Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004)

ISO 14644-5:2004 specifies basic requirements for cleanroom operations. It is intended for those planning to use and operate a cleanroom. Aspects of safety that have no direct bearing on contamination control are not considered in this part of ISO 14644 and national and local safety regulations must be observed. This document considers all classes of cleanrooms used to produce all types of products. Therefore, it is broad in application and does not address specific requirements for individual industries. Methods and programmes for routine monitoring within cleanrooms are not covered in detail in this part of ISO 14644 but reference should be made to ISO 14644-2 and ISO 14644-3 for monitoring particles, and ISO 14698-1 and ISO 14698-2 for monitoring micro-organisms.

Reinräume und zugehörige Reinraumbereiche - Teil 5: Betrieb (ISO 14644-5:2004)

Dieser Teil von ISO 14644 legt grundlegende Anforderungen an den Betrieb von Reinräumen fest. Er richtet sich an alle, die die Nutzung und den Betrieb eines Reinraums planen. Sicherheitsaspekte, die keinen direkten Bezug zur Kontaminationskontrolle haben, werden in diesem Teil von ISO 14644 nicht berücksichtigt. Landesspezifische und örtliche Sicherheitsbestimmungen sind ebenso einzuhalten. Diese Norm behandelt  alle Klassen von Reinräumen, die zur Herstellung der verschiedensten Produkte eingesetzt werden. Dieses Dokument ist daher auf eine breite Anwendung ausgelegt und geht daher auf besondere Anforderungen für einzelne Industriezweige nicht ein. Verfahren und Programme zur laufenden Überwachung im Reinraum werden in diesem Teil von ISO 14644 nicht im Einzelnen behandelt; hinsichtlich der Überwachung von Partikeln wird auf ISO 14644-2 und ISO 14644-3 und hinsichtlich der Überwachung von Mikroorganismen auf ISO 14698-1 und ISO 14698-2 verwiesen.

Salles propres et environnements maîtrisés apparentés - Partie 5: Exploitation (ISO 14644-5:2004)

L'ISO 14644-5:2004 spécifie les exigences de base pour l'exploitation des salles propres. Elle s'adresse aux personnes qui envisagent d'utiliser et d'exploiter une salle propre. Les aspects de sécurité qui ne concernent pas directement la maîtrise de la contamination ne sont pas pris en compte dans l'ISO 14644-5:2004. Les réglementations nationales ou locales en matière de sécurité doivent être respectées. Le présent document s'applique à toutes les classes de salles propres utilisées pour la production de tous les types de produits. Le présent document a donc un vaste domaine d'application et n'aborde pas les exigences particulières de telle ou telle industrie en particulier. Les méthodes et les programmes de surveillance régulière dans les salles propres ne sont pas abordés de manière détaillée dans l'ISO 14644-5:2004. Il convient cependant de se référer à l'ISO 14644-2 et à l'ISO 14644-3 pour la surveillance des particules, ainsi qu'à l'ISO 14698-1 et à l'ISO 14698-2 pour la surveillance des micro-organismes.

Čiste sobe in podobna nadzorovana okolja – 5. del: Delovanje (ISO 14644-5:2004)

General Information

Status
Published
Publication Date
14-Aug-2004
Current Stage
9093 - Decision to confirm - Review Enquiry
Due Date
31-Jul-2009
Completion Date
31-Jul-2009

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SLOVENSKI STANDARD
SIST EN ISO 14644-5:2005
01-januar-2005
ýLVWHVREHLQSRGREQDQDG]RURYDQDRNROMD±GHO'HORYDQMH ,62

Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-

5:2004)
Reinräume und zugehörige Reinraumbereiche - Teil 5: Betrieb (ISO 14644-5:2004)

Salles propres et environnements maîtrisés apparentés - Partie 5: Exploitation (ISO

14644-5:2004)
Ta slovenski standard je istoveten z: EN ISO 14644-5:2004
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
SIST EN ISO 14644-5:2005 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14644-5:2005
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SIST EN ISO 14644-5:2005
EUROPEAN STANDARD
EN ISO 14644-5
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2004
ICS
English version
Cleanrooms and associated controlled environments - Part 5:
Operations (ISO 14644-5:2004)

Salles propres et environnements maîtrisés apparentés - Reinräume und zugehörige Reinraumbereiche - Teil 5:

Partie 5: Exploitation (ISO 14644-5:2004) Betrieb (ISO 14644-5:2004)
This European Standard was approved by CEN on 29 July 2004.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European

Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national

standards may be obtained on application to the Central Secretariat or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation

under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official

versions.

CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,

Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,

Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels

© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-5:2004: E

worldwide for CEN national Members.
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SIST EN ISO 14644-5:2005
EN ISO 14644-5:2004 (E)
Foreword

This document (EN ISO 14644-5:2004) has been prepared by Technical Committee ISO/TC 209

"Cleanrooms and associated controlled environments" in collaboration with Technical Committee

CEN/TC 243 "Cleanroom technology", the secretariat of which is held by BSI.

This European Standard shall be given the status of a national standard, either by publication of

an identical text or by endorsement, at the latest by February 2005, and conflicting national

standards shall be withdrawn at the latest by February 2005.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of

the following countries are bound to implement this European Standard: Austria, Belgium,

Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,

Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,

Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice

The text of ISO 14644-5:2004 has been approved by CEN as EN ISO 14644-5:2004 without any

modifications.
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SIST EN ISO 14644-5:2005
INTERNATIONAL ISO
STANDARD 14644-5
First edition
2004-08-15
Cleanrooms and associated controlled
environments —
Part 5:
Operations
Salles propres et environnements maîtrisés apparentés —
Partie 5: Exploitation
Reference number
ISO 14644-5:2004(E)
ISO 2004
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SIST EN ISO 14644-5:2005
ISO 14644-5:2004(E)
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ii © ISO 2004 – All rights reserved
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SIST EN ISO 14644-5:2005
ISO 14644-5:2004(E)
Contents Page

Foreword............................................................................................................................................................ iv

Introduction ........................................................................................................................................................ v

1 Scope...................................................................................................................................................... 1

2 Normative references ........................................................................................................................... 1

3 Terms and definitions........................................................................................................................... 2

4 Specification of requirements ............................................................................................................. 3

Annex A (informative) Operational systems.................................................................................................... 7

Annex B (informative) Cleanroom clothing.................................................................................................... 13

Annex C (informative) Personnel .................................................................................................................... 18

Annex D (informative) Stationary equipment................................................................................................. 22

Annex E (informative) Materials and portable equipment ............................................................................ 26

Annex F (informative) Cleanroom cleaning ................................................................................................... 33

Bibliography ..................................................................................................................................................... 43

© ISO 2004 – All rights reserved iii
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SIST EN ISO 14644-5:2005
ISO 14644-5:2004(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies

(ISO member bodies). The work of preparing International Standards is normally carried out through ISO

technical committees. Each member body interested in a subject for which a technical committee has been

established has the right to be represented on that committee. International organizations, governmental and

non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the

International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards

adopted by the technical committees are circulated to the member bodies for voting. Publication as an

International Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent

rights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO 14644-5 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled

environments.

ISO 14644 consists of the following parts, under the general title Cleanrooms and associated controlled

environments:
 Part 1: Classification of air cleanliness

 Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1

 Part 3: Test methods
 Part 4: Design, construction and start-up
 Part 5: Operations

 Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)

 Part 8: Classification of airborne molecular contamination
The following part is under preparation:
 Part 6: Terms and definitions
iv © ISO 2004 – All rights reserved
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SIST EN ISO 14644-5:2005
ISO 14644-5:2004(E)
Introduction

Industries and organizations of all kinds utilize cleanrooms. Operational procedures have a profound effect on

the cleanliness levels achieved during the operation of the cleanroom and equipment. Consistent quality is

cleanliness dependent. Operational cleanliness can only be attained and maintained through a deliberate

programme established to specify, measure and enforce defined operational procedures. Regulatory agencies

that have authority over processes and products produced in the cleanroom may require additional

procedures and measures of cleanliness not covered in this general operating standard.

