purchase of this equipment.
When designing a new or refurbishing an existing CSSU, it is best to engage the

professional services of the sterilizer’s manufacturers/suppliers to determine the
type, size and quantity of sterilizer required. Some of the information that may be
requested include;
1) Number of hospital beds

2) Number of operating theatres, ICU, HDW, and wards
3) Number of delivery per day
4) Average number and type of surgical procedures per day per operating
theatre, or total surgical procedures for all the operating theatres
5) Number of hours the CSSU will be in-operation per day and number of
operating days per week
6) Number of outside box
It is better to have two smaller sized equipment than having one large equipment
to accommodate the services during maintenance and breakdown.
The number of equipment shall be calculated on the basis of running and standby
arrangement. All equipment shall be designed to be operated alternately at any
times.
Due to space utilization, the recommended size of sterilizer shall be 20cu.ft for
district hospitals and 30cu.ft for general hospitals. For the general hospital,
the designer shall consider the additional depth of the sterilizer in view of the
maintenance area behind the equipment and the width of physical barrier for the
double door type.
The usable volume for washer disinfector shall be in the range of 280-300L
for general hospitals and 180-200L for district hospitals. No gap between the
equipment and the floor shall be permitted in the double door washer disinfector
arrangement.
The major equipment characteristics shall include the following consideration.
1) Complimentary and functional

2) Ergonomics, hygiene and safe
3) Compatible
4) Adapted to the production
5) Complying to the applicable standards
59
6. Architectural and Engineering Services

6.1 Architectural Finishes
6.1.1 Wall
1) Full heighted fire wall shall be provided for the washer and sterilizer
room.
2) Walls shall be of solid construction so as to eliminate the risk of
infestation.
3) Walls shall be washable, scrub-able, smooth, water resistant and not
easily damaged by chemical and disinfectants e.g. tiled, epoxy painted
or spray painted. Tiled walls shall be encouraged to be installed in
soiled zone as they are easier to clean.
4) Walls shall be free of fissures, open joints, or crevices that may retain
or permit the passage of dirt particles.
5) Walls penetrated by pipes, ducts and conduits shall be tightly sealed.
6) Joints shall be avoided as they can hold moisture, encouraging the
growth of organisms. Joints of structural elements shall be sealed if
necessary.
7) In processing areas, finishes shall be suitable for frequent cleaning
and tolerant to surface-cleaning agents.
8) Proper insulation material shall be installed for areas served by the air
conditioning system. The thickness of insulation shall be specified to
meet the requirement of the 24 hours or 8 hours operation.
9) Walls shall be protected against accidental damage from wheeled
traffic by buffer rails and corner guards, which shall be appropriately
sited to reflect the specifications of trolleys in use.
6.1.2 Ceiling
1) Ceiling shall be monolithic from wall to wall without fissures; i.e. there
shall be no open joints that may retain or permit the passage of dirt
particles or supporting microbial growth. This type of ceiling is to be
implemented at the IAP area and sterile store.
meet the requirement of the 24 hours or 8 hours operation.
3) Seamless ceiling for packing and sterile store. Lighting casing in the
ceiling shall match the ceiling for ease of cleaning and maintenance.
4) Ceiling shall be cleanable, impervious and of durable finishes. The
ceiling shall be able to withstand disinfecting and cleaning agents
without deterioration.
5) Ceilings shall be resistant to humidity where steam and moisture may

