Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods (ISO 14698-1:2003)

ISO 14698:2003 establishes the principles and basic methodology of a formal system of biocontamination control (Formal System) for assessing and controlling biocontamination when cleanroom technology is applied for that purpose. It specifies the methods required for monitoring risk zones in a consistent way and for applying control measures appropriate to the degree of risk involved. In zones where risk is low, it can be used for information.

Reinräume und zugehörige Reinraumbereiche - Biokontaminationskontrolle - Teil 1: Allgemeine Grundlagen (ISO 14698-1:2003)

Dieser Teil von ISO 14698 legt die Grundlagen und grundlegende Verfahrensweisen für ein formelles System zur Biokontaminationskontrolle (Betriebliches System) in solchen Bereichen fest, in denen Reinraum-technologie zu diesem Zweck angewendet wird. Dieser Teil von ISO 14698 legt die Verfahren fest, die notwendig sind, um Risikobereiche konsistent zu überwachen und nach dem Grad der Gefährdung geeignete Kontrollmaßnahmen anwenden zu können. Für Bereiche mit nur geringem Risiko kann dieser Teil von ISO 14698 als Informationsquelle verwendet werden.
Es werden keine anwendungsspezifischen Anforderungen festgelegt. Auch werden Fragen des Brandschutzes und der Sicherheit nicht angesprochen. Im Hinblick auf diese Fragen siehe Sicherheits- und Brandschutzvorschriften.

Salles propres et environnements maîtrisés apparentés - Maîtrise de la biocontamination - Partie 1: Principes généraux et méthodes (ISO 14698-1:2003)

L'ISO 14698-1:2003 établit les principes et la méthodologie fondamentale d'un Système formalisé de maîtrise de la biocontamination (Système formalisé), système destiné à évaluer et à maîtriser la biocontamination, dans le cadre de l'application des technologies des salles propres à cet effet. L'ISO 14698-1:2003 spécifie les méthodes requises pour assurer une surveillance cohérente des zones à risque et pour appliquer les mesures de maîtrise adaptées au degré de risque concerné. Dans des zones où le risque est faible, l'ISO 14698-1:2003 peut servir de source d'informations.
L'ISO 14698-1:2003 ne fixe pas d'exigences spécifiques à des applications, ni ne traite des questions d'incendie et de sécurité pour lesquelles il convient de consulter les exigences réglementaires et autres documentations nationales ou locales.

Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods (ISO 14698-1:2003)

General Information

Status
Withdrawn
Publication Date
31-Aug-2003
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
12-Aug-2020

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SLOVENSKI STANDARD
SIST EN ISO 14698-1:2004
01-januar-2004
Cleanrooms and associated controlled environments - Biocontamination control -
Part 1: General principles and methods (ISO 14698-1:2003)

Cleanrooms and associated controlled environments - Biocontamination control - Part 1:

General principles and methods (ISO 14698-1:2003)
Reinräume und zugehörige Reinraumbereiche - Biokontaminationskontrolle - Teil 1:
Allgemeine Grundlagen (ISO 14698-1:2003)

Salles propres et environnements maîtrisés apparentés - Maîtrise de la biocontamination

- Partie 1: Principes généraux et méthodes (ISO 14698-1:2003)
Ta slovenski standard je istoveten z: EN ISO 14698-1:2003
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
SIST EN ISO 14698-1:2004 en

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

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SIST EN ISO 14698-1:2004
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SIST EN ISO 14698-1:2004
EUROPEAN STANDARD
EN ISO 14698-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2003
ICS 13.040.35
English version
Cleanrooms and associated controlled environments -
Biocontamination control - Part 1: General principles and
methods (ISO 14698-1:2003)

Salles propres et environnements maîtrisés apparentés - Reinräume und zugehörige Reinraumbereiche -

Maîtrise de la biocontamination - Partie 1: Principes Biokontaminationskontrolle - Teil 1: Allgemeine Grundlagen

généraux et méthodes (ISO 14698-1:2003) (ISO 14698-1:2003)
This European Standard was approved by CEN on 10 July 2003.

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 Management Centre 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 Management Centre has the same status as the official

versions.

