Component Cleanliness Analysis Report
Component Cleanliness Analysis Report
1. Sample details:
2. Extraction
Extraction method: Method of extraction of contaminants by pressure rinsing
Reference documents: ISO 16232-3:2007/ VDA 19.1:2015
I 075.51
PL-KL-03
Extraction liquid: Renoclean ISO
Volume of liquid: 3200 ml for rinsing all 8 parts + 100 ml for rinsing the gloves + 200 ml
for rinsing extraction equipment
Equipment, materials and Pall PCC60 Cleanliness cabinet, including filtration equipment with
measurement vacuum pump;
parameters: Flow rate: 1500 ml/ min;
Nozzle diameter: 3 mm
Date of analysis: 8/20/2019
Blank test: OK, according to blank report no. 64/2019
3. Gravimetric results:
Method: Particle mass determination by gravimetric analysis – industrial systems
Reference documents: ISO 16232-6:2007/ VDA 19.1:2015
I 075.51
PL-KL-03
Equipment, materials Memmert UNB 100 drying oven (30 min, 110°C) + Nalgene Desiccator
and measurement (30 min)
parameters: Kern & Sohn ABT 220-5DNM 5-digit analysis balance (0.01 mg)
Pall Ultipor 66N 5 µm membrane filter, 47 mm diameter;
Date of analysis: 8/20/2019
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KLARWIN TESTING LABORATORY
29 Horei Street, district 2,
Bucharest, Romania
Phone: (+4) 021 313 54 73
Fax: (+4) 021 315 72 64
[email protected], www.klarwin.com
Klarwin is a trademark of Process Engineering SRL
4. Microscopic analysis:
Method: Particle sizing and counting by microscopic analysis
Reference documents: ISO 16232-7:2007; ISO 16232-10:2007;
PL-KL-07/ I 075.51
Equipment, materials Jomesa HDF optical microscope
and measurement Scale: 6 µm/pixel
parameters:
Diameter of effective filtration area: 44 mm
Fiber criterion: length: width ratio>10
Date of analysis: 8/20/2019
Compliance Metallic particles: max. 7 particles between 400 – 600 µm, 0 particles >
specification: 600 µm
Nonmetallic particles: max. 7 particles between 400 – 600 µm, 0 particles
> 600 µm
Results: Particle count data – particles/ reference unit
Particles per filter
Size range, Particles/ part Particles/ 1000 cm2
membrane
µm
Total Metallic Total Metallic Total Metallic
5 – 15 15593 108 1949.1 13.5 15359.5 106.4
15 – 25 9347 530 1168.4 66.3 9207.1 522.1
25 – 50 9312 2256 1164.0 282.0 9172.6 2222.2
50 – 100 6573 3073 821.6 384.1 6474.6 3027.0
100 – 150 1806 973 225.8 121.6 1779.0 958.4
150 – 200 603 379 75.4 47.4 594.0 373.3
200 – 400 360 299 45.0 37.4 354.6 294.5
400 – 600 38 37 4.8 4.6 37.4 36.4
600 – 1000 11 11 1.4 1.4 10.8 10.8
> 1000 6 5 0.8 0.6 5.9 4.9
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KLARWIN TESTING LABORATORY
29 Horei Street, district 2,
Bucharest, Romania
Phone: (+4) 021 313 54 73
Fax: (+4) 021 315 72 64
[email protected], www.klarwin.com
Klarwin is a trademark of Process Engineering SRL
CLEANLINESS
ANALYSIS
REPORT
F-KL-09
Version 3.0
Note 4: This document and the information contained herein are strictly private, confidential and should
not be copied, distributed or reproduced partially without the express permission of the laboratory.
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