National foreword

This British Standard is the official English language version of EN ISO 14644‑7:2004. It is identical with ISO 14644‑7:2004

The UK participation in its preparation was entrusted to Technical Committee LBI/30, Cleanroom technology, which has the responsibility to:

aid enquirers to understand the text;
present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed;
monitor related international and European developments and promulgate them in the UK.

A list of organizations represented on this committee can be obtained on request to its secretary.

Cross-references

The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online.

This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.

Compliance with a British Standard does not of itself confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 14 October 2004

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

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.

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.

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

3 Terms and definitions

4 Requirements

5 Design and construction

5.1

5.2

5.3

5.4

5.5

5.6

5.7

5.8

5.9

5.10

5.11

5.12

5.13

5.14

5.15

5.16

5.17

5.18

5.19

6 Access devices

6.1 Use

6.2 Manual operation

6.3 Robotic handling

7 Transfer devices

7.1 Use

7.2 Selection

7.3 Fail-safe design

8 Siting and installing

8.1

8.2

9 Testing and approval

9.1 General

9.2 Glove breach test

9.3 Operating differential pressure

9.4 Leak testing

9.5 Periodic testing

Bibliography

BS EN ISO 14644-7:2004

Cleanrooms and associated controlled environments - Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)

Current, Under Review

Published:

14 Oct 2004