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

Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, 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

© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14698-1:2003 E

worldwide for CEN national Members.
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SIST EN ISO 14698-1:2004
EN ISO 14698-1:2003 (E)
CORRECTED 2003-10-01
Foreword

This document (EN ISO 14698-1:2003) 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 March 2004, and conflicting national

standards shall be withdrawn at the latest by March 2004.

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

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

Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,

Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and

the United Kingdom.
Endorsement notice

The text of ISO 14698-1:2003 has been approved by CEN as EN ISO 14698-1:2003 without any

modifications.

NOTE Normative references to International Standards are listed in Annex ZA (normative).

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SIST EN ISO 14698-1:2004
EN ISO 14698-1:2003 (E)
Annex ZA
(normative)
Normative references to international publications
with their relevant European publications

This European Standard incorporates by dated or undated reference, provisions from other

publications. These normative references are cited at the appropriate places in the text and the

publications are listed hereafter. For dated references, subsequent amendments to or revisions of

any of these publications apply to this European Standard only when incorporated in it by

amendment or revision. For undated references the latest edition of the publication referred to

applies (including amendments).

NOTE Where an International Publication has been modified by common modifications, indicated

by (mod.), the relevant EN/HD applies.
Publication Year Title EN Year
Cleanrooms and associated
ISO 14644-4 2001 EN ISO 14644-4 2001
controlled environments — Part 4:
Design, construction and start-up
Cleanrooms and associated
ISO 14698-2 2003 EN ISO 14698-2 2003
controlled environments -
Biocontamination control - Part 2:
Evaluation and interpretation of
biocontamination data
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SIST EN ISO 14698-1:2004
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SIST EN ISO 14698-1:2004
INTERNATIONAL ISO
STANDARD 14698-1
First edition
2003-09-01
Cleanrooms and associated controlled
environments — Biocontamination
control —
Part 1:
General principles and methods
Salles propres et environnements maîtrisés apparentés — Maîtrise de
la biocontamination —
Partie 1: Principes généraux et méthodes
Reference number
ISO 14698-1:2003(E)
ISO 2003
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SIST EN ISO 14698-1:2004
ISO 14698-1:2003(E)
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© ISO 2003

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ii © ISO 2003 — All rights reserved
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SIST EN ISO 14698-1:2004
ISO 14698-1:2003(E)
Contents Page

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

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

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

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

3 Terms and definitions........................................................................................................................... 1

4 Principles of biocontamination control .............................................................................................. 4

5 Establishing the Formal System ......................................................................................................... 5

6 Expression, interpretation and reporting of results........................................................................ 10

7 Verification of the Formal System..................................................................................................... 11

8 Training ................................................................................................................................................ 11

9 Documentation .................................................................................................................................... 11

Annex A (informative) Guidance on determining airborne biocontamination ........................................... 12

Annex B (informative) Guidance on validating air samplers ....................................................................... 15

Annex C (informative) Guidance on determining biocontamination of surfaces ...................................... 18

Annex D (informative) Guidance on determining biocontamination of textiles......................................... 20

Annex E (informative) Guidance on validating laundering processes........................................................ 22

Annex F (informative) Guidance on determining biocontamination of liquids .......................................... 26

Annex G (informative) Guidance on training ................................................................................................. 28

Bibliography ..................................................................................................................................................... 31

© ISO 2003 — All rights reserved iii
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SIST EN ISO 14698-1:2004
ISO 14698-1:2003(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 14698-1 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled

environments.

ISO 14698 consists of the following parts, under the general title Cleanrooms and associated controlled

environments — Biocontamination control:
— Part 1: General principles and methods
— Part 2: Evaluation and interpretation of biocontamination data
iv © ISO 2003 — All rights reserved
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SIST EN ISO 14698-1:2004
ISO 14698-1:2003(E)
Introduction

The principles described here are intended to promote appropriate hygienic practices. This part of ISO 14698 is

one of a number of standards considering factors important for the creation of clean, controlled environments.

Hygiene has become increasingly important in many areas of modern society. In such areas, hygiene or

biocontamination control methods are, or will be, used to create safe and stable products. International trade

in hygiene-sensitive products has greatly increased. At the same time, the use of antimicrobial agents has

been reduced or forbidden, creating a need for increased biocontamination control.