be encountered.
6) Light fittings shall be recessed, flush fitted and sealed to prevent dust
ingress.
6.1.3 Flooring
1) The finish, the screed and sub-flooring in the CSSU shall be suitable for
heavy trolley traffic.
2) The finishes shall be seamless, non-slip, easy to clean, resistant to
the disinfection procedure and not physically affected by germicidal
cleaning solution.
3) In processing areas, finishes shall be suitable for frequent cleaning
and tolerant to surface-cleaning agents.
4) Joints shall be avoided as they can hold moisture, encouraging the
growth of organisms. Joints of structural elements shall be sealed if
necessary.
meet the requirement of the 24 hours or 8 hours operation
6) The heavy duty, anti-slip, anti-septic vinyl sheet flooring shall be used
in the IAP area, sterile area and stores. It shall be laid with all joints to
be hot welded, and the skirting shall be backed by a coving and bent
up to a height of 100mm high to prevent dust from collecting.
7) Skirting, floor and wall joints shall be made integral with the floor,
tightly sealed against the wall, and constructed without voids.
8) Damp proof membrane shall be provided for the department if located
at the ground level.
9) The washing and soiled areas shall be provided with seamless tiles.
10) The vinyl flooring can be of different colors to distinguish one area
from another.
11) IAP area shall not be having any structural expansion joints.
12) The sterilizer room flooring shall fall naturally to a drain to facilitate
cleaning.
6.1.4 Door
1) There shall be separate doors for staff and goods.
2) Doors shall be adequately sized to allow clear access for staff and
trolleys to pass through.
3) The main door and exit door shall be the fire rated type.
4) All doors except in the change rooms shall have doors closer to reduce
air movement.
61
5) Doors shall open towards the higher pressure side where possible.
6) Visible panels shall be provided at doors that are open to walkways
and where privacy is not required and shall be of the double glazed
type.
7) Doors shall be provided with a kick-plate and push-plate
8) All emergency exit doors shall have electro-mechanical locking
mechanism to enable disengagement in the event of fire
9) The doors shall be lockable.
6.1.5 Windows
1) The room shall have ample daylight. Distribution and location of
windows shall take into account the need to prevent glare and excess
solar gain.
2) To avoid loss of control of air movement by the ventilation system, all
windows shall be fixed, non-openable, sealed and flush type.
3) Open-able windows may be considered for offices and staff rooms;
provided that they are secured.
4) The windows shall be easily accessible for cleaning both internally and
externally.
6.1.6 Worktops and sinks

1) The worktops are normally placed along the walls as to create space
in the middle of the zones. These worktops shall be made of stainless
steel.
2) The worktops shall be flushed to the wall and any gap shall be sealed;
where this is not possible, the worktops shall have a sufficiently large
gap to allow for easy cleaning.
3) Work table shall not be fixed so as to allow for easy cleaning of the
work area.
6.1.7 Painting
1) The paint shall be of anti-fungal and of the chemical resistant type.
2) Epoxy paint shall be applied.
3) The surface shall be pre-treated and smoothed for a better paint
finish.
4) The first layer of paint shall be completely dried before applying the
epoxy on any surfaces.
6.2 Mechanical Services
6.2.1 Air conditioning and ventilation

1) All processing and storage areas shall be provided with the mechanical
ventilation to provide cool, treated air for the comfort of the personnel
and minimize cross contamination.
2) The air pressurization scheme flowing from the cleanest to the most
soiled area shall be strictly complied.
3) A 100% exhaust ventilation shall be provided at all washer disinfectors,
cart washer, sterilizers and sterilizer rooms where heat and humidity
are generated. LEV shall be installed in the swab/gauze and linen
storage facility.
4) The clean and sterile areas in the department shall have air recirculation
to promote energy efficiency practice.
5) The air conditioning system installed shall have air filters to remove
particulates from the air supply. ASHRAE5 only stipulates that sterilized
products store shall have a minimum of one filter bed, having a
minimum MERV rating of 13.
6) The IAP and Sterile Zones shall have positive pressure with respect
to the adjoining areas. The air movement shall be from the IAP Zone
towards the Sterile and Soiled Zones.
7) Sterilized products storage area located within the operating theatre
shall be provided with HEPA filter. Separated sterilized products
storage area shall be equipped with secondary filter.
8) The ductworks shall be rigid and meet the fire requirements. Flexible
ductwork shall be avoided except for final connections to grilles and
diffusers; provided they meet the fire requirements and the length
shall not be more than 2.0 meter.
9) The ducts shall be adequately insulated to eliminate the risk of
condensation and reduce the noise from air movement. Ducts shall
also be well attenuated to minimize the noise transmission from AHU
to other parts of the duct.
10) The area above the sterilizer opening shall be provided with the
appropriate extractor system to capture hot and humid air that exit
the equipment.
11) The major environmental parameters monitoring devices i.e.
temperature and humidity meters shall be placed at suitable locations
to avoid false readings.
5 ASHRAE Handbook—HVAC Applications, HEALTH-CARE FACILITIES, 2007, Chapter 7, Page 7.3