This part of ISO 14644 addresses normative and informative operational requirements related to:

a) providing a system that defines policies and operational procedures;

b) clothing used to isolate human-generated contamination from the cleanroom environment;

c) training of personnel inside the cleanroom and monitoring their compliance to specified procedures and

disciplines;

d) transfer, installation and maintenance of stationary equipment (selection criteria is not discussed);

e) selection and use of materials and portable equipment in the cleanroom;

f) maintaining the cleanliness of the cleanroom through systematic cleaning and monitoring procedures.

© ISO 2004 – All rights reserved v
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SIST EN ISO 14644-5:2005
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SIST EN ISO 14644-5:2005
INTERNATIONAL STANDARD ISO 14644-5:2004(E)
Cleanrooms and associated controlled environments —
Part 5:
Operations
1 Scope

This part of ISO 14644 specifies basic requirements for cleanroom operations. It is intended for those planning

to use and operate a cleanroom. Aspects of safety that have no direct bearing on contamination control are

not considered in this part of ISO 14644 and national and local safety regulations must be observed. This

document considers all classes of cleanrooms used to produce all types of products. Therefore, it is broad in

application and does not address specific requirements for individual industries. Methods and programmes for

routine monitoring within cleanrooms are not covered in detail in this part of ISO 14644 but reference is made

to ISO 14644-2 and ISO 14644-3 for monitoring particles and ISO 14698-1 and ISO 14698-2 for monitoring

micro-organisms.
2 Normative references

The following referenced documents are indispensable for the application of this document. For dated

references, only the edition cited applies. For undated references, the latest edition of the referenced

document (including any amendments) applies.

ISO 14644-1:1999, Cleanrooms and associated controlled environments — Part 1: Classification of air

cleanliness

ISO 14644-2:2000, Cleanrooms and associated controlled environments — Part 2: Specifications for testing

and monitoring to prove continued compliance with ISO 14644-1

ISO 14644-3:— , Cleanrooms and associated controlled environments — Part 3: Test methods

ISO 14644-4:2001, Cleanrooms and associated controlled environments — Part 4: Design, construction and

start-up

ISO 14698-1:2003, Cleanrooms and associated controlled environments — Biocontamination control —

Part 1: General principles and methods

ISO 14698-2:2003, Cleanrooms and associated controlled environments — Biocontamination control —

Part 2: Evaluation and interpretation of biocontamination data
1) To be published.
© ISO 2004 – All rights reserved 1
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SIST EN ISO 14644-5:2005
ISO 14644-5:2004(E)
3 Terms and definitions

For the purposes of this part of ISO 14644, the following terms and definitions apply.

3.1 General Terms
3.1.1
biocleanroom

cleanroom used for products and processes that are sensitive to microbiological contamination

3.1.2
changing room

room where people entering or leaving a cleanroom put on or take off cleanroom clothing

NOTE Adapted from ISO 14644-4:2001, 3.1.
3.1.3
cross-over bench

bench that is used as an aid to changing of cleanroom clothing and which provides a barrier to the tracking of

floor contamination
3.1.4
disinfection
removal, destruction or de-activation of micro-organisms on objects or surfaces
3.1.5
fibre
particle having an aspect (length-to-width) ratio of 10 or more
[ISO 14644-1:1999, 2.2.7]
3.1.6
operator

person working in the cleanroom performing production work or carrying out process procedures

3.1.7
particle
minute piece of matter with defined physical boundaries
NOTE For classification purposes refer to ISO 14644-1:1999.
3.1.8
personnel
persons entering the cleanroom for any purpose
3.1.9
separative device

equipment utilizing constructional and dynamic means to create assured levels of separation between the

inside and the outside of a defined volume

EXAMPLES Some industry-specific examples of separative devices are clean air hoods, containment enclosures,

gloveboxes, isolators and minienvironments.
3.1.10
unidirectional airflow

controlled airflow through the entire cross-section of a clean zone with a steady velocity and approximately

parallel airstreams

NOTE This type of airflow results in a directed transport of particles from the clean zone.