This part of ISO 14698 is the first general International Standard for biocontamination control. However, many

factors besides cleanliness must be considered in the design, specification, operation and control of

cleanrooms and associated controlled environments.

In some circumstances, relevant regulatory agencies could impose supplementary policies or restrictions. In

such situations, appropriate adaptations of the standard testing procedures might be required.

© ISO 2003 — All rights reserved v
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SIST EN ISO 14698-1:2004
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SIST EN ISO 14698-1:2004
INTERNATIONAL STANDARD ISO 14698-1:2003(E)
Cleanrooms and associated controlled environments —
Biocontamination control —
Part 1:
General principles and methods
1 Scope

This part of ISO 14698 establishes the principles and basic methodology of a formal system of

biocontamination control (Formal System) for assessing and controlling biocontamination when cleanroom

technology is applied for that purpose. This part of ISO 14698 specifies the methods required for monitoring

risk zones in a consistent way and for applying control measures appropriate to the degree of risk involved. In

zones where risk is low, it can be used as a source of information.

Application-specific requirements are not given. Neither are fire and safety issues addressed; for these, see

regulatory requirements and other national or local documentation.
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 14644-4:2001, Cleanrooms and associated controlled environments — Part 4: Design, construction and

start-up

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

Part 2: Evaluation and interpretation of biocontamination data
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 General
3.1.1
action level

level set by the user in the context of controlled environments, which, when exceeded, requires immediate

intervention, including investigation of cause, and corrective action
3.1.2
alert level

level set by the user in the context of controlled environments, giving early warning of a drift from normal

conditions, which, when exceeded, should result in increased attention to the process

© ISO 2003 — All rights reserved 1
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SIST EN ISO 14698-1:2004
ISO 14698-1:2003(E)
3.1.3
bioaerosol
dispersed biological agents in a gaseous environment
3.1.4
biocontamination

contamination of materials, devices, individuals, surfaces, liquids, gases or air with viable particles

3.1.5
cleanroom

room in which the concentration of airborne particles is controlled, and which is constructed and used in a

manner to minimize the introduction, generation, and retention of particles inside the room, and in which other

relevant parameters e.g. temperature, humidity, and pressure, are controlled as necessary

[1]
[ISO 14644-1:1999, 2.1.1]
3.1.6
contact device

specially designed appliance holding an appropriate, sterile, culture medium with an accessible surface used

for surface sampling
3.1.7
contact plate
contact device where the container is a rigid dish
3.1.8
control point

point in a controlled environment at which control is applied and a hazard can be prevented, eliminated or

reduced to acceptable levels
3.1.9
controlled environment
defined zone in which sources of contamination are controlled by specified means
3.1.10
corrective action

action to be taken when the results of monitoring indicate that alert or action levels are exceeded

3.1.11
Formal System
system of biocontamination control with established and documented procedures
3.1.12
hazard
potential source of harm
[2]
[ISO/IEC Guide 51:1999, 3.5]
3.1.13
impact sampler

device designed to sample particles in the air, or other gas, through a collision with a solid surface

3.1.14
impingement sampler

device designed to sample particles in the air, or other gas, through a collision with a liquid surface and the

subsequent entering into the liquid
2 © ISO 2003 — All rights reserved
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SIST EN ISO 14698-1:2004
ISO 14698-1:2003(E)
3.1.15
qualification

process of demonstrating whether an entity — activity or process, product, organization, or any combination

thereof — is capable of fulfilling specified requirements
3.1.16
risk

combination of the probability of occurrence of harm and the severity of that harm

[2]
[ISO/IEC Guide 51:1999, 3.2]
3.1.17
risk zone

defined and delimited space where individuals, products or materials (or any combination of these) are

particularly vulnerable to contamination
3.1.18
settle plate

suitable container (e.g. a Petri dish) of appropriate size, containing an appropriate, sterile, culture medium,

which is left open for a defined period to collect viable particles depositing from the air

3.1.19
swab

sterile collection device, non-toxic and non-inhibitory to the growth of the microorganisms being sampled,

consisting of a specific matrix of suitable size, mounted on an applicator
3.1.20
target level

defined level set by the user as a goal for routine operations, for the user's own purpose

