Medical
Protein binding, Retention of Pyrogenicity Tests

Validation Capacity

Founded in 2007, Cobetter Filtration Validation Center has been approved by the CNAS (China National Accreditation Service for Conformity Assessment) certification. CNAS conducts laboratory tests according to the ISO 17025 system. The review, reports issued by the accredited laboratory are accepted in 58 organizations around the world.


In order to let you have a better understanding of our products of IV filter, we have done Protein binding,Retention of Pyrogenicity tests, the test results are as follows:


Protein Binding Test

Test Results

SpecificationTest objectBSA (μg/cm²)Lysozyme  (μg/cm²)

0.2μm PES 0.2+

P company ELE96LYL

40.86

6.36

G company 0.2+

36.66

2.42

Cobetter 0.2+

38.10

2.30

1.2μm PESP company 1.20.114.77
G company 1.2

0.29

8.12
Cobetter 1.20.151.23


Conclusion: Cobetter's 0.2 +, 1.2 PES membranes show similar or lower protein adsorption rates than competitors.



Retention of Pyrogenicity Test

Test Results

Solution EU/mlTime (h)

P Company
ELE96LYL

G Company
0.2+

Cobetter PES
0.2 +

Challenge Solution
(EU/ml)

0

1

1

1

8

1

1

1

24

1

1

1

48

1

1

1

72

1

1

1

96

1

1

1

Filtrate
(EU/ml)

0

< 0.03

< 0.03

1

8

< 0.03

< 0.03

< 0.03

24

< 0.03

< 0.03

< 0.03

48

< 0.03

< 0.03

< 0.03

72

< 0.03

< 0.03

< 0.03

96

< 0.03

< 0.03

< 0.03

Conclusion

 

Passed

Passed

Passed



Conclusion: Conclusion: under the same comparative test conditions, cobetter 0.2 + PES filter can effectively intercept and adsorb endotoxin in 96h infusion time, which can be claimed to be suitable for 96h products









For technical data sheet or application inquiry, you are more than welcome to contact our sales representative by sales@cobetterfilter.com or leave a message




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