Pall Minimate OAD65C12 User Manual

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 7
Normalized Water Permeability . . . . . . . . .7
System Hold-up Volume . . . . . . . . . . . . .10
Minimate TFF Capsule Integrity Test . . . . .10
Flushing and Cleaning After Use . . . . . . .12
Appendix B 14
Specifications . . . . . . . . . . . . . . . . . . . . .14
Certification . . . . . . . . . . . . . . . . . . . . . .15
Ordering Information . . . . . . . . . . . . . . . .15
Support Literatures . . . . . . . . . . . . . . . . .15
Where to Find More Information . . . . . . .15
Care and Use Procedures PN 88227
Minimate
™
TFF Capsule
1

Pall Minimate OAD65C12 Specifications

General

Brand	Pall
Model	Minimate OAD65C12
Category	Medical Equipment
Language	English

Summary

Instructions For Use

Required Equipment

Lists essential components like pump and reservoir for operation.

Installation

Step-by-step guide for connecting the TFF capsule and system components.

Calibrate Feed Pump

Procedure to ensure accurate flow rates by creating a pump calibration curve.

Flushing

Steps to remove preservatives and humectants from the capsule before use.

Sanitization (Recommended for critical applications)

Integrity Test (Optional)

Procedures to check for leaks or defects in the membrane and seals.

Concentration/Diafiltration

Core TFF processes for concentrating solutions or exchanging buffers.

Product Recovery

Product in Concentrate

Cleaning and Storage

Cleaning

Appendix A: Normalized Water Permeability

Determining the "original" normalized water permeability.

System Hold-up Volume

Minimate TFF Capsule Integrity Test

WATER DISPLACEMENT METHOD (QUANTITATIVE)

Quantitative air diffusion test to measure leak rates through wetted membranes.

PRESSURE-HOLD TEST METHOD (QUALITATIVE)

Flushing and Cleaning After Use

Post Treatment of Minimate TFF Capsule

Adding and circulating cleaning agent.

Determining Membrane Recovery

Determining the water permeability after cleaning