Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004)

ISO 14644-7:2004 specifies the minimum requirements for the design, construction, installation, test and approval of separative devices, in those respects where they differ from cleanrooms as described in ISO 14644-4 and 14644-5.
The application of ISO 14644-7:2004 takes into account the following limitations: user requirements are as agreed by customer and supplier; application-specific requirements are not addressed; specific processes to be accommodated in the separative-device installation are not specified; fire, safety and other regulatory matters are not considered specifically; where appropriate, national and local regulations apply.
ISO 14644-7:2004 is not applicable to full-suits.

Reinräume und zugehörige Reinraumbereiche - Teil 7: SD-Module (Reinlufthauben, Handschuhboxen, Isolatoren und Minienvironments) (ISO 14644-7:2004)

Dieser Teil der ISO 14644 legt die Mindestanforderungen an die Auslegung, die Ausführung, die Aufstellung, die Prüfung und die Abnahme von SD Modulen hinsichtlich der Aspekte fest, in denen diese von Reinräumen nach ISO 14644 4 und 14644 5 abweichen.
Bei der Anwendung dieses Teils der ISO 14644 werden die folgenden Einschränkungen berücksichtigt:
-   Benutzerspezifische Anforderungen gelten wie zwischen Kunde und Lieferant vereinbart.
-   Anwendungsspezifische Anforderungen werden nicht betrachtet.
-   Bestimmte Prozesse, die bei der Aufstellung des SD Moduls aneinander angepasst werden müssen, sind nicht festgelegt.
-   Brandschutztechnische, sicherheitstechnische und andere behördliche Vorschriften werden nicht gesondert betrachtet; sofern angemessen, gelten die entsprechenden nationalen und lokalen Vorschriften.
Dieser Teil der ISO 14644 ist nicht auf Vollanzüge anwendbar.

Salles propres et environnements maîtrisés apparentés - Partie 7: Dispositifs séparatifs (postes a air propre, boîtes a gants, isolateurs et mini-environnements) (ISO 14644-7:2004)

L'ISO 14644-7:2004 spécifie les exigences minimales de conception, de construction, d'installation, d'essai et de réception des dispositifs séparatifs pour les aspects qui les différencient des salles propres telles qu'elles sont décrites dans l'ISO 14644-4 et dans l'ISO 14644-5.
L'application de l'ISO 14644-7:2004 est sujette aux limitations suivantes: les exigences particulières à telle ou telle application ne sont pas spécifiées; les exigences de l'utilisateur sont celles convenues entre le client et le fournisseur; les procédés spécifiques qu'hébergera le dispositif séparatif ne sont pas spécifiés; les réglementations de sécurité et de protection incendie et toute autre exigence réglementaire ne font pas l'objet d'un examen particulier; il convient de se conformer aux réglementations nationales ou locales applicables; les scaphandres n'entrent pas dans son domaine d'application.

Čiste sobe in podobna nadzorovana okolja – 7. del: Zaprte enote (brezprašne komore, komore z rokavicami, izolatorji, mini okolja) (ISO 14644-7:2004)

General Information

Status
Published
Publication Date
28-Feb-2005
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
01-Mar-2005
Due Date
01-Mar-2005
Completion Date
01-Mar-2005

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SLOVENSKI STANDARD
SIST EN ISO 14644-7:2005
01-marec-2005
ýLVWHVREHLQSRGREQDQDG]RURYDQDRNROMD±GHO=DSUWHHQRWH EUH]SUDãQH
NRPRUHNRPRUH]URNDYLFDPLL]RODWRUMLPLQLRNROMD  ,62

Cleanrooms and associated controlled environments - Part 7: Separative devices (clean

air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004)
Reinräume und zugehörige Reinraumbereiche - Teil 7: SD-Module (Reinlufthauben,
Handschuhboxen, Isolatoren und Minienvironments) (ISO 14644-7:2004)

Salles propres et environnements maîtrisés apparentés - Partie 7: Dispositifs séparatifs

(postes a air propre, boîtes a gants, isolateurs et mini-environnements) (ISO 14644-

