Millidisk Barrier Filter

Description

One Size for All Requirements

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.

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.