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Fraunhofer Institute for Manufacturing
Engineering and Automation IPA
Director
Prof. Dr.-Ing. Fritz Klocke
Prof. Dr.-Ing. Thomas Bauernhansl
Nobelstrasse 12
70569 Stuttgart
Phone +49 711 970-00
Fax +49 711 970-1399
Report No. ME 1811-1085
Stuttgart, Germany, January 28, 2019
Test report
Cleanliness suitability and cleanroom suitability tests at Fraunhofer IPA
Customer: Memmert GmbH + Co. KG
Äußere Rittersbacherstrasse 38
91126 Schwabach
Germany
Project Manager: Dr.-Ing. Frank Bürger
Project Assistants: Dipl.-Ing. Eileen Junghans
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 2 Report No. ME 1811-1085
Index
1 Introduction and objectives 3
2 Overview of the measurements 4
3 Overview of results 6
4 Airborne particle emission tests 7
4.1 General information 7
4.2 Cleanroom environment 8
4.3 Test set-up and parameters 8
4.4 Measuring equipment 11
4.5 Localization tests 11
4.6 Qualification measurements 12
Procedure 12 4.6.1
Test piece TP01: description of the measuring points MP01 to 4.6.2MP09 13
Test piece TP02: description of the measuring points MP10 to 4.6.3MP19 16
Analysis of the results from the airborne particle emission tests 19 4.6.4
Course of particle emissions over time of TP01 19 4.6.5
Course of particle emissions over time of TP02 21 4.6.6
4.7 Classification 24
Statistical verification of the test results 24 4.7.1
Mean and maximum particle emission values and classification of 4.7.2TP01 25
Mean and maximum particle emission values and classification of 4.7.3TP02 28
4.8 Summary of the classification results 33
4.9 Annex: comparison of different classifications of airborne particulate contamination 35
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 3 Report No. ME 1811-1085
1 Introduction and objectives
The Memmert GmbH + Co. KG is a manufacturer of warming cabinets, cooled incubators and tempering baths, which are used in research and development in laboratories. These are manufactured to high standards of quality and successfully implemented in a wide range of industries.
To secure its position in the market, the company wishes to extend the use of its products to the clean applications. For this, it is imperative to understand the contamination behavior of these products, as well as their suitability for use in cleanrooms and with regard to cleanliness.
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 4 Report No. ME 1811-1085
2 Overview of the measurements
Tests were conducted on the constant climate chamber HPP1060 and the universal Oven UF1060 which are henceforth simply called test piece TP01 and TP02 in the report.
The following tables show the exact breakdown of the test pieces:
TP01
Description of test piece Constant climate chamber HPP1060
Description of test piece (short form)
HPP1060
Company name Memmert GmbH + Co. KG
Category Subcategory
Process Equipment Heating and Cooling
Serial number W918.0086
Color Stainless steel
Manufacturing date 9/2018
Test piece data TP01 Figure 1
TP02
Description of test piece Universal Oven UF1060
Description of test piece (short form)
UF1060
Company name Memmert GmbH + Co. KG
Category Subcategory
Process Equipment Heating and Cooling
Serial number B918.0087
Color Stainless steel
Manufacturing date 9/2018
Test piece data TP02 Figure 2
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 5 Report No. ME 1811-1085
The following table shows the corresponding tests carried out on all test pieces:
P
art
icle
em
issi
on
ESD
beh
av
ior
Ou
tgass
ing
Ch
em
ical re
sist
an
ce
Cle
an
ab
ilit
y (
part
icle
s)
H2O
2
ab
sorp
tio
n/d
eso
rpti
on
Bio
log
ica
l re
sist
an
ce
Su
rfa
ce r
ou
gh
ne
ss
Exp
ert
ise
TP01 X
TP02 X
Table of test pieces and corresponding tests Figure 3
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 6 Report No. ME 1811-1085
3 Overview of results
TP01: Particle emission (ISO 14644-1, -14)
Test parameter(s) Air Cleanliness Class
Outside: T = 50° C; humidity = 10 % 5
Inside: T = 50° C; humidity = 10 % 5
Overall result 5
TP02: Particle emission (ISO 14644-1, -14)
Test parameter(s) Air Cleanliness Class
Outside: T = 300° C; flap = open; fan = 100 % 6
Inside: T = 300° C; flap = open; fan = 100 % 6
Inside: T = 300° C; flap = open; fan = 0 % 6
Overall result 6
Overview of results Figure 4
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 7 Report No. ME 1811-1085
4 Airborne particle emission tests
4.1 General information
A major criterion in clean and hygienic areas in industry and research is the concentration of airborne particles. Besides the quantity of particles per unit of volume of air, the size distribution of the particles is also critical when it comes to fulfilling cleanliness requirements.
Cleanliness requirements are set against the release of particles from the operating utilities used in clean or hygienic areas. The cause of particle emissions from operating utilities is generally tribological stress, which leads to wear and the generation and release of particles.