63
12) The air handling or fan coil unit shall be placed or installed at a suitable
location to facilitate service and maintenance activities.
13) The subsequent table below provides the various parameters for
comfort and safe work environment.
Table 4: Ventilation & Parameters Controlled in CSSU

ETO-steriliz- Sterilizing Soiled or Clean work- Sterile stor-
er room equipment decontam- room (IAP age (Sterile
room ination Zone) Zone)
room
(Soiled
Zone)
Pressure in Negative Negative Negative Positive Positive
respect to ad-
jacent areas
Minimum N/R* N/R* 2 2 2
Outdoor Air
Change
Minimum Total 10 10 6 4 4
Air Change
All room air Yes Yes Yes N/R* N/R*
exhausted
directly to
outdoors
Air re-circulat- No No No R R
ed by means of
room units
Relative Hu- Max.60 Max.60 Max.60 Max. 60 Max.60
midity %
Temperature 0C 22 to 24 22 to 24 22 to 24 22 to 24 22 to 24
*N/R- No requirement
6.2.2 Fire System

1) Prior to any installation or upgrading of a department, all
documentation related to the proposed fire system in the department
shall be forwarded to the Fire Department for approval.
2) The fire requirement of this department shall comply with the latest
version of Malaysian “UNIFORM BUILDING BY-LAWS
3) Access hatch on the ceiling shall be suitably positioned to allow easy
access to inspect fire dampers.
4) Fire safety policies including evacuation procedures shall be developed
and implemented to promote awareness of the fire hazards and safety
aspects of the place to the personnel.
6.2.3 Noise
1) The noise within the ventilation plant rooms shall not be greater than
85 dBA6.
2) The noise level within the department shall not be more than
the values stipulated in the current version of the FACTORY AND
MACHINERY ACT (NOISE EXPOSURE), REGULATIONS by the Malaysian
Department of Health and Safety.
3) Proper acoustic ceiling tiles, soft floor (vinyl) and engineering controls
shall be implemented to reduce the sound levels.
6.2.4 Water
The detailed water requirements e.g. the pressure, flow rate and quality
shall be determined to allow a smooth operation of the major washer and
sterilizing equipment. There are three types of water used in CSSU.
6.2.4.1 Potable Water

a) Potable water shall be supplied for use in the staff’s rest room,
prayer ablution area and washrooms. Potable water shall also
be used in normal rinsing of the medical devices in the washers
as well as in the cart washers.
b) Potable water shall be tapped directly from the normal water
supply.
6.2.4.2 Hot Water

a) Hot water shall either be from the central hot water supply
or from dedicated hot water boilers. Water from the central
supply shall be supplied to the CSSU at 60oC ± 2.5oC.
b) Hot water is used at the manual washing area and in the washer
disinfector. To prevent scalding, thermostatically mixing devices
shall be installed at the taps.
c) Hot water from the central supply shall be boosted at the
washer disinfector if required
6.2.4.3 Treated Water

a) The sediment filter shall be installed to prolong the life span of
the water treatment system.
b) The reverse osmosis (RO) water shall be installed for washers
and sterilizer usage. The system capacity shall be able to cater
to the day’s minimum operation of washing & sterilization.
6 Health Technical Memorandum 2025, Ventilation in healthcare premises, NHS, 1996

