Millidisk Barrier Filter

Click below for more information:
Specifications
Ordering Information
Related Products
Technical Library

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
Filters	Hydrophilic and Hydrophobic PVDF
Support Discs and Adapter	Polysulfone
O-ring	Silicone
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) nitrogen 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

Related Products (return to top)

Millidisk Sanitary Cartridge Housings

This Series 2000 cartridge housing line accomodates Millidisk cartridge filters. They are designed to handle the most critical sterile filtration steps for pharmaceutical, biotechnology, and industrial processing applications.
» Learn More...

Millidisk Sanitary Cartridge Housings European Version

Millidisk housings are designed for sterilizing liquids and gases using Millidisk cartridge filters
» Learn More...

Integritest Exacta Automatic Filter Integrity Test Instrument

The Integritest Exacta is an easy to use, easy to validate, highly accurate, automatic integrity tester for the regulated biopharmaceutical industry. For production operators, supervisors, and validation managers who need to perform on-site filter integrity tests, Millipore's Integritest Exacta Integrity Tester is a premium instrument providing the highest level of confidence in the regulated biopharmaceutical industry.
» Learn More...