To determine the release of particles from operating utilities, particle emission measurements can be conducted in a test cleanroom with a low-turbulence displacement airflow following the procedure laid down in ISO 14644-14. The results enable the suitability of operating utilities to be determined for use in discrete air cleanliness classes according to ISO 14644-1. The VDI 2083 series uses the term cleanroom suitability to describe the suitability of operating utilities for discrete air cleanliness classes. Cleanroom suitability is one aspect of cleanliness suitability, which also includes all other cleanliness criteria relevant to a process. Apart from the release of particles, other cleanliness suitability criteria are, for example, chemical resistance, biological resistance, microbicidity and outgassing from materials, as well as the cleanability and hygienic design of components or equipment.
In the case of operating utilities such as manufacturing equipment, particle emission measurements serve not only to determine the influence of these systems on the environment (protection of the cleanroom) but also on the interior of the equipment itself (protection of the product).
By conducting localized particle emission measurements with optical particle counters in a test cleanroom with a low-turbulence displacement airflow, the cause of high particle emissions can be derived from the results obtained from the various measuring points.
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 8 Report No. ME 1811-1085
4.2 Cleanroom environment
All tests are carried out in the Fraunhofer IPA competence center for ultraclean technology and micromanufacturing. Measurements are performed in a cleanroom fulfilling Class 1 specifications (in accordance with ISO 14644-1). A vertical low-turbulence displacement airflow prevails in the cleanroom. Air is introduced via the ceiling and extracted via a raised floor. The velocity of the flow of first air (filtered air introduced into the cleanroom) is 0.45 m/s. Environmental conditions in the cleanroom are kept constant with a room temperature of 22 °C ± 0.5 °C and a relative humidity of 45 % ± 5 %.
According to ISO 14644-1, Cleanroom Class 1 means that only ten particles the size of 0.1 µm may be found a reference volume of one cubic meter. In practical operation, even fewer particles are found in this cleanroom class.
4.3 Test set-up and parameters
Test set-up Memmert GmbH + Co. KG supplied Fraunhofer IPA with the test pieces. The test pieces were suitable for continuous, maintenance-free operation.
On delivery, the test pieces were introduced into the cleanroom at the Fraunhofer IPA in Stuttgart. They were then assembled and put into operation (complete with all the functional components required for its assembly and operation) by the customer.
Transfer of the test pieces into the cleanroom The test pieces were brought into the cleanroom. In doing so, all surfaces and other functional elements were first wiped clean with low particle emission cleanroom cloths soaked in a mixture of isopropanol and DI-water and then dried with a jet of ionizing purified compressed air.
Pre-conditioning the test pieces The test pieces were first operated in the reference cleanroom with a typical average load for a period of 24 hours while exposed to a flow of clean first air. In this way, the raised quantity of particles emitted during the running-in phase, which is not representative as far as later operation is concerned, is not included in the assessment.
Test parameters To determine particle emissions from the test pieces, they were operated using the parameters specified below.
The operating parameters selected for the test pieces were arranged with the customer before the start of the project:
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 9 Report No. ME 1811-1085
TP01:
Temperature: .........................................................................................50° C
Humidity: .............................................................................................. 10 %
TP02:
Outside
Temperature: ....................................................................................... 300° C
Flap: .......................................................................................................open
Fan: ..................................................................................................... 100 %
Inside Parameter Set 1
Temperature: ....................................................................................... 300° C
Flap: .......................................................................................................open
Fan: ..................................................................................................... 100 %
Inside Parameter Set 2
Temperature: ....................................................................................... 300° C
Flap: .......................................................................................................open
Fan: ......................................................................................................... 0 %
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 10 Report No. ME 1811-1085
Overview of the test set-up and test piece
Overview of the test set-up and test piece TP01 Figure 5
Overview of the test set-up and test piece TP02 Figure 6
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 11 Report No. ME 1811-1085
4.4 Measuring equipment
In the tests to determine particle emissions, the following type of laser particle measuring device was used.
Type LasAir II 110 / LasAir III 110 from PMS with the measuring ranges of
0.1 µm, 0.2 µm, 0.3 µm, 0.5 µm, 1.0 µm and 5.0 µm.
Optical particle counters function according to the principle of scattered light. Via a sampling probe, a defined volume of air of 1 cubic foot (1 cft = 28.3 liters) is sucked in every minute and guided into a measuring chamber via a tube connected to it. The air sucked in is illuminated by a light source - in modern devices either a laser or laser diode. As soon as a particle carried by the airflow is struck by the beam of light, light is scattered and recorded by photo-detectors.
The number of impulses recorded corresponds with the number of particles present in the volume of air. The amplitude of the impulses indicates the particle size.
4.5 Localization tests
To select the measuring points for the subsequent qualification tests, separate localization tests were performed for each set of parameters.
