Porvair Filtration Group Limited

1 Concorde Close, Fareham

Hampshire, PO 15 5RT
UK

Certificate of Analysis/Conformance
Cartridge Filter: PES Pleated Filter Cartridge
Pore Size: 0.22+0.22µm
Catalogue Number: DPS10-DDT-2222
Lot Number: DAA69140228

Materials of Construction
Filter media: Polyethersulfone Membrane
Supports/Drainage: Polypropylene
Core/Cage/End Caps: Polypropylene
End Caps Insert: PBT
Sealing Technology: Weld (No Adhesives)
Seal Material: Silicone

ISO 9001 Quality Standard

This product was manufactured in Porvair facility for which Quality Management System is approved by an accredited registering body to the appropriate
ISO9001-2008 Quality Systems Standard. Each membrane filter element was manufactured in a clean room with controlled environment.

Integrity Test Values

Each membrane filter element has been individually tested for integrity by means of the corresponding validation guide. The bubble point of the
membrane filter has been validated for bacterial removal by correlating the above parameter with microbiological challenge test following HIMA
methodology.
For this element, the bubble point measured: ≥0.34MPa in Water
The diffusion is measured: ≤15ml/min in Water (2750mbar)

Bacterial Endotoxins
A cartridge aqueous extraction contains less than 0.25EU/ml, met with adequate safety margin the current USP requirements as determined using the
limulus amebocyte lysate (LAL) test.

Component Materials Toxicity

Component material were tested and meet the criteria for the USP class IV biological test for plastics.

USP Oxidizable Substances

Effluent was negative after a water flush of 2000ml per autoclaved 20-inch cartridge.

Gravimetric Extractable
The extractable level was equal to or less than 20mg per 10-inch cartridge after 24 hours in ASTM type 1 reagent-grade water at controlled room
temperature.

In addition to the above tests, this product has also met all other manufacturing standards required for this product.
This filter is not supplied sterile.
The quality criterion# Q/CBT 001-2013

Jeff Kirby Digitally Signed

Quality Assurance Manager Date: 2013-11-28 09:23:45