CorrTest Integrity Testing Kits

CorrTest Integrity Testing Kits

Description
Removing viruses from mammalian recombinant proteins, tissue extracts, monoclonal antibodies or blood derivatives—and validating the removal process—are key elements in the downstream production of biopharmaceuticals.

The Viresolve line of membranes has been specifically developed for the efficient removal of virus particles from protein aceous solutions. Millipore has an extensive validation package detailing the ability of the Viresolve membrane for retaining a variety of mammalian viruses in a predictable manner. However, to completely validate the virus removal by the Viresolve module within a specific process run, it is necessary to have some means of verifying pre- and post-use membrane integrity . The patented CorrTest integrity test was developed to meet these needs.

An important feature associated with CorrTest integrity test is that it is based upon a sound theoretical framework. The CorrTest integrity test has been specifically developed to correlate and predict the retention of FX-174, a 28 nm bacteriophage used by Millipore as a lot release specification for membrane-based filters. This test can reliably and reproducibly predict the FX-174 retention of a given Viresolve product.

The components used to form the two immiscible fluids are easily removed from the membrane structure with a simple flushing protocol and are acceptable reagents for pharmaceutical applications. Consequently, the developed integrity test can be classified as non-destructive and can thus be employed both pre- and post-use to validate virus removal with the Viresolve module.

Concerns with post-processing biofoulants interfering with a post-use integrity test protocol have been addressed by methods for cleaning the membrane prior to a post-use integrity test.


Specifications    (return to top)
Materials
These chemical components and the associated test fluids are certified to be manufactured under cGMP.
Wetting Fluid:
Polyethylene glycol
Intrusion fluid:
Ammonium sulfate mixture

Interfacial Tension
These solutions exhibit an interfacial tension of 0.489–0.527 dynes per centimeter as measured by a drop volume tensiometer using a qualified product.

Water Quality
The water used in the manufacturing of the CorrTest integrity test is produced using Super-Q-UF water.

Material Bioburden
Both CorrTest fluids are filtered through a 0.22 µm filter prior to packaging.