Small Virus Removal for Bioprocesses
Pegasus Protect virus prefiltration combines with Pegasus Prime virus filtration to deliver the first gamma-sterilized pre-filter & virus filter combination. Together, these simplify process development, validation and operations while saving time and delivering improved process economy.
Process developers can quickly deliver a robust, scalable virus filtration process using a minimum of sample volume, and be confident of successful virus validation. This choice supports clinical manufacturing with a solution that is easy to use and versatile to work alone or with integrated and automated single-use systems.
The Microdisc capsules containing Pegasus Prime virus media are ideal for the confirmation and validation of performance at a small scale using minimal volumes of process fluid and virus spike preparations and deliver consistently high log reduction value (LRV) irrespective of the virus validation choices.
The predicted process flow, filter capacity or virus retention established during these studies scales to a range of products available to support your process at all scales and offer the highest degree of manufacturing control, flexibility and security.
Features and Benefits
|Robust high LRV, independent of process fluid, process parameters or validation procedure||Reliable performance and assured patient safety
|Robust capacity and high flow||Small filtration footprints and short process times
|Gamma irradiated > 25 kGy||Virus clearance and process performance representative of larger manufacturing scale devices.|
|Full scale-up range with identical membrane at all scales||Reliable scalability
|Full pre-filter scale-up range with consistent pre-filter to virus filter area ratios||Control scale-up risks
|Easy to use||Luer Lock connectivity for easy testing|
Filter Membrane: Polyethersulfone
Capsule Hardware: Polypropylene
Support Substrate : Polyester
Pore size : 20 nm nominal
Virus: > 4 log reduction value with mammalian parvoviruses
Effective Filter Area (EFA) (Nominal)
2.8 cm2 (0.43 in.2)
Maximum Temperature: 40 °C
Maximum Pressure: 3.1 bar (45 psi)*
Maximum Differential Pressure: 3.1 bar (45 psi)*
*up to 12 hours at 25 °C; up to 6 hours at 40 °C
Liquid Flow v Differential Pressure (Typical)
1.4 – 2.6 mL/min at 2.1 bard, water at 20 °C
Length: 21 mm (0.8 in.)
Diameter: 29 mm (1.2 in.)
Female Luer-Lock inlet, male slip Luer outlet
Pegasus Prime delivers robust, high LRV independent of process parameters, process fluid and validation choices.
Robust, High Virus Retention
1 Tested using phage PP7
2 Tested using phage ?X174
Robust Virus Filter Sizing
The performance established during Microdisc filterability trials scales reliably to full scale devices as shown in Figure 3. Where intermediate scale trials to confirm the performance are required, Mini Kleenpak filterability tools are available and contain the same Pegasus Prime virus media in a low area, pleated filter configuration to minimize the volume of fluid required.
Polyclonal IgG at 50% flux decay; n≥9 from 3 different lots
|3MCFPRM4||Pall Microdisc Capsules with Pegasus Prime Virus Removal Filter Membrane||4/box|
|3MCFPRM12||Pall Microdisc Capsules with Pegasus Prime Virus Removal Filter Membrane||12/box
(4 x 3 lots)