Critical contamination sites (these are generally areas subjected to tribological stress, such as bearings slits) were systematically investigated for particle emissions, taking into consideration the motion sequences planned. The surface of the test piece was also visually assessed. By comparing the values obtained, sites could be identified where especially high levels of particulate emission were generated during motion sequences. A particle measuring probe was carefully positioned at these sites to detect the maximum number of particles being emitted from the test object.
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 12 Report No. ME 1811-1085
4.6 Qualification measurements
Procedure 4.6.1
The qualification tests were performed according to ISO 14644-14.
Measuring probes were placed at each of the critical sites identified (= measuring points). At each measuring point, particle emission measurements were recorded with measuring intervals of 1/min over a period of 100 minutes. To better compare results, up to 9 particle counters were used in parallel at up to 9 different measuring points for each test series to record particle emission values.
The measurement volume is sucked in at a rate of 1 cft/min. Particle measurements are shown cumulatively for each particle size channel, i.e. the figure shown for a particle size channel refers to all particles equal to or larger
than the particle size channel stated ( 0.1 µm, 0.2 µm, 0.3 µm, 0.5 µm, 1.0 µm or 5.0 µm).
The selected time of 100 minutes ensures adequate statistical certainty of the test results and safeguards against faulty measurements. Each measurement value contains information about the particle size, the quantity of particles generated and the site where the particles were emitted.
The results were analyzed statistically conform to the procedure described in the guideline ISO 14644-14, thus enabling the suitability of the operating utility for use in cleanrooms classified according to ISO 14644-1 to be determined.
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 13 Report No. ME 1811-1085
Test piece TP01: description of the measuring points MP01 to MP09 4.6.2
Outside
The following photographs show the exact points selected to measure airborne particles emitted from the test piece.
MP02
MP08
MP07
MP06
MP05
MP02 MP01 MP04
MP01
MP03
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 14 Report No. ME 1811-1085
MP03
MP06 MP05
MP04
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 15 Report No. ME 1811-1085
Measuring points MP01 to MP08 selected to measure airborne particle emissions from TP01 Figure 7
Inside
The following photographs show the exact point selected to measure airborne particles emitted from the test piece.
Measuring point MP09 selected to measure airborne particle emissions from TP01 Figure 8
MP09
MP08 MP07
MP09
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 16 Report No. ME 1811-1085
Test piece TP02: description of the measuring points MP10 to MP19 4.6.3
Outside
The following photographs show the exact points selected to measure airborne particles emitted from the test piece.
MP11 MP10
MP18 MP17
MP16
MP15
MP14 MP13 MP12
MP11 MP10
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 17 Report No. ME 1811-1085
Measuring points MP10 to MP18 selected to measure airborne particle emissions from TP02 Figure 9
MP18 MP15
MP14 MP13
MP12
MP17 MP16
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 18 Report No. ME 1811-1085
Inside
The following photographs show the exact point selected to measure airborne particles emitted from the test piece.
Measuring point MP19 selected to measure airborne particle emissions from TP02 Figure 10
MP19
MP19
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 19 Report No. ME 1811-1085
Analysis of the results from the airborne particle emission tests 4.6.4
The emission tests mentioned in Chapter 4.6.1 were analyzed according to ISO 14644-14. This included:
The course of particle emissions at each measuring point over time
Classification of the various measuring points according to ISO 14644-1 with
mean and maximum particle emission values
Course of particle emissions over time of TP01 4.6.5
The following diagrams show the course of particle emissions at each of the measuring points, as well as for the stated particle size channels, over the total testing time required by the qualification test. The measuring interval of 1 min was the same for all tests. This equates to a test volume of cubic foot (cft).
Outside 4.6.5.1
Occurrence of contamination over time:
Course of the emission of airborne particles 0.1 µm over time from the test piece at measuring points MP01 Figure 11to MP04 over the period of 100 minutes
0
20
40
60
80
100
120
140
160
0 10 20 30 40 50 60 70 80 90 100
Part
ike
l ≥
0,1
µm
pro
min
Messzeit [min]
Memmert GmbH + Co. KGConstant climate chamber HPP1060
OutsideMesspunkte MP01 bis MP04
Messpunkt MP01 Messpunkt MP02 Messpunkt MP03 Messpunkt MP04
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 20 Report No. ME 1811-1085
Course of the emission of airborne particles 0.1 µm over time from the test piece at measuring points MP05 Figure 12to MP08 over the period of 100 minutes
Inside 4.6.5.2
Occurrence of contamination over time:
Course of the emission of airborne particles 0.1 µm over time from the test piece at measuring point MP09 Figure 13over the period of 100 minutes
0
100
200
300
400
500
600
700
0 10 20 30 40 50 60 70 80 90 100
Part
icle
s ≥
0.1
µm
pe
r m
in
Measuring time [min]
Memmert GmbH + Co. KGConstant climate chamber HPP1060
OutsideMeasuring Points MP05 to MP08
Measuring Point MP05 Measuring Point MP06 Measuring Point MP07 Measuring Point MP08
0
10
20
30
40
50
60
70
80
90
0 10 20 30 40 50 60 70 80 90 100
Part
icle
s ≥
0.1
µm
pe
r m
in
Measuring time [min]
Memmert GmbH + Co. KGConstant climate chamber HPP1060
InsideMeasuring Point MP09
Measuring Point MP09
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 21 Report No. ME 1811-1085
Course of particle emissions over time of TP02 4.6.6
The following diagrams show the course of particle emissions at each of the measuring points, as well as for the stated particle size channels, over the total testing time required by the qualification test. The measuring interval of 1 min was the same for all tests. This equates to a test volume of cubic foot (cft).
