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 cleanroom technology for more than 40 years. This document has now officially been replaced by a standard of the International Organisation for Standardization (ISO). The name of the new document is ISO 14644-1 Cleanrooms and Associated Controlled Environments - Part 1 Classification of air cleanliness.

The Institute of Environmental Sciences and Technology (IEST) acts as office for ISO/TC 209 and has developed this document as the first in a series of 11 documents in order to harmonise the requirements worldwide.

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

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

At the beginning of the 90s, ISO began to establish Guidelines of world-wide validity. In analogy to the VDI (association of German engineers) 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 ISO Guideline cover most of VDI 2083-3, in 2000 the VDI started to revise Sheet 3 of this Guideline. The objective of the revision is to enlarge on those items of which the ISO Guideline does not give as many details as is usual or necessary in the German-speaking countries in a way that they can be put into practice more easily. When the two Guidelines will be available to the users - probably in 2002 - the ISO Guideline shall be applicable in general, whereas for some items the VDI Guideline shall supply further details. The German version of the ISO Guideline is planned to be published as DIN - EN 14644 - 3. However, which test and measuring methods should be used in acceptance tests or requalifications remains in the end an agreement between user and supplier.

Contents - ISO 14644 Part 3 - Metrology and test methods

The ISO Guideline 14644 Part 3 has been published as CD (Committee Draft). Its contents are structured as follows:

 

Foreword and Introduction

 

1

Scope

Represents the field of application

2

Normative references

References to those parts of ISO 14644 that have already been published

3

Terms and definition

Explanation of the terms appearing in the Guideline

4

Testing procedures

 

4.1

Recommended tests

Overview of the recommended tests and measurements

4.2

Purpose of tests

For what purpose 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 the measurement parameters, the testing procedures to be applied and the instruments to be used. It also shows the ISO standards that are to be applied just like in the case of the airborne particle count for classification 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 installation and 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 the recommended test parameters, the related testing procedures and the suitable measurement instruments

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

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

Test activity

Test selec-
ted and sequence

Procedure reference

Instrument selection

Test Inst. selected

Comments

Airborne particle count for classification and test measurement [] B.1 C.1    
Discrete-particle counter    
Airborne particle count for ultrafine particles [] B.2 C.2    
Condensation nucleus counter    
Discrete-particle counter    
Size cut-off device    
Airborne particle count for macroparticles   B.3 C.3   To be tested by outsource contractor
With particle collection   B.3.3.1 Microscopic measurement on collected filter paper    

Table: Extract of the table in Annex A - Choice of recommended tests of an installation 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 various tests and measurements. Apart from this, the recommended procedures are described. The structure of each of the procedures B.1 to B.14 is given in the following order:

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

To all those interested in detailed knowledge of GMP design we recommend:
4-day Education Course
"Pharmaceutical Engineering" in Copenhagen on 9-12 December
(repeated owing to large demand)

Author: 
Harald Martin
CONCEPT HEIDELBERG

 

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK