EN ISO 14644-7:2004

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 à air propre, boîtes à 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: 30-Sep-2004
• ICS: 13.040 - Air quality
• Technical Committee: CEN/TC 243 - Cleanroom technology
• Drafting Committee: CEN/TC 243 - Cleanroom technology
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Start Date: 31-Jul-2009
• Completion Date: 31-Jul-2009
• Ref Project: SIST EN ISO 14644-7:2005 - Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004)

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2005
ýLVWHVREHLQSRGREQDQDG]RURYDQDRNROMD±GHO=DSUWHHQRWHEUH]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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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.
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
ISO 14644-7:2004(E)
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ii © ISO 2004 – All rights reserved

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 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

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.
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
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 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

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
R
h
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
–1
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 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

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 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 be considered for applications requiring molecular containment.
6.2.2.2 Glove ports and glove cuff rings devices shall be designed for ease of change, integrity testing
and security of operation.
6.2.2.3 The following selection criteria shall be considered in choosing gauntlet, glove sleeve and half-
suit system materials that are vital in maintaining separation:
a) materials and tools to be handled within the separative device;
b) temperature limitations of the glove materials;
c) acceptable permeability;
d) chemical resistance or mechanical strength, or both;
e) sorption and desorption of chemicals;
f) known shelf and service lives of glove material;
g) differential pressures, including transient excursions (operating and abnormal pressures);
h) operations to be performed.
6 © ISO 2004 – All rights reserved

ISO 14644-7:2004(E)
6.2.3 Remote manipulation
Remote-handling systems consist of mechanical or servo links between an operator’s hands and arms to a
mechanical manipulation system within separative devices designed for specific applications.
6.3 Robotic handling
Robotic handling consists of automated systems designed to manipulate materials in a separative device
following a process sequence for specific applications.
7 Transfer devices
7.1 Use
Transfer devices shall not diminish the performance of separative devices. In specific applications, transfer
devices become critical in maintaining integrity of the device or process. Some transfer devices are used as
independent separative devices.
7.2 Selection
Selection of a transfer device shall be based on the level of separation required by the application. The hourly
leak rate of the transfer device shall not be greater than the hourly leak rate of the separative device which the
transfer device serves. Transfer devices shall minimize the transfer of unwanted matter. Outline diagrams and
descriptions of possible types of transfer device are included in Annex D. These diagrams are only illustrative
examples of possible configurations.
7.3 Fail-safe design
In the event of power failure, transfer devices that have electrical interlocking mechanisms shall prevent
access via the transfer device.
8 Siting and installing
8.1 The cleanroom classification of the room housing the separative device depends on the application, the
design, and the operational capability of the separative device. Reference should be made to ISO 14644-4.
8.2 The appropriateness of the following points shall be considered:
a) air classification of the room (ISO 14644-1);
b) operational ergonomics;
c) maintenance;
d) toxicity of materials;
e) all process hazards;
f) byproduct hazards;
g) potential cross-contamination;
h) disposal matters;
i) any mandatory regulatory requirements.
ISO 14644-7:2004(E)
9 Testing and approval
9.1 General
9.1.1 Selection of test procedures depends upon location, design, configuration and application of the
separative device.
9.1.2 If air supply and exhaust systems are an integral part of the separative device, these systems shall
also be tested.
9.1.3 In some situations, the air cleanliness in the separative device is not measurable by ISO 14644-1.
Therefore alternative test procedures are required.
[18] [19]
EXAMPLE 1 Testing of molecular contamination .
[30]
EXAMPLE 2 Testing by particle surface contamination .
9.1.4 Certain conditions or operational states (e.g. dusty materials, out-gassing materials, or both types of
materials) may not permit particulate sampling during operations or would present a hazard. Alternative states
(e.g. before and after operations, but still in the operational state) may need to be sampled to determine the
possibility of intrinsic contamination.
9.1.5 In the case of small-volume separative devices, a risk exists that pressure integrity and particle/aero-
biocontamination counts are affected by the sample airflow rate of the air sampling instrument, if the sample
airflow rate of the instrument is similar to the airflow rate of the separative device.
9.1.6 Appropriate test parameters shall be agreed between customer and supplier.
9.1.7 Separative device and auxiliary equipment testing and approval shall generally be performed with
reference to ISO 14644-1, 14644-2, 14644-3, and 14644-4. Guidance is given in the annexes in this part of
ISO 14644.
9.2 Glove breach test
When appropriate, the airflow through one open glove port shall be measured by placing an anemometer at the
centre of the glove port. The velocity shall be agreed between customer and supplier (guidance value: 0,5 m/s).
9.3 Operating differential pressure
9.3.1 The differential pressure shall be tested in the at-rest and operational states.
9.3.2 When devices depend on differential pressure, the differential pressure should be continuously
monitored and alarmed.
9.4 Leak testing
9.4.1 When appropriate, a leak test shall be performed. Guidance is given in Annexes E and F.
NOTE Integrity testing on some separative devices that operate close to atmosphere pressure (less than 1 000 Pa)
requires detailed procedures and sensitive test equipment to establish a quantifiable leak rate. The resulting leak
determines acceptability for the intended application (see Annex A).
9.4.2 When appropriate, an induction leak test shall be performed. Guidance is given in Annex E.
NOTE Induction leaks can occur when the velocity across an orifice creates a pressure depression and induces a
reverse flow through the orifice (Venturi effect). Devices that operate at low differential pressures may be compromised by
induction leakage. Similarly, devices that utilise over pressure or flow to minimise or prevent the transfer of unwanted
matter may be at risk from induction leakage when operating under transient volume changes such as glove entry or
withdrawal.
8 © ISO 2004 – All rights reserved