65
c) The RO water system shall include storage tank & carbon filter.
The system shall have a by-pass route to normal water for
maintenance.
d) The recommended flow rate shall be 20 L/min for washer & 50
L/min for the sterilizer.
6.2.5 Steam
Saturated steam for the sterilizer can either come from the in-house central
steam reticulation system or dedicated steam generators. There shall be
sufficient and clean saturated steam supplied to the sterilizer.
The recommended steam dryness shall not be below than 97% and the
quantity of steam for the equipment shall strictly follow the manufacturer’s
requirement.
In case the steam supply is from dedicated steam generators, the water
supplied to the steam generator shall be treated as discussed in the section
on Treated Water.
Steam generators shall be required to have JKKP certificate and regularly

inspected for continuing validity.
6.2.6 Compressed Air

1) The compressed air shall come from dedicated air compressors.
2) Dedicated air compressors shall be placed in cool and clean plant
room to prolong the life of the compressors as well as improve air
quality (dryness).
3) Air compressors shall be required to have a fitness certificate from the
Department of Health & Safety and regularly inspected for continuing
validity.
6.2.7 Drainage
1) Effluents from the clinical sinks, ultrasonic cleaners, washer disinfectors
and steam sterilizers shall be considered as potentially contaminated
with chemical and microorganism; and shall be discharged to the
sewerage treatment plant.
2) The drain shall be properly sized to accommodate simultaneous
operation of the equipment.
3) Special drain pipe or drainage system shall be provided for the
discharge of effluents from washer and sterilizer.
4) Exposed drains shall be avoided, especially in the clean zones.
5) The steel material used in the construction of the drainage system

shall be chosen to withstand a high temperature effluent.
6.3 Electrical Services
6.3.1 Electrical Installation

1) Electrical installation shall comply with the latest version of Malaysian
standard for electrical installation of building and Energy Commission
Requirements.
2) A dedicated switchboard shall be installed for the department,
complete with surge protection devices. Energy sub-meter is to be
installed.
3) Separate distribution boards shall be installed for normal and
emergency circuits.
6.3.2 Lighting
1) The lighting intensity requirement for the various areas in the CSSU
shall have the following values.
Area Luminance (lux)7
Soiled Zone 300
Clean Zone 300
Stores 150
Sterilizer and cart washer plant 200
room
Task lighting (IAP workstation) 500
2) The type of luminaries used at various areas in CSSU shall be based on

the degree by which it is protected against the ingress of moisture and
dust, and this is provided below;
Area Luminaries8 Description of Type of
Luminaries
Soiled Zone IP 65 Jet proof and dust tight
Clean Zone IP 65 Jet proof and dust tight
Stores IP 65 Jet proof and dust tight
Sterilizer and cart IP 65 Jet proof and dust tight
washer plant room
7 Chartered Institute of Building Services Engineers (CIBSE) Lighting Guide LG2, Hospitals and healthcare
buildings, Page 60
8 Chartered Institute of Building Services Engineers (CIBSE) Lighting Guide LG2, Hospitals and healthcare
buildings, Page 71
67
3) Energy-efficient luminaries shall be used.

4) Where areas are unoccupied for long periods e.g. office and store;
suitable automatic/presence switching shall be considered.
5) Appropriate color finishes and lighting in the CSSU shall be considered
to ensure that the quality of work is not compromised.
6.3.3 Switch Socket Outlets

1) There shall be a sufficient number of 13-amp switch socket outlets
(SSO). The number of SSO shall correspond to the number of
equipment as listed in the schedule list of equipment in the CSSU
e.g. for ultrasonic washer, sealers, table top light with magnifier,
computers etc.
2) SSO shall also be provided at the corridors and individual rooms for
cleaning equipment.
3) The type of SSO material and how it is mounted shall be consistent
with the SSO installed throughout the hospital.
4) Isolators shall be installed for all heavy equipment within CSSU e.g.
sterilizer, washer disinfectors, cart washers, air compressor, steam
boilers etc. In wet areas, the isolators shall be of the water proof type.
5) The built-in steam generator shall consume higher ampere apart from
the equipment and shall be duly allocated.
6) All SSO shall be labeled and preferably color coded based on the
hospital norms.
6.3.4 Emergency Supply