[ISO 14644-4:2001, 3.11]
2 © ISO 2004 – All rights reserved
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SIST EN ISO 14644-5:2005
ISO 14644-5:2004(E)
3.2 Occupancy states
3.2.1
as-built

condition where the installation is complete with all services connected and functioning but with no production

equipment, materials or personnel present
[ISO 14644-4:2001, 2.4.1]
3.2.2
at-rest

condition where the installation is complete with equipment installed and operating in a manner agreed upon

by the customer and supplier, but with no personnel present
[ISO 14644-4:2001, 2.4.2]
3.2.3
operational

condition where the installation is functioning in the specified manner, with the specified number of personnel

present and working in the manner agreed upon
[ISO 14644-4:2001, 2.4.3]
4 Specification of requirements
4.1 Operational systems

4.1.1 A system of operational procedures shall be established and documented that will provide a

framework for producing the quality products and processes for which the cleanroom was designed.

4.1.2 A set of risk factors, appropriate for the use of the cleanroom, shall identify the areas where there is a

risk of contamination to the process. A method for monitoring these risks shall be instituted so that action can

be taken when conditions violate the contamination limits for the cleanroom classification.

NOTE Although not covered in detail in this part of ISO 14644, it is important to routinely monitor the operation of a

cleanroom. Guidance for monitoring particles is given in ISO 14644-2 and ISO 14644-3. Guidance for monitoring

biocontamination is given in ISO 14698-1 and ISO 14698-2.

4.1.3 A system for training personnel in cleanroom procedures shall be instituted. A method for monitoring

compliance to those training procedures shall be specified.

4.1.4 A documentation system shall be maintained to provide evidence that all personnel have received

suitable levels of training for their assignments.

4.1.5 A set of procedures shall be documented to describe how the cleanroom mechanical systems are to

be operated, maintained, repaired and monitored (see ISO 14644-4).

4.1.6 All activities that modify, supplement or enlarge the cleanroom shall be planned and include all

relevant personnel. Any significant change of operational use may be subject to re-qualification of the

installation in compliance with ISO 14644-2.

4.1.7 A system shall be documented that encourages and enforces safety for personnel in the cleanroom

that may influence aspects of contamination control.

NOTE Informative guidance concerning the operational systems requirements listed in 4.1.1 to 4.1.7 can be found in

Annex A.
© ISO 2004 – All rights reserved 3
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SIST EN ISO 14644-5:2005
ISO 14644-5:2004(E)
4.2 Cleanroom clothing

4.2.1 Cleanroom clothing shall protect the environment and products from contamination generated by the

personnel and their everyday clothing. To maximize this containment, the choice of barrier fabric, the clothing

style and extent of coverage of personnel by the cleanroom clothing shall be established.

4.2.2 Cleanroom clothing shall be made of fabrics and materials that will resist breakdown (minimal linting)

and therefore not shed contamination.

4.2.3 The frequency of changing into fresh cleanroom clothing before entering the cleanroom shall be

determined in accordance with the product and process cleanliness requirements.

4.2.4 Reusable cleanroom clothing shall be processed at regular intervals to remove contamination.

4.2.5 The necessary cleaning, processing (including sterilization or disinfection where required) and

packaging of clothing shall be defined.

4.2.6 Cleanroom clothing shall be transported and stored in a specified manner to minimize contamination.

4.2.7 Cleanroom clothing (clean packaged or dirty) shall not be removed beyond the confines of the storage

area and cleanroom except for laundering, repair or exchange purposes.

4.2.8 Cleanroom clothing shall be put on and taken off in such a way that the spread of contamination is

avoided or minimized.

4.2.9 If clothing is to be reused, it shall be removed and stored to ensure that contamination is minimized.

4.2.10 Cleanroom clothing shall be checked at regular intervals to ensure that it retains acceptable

contamination control characteristics.

4.2.11 Consideration shall be given for the comfort of personnel wearing the cleanroom clothing.

4.2.12 Consideration shall be given to special (e.g. chemical, physical or microbiological) properties of the

clothing that may be necessary for specific applications.

4.2.13 Consideration shall be given to special concerns for cleanroom clothing during and after emergency

evacuations.