ISO 14644-7:2004(E)
9.5 Periodic testing
9.5.1 Testing shall be conducted in accordance with 9.5.2 and 9.5.3 and ISO 14644-1, ISO 14644-2,
ISO 14698-1 and ISO 14698-2.
9.5.2 The tests and checks are a function of the application and instrumentation/detection systems. Routine
tests shall be established and recorded for comparison preventative maintenance requirements.
9.5.3 The following recommendations for testing are given:
a) half-suit/glove testing
1) on commissioning,
2) prior to and after completion of work,
3) after glove/glove sleeve changes;
b) pressure testing
1) on commissioning,
2) after any airflow or filter-pressure parameter changes,
3) after maintenance affecting the separative device envelope or pressure control devices;
c) induction testing on commissioning;
d) instrumentation and alarm system testing
1) on commissioning,
2) after maintenance affecting the control system,
3) at the frequency dictated by the instrumentation manufacturer,
4) at predetermined periods consistent with use and operational requirements.

ISO 14644-7:2004(E)
Annex A
(informative)
Separation continuum concept
A separative device utilises physical means, aerodynamic means, or both, to create improved levels of
separation between the inside and outside of a defined volume. Physical separation means include both rigid
and flexible barriers. Aerodynamic means include air/gas flow with or without filtration. Generally, the
assurance of maintaining separation increases with the degree of rigidity of the physical separation, as shown
schematically in Figure A.1. Examples of common types of separative device for a variety of applications are
given in Table A.1. However, it must be emphasised that there is not a direct relationship between airborne
particulate cleanliness class, as defined in ISO 14644-1, and the position of a separative device in the
separation continuum. Two measures of this separation are the separation descriptor and the hourly leak rate
(pressure integrity). The separation descriptor [A :B ] is a convenient measure when the hourly leak rate is
a b
[25]
not appropriate . A four-level classification system of hourly leak rate (R ) is given in ISO 10648-2.
h
ISO 10648-2 classification is generally applied to devices with rigid physical barriers. It is acknowledged that
overlap exists with ISO 14644-4, particularly with the first three items of the Figure A.1.

Figure A.1 — Schematic of the separation continuum illustrating increasing assurance of maintaining
separation as the separation ranges from aerodynamic to physical means with overlapping
separation approaches as a parameter
10 © ISO 2004 – All rights reserved