7:2004)
Ta slovenski standard je istoveten z: EN ISO 14644-7:2004
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
SIST EN ISO 14644-7:2005 en

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

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SIST EN ISO 14644-7:2005
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SIST EN ISO 14644-7:2005
EUROPEAN STANDARD
EN ISO 14644-7
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2004
ICS 13.040.35
English version
Cleanrooms and associated controlled environments - Part 7:
Separative devices (clean air hoods, gloveboxes, isolators and
mini-environments) (ISO 14644-7:2004)

Salles propres et environnements maîtrisés apparentés - Reinräume und zugehörige Reinraumbereiche - Teil 7: SD-

Partie 7: Dispositifs séparatifs (postes à air propre, boîtes à Module (Reinlufthauben, Handschuhboxen, Isolatoren und

gants, isolateurs et mini-environnements) (ISO 14644- Minienvironments) (ISO 14644-7:2004)

7:2004)
This European Standard was approved by CEN on 1 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 14644-7:2004: E

worldwide for CEN national Members.
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SIST EN ISO 14644-7:2005
EN ISO 14644-7:2004 (E)
Foreword

This document (EN ISO 14644-7:2004) 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 April 2005, and conflicting national

standards shall be withdrawn at the latest by April 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 14644-7:2004 has been approved by CEN as EN ISO 14644-7:2004 without any

modifications.
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SIST EN ISO 14644-7:2005
INTERNATIONAL ISO
STANDARD 14644-7
First edition
2004-10-01
Cleanrooms and associated controlled
environments —
Part 7:
Separative devices (clean air hoods,
gloveboxes, isolators and mini-
environments)
Salles propres et environnements maîtrisés apparentés —
Partie 7: Dispositifs séparatifs (postes à air propre, boîtes à gants,
isolateurs et mini-environnements)
Reference number
ISO 14644-7:2004(E)
ISO 2004
---------------------- Page: 5 ----------------------
SIST EN ISO 14644-7:2005
ISO 14644-7:2004(E)
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© ISO 2004

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,

electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or

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Published in Switzerland
ii © ISO 2004 – All rights reserved
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SIST EN ISO 14644-7:2005
ISO 14644-7:2004(E)
Contents Page

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

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

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

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

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

4 Requirements ........................................................................................................................................ 3

5 Design and construction...................................................................................................................... 5

6 Access devices ..................................................................................................................................... 6

6.1 Use.......................................................................................................................................................... 6

6.2 Manual operation .................................................................................................................................. 6

6.3 Robotic handling................................................................................................................................... 7

7 Transfer devices.................................................................................................................................... 7

7.1 Use.......................................................................................................................................................... 7

7.2 Selection ................................................................................................................................................ 7

7.3 Fail-safe design ..................................................................................................................................... 7

8 Siting and installing.............................................................................................................................. 7

9 Testing and approval............................................................................................................................ 8

9.1 General................................................................................................................................................... 8

9.2 Glove breach test.................................................................................................................................. 8

9.3 Operating differential pressure ........................................................................................................... 8

9.4 Leak testing ........................................................................................................................................... 8

9.5 Periodic testing ..................................................................................................................................... 9

Annex A (informative) Separation continuum concept ................................................................................ 10

Annex B (informative) Air-handling systems and gas systems................................................................... 13

Annex C (informative) Access devices........................................................................................................... 16

Annex D (informative) Examples of transfer devices ................................................................................... 22

Annex E (informative) Leak testing................................................................................................................. 31

Annex F (informative) Parjo leak test method ............................................................................................... 40

Bibliography ..................................................................................................................................................... 51

© ISO 2004 – All rights reserved iii
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SIST EN ISO 14644-7:2005
ISO 14644-7:2004(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 14644-7 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 4: Design, construction and start-up
 Part 5: Operations
 Part 6: Vocabulary

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

The following parts are under preparation:
 Part 3: Test methods
 Part 8: Classification of airborne molecular contamination
iv © ISO 2004 – All rights reserved
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SIST EN ISO 14644-7:2005
ISO 14644-7:2004(E)
Introduction

In the spirit of the generic requirements of an International Standard, the term “separative devices” was

developed by Technical Committee ISO/TC 209 to encompass the wide continuum of configurations from

open unrestricted air overspill to wholly contained systems. Common terms-of-trade, such as clean air hoods,

gloveboxes, isolators and mini-environments, have different meanings depending on the specific industry.