Outside 4.6.6.1
Occurrence of contamination over time:
Course of the emission of airborne particles 0.1 µm over time from the test piece at measuring points MP10 Figure 14to MP12 over the period of 100 minutes
0
200000
400000
600000
800000
1000000
1200000
1400000
1600000
1800000
0 10 20 30 40 50 60 70 80 90 100
Part
icle
s ≥
0.1
µm
pe
r m
in
Measuring time [min]
Memmert GmbH + Co. KGUniversal Oven UF1060
OutsideMeasuring Points MP10 to MP12
Measuring Point MP10 Measuring Point MP11 Measuring Point MP12
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 22 Report No. ME 1811-1085
Course of the emission of airborne particles 0.1 µm over time from the test piece at measuring points MP13 Figure 15to MP16 over the period of 100 minutes
Course of the emission of airborne particles 0.1 µm over time from the test piece at measuring points MP17 Figure 16and MP18 over the period of 100 minutes
0
500000
1000000
1500000
2000000
2500000
3000000
3500000
4000000
4500000
5000000
0 10 20 30 40 50 60 70 80 90 100
Part
icle
s ≥
0.1
µm
pe
r m
in
Measuring time [min]
Memmert GmbH + Co. KG Universal Oven UF1060
OutsideMeasuring Points MP13 to MP16
Measuring Point MP13 Measuring Point MP14 Measuring Point MP15 Measuring Point MP16
0
500000
1000000
1500000
2000000
2500000
3000000
3500000
4000000
0 10 20 30 40 50 60 70 80 90 100
Part
icle
s ≥
0.1
µm
pe
r m
in
Measuring time [min]
Memmert GmbH + Co. KGUniversal Oven UF1060
OutsideMeasuring Points MP17 and MP18
Measuring Point MP17 Measuring Point MP18
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 23 Report No. ME 1811-1085
Inside: Parameter Set 1 4.6.6.2
Occurrence of contamination over time:
Course of the emission of airborne particles 0.1 µm over time from the test piece at measuring point MP19 Figure 17over the period of 100 minutes
Inside: Parameter Set 2 4.6.6.3
Occurrence of contamination over time:
Course of the emission of airborne particles 0.1 µm over time from the test piece at measuring point MP19 Figure 18over the period of 100 minutes
0
50000
100000
150000
200000
250000
300000
350000
400000
0 10 20 30 40 50 60 70 80 90 100
Part
icle
s ≥
0.1
µm
pe
r m
in
Measuring time [min]
Memmert GmbH + Co. KGUniversal Oven UF1060Inside - Parameter Set 1Measuring Point MP19
Measuring Point MP19
0
5000
10000
15000
20000
25000
0 10 20 30 40 50 60 70 80 90 100
Part
icle
s ≥
0.1
µm
pe
r m
in
Measuring time [min]
Memmert GmbH + Co. KGUniversal Oven UF1060Inside - Parameter Set 2Measuring Point MP19
Measuring Point MP19
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 24 Report No. ME 1811-1085
4.7 Classification
The aim of the tests was to ascertain to what extent the test piece may be operated in clean environments. For this, based on the procedure described in the guideline “Assessment of suitability for use of equipment by airborne particle concentration ISO 14644-14”, the empirically-calculated measurement values were analyzed statistically and assessed according to the class limits stated in ISO 14644-1.
Statistical verification of the test results 4.7.1
International standards defining air cleanliness, such as ISO 14644-1, state limit values for the air cleanliness classes that are defined in the respective norm. These limit values are set for a specific number of particle size channels (e.g.
0.1 µm, 0.2 µm, 0.3 µm, 0.5 µm, 1.0 µm and 5.0 µm). When comparing empirically-derived values (e.g. from a qualification test) with such limit values, a certain degree of certainty is required by which the limit value may not be exceeded.
When classifying operating utilities, the standard deviation and mean values are calculated from the measurement values obtained. ISO 14644-14 describes a method which correlates these values with the limit values stated in ISO 14644-1. If a test piece is declared suitable for different classes, the assessment of the test piece is based on the highest class (worst-case assumption).