ISO 14644-7:2004(E)
Table A.1 — Separation continuum
Examples of terms
Separation approaches Means Device descriptor in common usage
and synonyms
Unrestricted air overspill Aerodynamic measures Open — no curtains or Clean air device, laminar flow
and filtration screens. Operator equipped hood, clean air hood
with normal cleanroom
garments and gloves may
reach into device for access
and transfer. Clean zone is at
positive pressure.
Restricted air overspill Aerodynamic and physical Access severely restricted by Laminar-flow hood, clean air
curtains or fixed screens. hood, directed air hood, clean
work station
Nominally enclosed — not Aerodynamic and physical Nominally enclosed; may Point-of-fill device, filling
capable of contained/ incorporate access devices tunnel
controlled atmosphere and transfer devices.
operation
Nominally enclosed — may Aerodynamic and physical Large degree of physical Filling tunnel, point-of-fill
be capable of separation in design. May be device, laminar-flow tunnel,
contained/controlled capable of controlled/ clean tunnel, sterilising oven,
atmosphere operation — contained atmosphere mini-environments for
single or dual mode operation. electronics
Closed/undefined pressure Physical Closed devices with Isolators, glove bags, powder
integrity — performance may undefined integrity. May have transfer control or hopper,
be hourly leak rate or other flexible film walls. flexible film/half-suit isolator,
parameter mini-environments for
electronics
Low pressure integrity/high Physical Rigid construction allows Isolators, gloveboxes, powder
hourly leak rate enclosure — pressure integrity test of leak transfer control or hopper,
positive or negative pressure rate. May be operated under animal test house isolator,
operation negative pressure. biochemical instructional
isolators; containment
enclosures
Medium pressure Physical Medium pressure integrity. Isolators, gloveboxes,
integrity/medium hourly leak containment enclosures
rate enclosure — positive or
negative pressure operation
High pressure integrity/low Physical High pressure integrity, Isolators, gloveboxes, nuclear
hourly leak rate enclosure — vacuum and inert gas glove box, low molecular
positive or negative pressure operation, containment at containment enclosures
operation molecular level.
NOTE 1 Examples are not design specifications or recommendations.
NOTE 2 Device boundaries may overlap.
Dual mode separative devices usually have a large degree of physical separation in their design, and may be
capable of either open or contained atmosphere operation during specific periods of their operation.
Air/gas supplied to a separative device should be of sufficient quality to comply with one or more of the
classes described in ISO 14644-1. The configuration of the airflow supplied will be application specific.
Both dynamic and static conditions should be specified with regard to
a) air cleanliness required in the separative device,
ISO 14644-7:2004(E)
b) hourly leak rate or separation descriptor, or both,
c) material ingress (transfer devices),
d) material egress (transfer devices).

12 © ISO 2004 – All rights reserved

ISO 14644-7:2004(E)
Annex B
(informative)
Air-handling systems and gas systems
B.1 General
B.1.1 It is normal to protect the extract or exhaust system by an internally-fitted safe change filter.
B.1.2 Over-pressure in a separative device can be avoided by the use of an oil-filled pressure-relief device.
The discharge of the pressure-relief device is connected to the exhaust gas system.
B.2 Air-handling systems
B.2.1 Separative device air-handling systems are required to be capable of supplying or extracting sufficient
air volume to or from a separative device via the installed filters and associated ductwork of the device.
B.2.2 Air-handling systems should be capable of the following functions:
a) isolating the separative device by valves or sealing plates upstream and downstream of inlet and outlet
filtration for safety, decontamination/sterilisation/sanitation/disinfection and integrity testing purposes;
NOTE This does not apply to unrestricted air overspill, restricted air overspill and nominally enclosed separative
devices.
b) allowing connections and any other provisions for treatment of air;
c) accommodating the total system initial pressure drop and final pressure drop, allowing for filter loading;
d) changing potentially contaminated filters via a safe change-filter operation that ensures contaminated
filters are safely changed. Provision of operator and third-party protection is essential;
e) providing all filters and associated seals with aerosol testing facilities;
f) having secondary HEPA/ULPA filters on any recirculated air;
g) having instrumentation to show separative-device operating pressure/depression and provision for
fan/blower failure alarms;
h) having, if required, particle sampling ports to enable air quality to be sampled in the separative device and
its transfer devices;
i) maintaining the separative-device extraction systems at negative pressure;
j) ensuring, in the event of glove loss and alarm, capability of an airflow with minimum breach velocity to
provide protection to either operator or product;
k) complying with any other equipment or device required by local regulations.
ISO 14644-7:2004(E)
B.3 Gas systems
B.3.1 Introduction
Separative devices with high pressure integrity are normally required for molecular levels necessary for
anaerobic or low m
...