Millidisk Barrier Filter

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Millidisk Barrier Filter

Description
The Millidisk Barrier Filter was developed to facilitate in-line post steam-in-place (SIP), pre-use integrity testing of single and/or redundant liquid filter systems. The unique combination of hydrophilic and hydrophobic sterilizing grade Durapore membrane in one filter unit allows for steam penetration, condensate removal, filter drying, filter wetting and filter integrity testing without compromising the sterility of the steam sterilized or autoclaved system.

Regulatory authorities in Europe have introduced new guidance with respect to filter integrity testing, specifically regarding post SIP, pre-use testing of sterilizing grade liquid filters. The European GMP directive of 1997 for human and veterinary medicinal products, annex 1, point 85 states: "The integrity of the sterilized filter should be verified before use and should be confirmed immediately after use by an appropriate method such as bubble point, diffusive flow or pressure hold test." The Millidisk Barrier Filter is the best choice for meeting this recommendation.

The Millidisk Barrier Filter is 100% integrity tested in both forward and reverse directions prior to packaging.

One Size for All Requirements
The Millidisk Barrier Filter can be used for all process systems containing sterilizing grade liquid filters ranging from the smallest area up to filtration areas representing 5-round 10 in. applications.

Specifications (return to top)

Materials of Construction
Filters
Hydrophilic and Hydrophobic PVDF
Support Discs and Adapter
Polysulfone
O-ring
Silicone O-rings
Connection
Code M (2-118) O-rings
Filtration Area, cm²
2000
Maximum Differential Pressure, bar (psid)
Product Qualification Value
Forward - 4.1 (60) @ 25 °C; 1.7 (25) @ 80 °C; 0.35 (5) @ 123 °C; Reverse - 0.7 (10) @ 25 °C
In-Process Value
The maximum forward differential pressure during this operation should not exceed 1.4 bar (20 psi) at 25 °C so that the pores of the hydrophobic Durapore membrane are not intruded when wetting
Bacterial Retention
Quantitative retention of 10⁷ CFU/cm² Brevundimonas diminuta (ATCC^® 19146) per ASTM F838-83 methodology
Bacterial Endotoxins
<0.5 EU/mL as determined by the LAL test
Toxicity
Component materials meet the requirements of the USP Class VI Biological Test for Plastics.
Sterilization
4 SIP cycles of 60 min @ 135 °C; 4 autoclave cycles of 60 min @ 126 °C
Integrity Test, Bubble Point
≥1280 mbar (18.5 psig) with 70//30 % IPA/water

Ordering Information (return to top)

Select up to 5 products to compare them side by side

Compare	Catalogue No.	Description	Qty/Pk
	MCGBL4S03	Millidisk Barrier Filter 0.22 µm hydrophilic/phobic	3	» Add to Cart

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