Equipment shall be connected to standby generator and include the
following;
1) Security system, communication system, clock, alarm system, lighting
and power sockets.
2) One unit of Washer disinfectors, one unit of ultrasonic disinfector and
one unit of sterilizer.
3) The change-over switch shall be installed to allow any unit of the
above major equipment (item 2) to be operated at any required time.
6.4 Communication
6.4.1 Internal communication

Internal communication in the form of intercom shall be provided between
the three zones i.e. soiled zone, clean zone and sterile zone.
6.4.2 External communication

There shall be direct communication links (telephone) between CSSU and
other support facilities (e.g. stores), user departments (e.g. OTs, CCU) and
CSSU.
6.5 IT link
Data points shall also be provided if the CSSU has its own IT module to track its
inventory. Where available and required, the CSSU module can be integrated with
the Hospital Management System.
6.6 Security
All entrances and exits shall be secured to prevent unauthorized persons entering
the CSSU.
Basic security features e.g. intercom shall be installed at the entrances for
unauthorized persons to seek access to CSSU.
Card access facilities shall be installed at the CSSU for its authorized staff.
Centrally monitored CCTV system shall be installed where possible.

69
7. Acquiring and Installing of Major CSSU equipment
7.1 Elements to consider prior to acquiring of equipment
7.1.1 The type and quantity of load

The type and quantity of load shall depend on the type and maximum
number of operations carried out in a day and load from other sources of
generation e.g. critical units.
7.1.2 The type and quantity of equipment

The quantity of the sterilizer shall be determined by the total load, cycle
time and the operating hours. Normally, this can be calculated from the load
information.
7.1.3 Floor area requirement

The space required by CSSU shall be determined by the size and number of
the equipment, operational ancillary set-up sterilizer, auxiliary equipment
and furniture, movement of staff and goods, space for servicing and heat
dissipation, type of door configuration and plumbing requirement.
7.1.4 Quality of water supply

Where high purity water is required for steam generation, Water Softeners,
Reverse Osmosis or De-ionization or a combination of these water treatment
solutions shall be considered.
7.1.5 The type of steam

The steam supplied to the sterilizer shall come either from the in-house main
central facility or dedicated steam generators for the sterilizers (additional
power supply capacity required).
7.1.6 Utilities requirements

All utilities requirement for the efficient functioning of major equipment i.e.
electrical supply, water supply and steam shall be adequately provided as
per the manufacturer’s requirement.
7.1.7 Energy and water saving features

All major equipment shall preferably have energy and/or water saving
features.
7.1.8 Accessibility to install and remove the sterilizer

There shall be a sufficiently sized route to lift or cart the sterilizer from the
outside to the final installation site. Proper planning can reduce installation
time and costly knock-downs.
7.1.9 Warranty
Manufacturers do provide warranty. However, the type and period of
warranty shall be established during the specification requirements.
7.1.10 About the manufacturer and supplier

The basic information about the brand and manufacturer of major
equipment shall be obtained to determine the reliability of the equipment.
Any feedback from other users shall be considered during the evaluation or
selection of equipment.
7.1.11 Spare parts availability

