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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" applications.

Specifications (return to top)

Materials of Construction
FiltersHydrophilic and Hydrophobic PVDF
Support Discs and AdapterPolysulfone
O-ringSilicone
ConnectionCode M (2-118) O-rings
Filtration Area, cm22000
Maximum Differential Pressure, bar (psid)
Product Qualification ValueForward: 4.1 (60) @ 25 °C; 1.7 (25) @ 80 °C; 0.35 (5) @ 123 °C. Reverse: 0.7 (10) @ 25 °C
In-Process ValueThe 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 RetentionQuantitative 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
ToxicityComponent materials meet the requirements of the USP Class VI Biological Test for Plastics.
Sterilization4 SIP cycles of 60 min @ 135 °C; 4 autoclave cycles of 60 min @ 126 °C
Integrity Test, Bubble Point≥1280 mbar (18.5 psig) nitrogen with 70//30 % IPA/water


Ordering Information  (return to top)

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MCGBL4S03 Millidisk Barrier Filter 0.22 µm hydrophilic/phobic 3 » Add to Cart


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