|Scaling Up with Tangenital Flow Filtration|
Campbell, Melissa; Coons, Elizabeth
GEN; v. 21, no. 16; Sept. 15, 2001, p. 60 2001
|Evaluation of Microporous Tangential-Flow Filtration in the Production of Diphtheria and Pertussis Vaccines|
Rao, Y. Udaya Bhaskara, M.S. Mahadevan, and Stephen L. Michaels; Pharmaceutical Technology
Pharmaceutical Technology 1992
|Validation of Tangential Flow Filtration (TFF) Systems|
Michaels, Stephen L.
Journal of Parenteral Science and Technology (Sept/Oct 1991). 1991
|What is the sample volume range for the Pellicon II Mini system?||The Pellicon II Mini system is capable of volumes in the approximate range of 1- 50 L concentrating down to 100 mL. More or less volume can be processed depending on the individual needs of the operation, ie. process time, sensitivity of product, etc.|
|What is Normalized Water Permeability?||NWP is a measure of the ability of pure water to pass through the filter membrane. NWP is a property of the TFF system and is contributed to by the membrane as well as the feed and permeate flow paths in the filter.|
|How does NWP aid in effective cleaning procedure development?||Fouling and polarization leave residues on the membrane that can reduce filter permeability. Effective cleaning removes these residues, restoring the permeability of the membrane. Ideally, NWP after cleaning should equal NWP before use although there can be variation up to +/-15% due to membrane compaction under pressure and measurement error.
NWP validates the ability of cleaning to restore filtration rate of a system.
|Are there any microporous offerings in the tangential flow filtration line of products?||While the Prep/Scale and Pellicon XL are not available in a microporous format, the Pellicon II Mini and Pellicon II systems are. The microporous membranes are made of Millipore's Durapore membrane, low protein binding PVDF, and are available in 0.1um, 0.22um, 0.45um, and 0.65um.|
|Is there a prefiltration requirement for use with the Pellicon system?||Yes, the Pellicon system requires a 100um prefiltration. Depending on the process volume, Millipore offers an array of prefiltration modules. Contact Technical Services for help in choosing a module.|
|What is the part number for the Gauge Kit that is used with the Pellicon XL?||Gauge Kit for Pellicon XL Device (0-60 psi):
Part number XXPXLGAGE, 1 per kit. Includes an inlet pressure gauge and t-fitting. This gauge is recommended when the Pellicon is used in the absence of a Labscale TFF system in order to ensure that the pressure on the tubing is known and not allowed to exceed it's recommended maximum.
|How is NWP measured?||NWP is measured by filtering pure water throught he system at controlled cross flow, Trans Membrane Pressure and temperature. The filtrate flow rate is measured. The flow rate is normalized to the membrane area, TMP and temperature.
Please refer to the operator's manual or contact Techical Service for further questions regarding the calculation of NWP.
|Pellicon® XL 50 Device Operating Instructions|