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 25 Report No. ME 1811-1085
Mean and maximum particle emission values and classification of TP01 4.7.2
The following tables show the respective maximum values and arithmetical mean values of particle emissions recorded at the corresponding measuring points (MP) over the total testing time of 100 minutes. The applicable air cleanliness class according to ISO 14644-1 for each measuring point is highlighted.
Outside 4.7.2.1
Statistical characteristics of the measuring points MP01 to MP04 Figure 19
MP01 MP02 MP03 MP04
0.1 µm 0,1 0,8 45,2 0,0
0.2 µm 0,0 0,4 30,8 0,0
0.3 µm 0,0 0,3 26,3 0,0
0.5 µm 0,0 0,1 16,4 0,0
1.0 µm 0,0 0,0 4,5 0,0
5.0 µm 0,0 0,0 0,0 0,0
0.1 µm 0,4 1,0 17,9 0,1
0.2 µm 0,0 0,7 12,3 0,0
0.3 µm 0,0 0,7 11,8 0,0
0.5 µm 0,0 0,4 8,9 0,0
1.0 µm 0,0 0,1 3,2 0,0
5.0 µm 0,0 0,0 0,1 0,0
2 4 5 1
0.1 µm 3 5 137 1
0.2 µm 0 3 60 0
0.3 µm 0 3 56 0
0.5 µm 0 2 42 0
1.0 µm 0 1 14 0
5.0 µm 0 0 1 0
0.1 µm 0 0 21 0
0.2 µm 0 0 14 0
0.3 µm 0 0 9 0
0.5 µm 0 0 5 0
1.0 µm 0 0 0 0
5.0 µm 0 0 0 0
Maximum value
for the detection size
[particles / cft]
Minimum value
for the detection size
[particles / cft]
Memmert GmbH + Co. KG
Constant climate chamber HPP1060
Outside
Measuring Points MP01 to MP04
Statistical parametersMeasuring Point
Mean value
for the detection size
[particles / cft]
Standard deviation
for the detection size
[particles / cft]
Air Cleanliness Class [ISO 14644-1]
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 26 Report No. ME 1811-1085
Statistical characteristics of the measuring points MP05 to MP08 Figure 20
From the respective calculations for the detection sizes 0.1 µm, 0.2 µm, 0.3 µm, 0.5 µm, 1.0 µm and 5.0 µm, it can be derived that the test piece is suitable for use in ISO Class 5 cleanrooms according to ISO 14644-1.
MP05 MP06 MP07 MP08
0.1 µm 36.7 5.5 288.8 41.8
0.2 µm 14.5 3.1 101.8 15.4
0.3 µm 5.0 2.3 27.5 8.0
0.5 µm 1.6 1.4 6.1 3.6
1.0 µm 0.5 0.4 1.8 1.0
5.0 µm 0.0 0.0 0.0 0.0
0.1 µm 35.7 3.4 237.9 30.0
0.2 µm 14.2 1.9 80.2 12.1
0.3 µm 5.3 1.5 17.4 7.7
0.5 µm 2.1 1.2 2.9 4.4
1.0 µm 0.9 0.6 1.5 2.2
5.0 µm 0.0 0.0 0.0 0.1
4 4 5 5
0.1 µm 99 19 631 148
0.2 µm 40 10 240 89
0.3 µm 18 7 66 73
0.5 µm 9 6 13 43
1.0 µm 5 3 7 21
5.0 µm 0 0 0 1
0.1 µm 0 0 7 4
0.2 µm 0 0 5 1
0.3 µm 0 0 4 0
0.5 µm 0 0 1 0
1.0 µm 0 0 0 0
5.0 µm 0 0 0 0
Maximum value
for the detection size
[particles / cft]
Minimum value
for the detection size
[particles / cft]
Memmert GmbH + Co. KG
Constant climate chamber HPP1060
Outside
Measuring Points MP05 to MP08
Statistical parametersMeasuring Point
Mean value
for the detection size
[particles / cft]
Standard deviation
for the detection size
[particles / cft]
Air Cleanliness Class [ISO 14644-1]
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 27 Report No. ME 1811-1085
Inside 4.7.2.2
Statistical characteristics of the measuring point MP09 Figure 21
From the respective calculations for the detection sizes 0.1 µm, 0.2 µm, 0.3 µm, 0.5 µm, 1.0 µm and 5.0 µm, it can be derived that the test piece is suitable for use in ISO Class 5 cleanrooms according to ISO 14644-1.
