Quality Certificate- (P)-PP100

Type : (P)-PP100
Absolute retention rate : 5 µm

- This filter element was completely staged, assembled, tested and packaged in Class 100
clean room facility, whose Quality Management System is approved by an accredited
registering body to the appropriate ISO9000 Quality Systems Standard.

- This filter element shows a retention rate > 5000 (100%) @ 5 µm, obtained from a controlled
laboratory test using latex spheres in deionised water at a flow rate of 7.6 l/m (2 gpm) per
10” element.

- This filter element was manufactured with a Polypropylene filter matrix which meets the
criteria for a “non-fibre” releasing filter as defined in 21 CFR 210.3 (b)(6).

- This filter element has been fabricated without the use of binders, adhesives, additives or
surface-active agents.

- All components meet the EU and USA requirements for Food Contact Use in accordance
with CFR (Code of Federal Regulations) Title 21 and EEC/1935/2004.

- All component materials have been tested and meet the criteria for the USP Class VI
Biological Test for Plastics.

- This filter element is non-toxic per the current USP General Safety Test.

- The cartridge aqueous extraction contains less than 0.5 EU/ml as determined using the
Limulus Amebocyte Lysate (LAL) test.

- The level of extractables of an 10” cartridge after 24 hours in a 70/30% IPA/Water mixture at
20°C was equal to or less than 35mg.

- The typical flow rate of a 10” filter element of this type is equal to or larger than 172 l/min (45
gpm) at 0.1bar (1.45 psi) using deionised water at 25°C.

........……………………………………. ………………………………….
Product Line Manager Process Filtration Head of Quality Department
Dr. P. Schwarz A. Viverit

Haan, 14/04/2008

Donaldson Filtration Deutschland GmbH · Industrial Filtration Solutions · Büssingstraße 1 · D-42781 Haan
Phone +49/2129/569-0 · Fax +49/2129/569-100 · www.donaldson.com