Minidisc Capsules with Ultipor® VF Grade DV20 Virus Removal Filter Membrane

Minidisc filter capsules incorporate Ultipor® VF Grade DV20 membrane and are validated for virus removal.

They are also suitable for small-scale membrane qualification studies such as bacteriophage or prion (TSE agent) clearance, as well as membrane flow rate, capacity and protein transmission studies. Every filter is identified by a lot number and a unique serial number for complete traceability of manufacturing history and for user’s traceability system and manufactured under a Quality Management System certified to ISO 9001:2008.

Key Features

• Incorporates Ultipor VF Grade DV20 virus removal filter membrane
• Identical membrane to larger virus cartridges
• Fully disposable capsule with Luer-Lok* connections
• Individual capsules identified by lot and serial number
• 100% manufacturing assembly tested
• Membrane bacteriophage tested
• Pre- and post-installation tested
• Low protein-binding
• Robust membrane with high viral clearance and resistance to plugging
  

Benefits

• Robust, high viral clearance
• Reliable scalability
• Easy handling, ready to use
• Easy identification of individual capsules with complete traceability of manufacturing history
• Assurance of consistently high quality at point of use
• Flow decay minimized at high virus spike concentrations and with more complex or concentrated feeds

High Quality Standards

Meets the current USP requirements under Section <85> Bacterial Endotoxins Test

Materials

Filter fluid path components have met the specifications under Section <88> Biological Reactivity Tests in vivo listed in the current revision of the United States Pharmacopeia (USP) for Class VI plastics at 121°C.

• Virus removal and small-scale membrane qualification studies such as bacteriophage or prion (TSE agent) clearance
• Membrane flow rate studies
• Capacity studies
• Protein transmission studies

Materials of Construction

Item	Material
Membrane	Hydrophilic modified polyvinylidene fluoride (PVDF)
Support Disc	Polypropylene (Non-woven)
O-ring	EPDM
Capsule Inlet and Outlet	Polycarbonate

Removal Rating

Item	Removal
Small viruses	> 3 log TR*†
Large viruses	> 6 log TR **

* Claims based on challenge with parovirus model bacteriophage (bacterial virus) PP7
** Claims based on challenge with parovirus model bacteriophage (bacterial virus) PR772
† > 4 LRV for PP7 bacteriophage per Parenteral Drug Association (PDA) TR 41 rating method for small virus-retentive filters. > 4 LRV typically with mammalian parvoviruses

Effective Surface Area

9.6 cm² (1.49 in²)

Operating Parameters²

Maximum Temperature	25 °C
Maximum Operating Pressure	3.1 barg (45 psig)
Maximum Differential Pressure	3.1 barg (45 psig)

² Using compatible liquids. Maximum air/gas pressure for installation test 3.4 bar g (50 psi)

Typical Flow vs. Differential Pressure

Typical Clean Water Flow at Ambient Conditions

Please download and read the Instructions For Use for Minidisc Virus Removal Filter Capsules - these instructions contain important information which should be followed before using the product.

 Instructions For Use: Minidisc Virus Removal Filter Capsules (PDF, 500 kb)

Description	Part Number*
Minidisc Capsules with Ultipor® VF Grade DV20 Membrane	10MCFDV20

* Capsules are supplied in boxes of 3

Equipment Required for Laboratory Testing

Pressure Vessels	Part Number
Junior-style vessel	BLS7001G23J
Sealkleen vessel	ZLK702G23LHKH4
Novasip™ vessel	C3EP1

Accessories (Novasip Vessel)	Part Number
Adapter 1 in. TC/Male Stäubli connector plug (3 mm) R ¼ in.	GFX0290
TC clamp + silicone gasket	SLK1TC23H4

Accessories (Junior, Sealkleen Vessels)	Part Number
Adapter 1 in. TC/Male Stäubli connector plug (3 mm) R ¼ in.	GFX0290
Male Stäubli connector plug (3 mm) R ¼ in.	GFX0235