Measuring PointMP09
0.1 µm 56,3
0.2 µm 34,6
0.3 µm 27,1
0.5 µm 12,5
1.0 µm 2,0
5.0 µm 0,0
0.1 µm 13,0
0.2 µm 7,4
0.3 µm 6,2
0.5 µm 4,1
1.0 µm 1,6
5.0 µm 0,0
5
0.1 µm 84
0.2 µm 55
0.3 µm 40
0.5 µm 21
1.0 µm 8
5.0 µm 0
0.1 µm 28
0.2 µm 15
0.3 µm 12
0.5 µm 4
1.0 µm 0
5.0 µm 0
Maximum value
for the detection size
[particles / cft]
Minimum value
for the detection size
[particles / cft]
Memmert GmbH + Co. KG
Constant climate chamber HPP1060
Inside
Measuring Point MP09
Statistical parameters
Mean value
for the detection size
[particles / cft]
Standard deviation
for the detection size
[particles / cft]
Air Cleanliness Class [ISO 14644-1]
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 28 Report No. ME 1811-1085
Mean and maximum particle emission values and classification of TP02 4.7.3
The following tables show the respective maximum values and arithmetical mean values of particle emissions recorded at the corresponding measuring points (MP) over the total testing time of 100 minutes. The applicable air cleanliness class according to ISO 14644-1 for each measuring point is highlighted.
Outside 4.7.3.1
Statistical characteristics of the measuring points MP10 to MP12 Figure 22
MP10 MP11 MP12
0.1 µm 1140281,6 701000,4 729227,3
0.2 µm 24325,6 22389,4 23059,8
0.3 µm 615,3 478,1 522,9
0.5 µm 6,9 1,7 2,2
1.0 µm 2,4 0,6 0,7
5.0 µm 0,1 0,0 0,0
0.1 µm 176442,2 193234,3 206272,3
0.2 µm 7322,9 6929,3 7620,5
0.3 µm 283,5 238,1 273,4
0.5 µm 5,9 1,4 1,6
1.0 µm 2,5 1,0 0,8
5.0 µm 0,3 0,0 0,1
6 6 6
0.1 µm 1644537 1168431 1179773
0.2 µm 50339 47663 50962
0.3 µm 1706 1407 1521
0.5 µm 38 7 7
1.0 µm 17 6 3
5.0 µm 2 0 1
0.1 µm 762477 145659 168005
0.2 µm 6304 4132 4981
0.3 µm 213 94 120
0.5 µm 0 0 0
1.0 µm 0 0 0
5.0 µm 0 0 0
Maximum value
for the detection size
[particles / cft]
Minimum value
for the detection size
[particles / cft]
Memmert GmbH + Co. KG
Universal Oven UF1060
Outside
Measuring Points MP10 to MP12
Statistical parametersMeasuring Point
Mean value
for the detection size
[particles / cft]
Standard deviation
for the detection size
[particles / cft]
Air Cleanliness Class [ISO 14644-1]
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 29 Report No. ME 1811-1085
Statistical characteristics of the measuring points MP13 to MP16 Figure 23
MP13 MP14 MP15 MP16
0.1 µm 3654759,7 2270022,9 2521813,3 2539319,5
0.2 µm 137578,9 84822,2 210076,2 146063,3
0.3 µm 5274,7 2736,8 5124,0 3672,9
0.5 µm 8,0 6,5 23,3 9,8
1.0 µm 1,7 1,5 6,3 1,6
5.0 µm 0,1 0,1 0,2 0,1
0.1 µm 291722,2 311028,3 387177,4 278084,1
0.2 µm 57014,0 35660,7 55735,2 57587,8
0.3 µm 3359,7 1785,0 2661,1 2433,5
0.5 µm 3,9 2,7 10,0 4,1
1.0 µm 1,6 1,4 3,8 1,8
5.0 µm 0,3 0,3 0,4 0,3
5 5 5 5
0.1 µm 4333045 3063254 3682757 3245531
0.2 µm 342433 220982 371127 372329
0.3 µm 15881 9206 14532 12250
0.5 µm 27 13 59 30
1.0 µm 8 6 23 11
5.0 µm 2 2 2 2
0.1 µm 2848188 1486632 1816745 1835586
0.2 µm 59065 35137 110059 63258
0.3 µm 1292 619 1692 768
0.5 µm 2 1 9 3
1.0 µm 0 0 0 0
5.0 µm 0 0 0 0
Maximum value
for the detection size
[particles / cft]
Minimum value
for the detection size
[particles / cft]
Memmert GmbH + Co. KG
Universal Oven UF1060
Outside
Measuring Points MP13 to MP16
Statistical parametersMeasuring Point
Mean value
for the detection size
[particles / cft]
Standard deviation
for the detection size
[particles / cft]
Air Cleanliness Class [ISO 14644-1]
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 30 Report No. ME 1811-1085
Statistical characteristics of the measuring points MP17 and MP18 Figure 24
From the respective calculations for the detection sizes 0.1 µm, 0.2 µm,
0.3 µm, 0.5 µm, 1.0 µm and 5.0 µm, it can be derived that the test piece is suitable for use in ISO Class 6 cleanrooms according to ISO 14644-1.
MP17 MP18
0.1 µm 2220777,6 2020629,7
0.2 µm 128841,2 95005,7
0.3 µm 1125,9 390,6
0.5 µm 139,5 31,0
1.0 µm 49,1 11,3
5.0 µm 1,8 0,2
0.1 µm 358518,1 676581,7
0.2 µm 32870,2 30094,7
0.3 µm 307,1 153,1
0.5 µm 43,0 11,7
1.0 µm 19,1 5,5
5.0 µm 1,5 0,5
6 6
0.1 µm 3097062 3389622
0.2 µm 211405 190805
0.3 µm 1969 1068
0.5 µm 356 71
1.0 µm 135 30
5.0 µm 7 2
0.1 µm 1582323 684823
0.2 µm 58834 40857
0.3 µm 610 164
0.5 µm 71 10
1.0 µm 23 3
5.0 µm 0 0
Maximum value
for the detection size
[particles / cft]
Minimum value
for the detection size
[particles / cft]
Memmert GmbH + Co. KG
Universal Oven UF1060
Outside
Measuring Points MP17 and MP18
Statistical parametersMeasuring Point
Mean value
for the detection size
[particles / cft]
Standard deviation
for the detection size
[particles / cft]
Air Cleanliness Class [ISO 14644-1]
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 31 Report No. ME 1811-1085
Inside: Parameter Set 1 4.7.3.2
Statistical characteristics of the measuring point MP19 Figure 25
From the respective calculations for the detection sizes 0.1 µm, 0.2 µm, 0.3 µm, 0.5 µm, 1.0 µm and 5.0 µm, it can be derived that the test piece is suitable for use in ISO Class 6 cleanrooms according to ISO 14644-1.
Measuring PointMP19
0.1 µm 160206,6
0.2 µm 1061,8
0.3 µm 15,5
0.5 µm 2,0
1.0 µm 0,4
5.0 µm 0,0
0.1 µm 89848,2
0.2 µm 581,7
0.3 µm 5,5
0.5 µm 1,7
1.0 µm 0,7
5.0 µm 0,1
6
0.1 µm 361057
0.2 µm 2901
0.3 µm 30
0.5 µm 10
1.0 µm 4
5.0 µm 1
0.1 µm 10034
0.2 µm 64
0.3 µm 5
0.5 µm 0
1.0 µm 0
5.0 µm 0
Maximum value
for the detection size
[particles / cft]
Minimum value
for the detection size
[particles / cft]
Memmert GmbH + Co. KG
Universal Oven UF1060
Inside - Parameter Set 1
Measuring Point MP19
Statistical parameters
Mean value
for the detection size
[particles / cft]
Standard deviation
for the detection size
[particles / cft]
Air Cleanliness Class [ISO 14644-1]
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 32 Report No. ME 1811-1085
Inside: Parameter Set 2 4.7.3.3
Statistical characteristics of the measuring point MP19 Figure 26
From the respective calculations for the detection sizes 0.1 µm, 0.2 µm, 0.3 µm, 0.5 µm, 1.0 µm and 5.0 µm, it can be derived that the test piece is suitable for use in ISO Class 6 cleanrooms according to ISO 14644-1.
Measuring PointMP19
0.1 µm 17914,2
0.2 µm 1,3
0.3 µm 0,0
0.5 µm 0,0
1.0 µm 0,0
5.0 µm 0,0
0.1 µm 1641,1
0.2 µm 1,2
0.3 µm 0,0
0.5 µm 0,0
1.0 µm 0,0
5.0 µm 0,0
6
0.1 µm 22323
0.2 µm 5
0.3 µm 0
0.5 µm 0
1.0 µm 0
5.0 µm 0
0.1 µm 14705
0.2 µm 0
0.3 µm 0
0.5 µm 0
1.0 µm 0
5.0 µm 0
Maximum value
for the detection size
[particles / cft]
Minimum value
for the detection size
[particles / cft]
Memmert GmbH + Co. KG
Universal Oven UF1060
Inside - Parameter Set 2
Measuring Point MP19
Statistical parameters
Mean value
for the detection size
[particles / cft]
Standard deviation
for the detection size
[particles / cft]
Air Cleanliness Class [ISO 14644-1]
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 33 Report No. ME 1811-1085
4.8 Summary of the classification results
TP01
The following table gives an overview of the classification of the various measuring points MP01 to MP09:
Constant climate chamber HPP1060 manufactured by Memmert GmbH + Co. KG
Outside
Measuring Point MP01 MP02 MP03 MP04
Air Cleanliness Class (according to ISO 14644-1)
2 4 5 1
Measuring Point MP05 MP06 MP07 MP08
Air Cleanliness Class (according to ISO 14644-1)
4 4 5 5
Inside
Measuring Point MP09 -- -- --
Air Cleanliness Class (according to ISO 14644-1)
5 -- -- --
Overall classification of the constant climate chamber HPP1060 Figure 27
From the calculations of the probability of exceeding limiting values for the
detection sizes 0.1 µm, 0.2 µm, 0.3 µm, 0.5 µm, 1.0 µm and 5.0 µm, it can be derived that the constant climate chamber HPP1060 manufactured by Memmert GmbH + Co. KG is suitable for use in cleanrooms fulfilling the specifications of ISO Class 5 in accordance with ISO 14644-1 when operated with the specified parameters.