The availability of spare parts for a certain period of time shall be specified
in the purchasing document. The preferred genuine part shall be readily
available and competitive in price.
7.2 Roles and responsibilities of user during planning, installation, testing and
commissioning of upgraded facilities or equipment replacement.
The following are some of the roles and responsibilities of the users during the
upgrading of existing facilities or replacement of equipment. It shall serve as a
guidance to ensure proper execution of the project.
1) The upgrading contractor shall provide the complete implementation

schedule of the project to enable proper planning of service continuity.
2) The hospital shall appoint a representative from the CSSU to participate in all
relevant meetings to keep abreast on the development of the project.
3) The appointed representative shall participate in the planning of facility
shutdown and redeployment of service.
4) For equipment replacement, the anticipated new equipment shall fit the
existing space as well as meet the load demand.
5) The information of availability of the utilities required to support the
equipment shall be obtained from the maintenance company. All upgrading
of identified scope of utilities to support the new equipment shall be done
prior to the installation to avoid any purchasing/contractual problems.
6) The existing equipment to be replaced shall be processed for BER certification.
7) The representative shall participate in the testing and commissioning of the
upgraded facility or new equipment.
8) The proper training program for CSSU personnel upon completion of the
project/installation shall be carried out by the contractor/supplier.
9) The representative shall ensure all relevant statutory certification and the
test result shall be submitted during the handing over.
10) All defects shall be addressed to the relevant parties and all rectification
work shall be rectified.
71
8. Upgrading of Existing CSSU
Some common reasons for upgrading are increase in demands, compliance to new
requirement and poor existing facilities. To meet the above requirements, there
is a need to make a decision to either build a new facility or upgrade an existing
facility or premise.
The following need to be considered when upgrading an existing facility:

1) The structural building and space area’s ability to take additional loads. Most
existing units are insufficient in space and designed to cater extra loads.
2) Suitability of the facility with respect to the location in view of transporting
and circulation of items within the allowable environment.
3) Adequacy of required space (height and floor area) to satisfy the addition
of equipment, infection control protocol compliance, workflow, ventilation
requirement and maintenance activities.
4) Physical constraints that hamper installation e.g. alcoves, bends, columns
etc. shall be observed prior to proper planning.
5) The age and state of the building, condition and adequacy and safety of
its engineering facilities e.g. electrical, plumbing, fire and steam system to
support additional equipment. Upgrading of existing engineering system
may be necessary and has to be completed before the arrival of equipment.
6) The possibilities of achieving a full compliance to the standard or otherwise,
few adjustments shall be made especially when dealing with the existing
space area.
7) The proper projected loads shall be included as to ensure the department is
undersized.
8) Accessibility for bringing in operational consumables/goods to be used by
the department and the maneuverability of vehicle from other facilities.
9) The possibilities of providing reserved space for future expansion and
addition of equipment and the availability of extra loading capacities of the
engineering system.
Another critical element to be considered during upgrading is the disruption of the

operations of existing services. The department and hospital management shall
plan and execute the appropriate decontamination & sterilization activities during
the period of upgrading.
An earlier engagement with the nearest health facility shall be organized and the
mode of transporting the dirty and clean products shall be fully established to
avoid interruption to the service.
9. References
AFS Association Francaise de Sterilisation. 2008. Architecture and Sterilisation

Premises – Part 2. Central Service Vol. 16
AIA Guidelines for design and Construction of Hospital and Healthcare facilities,
2001 Edition
HVAC Design Manual for Hospitals and Clinics (Second Edition) ASHRAE, 2013
AS/NZS 2107:2000 ACOUSTICS REQUIREMENTS FOR HEALTHCARE BUILDINGS
BS EN 285 Sterilisation – Steam Sterilisers – Large Sterilisers
Chartered Institute of Building Services Engineers (CIBSE) Lighting Guide LG2,
Hospitals and healthcare buildings
Chemical disinfection of medical and surgical materials. In: Lawrence C. Block SS
eds., 1968, Spaulding E.H.
Guidelines for Community Noise, World Health Organization, Geneva, 1999
Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008
HTM 01-01: Decontamination of reusable medical devices Part C- Sterilizers
HTM 2025, Ventilation in Healthcare Premises - Design Considerations, Reprint
with Amendments, 1999
HBN 13-Sterile Services Department, NHS Estate
Health Technical Memorandum 05-02: Firecode Guidance in support of functional
provisions (Fire safety in the design of health care premises) 2014 edition
IUSS Health Facility Guides, Central Sterile Service Department (Proposal V.1) 2014
UNIFORM BUILDING BY-LAWS, 1984” (revised version 2013)
GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)
Engineering Services Division
Level 3-7, Block E3, Parcel E, Precinct 1
Federal Government Administrative Centre
62590 Putrajaya
Tel: 603-8000 8000 | Fax: 603-8892 4855/4872
Website: http://engineering.moh.gov.my