3.1.21
validation

confirmation, through the provision of objective evidence, that the requirements for a specific intended use or

application have been fulfilled
[3]
[ISO 9000:2000, 3.8.5]
3.1.22
verification

confirmation, through the provision of objective evidence, that specified requirements have been fulfilled

[3]
[ISO 9000:2000, 3.8.4]

NOTE Monitoring and auditing methods, procedures and tests, including random sampling and analysis, can be used

in the verification of the Formal System.
3.1.23
viable particle
particle that consists of, or supports, one or more live microorganisms
3.1.24
viable unit
one or more viable particles which are enumerated as a single unit

NOTE When viable units are enumerated as colonies on agar media, it is common usage to name them colony

forming units (CFU). One CFU might consist of one or more VU.
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SIST EN ISO 14698-1:2004
ISO 14698-1:2003(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
[1]
[ISO 14644-1:1999, 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
[1]
[ISO 14644-1:1999, 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
[1]
[ISO 14644-1:1999, 2.4.3]
4 Principles of biocontamination control

4.1 A formal system of biocontamination control (Formal System) shall be established, implemented and

maintained within cleanrooms and associated environments. The Formal System will assess and control

factors that can affect the microbiological quality of the process and product.
[4], [5]

There are a number of accepted methods for achieving this goal by risk assessment . The hazard analysis

[6], [7], [8], [9] [10]

critical control point (HACCP) system is commonly used. Fault tree analysis (FTA) , or the failure

[11]

mode and effect analysis (FMEA) , or any other validated equivalent system can be used.

In many such methods, any type of hazard can be considered. Within this part of ISO 14698, only

microbiological hazards are addressed.

4.2 To assess and control the microbiological hazards, any selected system shall address the following

principles:

a) identification of potential hazard(s) to the process or product, assessment of the likelihood of occurrence

of these hazard(s), and identification of measures for their prevention or control;

b) designation of risk zones and, in each zone, determination of the points, procedures, operational steps

and environmental conditions that can be controlled to eliminate the hazard(s) or minimize the likelihood

of their occurrence;
c) establishment of limits to ensure control;
d) establishment of a monitoring and observation schedule;

e) establishment of corrective actions to be taken when monitoring results indicate that a particular point,

procedure, operational step or environmental condition is not under control;

f) establishment of procedures, which may include supplementary tests and procedures, to verify that the

chosen Formal System is working effectively;
g) establishment of training procedures;
h) establishment and maintenance of appropriate documentation.
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SIST EN ISO 14698-1:2004
ISO 14698-1:2003(E)
5 Establishing the Formal System
5.1 General requirements

It is the responsibility of the user to develop, initiate, implement and document a Formal System for

biocontamination control that allows detection of adverse conditions in a timely fashion. It is imperative that

such a programme be tailored to the field of application, to the specific facility and to specified conditions, and

that this system be an integral part of a quality management system. The quality management system shall

include an appropriate training programme for the selected Formal System.

In addition, it is essential that a monitoring programme (see 5.3) be designed and implemented in a manner

that minimizes the possibility of the sampling activities themselves contributing to the contamination of the

product or risk zone or both.

Risk zones shall be classified according to relevant guidelines, regulations (where these exist) and the chosen

Formal System. Risk zones may also be classified according to the level of aerial and surface

biocontamination, for example, low, medium, high or very high risk.

NOTE The first two parts of a Formal System, as given in 4.2 a) and b), are not discussed in detail in this part of

ISO 14698, but information on how to identify, assess and control hazards is given in other sources. See, for example, [12].

5.2 Alert, action and target levels

The user of a cleanroom or controlled environment shall set microbiological alert and action levels. These

levels shall be appropriate to the field of application, to the classification of the risk zones and to what is

achievable using current technology. Microbiological target levels may be used as an alternative to

microbiological alert and action levels in some specific fields of application.

During initial start-up and at intervals established according to the Formal System, data on biocontamination

levels should be reviewed to establish or confirm a baseline for the determination of alert and action levels.

Alert and action levels may be related to the target levels in any specific applications where these are set.

Alert and action levels should be reviewed and adjusted as appropriate.
5.3 Monitoring of biocontamination
5.3.1 General

Detection and monitoring of biocontamination in risk zones shall be carried out by sampling and enumerating

viable units with appropriate methods in accordance with a sampling plan.