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 34 Report No. ME 1811-1085
TP02
The following table gives an overview of the classification of the various measuring points MP10 to MP19:
Universal Oven UF1060 manufactured by Memmert GmbH + Co. KG
Outside
Measuring Point MP10 MP11 MP12 MP13 MP14
Air Cleanliness Class (according to ISO 14644-1)
6 6 6 5 5
Measuring Point MP15 MP16 MP17 MP18 --
Air Cleanliness Class (according to ISO 14644-1)
5 5 6 6 --
Inside: Parameter Set 1
Measuring Point MP19 -- -- -- --
Air Cleanliness Class (according to ISO 14644-1)
6 -- -- -- --
Inside: Parameter Set 2
Measuring Point MP19 -- -- -- --
Air Cleanliness Class (according to ISO 14644-1)
6 -- -- -- --
Overall classification of the Universal Oven UF1060 Figure 28
From the calculations of the probability of exceeding limiting values for the
detection sizes 0.1 µm, 0.2 µm, 0.3 µm, 0.5 µm, 1.0 µm and 5.0 µm, it can be derived that the Universal Oven UF1060 manufactured by Memmert GmbH + Co. KG is suitable for use in cleanrooms fulfilling the specifications of ISO Class 6 in accordance with ISO 14644-1 when operated with the specified parameters.
Cleanliness suitability and cleanroom suitability tests Fraunhofer IPA 35 Report No. ME 1811-1085
4.9 Annex: comparison of different classifications of airborne particulate
contamination
In the following table, the limit values defining air cleanliness classes according to the international standard ISO 14644-1 are compared with the limit values stated in EG GMP Guideline Volume 4 Annex 1 and in the American norm US Federal Standard 209E (retracted). The comparison concerns the particle size channels stated explicitly in ISO 14644-1; limit values are stated for the reference volumes of 1 m3 and 1 cft (1 cubic foot = 0.0283 m3).
Overview of limit values for airborne particles per m³ or cft for the standards ISO 14644-1, Figure 29
EU GMP Guideline Volume 4, Annex 1 and US Federal Standard 209E (retracted)
Although limit values are stated for tests on biotic airborne particles in EU GMP Guideline Volume 4, Annex 1, this does not form part of the qualification tests conducted at Fraunhofer IPA. Since all manufacturing environments have their own individual germ spectrum, these tests cannot be conducted in a reference laboratory and therefore need to be performed in the respective manufacturing environment. The individual germ spectrum and magnitude of microbial loads are decisively influenced by the production processes, the environment and operating staff in the relevant production areas.
1 10 0,3
2 100 3 24 1 10 0,3
3 1,000 30 237 7 102 3 35 1
1 1,240 35 265 8 106 3 35 1
4 10,000 300 2,370 67 1,020 29 352 9,9 83 2
10 12,000 340 2,650 75 1,060 29 353 10
5 100,000 2,833 23,700 671 10,200 289 3,520 100 832 24
A 3,520 100 20 0,6
A 3,520 100 20 0,6
B 3,520 100 29 0,8
100 26,500 750 10,600 300 3,530 100
6 1,000,000 28,329 237,000 6,710 102,000 2,890 35,200 997 8,320 235 293 8
1,000 35,300 1,000 247 7
7 352,000 9,972 83,200 2,357 2,930 83
B 352,000 9,972 2,900 82
C 352,000 9,972 2,900 82
10,000 353,000 10,000 2,470 70
8 3,520,000 99,716 832,000 23,569 29,300 830
C 3,520,000 99,716 29,000 821
D 3,520,000 99,716 29,000 821
100,000 3,530,000 100,000 24,700 700
9 35,200,000 997,167 8,320,000 235,694 293,000 8,300
per
[m³]
per
[cbf]
per
[m³]
per
[cbf]
per
[m³]
per
[cbf]
per
[m³]
per
[cbf]
US Fed.
Standard
209E*
DIN EN
ISO
14644-1 per
[m³]
per
[cbf]
per
[m³]
per
[cbf]
Regulatory
0.2 μm 0.5 μm 1.0 μm 5.0 μm
Limiting values of each Air Cleanliness Class for differing particle sizes and reference volumes
(acc. to ISO 14644-1)
0.1 μm 0.3 μmEG-GMP
"in
operation"
EG-GMP
"at
rest"