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GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

Message from The Director General of Health 6

2.0 Central Sterile Supply Unit (CSSU) 16

3.0 General Function and Layout 22

4.0 Service Area within Zone 27

4.2 Clear Zone 36

5.0 General information 57

6.0 Architectural and Engineering Services 59

6.2 Mechanical Services 62

7.0 Acquiring and Installing of Major CSSU Equipment 69

8.0 Upgrading of Existing CSSU 71

Good engineering practice in construction, selection of appropriate material and

Datuk Dr. Noor Hisham Bin Abdullah

These guidelines are also prepared to serve as a guiding document in establish-

Haji Md. Jalal Bin Bongkik

Engineering Services Division, Ministry of Health Malaysia (MOH)

1. Tn. Haji Md. Jalal Bin Bongkik

Planning Division, Ministry of Health

Medical Development Division, Ministry of Health

Tengku Ampuan Rahimah Hospital

Sungai Buloh Hospital

Malaysian Sterile Service Association

Class 8 Class 8 is a classification number in the ISO 14644 clean-room standard

Microbial Deposition of viable or potentially viable elements of bacteria, fungi or

Porous-load A clinical sterilizer designed to process, by exposure to high temperature

Sterile Free from viable micro-organisms, including bacterial spores and

Sterilization A process undertaken to render a load sterile.

Sterilizer An apparatus designed to achieve sterilization. (See also Porous-load

Sterilization BS EN 285 specifies that a sterilizing module is a rectangular shape

Section 2 : Central Sterile Supply Unit (CSSU)

Section 3 : General Function and Layout

Section 4 : Service Area within Zone

Section 5 : General Information

Section 6 : Architectural and Engineering Services

Section 7 : Acquiring and Installation of Major CSSU Equipment

Section 8 : Upgrading of Existing CSSU

2. Central Sterile Supply Unit (CSSU)

2.1 Primary Functions

1) To receive, decontaminate, clean, dry, pack and sterilize contaminated re-

Figure 1- Primary Functions

2.3.2 Type of Sterilization

Sterilization describes a process that destroys or eliminates all forms

The level of sterility is referred as Sterility Assurance Level (SAL). SAL is

There are three main parameters to be considered during sterilization i.e.

a. High temperature (Steam) Sterilization

Another design in steam sterilization is a steam flush-pressure pulsing

The medical devices shall be exposed to direct steam contact at the

Portable (table-top) steam sterilizers shall be used in outpatient, dental, and

Similarity, the steam cycle shall be monitored by mechanical, chemical,

b. Low temperature sterilization

1) Hydrogen Peroxide Gas Plasma

The sterilant used in this sterilizer is Hydrogen Peroxide solution which

The advantage of this sterilizer is that the by-products of this type of

2) Ethylene Oxide (EtO) Gas Sterilizer

The sterilant used in this sterilizer is EtO gas which is colorless,

The distinct disadvantage of this sterilizer is the long processing time

Peracetic acid is a highly biocidal oxidizer that maintains its efficacy

The sterilant, 35% peracetic acid, and an anticorrosive agent are

The sterilant is pumped through the channels of the endoscope for

3. General Function and Layout

The provision of proper air movement, environmental parameters controlled and

The use of information technology in the process of registration, verification, validation,

3.1 Basic CSSU Layout