FDA: Federal Standard 209 Replaced

GMP News No. 192

GMP News
3 May 2002
 

FDA:Federal Standard 209 Replaced

 
The Federal Standard 209 was the most important document in the field of cleanroomtechnology for more than 40 years. This document has nowofficially been replaced by a standard of the International Organisation for Standardization (ISO).The name of the new document is ISO 14644-1 Cleanrooms andAssociated Controlled Environments - Part 1 Classification of aircleanliness.

The Institute of Environmental Sciencesand Technology (IEST) acts as office for ISO/TC 209 and has developed thisdocument as the first in a series of 11 documents in order toharmonise the requirements worldwide.

Details regarding the series ISO 14644can be found in our News of 17 December 2001, in which we reported about the innovations already atthe end of last year.

In addition to Part 1 of ISO 14644, whichhas now come into force, Part 3 is currently under discussion:

At the beginning of the 90s, ISO began to establish Guidelines ofworld-wide validity. In analogy to the VDI (association of Germanengineers) Guideline 2083 Sheet 3 - Messtechnik in der Reinraumluft(Metrology in Cleanroom Air), the ISO Guideline 14644 Part 3 -Metrology and Test Methods was created. Since the contents of the ISOGuideline cover most of VDI 2083-3, in 2000 the VDI started to reviseSheet 3 of this Guideline. The objective of the revision is to enlarge onthose items of which the ISO Guideline does not give as many details as isusual or necessary in the German-speaking countries in a way that they canbe put into practice more easily. When the two Guidelines will beavailable to the users - probably in 2002 - the ISO Guideline shall beapplicable in general, whereas for some items the VDI Guideline shallsupply further details. The German version of the ISO Guideline is plannedto be published as DIN - EN 14644 - 3. However, which test and measuringmethods should be used in acceptance tests or requalifications remains inthe end an agreement between user and supplier.

Contents - ISO 14644 Part 3 - Metrology and test methods

The ISO Guideline 14644 Part 3 has beenpublished as CD (CommitteeDraft). Its contents are structured as follows:

 

Foreword and Introduction

 

1

Scope

Representsthe field of application

2

Normative references

Referencesto those parts of ISO 14644 that have already been published

3

Terms and definition

Explanationof the terms appearing in the Guideline

4

Testing procedures

 

4.1

Recommended tests

Overview ofthe recommended tests and measurements

4.2

Purpose of tests

For whatpurpose is the test or measurement carried out?

5

Documentation

Documentation

Annexes to the ISO 14644-3 Guideline:

Annex A

Choice of recommended tests of an installation and the sequence in which to carry them out

Annex B

Recommendations for test methods

Annex C

Test instrumentation

Annex D

Sources of information and bibliographical references

Testing Procedures - Chapter 4 of ISO 14644-3

A well-structured table describes the relationship between themeasurement parameters, the testing procedures to be applied and theinstruments to be used. It also shows the ISO standards that are to beapplied just like in the case of the airborne particle count forclassification defined in 14644 part 1.

Recommended test items

Clause for Procedure (Annex B)

Clause for Instrument (Annex C)

Referred to ISO standard

Airborne particle count for classification of the installationand test measurement

B.1

C.1

14644-1

14644-2

Airborne particle count for ultrafine particles

B.2

C.2

14644-1

Airborne particle count for macroparticles

B.3

C.3

14644-1

Airflow test

B.4

C.4

14644-1&2

Air pressure difference test

B.5

C.5

14644-1&2

Installed filter system leakage test

B.6

C.6

14644-2

Airflow visualization

B.7

C.7

14644-2

Airflow direction test

B.8

C.8

 

Temperature test

B.9

C.9

 

Humidity test

B.10

C.10

 

Electrostatic and ion generator test

B.11

C.11

 

Particle deposition test

B.12

C.12

 

Recovery test

B.13

C.13

14644-2

Containment leak test

B.14

C.14

14644-1&2

Table: Overview of therecommended test parameters, the related testing procedures and thesuitable measurement instruments

Annex A - Choice of recommended tests of an installation and thesequence in which to carry them out

In this chapter the recommended testing procedures are explained. Atable helps you to select the test sequence as well as the measuringinstrument or the testing equipment used.
In the second column, the test sequence is selected, and the fourth columnenables you to select the corresponding measuring instrument. All of thetesting procedures are listed in the table.

Test activity

Test selec-
ted and sequence

Procedure reference

Instrument selection

Test Inst. selected

Comments

Airborneparticle count for classification and test measurement[]B.1C.1  
Discrete-particlecounter  
Airborneparticle count for ultrafine particles[]B.2C.2  
Condensation nucleuscounter  
Discrete-particle counter  
Size cut-off device  
Airborne particle countfor macroparticles B.3C.3 To be tested by outsourcecontractor
With particle collection B.3.3.1Microscopic measurement oncollected filter paper  

Table: Extract of thetable in Annex A - Choice of recommended tests of aninstallation and the sequence in which to carry them out

Annex B - Recommendation for test methods

In Annex B you can find recommendations on how to carry out the varioustests and measurements. Apart from this, the recommended procedures aredescribed. The structure of each of the procedures B.1 to B.14 is given inthe following order:

  • Application
  • Description of the measuring / testing procedure
  • Instruments used during the procedure
  • Documentation of the procedure

 

Author: 
Harald Martin
CONCEPT HEIDELBERG

 

 

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