Examples of sources of biocontamination that can constitute a hazard are air, surfaces, textiles and liquids

(see Annexes A, C, D and F).

Microbiological sampling may be useful for providing baseline data as new installations are constructed and

commissioned, including, as relevant, in the as-built state. Monitoring in risk zones shall be performed when

the installation is in the as-built and at-rest states. Monitoring shall also be performed routinely in the

operational state according to the selected Formal System.
5.3.2 Sampling
5.3.2.1 General

The appropriate sampling method and related procedures shall be selected and performed to reflect the

complexity and variety of situations. Sampling shall be carried out using a device and method selected in

accordance with the written procedure and in accordance with the instructions provided by the device

manufacturer.
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SIST EN ISO 14698-1:2004
ISO 14698-1:2003(E)
5.3.2.2 Sampling device

A sampling device shall be selected according to the area being monitored. The selection for a particular

application shall take into consideration the following factors:
a) type of viable particles for which to sample;
b) sensitivity of the viable particles to the sampling procedure;
c) expected concentration of the viable particles;
d) indigenous microbial flora;
e) accessibility of the risk zones;
f) ability to detect low levels of biocontamination;
g) ambient conditions in the risk zone being sampled;
h) time and duration of sampling;
i) sampling method, material and properties of the sampling medium;
j) effect of the sampling device on the process or environment to be monitored;
k) collection accuracy and efficiency;
l) incubation and viable particle detection and evaluation method;

m) type of information to be obtained (e.g. qualitative or quantitative aspects);

n) efficiency of extraction/rinse fluids, where appropriate.
5.3.2.3 Sampling plan

A sampling plan shall be developed through the selected Formal System and shall be documented. A

documented sampling plan is essential for accurately assessing and interpreting biocontamination data.

Sampling shall be carried out when the area is in the operational condition and during periods of greatest

stress in the system, for example, before the end of a shift or when the greatest amount of activity is taking

place. Sampling in the at-rest condition may also provide useful information about the facility design and

performance.
The sampling plan shall comprise the following:

a) initial sampling plan to provide a reference point or baseline within the framework of the chosen Formal

System;

b) routine sampling plan resulting from the implementation of the chosen Formal System.

5.3.2.4 Design of the sampling plan

The sampling plan shall take into account the cleanliness level of the risk zone and the degree of

biocontamination control required for the activity being conducted, to protect individuals, the environment, the

process and the product. The following are examples of elements to be considered:

a) choice of the sampling location, taking account of the location and function of the risk zone;

6 © ISO 2003 — All rights reserved
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SIST EN ISO 14698-1:2004
ISO 14698-1:2003(E)

b) number of samples (limited or small sample volumes may not provide representative results, although, in

some cases, large numbers of samples may compensate for the size of the sample volumes);

c) frequency of sampling;

d) methods of sampling, including whether the tests will be qualitative or quantitative;

e) volume to be taken or the area that should be covered to constitute a sample;
f) diluents, rinse fluids, neutralizers, etc.;

g) factors pertinent to a particular situation that could affect culturing results;

h) impact of operations, personnel and equipment in risk zones which contribute to biocontamination, such

1) compressed gases,
2) room air,
3) manufacturing equipment,
4) monitoring/measuring devices,
5) storage containers,
6) number of persons present in zone,
7) unprotected surfaces of personnel,
8) personal attire,
9) protective clothing,
10) walls/ceilings,
11) floors,
12) doors,
13) benches,
14) chairs, or
15) air admitted from other sources.
5.3.2.5 Frequency of sampling

The frequencies of sampling shall be developed using the selected Formal System and shall be confirmed or

modified as necessary in the following cases:
a) when alert or action levels are exceeded consecutively;
b) after prolonged shut-down of activities;
c) on detection of infectious agents in risk zones;

d) after any significant maintenance work has been undertaken on the ventilation system;

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SIST EN ISO 14698-1:2004
ISO 14698-1:2003(E)
e) after changes to the process that affect the cleanroom environment;
f) after recording of unusual results;
g) after changes to the cleaning or disinfection procedures;
h) after unplanned incidents that could contribute to biocontamination.
5.3.2.6 Sampling sites

Sampling sites shall be determined through the selected Formal System, and included in the sampling plan.

More than one sample may be taken at e
...

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