Pall Minimate OA001C12 Care And Use Download

Page: 15 / 18

Certification

Pall Corporation certifies that the Minimate

™

TFF Capsule is:

•

100% POST PRODUCTION INTEGRITY TESTED

• Field integrity testable using pressure hold or forward

flow tests

• Materials of construction pass United States

Pharmacopeia (USP) Biological Reactivity Test,
In Vivo <88> after preconditioning

• In compliance with published product specifications

• Manufactured in ISO9000 certified facilities

The certificate of test provided does not apply to products
that have been opened or damaged by conditions outside
the control of Pall Corporation.

Where to Find More Information

This manual,

Minimate TFF Capsule Care and Use

Procedures (PN88227)

is supplied on the Minimate TFF

Capsule CD-Rom (PN88201) enclosed with the product.
Many additional accessories are available for this product,
including pumps, reservoirs and connectors. For further
assistance, please consult with your local Pall representative
or distributor.

Support Literature

• Minimate TFF Capsule Data Sheet, USD 2218

• Minimate TFF Capsule Quick Start Guide, PN 88200

• Minimate TFF Capsule CD-Rom, PN 88201

• Introduction to TFF for Laboratory and Process

Development Applications, PN 33213

• Diafiltration: A Fast, Efficient Method for Desalting, or

Buffer Exchange of Biological Samples, PN 33289

• Desalting and buffer exchange by Dialysis, Gel Filtration

or Diafiltration PN 33290

• Minim

™

System Product Data, USD 2069

• LV Centramate

™

Data Sheet, USD 2098

• Centramate

™

Cassette Data Sheet, USD 2080

www.pall.com/lab

Summary of Contents for Minimate OA001C12

Page 1: ... 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 Liter...

Page 2: ...tration Replace dialysis applications Depyrogenate water buffers and media solutions Product Information The Minimate TFF Capsule comes with threaded luer plugs in each of the 4 ports A fitting package with the following components is included Fittings Package Part No 88216 includes A Tubing 3 2 mm 1 8 i d 120cm 4 ft B Male luer to hose barb fittings 3 2 mm 1 8 2 C Female luer to hose barb fitting...

Page 3: ...ing to one of the filtrate vent ports Note Depending on the orientation of the capsule choose the filtrate port that is at the highest elevation This allows air to be completely expelled from the filtrate side of the membrane The filtrate channel can be drained easily by opening the other filtrate port as a vent 10 Attach a piece of tubing to the filtrate hose barb 11 Install a tubing clamp over e...

Page 4: ...mL min Slowly tighten retentate screw clamp to increase backpressure This will increase flow through the filtrate lines Tighten clamp until filtrate flow rate is approximately equal to the retentate flow rate or until feed pressure reaches 2 bar 30 psi Do not exceed a feed pressure of 2 bar 30 psi Pump at least 250 mL of the water through the retentate tubing and 250 mL through the filtrate tubing...

Page 5: ... Test Optional An integrity test is performed to identify any gross defects in the device membrane or seals that could cause product loss prior to use Capsules are 100 integrity tested after manufacturing Therefore it is not necessary to perform an integrity test on a new Minimate TFF Capsule However for critical applications or if the capsule will be reused it is recommended that an integrity tes...

Page 6: ...inutes to try and recover additional product The remaining liquid in the system can be pumped out into a separate container by allowing air to be pumped through capsule to displace it A decision can then be made whether to combine this volume with the main product Product in Filtrate If the product is in the filtrate raise the vent port so it is higher than the collection vessel Make sure the end ...

Page 7: ... is shown below To determine the NWP a pressure gauge is required on the feed and retentate ports Filtrate pressure should be zero 0 provided there are no restrictions on the filtrate line and that the filtrate line is open to atmosphere Recirculate the filtrate and retentate streams back to the feed reservoir to minimize the volume of water needed Removing air from the retentate All air must be r...

Page 8: ...Rate LMH Filtrate Flux Rate mL min cm2 x 600 Water Permeability LMH TMP Filtrate Flux Rate LMH TMP NWP LMH TMP 20 C Filtrate Flux Rate LMH x Temperature Correction Factor TCF at operating temperature Table 3 Temperature Correction Factors TCF 20 C for determining Normalizing Water Permeability Temperature Correction Factors TCF 20 C for determining Normalizing Water Permeability T C TCF 20 C T C T...

