Table of Contents
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Care and Use Procedures
Minimate
™
TFF Capsule
Table of Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . .2
Applications . . . . . . . . . . . . . . . . . . . . . . .2
Product Information . . . . . . . . . . . . . . . . .2
Instructions For Use . . . . . . . . . . . . . . . . .3
Installation . . . . . . . . . . . . . . . . . . . . . . . .3
Calibrate Feed Pump . . . . . . . . . . . . . . . .4
Flushing . . . . . . . . . . . . . . . . . . . . . . . . . .4
Sanitization . . . . . . . . . . . . . . . . . . . . . . .5
(Recommended for critical applications)
Normalized Water Permeability (NWP) . . . .5
(Optional)
System Hold-up Volume (Optional) . . . . . .5
Integrity Test (Optional) . . . . . . . . . . . . . . .5
Buffer-Conditioning (Optional) . . . . . . . . . .5
Concentration/Diafiltration . . . . . . . . . . . . .6
Product Recovery . . . . . . . . . . . . . . . . . . .6
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . .6
Storage of the Minimate TFF Capsules . . . .6
Disposal of the Minimate TFF Capsule . . . .6
Appendix A
Normalized Water Permeability . . . . . . . . .7
System Hold-up Volume . . . . . . . . . . . . .10
Minimate TFF Capsule Integrity Test . . . . .10
Flushing and Cleaning After Use . . . . . . .12
Specifications . . . . . . . . . . . . . . . . . . . . .14
Certification . . . . . . . . . . . . . . . . . . . . . .15
Ordering Information . . . . . . . . . . . . . . . .15
Support Literatures . . . . . . . . . . . . . . . . .15
Where to Find More Information . . . . . . .15
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Summarization of Contents
Minimate TFF Capsule Care and Use Procedures
Introduction
The Minimate™ TFF capsule is the central part of a system for performing concentration or diafiltration on solutions of biomolecules.
Applications
Tangential flow filtration is a rapid and efficient method for the concentration or diafiltration of biomolecules.
Product Information
The Minimate TFF Capsule comes with threaded luer plugs in each of the 4 ports.
Fittings Package
Part No. 88216 includes tubing, hose-barb fittings, tubing clamps, and adhesive strip.
Instructions For Use
Guides the user through setup and operation of the Minimate TFF Capsule system.
Required Equipment
Requires a peristaltic pump or equivalent and a feed reservoir.
Recommended Equipment
Pressure measuring device and magnetic stir plate with stir bar are recommended.
Installation
Step-by-step guide on how to connect tubing and fittings to the Minimate TFF capsule.
Calibrate Feed Pump
Procedure to calibrate the pump for accurate flow rate settings.
Flushing
Procedure to flush out glycerin and preservative from the capsule before use.
Sanitization
Recommended for critical applications to sanitize and depyrogenate the capsule.
Normalized Water Permeability (NWP)
Procedure to measure membrane performance and evaluate cleaning effectiveness.
System Hold-up Volume
Determines the total volume within the feed/retentate flow path of the TFF system.
Integrity Test
Identifies defects in the device membrane or seals to prevent product loss.
Buffer-Conditioning
Preconditions the capsule into the sample buffer before sample addition.
Concentration/Diafiltration
Refer to application notes for details on these processes.
Product Recovery
Procedure to recover product from the membrane after concentration/diafiltration.
Cleaning
Procedure to clean the capsule after use for reuse, including recommended solutions.
Storage of Minimate TFF Capsules
Objective is to keep membranes wet and prevent microbial growth during storage.
Disposal of Minimate TFF Capsule
Recommended procedure for sterilization and disposal of the capsule.
Appendix A: Normalized Water Permeability
Determining NWP for Minimate TFF Capsule
Procedure to measure membrane performance using water filtrate flux rates at specified transmembrane pressures.
Determining Original NWP
Plot filtrate flux rate vs. TMP to determine original NWP at 0.7 bar (10 psig).
Example: Determining NWP
Demonstrates calculation of original normalized water permeability using sample data.
System Hold-up Volume
Procedure to Determine System Hold-up Volume
Steps to measure the total volume contained within the feed/retentate flow path.
Procedure to Determine Minimum Working Volume
Steps to determine the minimum volume of liquid required to prevent air draw into the system.
Minimate TFF Capsule Integrity Test
Forward Flow Air Integrity Test Procedure
Procedure for a quantitative air diffusion test to confirm capsule integrity.
Water Displacement Method (Quantitative)
Quantitative test measuring air diffusion through wetted membrane or seals.
Pressure-Hold Test Method (Qualitative)
Simple, quick method testing for pressure decline indicating air leakage.
Flushing and Cleaning After Use
Recommended Cleaning Agents
Lists cleaning solutions like NaOH, NaOCl, and acids for Omega membranes.
Post Treatment
Procedures for flushing remaining product and contaminants before cleaning.
Flushing Retentate Stream
Directs retentate to drain to remove excess matter before cleaning.
Flushing System with Water
Procedure to flush the system with deionized water or WFI after cleaning.
Adding and Circulating Cleaning Agent
Procedure to add and circulate cleaning solution for effective cleaning.
Flushing Cleaning Agent from Capsule
Procedure to purge the capsule of cleaning solution with water.
Determining Membrane Recovery
Calculating Membrane Recovery
Compares normalized water permeability after cleaning to the original NWP.
Determining Water Permeability After Cleaning
Measures water permeability after cleaning to calculate membrane recovery.
Appendix B: Specifications
Product Specifications
Details materials of construction, dimensions, filtration area, and operating parameters.
Connections
Describes the type of connections for Feed, Retentate, and Filtrate ports.
Certification
Pall Corporation's certification of the Minimate TFF Capsule's quality and testing.
Support Literature
Lists available documentation and resources for the Minimate TFF Capsule.
Where to Find More Information
Information on obtaining the manual, CD-ROM, and contacting Pall representatives.
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