NOTE Informative guidance concerning cleanroom clothing requirements listed in 4.2.1 to 4.2.13 can be found in

Annex B.
4.3 Personnel

4.3.1 Personal and other items not intended for cleanroom use shall not be allowed inside the cleanroom,

unless approved.

4.3.2 Personnel shall be instructed in hygiene-related issues that will prepare them for properly working in

the cleanroom environment.

4.3.3 A policy concerning jewellery, cosmetics and similar materials that can cause contamination problems

shall be determined.

4.3.4 Cleanroom personnel shall be trained to conduct themselves in a manner that minimizes generation

of contamination which can be transferred or deposited on or into the product.

4.3.5 Personnel shall be protected against hazards. Personnel shall receive safety training for all known

health and safety risks associated with their work.

NOTE Informative guidance concerning personnel requirements listed in 4.3.1 to 4.3.5 can be found in Annex C.

4 © ISO 2004 – All rights reserved
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SIST EN ISO 14644-5:2005
ISO 14644-5:2004(E)
4.4 Stationary equipment

4.4.1 All equipment, with its associated moving and rigging equipment, shall be thoroughly cleaned or

decontaminated, or both, before being transported into the cleanroom environment.

4.4.2 Procedures relating to the entry of equipment into a controlled environment shall be specified to

ensure that all equipment undergoes the necessary cleaning and decontaminating.

4.4.3 Installation of equipment shall be planned and carried out to minimize the impact on the cleanroom

environment.

4.4.4 Equipment maintenance, repairs and calibration procedures shall be performed in such a way as to

control and minimize contamination of the cleanroom.

4.4.5 Documented procedures relating to maintenance work and repairs shall be specified to control

contamination.

4.4.6 Preventive maintenance schedules shall be established and timed to renew and replace components

before the components become contamination sources.

NOTE Informative guidance concerning stationary equipment requirements listed in 4.4.1 to 4.4.6 can be found in

Annex D.
4.5 Materials and portable and mobile equipment

4.5.1 All materials, as well as portable and mobile equipment, shall be appropriate for the level of

cleanroom cleanliness, and in use, shall not compromise the product and process.

4.5.2 Procedures shall be established to ensure materials and portable and mobile equipment entering the

cleanroom are not contaminated.

4.5.3 Procedures shall be established to minimize the quantities of materials stored in the cleanroom.

Consideration shall be given to shelf-life limitations, if applicable.

4.5.4 Materials stored in the cleanroom shall be subject to defined procedures and, where necessary, shall

be held in protective storage or isolation. The risk of contamination arising from the storage and subsequent

use of materials and portable and mobile equipment in the cleanroom shall be considered.

4.5.5 All used and waste materials shall be collected, identified and removed in accordance with defined

procedures. Waste materials shall be removed frequently and in a manner that does not compromise the

cleanliness of the product or process. Procedures for hazardous materials must conform to statutory

requirements set by local and other regulatory agencies.

NOTE Informative guidance concerning materials and portable equipment requirements listed in 4.5.1 to 4.5.5 can be

found in Annex E.
4.6 Cleanroom cleaning

4.6.1 Cleaning methods and procedures shall be specified and routinely followed to maintain cleanroom

surfaces at acceptable cleanliness levels.

4.6.2 Personnel responsible for the cleaning operation shall be designated and receive specific training for

accomplishing the task.

4.6.3 Cleaning schedules shall be defined and carried out at effective frequencies to ensure that specified

cleanliness levels are maintained.

4.6.4 Appropriate contamination checks shall be carried out on a routine basis to ensure the cleanroom is

maintained at specified levels.
© ISO 2004 – All rights reserved 5
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SIST EN ISO 14644-5:2005
ISO 14644-5:2004(E)

4.6.5 An assessment shall be made to identify any cleaning procedures that will place products or

processes at risk during the performance of such cleaning tasks. Preparations should be made to remove or

cover work-in-process before cleaning begins.

4.6.6 Special cleaning procedures and techniques shall be defined for unavoidable accidents or system

failures that create contamination that places the cleanroom, products, processes or personnel at risk.

NOTE Informative guidance concerning cleaning requirements listed in 4.6.1 to 4.6.6 can be found in Annex F.