Difficulties experienced in the manufacture and handling of certain products or materials have driven the

development of separative devices. These difficulties include product sensitivity to particles, chemicals, gases

or microorganisms; operator sensitivity to the process materials or byproducts; and both product and operator

sensitivity.

Separative devices provide assured protection in varying levels by utilising physical or dynamic barriers, or

both, to create separation between operation and operator. Certain processes may require special

atmospheres to prevent degradation or explosions. Some systems may be capable of providing 100 %

recirculation of the contained atmosphere to allow inert gas operation or biodecontamination with reactive

gases.

Usually people do not work directly inside the separative-device environment during production. These

separative devices may be movable or fixed, and used for transport, transfer and process. The product or

process, or both, are manipulated remotely with access devices either manually, with protection by barrier

technology such as wall-integrated personal interface systems (e.g. gloves, gauntlets, half-suits), or

mechanically with robotic handling systems.

Air cleanliness definitions and test methods covered in ISO 14644-1, 14644-2 and 14644-3 generally apply

within separative devices. In applications with biological contamination requirements, ISO 14698-1 and

14698-2 will apply. However, some applications can have special requirements for monitoring because of

extreme conditions that may be encountered. These unique conditions are covered in this part of ISO 14644.

Transfer devices to move material in and out of separative devices form an important portion of this part of

ISO 14644. In addition, material can be moved from one fixed separative device to another in transport

containers.

Design and construction of cleanrooms, including generic aspects of clean zones, are covered in ISO 14644-4.

ISO 14644-4:2001, Figure A.4, illustrates aerodynamic measures or air overspill often used in industry-specific

separative devices called clean air hoods and mini-environments. Mini-environments are often used in the

electronics industry with transport containers, called boxes or pods, to provide very clean process conditions.

The application of barrier technology used in industry-specific separative devices called isolators is shown in

ISO 14644-4:2001, Figure A.5. Separative devices, often called gloveboxes, containment enclosures or

isolators, are used in the medical products and nuclear industries to provide protection to the operator as well

as the process. Isolators may be rigid- or soft-walled depending on the application. The Bibliography contains

industry-specific references. However, from a unifying conceptual standpoint, a continuum of separation exists

between the operation and the operator, ranging from totally open to totally enclosed systems depending on

the application. Similarly, a continuum exists for containment.

The concept of separative devices is not limited to one specific industry, as many industries use these

technologies for different requirements. In that light, this part of ISO 14644 provides a generic overview of the

requirements involved.
© ISO 2004 – All rights reserved v
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SIST EN ISO 14644-7:2005
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SIST EN ISO 14644-7:2005
INTERNATIONAL STANDARD ISO 14644-7:2004(E)
Cleanrooms and associated controlled environments —
Part 7:
Separative devices (clean air hoods, gloveboxes, isolators and
mini-environments)
1 Scope

This part of ISO 14644 specifies the minimum requirements for the design, construction, installation, test and

approval of separative devices, in those respects where they differ from cleanrooms as described in

ISO 14644-4 and 14644-5.

The application of this part of ISO 14644 takes into account the following limitations.

 User requirements are as agreed by customer and supplier.
 Application-specific requirements are not addressed.

 Specific processes to be accommodated in the separative-device installation are not specified.