Page 9: ... 15 Filtrate Pressure psi bar 0 0 0 TMP psi bar 5 10 15 Filtrate Flow Rate mL min 4 6 9 2 13 8 Filtrate Flux Rate mL min cm2 0 092 0 184 0 276 Filtrate Flux Rate LMH 55 110 165 Water Permeability LMH TMP 11 NWP LMH TMP 20 C 12 2 Water Permeability 110 LMH 10 psig 11 0 LMH psig Normalized Water Permeability 11 0 LMH psig x TCF 20 C where TCF 20 C 1 109 Correcting water permeability for temperature ...

Page 10: ... to determine Minimum Working Volume 1 Add water to the reservoir 2 Direct retentate and filtrate lines into feed reservoir Open the retentate clamp and close the filtrate clamp 3 Adjust pump to deliver the operating retentate flow rate that will be used for the process 4 Direct the retentate line to drain Watch the water in the reservoir When the water reaches a level where it appears that air is...

Page 11: ...Integrity Test Procedure 1 Empty the feed reservoir 2 Open retentate and filtrate screw clamps and pump out liquid from feed and retentate tubing 3 Fill a 400 mL or larger beaker and a 25 mL graduated cylinder with water 4 Invert the full graduated cylinder into the large beaker Place a piece of paper or Parafilm over the mouth of the cylinder Turn the cylinder over and remove the piece of paper a...

Page 12: ... C 0 1N nitric acetic or phosphoric acid Post Treatment of Minimate TFF Capsule Before introducing the cleaning solution into the membrane system remaining product and contaminants should first be flushed free using either buffer or spent filtrate The use of a buffered flush will eliminate possible solubility changes Spent filtrate assuming the product is in concentrate eliminates the need for fre...

Page 13: ...recondi tioned described on page 5 Water should be wateWFI or at a minimum 0 2 µm filtered DI water All water permeability rates are normalized to a temperature of 20 C by using a temperature correction factor TCF 20 C in Table 3 Determining the water permeability after cleaning 1 Add water to the reservoir 2 Return the retentate and filtrate line back to the feed reservoir 3 Open the retentate an...

Page 14: ...cm x 3 8cm x 1 8cm L x W x H nominal 8in x 1 5 in x 0 7 in Effective Filtration Area 50 cm2 Product Hold Up Volume feed retentate 1 6mL Forward Flow Air Integrity Value 7 mL min at 0 75 bar 10 psi Operating Temperature Range 5 ºC 41 ºF to 50 ºC 122 ºF Maximum Operating Pressure at 20 ºC 68 ºF 4 bar 400 kPa 60 psi Recommended Crossflow 30 40 mL min 0 6 0 8 Liters min ft2 Connections Feed Female Lue...

Page 15: ...cedures PN88227 is supplied on the Minimate TFF Capsule CD Rom PN88201 enclosed with the product Many additional accessories are available for this product including pumps reservoirs and connectors For further assistance please consult with your local Pall representative or distributor Support Literature Minimate TFF Capsule Data Sheet USD 2218 Minimate TFF Capsule Quick Start Guide PN 88200 Minim...

Page 16: ...ure Readings Flow Rate Flux Rate Volume Conc Diafiltrate Comments Time Temp Feed Retent Filtrate TMP Delta P Retent CFF Filtrate Filtrate Feed Filtrate Factor Volumes hr min C psi bar psi bar psi bar psi bar psi bar L min L min ft 2 mL min LMH mL mL x DV Initial Water Data Filtrate Flux Rate Delta P Process Data Optimization Yes or No Final Water Data Filtrate Flux Rate Delta P ...

Page 17: ... Measured filtrate flow rate Filtrate Flux Rate LMH Filtrate flow rate membrane area Liters hour meter2 Volume Feed mL Remaining Feed Volume Starting Volume Total collected filtrate volume Starting Volume equals process volume added to reservoir plus hold up volume if system was filled with liquid Filtrate mL Total collected filtrate volume Concentration Factor X Starting Volume Starting Volume Fi...

Page 18: ...2 2545 5990 United Kingdom Portsmouth Tel 023 92 302600 Fax 023 92 302601 Lab UK pall com 18 Product No Description OAD65C12 Minimate TFF Capsule w 650 dalton Omega OA001C12 Minimate TFF Capsule w 1Kd Omega OA003C12 Minimate TFF Capsule w 3Kd Omega OA005C12 Minimate TFF Capsule w 5Kd Omega OA010C12 Minimate TFF Capsule w 10Kd Omega OA030C12 Minimate TFF Capsule w 30Kd Omega OA050C12 Minimate TFF C...

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