6 © ISO 2004 – All rights reserved
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SIST EN ISO 14644-5:2005
ISO 14644-5:2004(E)
Annex A
(informative)
Operational systems
A.1 General

It is essential that management provides leadership that will focus the attention of its staff on generating and

maintaining systems that will encourage good cleanroom practices. A management structure should be

defined and published to ensure all parties are aware of their responsibilities. Good cleanroom practices will

have a significant impact on the quality of products being produced and the processes performed in the

cleanroom. This annex is provided to assist management in identifying those systems.

A.2 Assessing contamination risks
A.2.1 Methods for assessing risks

A risk assessment should be made to determine any relevant contamination control factors that may affect the

products or processes performed in the cleanroom.

Some examples of methods used for determining and managing these factors include:

[1]
a) HACCP (Hazard Analysis Critical Control Point) ;
[2][3]
b) FMEA (Failure Mode Effects Analysis) ;
[4]
c) FTA (Fault Tree Analysis) .
A.2.2 Determining operational risks
A.2.2.1 General

Improper control of the critical elements of an operational cleanroom can pose a risk to the cleanliness of the

cleanroom and the quality of the product. A list of these critical elements and some of the associated risks can

be found beginning in A.2.2.2 to A.2.2.6. An assessment of these risks should be carried out and plans

formulated by each organization to remedy non-compliant situations. In this assessment, it is especially

important to consider the following:
a) concentration of contamination in or on the risk factor;
b) distance from the risk to the product;
[5]
c) importance of the method used to protect product from the risk .

Information concerning cleanroom support parameters and factors including heating, ventilation and air

conditioning functions, pressure, temperature, humidity, air change failure and filter failure are discussed in

ISO 14644-2, ISO 14644-3 and ISO 14644-4.
© ISO 2004 – All rights reserved 7
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SIST EN ISO 14644-5:2005
ISO 14644-5:2004(E)
A.2.2.2 Cleanroom clothing

Risk factors that may influence the operation or environmental quality of the cleanroom include:

a) required human containment (coveralls, frocks, hoods, gloves, boots, masks, etc);

b) material performance (weave characteristics, filament types, sterility, antistatic, calendering, etc);

c) design and construction (special tailoring requirements);
d) comfort;
e) usage (launderable versus disposable);
f) choice of personal clothing worn under cleanroom clothing;
g) time interval or number of wearings before laundering is required;
h) choice of cleanroom clothing laundry;
i) renewing, packaging, storage and distribution.
A.2.2.3 Personnel

Risk factors that may influence the operation or environmental quality of the cleanroom include:

a) selection of personnel;
b) education and training;
c) safety (including emergency procedure);

d) personal attire, hygiene and behaviour, (including behaviour prior to entering the cleanroom);

e) chronic and acute medical conditions;
f) personnel who shed significantly more contamination than other personnel;
g) who is allowed to enter;
h) special procedures for visitors;
i) maximum occupancy;
j) entry and exit procedures;
k) movement and activity of personnel within the cleanroom.
A.2.2.4 Stationary equipment

Risk factors that may influence the operation or environmental quality of the cleanroom include:

a) entry and exit procedures;
b) installation;
c) cleaning techniques;
d) contamination generation;
8 © ISO 2004 – All rights reserved
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SIST EN ISO 14644-5:2005
ISO 14644-5:2004(E)
e) generation of heat, humidity and electrostatic charge;
f) maintenance and repair;
g) cleanliness of process material and utilities delivery systems;
h) potential equipment failures.
A.2.2.5 Materials and portable and mobile equipment

Risk factors that may influence the operation or environmental quality of the cleanroom include:

a) compatibility and selection;
b) entry, exit and movement procedures;
c) storage factors while in the cleanroom;
d) contamination factors during use;
e) generation of electrostatic charges;
f) liquid and gas purity supplied by delivery systems;
g) waste disposal;
h) packaging.
A.2.2.6 Cleanroom cleaning

Risk factors that influence the operation or environmental quality of the cleanroom may include:

a) routine environmental contaminating factors (airflows, airborne particles, out-gassing, hazardous gas,

micro-organisms, vibration
...

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