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officially been replaced by a standard of the International Organisation for Standardization (ISO).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
|