 Fire, safety and other regulatory matters are not considered specifically; where appropriate, national and

local regulations apply.
This part of ISO 14644 is not applicable to full-suits.
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 10648-2:1994, Containment enclosures — Part 2: Classification according to leak tightness and

associated checking methods

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
1) To be published.
© ISO 2004 – All rights reserved 1
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SIST EN ISO 14644-7:2005
ISO 14644-7:2004(E)

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

General principles and methods

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

Evaluation and interpretation of biocontamination data
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 14644-1, 14644-2, 14644-4 and the

following apply.
3.1
access device

device for manipulation of processes, tools or products within the separative device

3.2
action level

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

intervention, including the investigation of cause, and corrective action
3.3
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

3.4
barrier
means employed to provide separation
3.5
breach velocity

velocity through an aperture sufficient to prevent movement of matter in the direction opposite to the flow

3.6
containment

state achieved by separative devices with high degree of separation between operator and operation

3.7
decontamination
reduction of unwanted matter to a defined level
3.8
gauntlet
one-piece glove covering the full arm-length
3.9
glove

〈of separative devices〉 component of an access device that maintains an effective barrier while enabling the

hands of the operator to enter the enclosed volume of an separative device
3.10
glove port
attachment site for gloves, sleeves and gauntlets
3.11
glove sleeve system

multi-component access device that maintains an effective barrier while enabling replacement of the sleeve

piece, connecting cuff piece and glove
2 © ISO 2004 – All rights reserved
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SIST EN ISO 14644-7:2005
ISO 14644-7:2004(E)
3.12
half-suit

access device that maintains an effective barrier while enabling the head, trunk and arms of the operator to

enter the working space of the separative device
3.13
hourly leak rate

ratio of the hourly leakage q of the containment enclosure under normal working conditions (pressure and

temperature) to the volume V of the said containment enclosure
NOTE It is expressed in reciprocal hours (h ).
[ISO 10648-2:1994]
3.14
leak

〈of separative devices〉 defect revealed by testing under a pressure differential after corrections for

atmospheric conditions
3.15
pressure integrity

capability to provide a quantifiable pressure leakage rate repeatable under test conditions

3.16
separation descriptor
[A :B ]
a b

numerical abbreviation summarizing the difference in cleanliness classification between two areas as ensured

by a separative device under specified test conditions, where
A is the ISO class inside the device;
a is the particle size at which A is measured;
B is the ISO class outside the device;
b is the particle size at which B is measured
3.17
separative device

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

inside and outside of a defined volume

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

gloveboxes, isolators and mini-environments.
3.18
transfer device

mechanism to effect movement of material into or out of separative devices while minimizing ingress or egress

of unwanted matter
4 Requirements

The following information shall be defined, agreed and documented between customer and supplier:

a) number, date of publication, and edition of this part of ISO 14644;

b) established role of other relevant parties to the project (e.g. consultants, designers, regulatory authorities,

service organizations);
© ISO 2004 – All rights reserved 3
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SIST EN ISO 14644-7:2005
ISO 14644-7:2004(E)

c) intended general purpose of equipment, planned operations and any constraint imposed by the operating

requirements such as material compatibility, residues and effluents;
d) reliability and availability;
e) when appropriate, any applicable hazard analysis;
[23]
NOTE HACCP, HAZOP, FMEA, FTA methods or similar have been found to be suitable;

f) required airborne particulate cleanliness class or demands for cleanliness in accordance with ISO 14644-1

[18] [19]

and 14644-2. Where appropriate, airborne molecular contamination should be considered ;

g) specified operational states (e.g. as-built, at-rest, operational) (see ISO 14644-1) and recovery time (e.g.

maintenance, cleaning, etc.);
[25]
h) where appropriate, a specified separation descriptor ;

i) if devices depend on differential pressure, the differential pressure shall be continuously monitored and

alarmed in some applications;

j) where appropriate, a specified hourly leak rate (for an example of methodology, see Annex E);

k) other operational parameters, including
1) test points,
2) alert and action levels to be measured to ensure compliance,
3) test methods;

l) contamination-control concept, including the establishment of installation, operation and performance

criteria;

m) required methods of measurement, sample locations, control, monitoring and documentation;

n) mode of entry or exit of separative devices and related equipment, apparatus, supplies and personnel into

the controlled environment required during
1) installation,
2) commissioning,
3) operation,
4) maintenance;
o) layout and configuration of the installation;

p) critical dimensions, mass and weight restrictions, including those related to available space;

q) process requirements that affect the installation;
r) process equipment list with utility requirements;
s) maintenance requirements of the installation;

t) responsibilities for the preparation, approval, execution, supervision, documentation, statement of criteria,

basis of design, construction, testing, training, commissioning and qualification, including performance,

witnessing, and reporting of tests;
u) identification and assessment of external environmental influences;

v) additional information required by the particular application and requirements in Clauses 5, 6, 7 and 8 of

this part of ISO 14644;
w) compliance with local regulations.
4 © ISO 2004 – All rights reserved
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SIST EN ISO 14644-7:2005
ISO 14644-7:2004(E)
5 Design and construction

5.1 Design shall include capability to support qualification and to comply with regulatory requirements.

5.2 Separative-device design shall provide the process, the operator or third party with protection against

contamination appropriate to the operation being performed.

5.3 Consideration shall be given to separation means (see Annex A). The separation descriptor, where

applicable, shall be taken into account.
The risk of concentrated leaks should be addressed.

5.4 Consideration shall be given to malfunction, procedures and ancillary systems involved with the

separative-device application (see Annex B).

5.5 Consideration shall be given to access devices and transfer devices (see Annexes C and D).

5.6 Separative devices shall be ergonomically designed for easy access to all internal surfaces and work

areas, and with respect to the process undertaken.

5.7 Access devices shall be of the minimum size and number consistent with operation, cleaning and

maintenance. (See Clause 6.)

5.8 Consideration shall be given to differential operating pressure, including excursions.

5.9 Hourly leak rate, when applicable, shall be taken into account (see Annex A). The rigidity or flexibility of

the separative device shall be taken into account if quantified leak rates are required.

5.10 External influences, such as air flow, vibration and pressure differences, shall be considered to avoid

adverse effects on integrity and function.
5.11 Where appropriate, hazard analysis shall be performed [see 4 e)].

5.12 Provision for cleaning or decontamination, including possible disposal of the device or its components,

shall form part of the design criteria.
5.13 Built-in test facilities and appropriate alarms shall be included.
5.14 Transfer device(s) shall be appropriate to process and routine operation.
5.15 Filtration shall be appropriate for application.
5.16 Volumetric flow rate shall be appropriate for application.
5.17 Exhaust effluents shall undergo treatment where appropriate.

5.18 Whenever possible, items requiring maintenance shall be external to the separative device.

5.19 Materials used in the construction of separative devices, including sealing materials, fans, ventilation

systems, piping and associated fittings, shall be chemically and mechanically compatible with the intended

processes, process materials, application and decontamination methods. Protection against corrosion and

degradation during prolonged use shall be considered. Heat and fire resistant construction materials shall be

considered when appropriate (see Annex B). Where appropriate, materials used shall be checked for thermal

characteristics, sorption and out gassing properties. Materials selected for viewing panels shall be tested and

proven to remain transparent and resistant to changes that would prevent clear visibility.

© ISO 2004 – All rights reserved 5
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SIST EN ISO 14644-7:2005
ISO 14644-7:2004(E)
6 Access devices
6.1 Use

Access devices are used to manipulate processes, products or tools within the separative device.

Manipulation is achieved by manual operation or robotic handling.
6.2 Manual operation
6.2.1 Devices for manual operation
Operator manual-manipulation devices consist of
a) gauntlets,
b) glove systems (e.g. sleeve, cuff-ring and glove),
c) half-suits and similar devices that allow extended reach,
d) remote manipulator.
Where full-suits are used, reference should be made to appropriate standards.

Where possible, consideration should be given to alternative manipulation devices that minimize the number

of holes pierced through the structure of the separative device.
6.2.2 Gauntlets, glove systems, half-suits

6.2.2.1 When using gauntlets, glove systems and half-suits, these types of flexible-membrane access

device systems shall be designed and constructed to allow for glove change without breaching the separative

device (see Annex C). These systems are unlikely to maintain molecular containment, therefore alternative

systems should
...

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