Repligen Tangenx pro pd User manual

IF.PUG.012 R3

TANGENX™ PRO PD CASSETTE INSTALLATION

1. Lift the end plate off the manifold of the TangenX™ PRO PD cassette holder.

2. Remove the protective blue sheet and rinse the EPDM gaskets with deionized

water or WFI. Place a rinsed gasket flat against the bottom manifold; ensure

that the holes in the gasket line up with the holes in the manifold.

3. Using scissors carefully open the cassette bag to remove cassette.

WARNING: Each cassette is stored in an aqueous solution containing

15-20% glycerin and 0.1% sodium azide, pH 7 – 10. Follow standard

safety procedures for handling aqueous glycerin/sodium azide,

including the use of gloves, safety goggles, and lab coat.

4. Place the cassette into the holder flat against the gasket. Place another gasket

on top of the cassette. Ensure that the holes in the manifold, gaskets, and

cassette are completely aligned. If you are using multiple cassettes, continue

the same gasket/cassette/gasket pattern, ending with a gasket between the

last cassette and the end plate.

5. Place the end plate on top of the last gasket of the cassette or cassette stack.

6. Install the tie-rod spacers (if used) and washers on each bolt leaving a

minimum of 18 mm (0.75 inch) of thread exposed on the rod. By hand, screw

the nut on each bolt and hand tighten evenly by alternating from one nut to

the other. Bolts must be further tightened to within the recommended

torque values using a calibrated manual torque wrench.

7. Proceed to step 8 for a two bolt hardware design or skip to step 9 for a four

bolt hardware design.

8. Using the calibrated torque wrench with a deep style socket, tighten each hex

nut ¼ turn following the torque sequence illustrated in Figure 2 for a two bolt

hardware. Tighten the first nut ¼ turn, and then tighten the second nut ¼

turn alternating back and forth until the torque wrench "clicks". Repeat this

sequence until the wrench "clicks" without turning the nut. The "click" of the

torque wrench indicates that the nut has reached the set point torque value.

9. Using the calibrated torque wrench with a deep style socket, tighten each hex

nut ¼ turn following the torque sequence illustrated in Figure 3 for a four bolt

hardware. In ¼ turn increments, tighten the first, second, third, and fourth

nut alternating back and forth until the torque wrench "clicks". Repeat this

sequence until the wrench "clicks" without turning the nut. The "click" of the

torque wrench indicates that the nut has reached the set point torque value.

CAUTION: Nuts must be tightened uniformly to avoid damaging

the cassette. Leakage may result from non-parallel plate

alignment or over compression of the cassettes at one end.

10. Wait 5-10 minutes and allow the gaskets to relax before re-torqueing.

Check each nut, per Figure 1 or 2 sequences, using the torque wrench at

its set point torque value.

11. Re-torque as needed, to create a liquid-tight seal.

NOTE: Torque may change during processing as the cassettes may

compress, or as the cassettes expand or contract with

temperature changes. Periodically check the torque of the bolts

and adjust torque as needed.

FIGURE 2

TORQUE SEQUENCE FOR TANGENX™ PRO PD CASSETTES

(2 Bolt Design)

FIGURE 3

TORQUE SEQUENCE FOR TANGENX™ PRO PD CASSETTES

(4 Bolt Design)

TangenX™ PRO PD

Cassette Holder

COMPATIBILITY GUIDE

REPLIGEN TANGENX™ STANDARD WARRANTY

Repligen Corporation warrants its TangenX™ products will meet their

applicable published specifications when used in accordance with their

applicable instructions for a period of one year from shipment of the

products. REPLIGEN MAKES NO OTHER WARRANTY, EXPRESSED OR

IMPLIED. THERE IS NO WARRANTY OF MERCHANTABILITY OR FITNESS

FOR A PARTICULAR PURPOSE. The warranty provided herein and the

data, specifications and descriptions of Repligen TangenX™ products

appearing in published catalogues and product literature may not be

altered except by express written agreement signed by an officer of

Repligen. Representations, oral or written, which are inconsistent with

this warranty or such publications are not authorized and if given,

should not be relied upon.

In the event of a breach of the foregoing warranty, Repligen’s sole

obligation shall be to repair or replace, at its option, the applicable

product or part thereof, provided the customer notifies Repligen

promptly of any such breach. If after exercising reasonable efforts,

Repligen is unable to repair or replace the product or part, then

Repligen shall refund to the customer all monies paid for such

applicable product or part. REPLIGEN SHALL NOT BE LIABLE FOR

CONSEQUENTIAL, INCIDENTAL, SPECIAL OR ANY OTHER DAMAGES

RESULTING FROM ECONOMIC LOSS OR PROPERTY DAMAGE

SUSTAINED.

Phone 508.845.6400 | Fax 508.845.3030

www.repligen.com/tangenx

[email protected]m

IF.PUG.012 R3

INTRODUCTION

Tangential flow filtration cassettes are typically installed in a stainless steel

cassette holder consisting of two steel plates, one acting as a flow distribution

manifold and the other as a mating solid flat surface. Repligen offers a complete

series of high performance stainless steel cassette holders and are designed for

optimal performance with TangenX™ PRO PD cassettes. In addition to TangenX™

cassette holders, TangenX™ PRO PD cassettes have been designed to be

compatible with other types from alternative manufacturers. The following guide

will outline the compatibility of the TangenX™ PRO PD cassettes with these other

types of cassette holders and act as a supplement to the standard user guide.

TANGENX™ PRO PD CASSETTES

•TangenX™ PRO PD cassettes are offered with two different notch patterns on

the end of the cassette. One has notches located the 0.850in (21.59mm) from

the edge and the other with notches located 0.756in (19.21mm) from the

edge.

•Initially identify which type of corresponding bolt pattern the intended

cassette holder uses. The following is a partial list of cassette holders and

their bolt pattern offset measurement.

o0.850in (21.59mm) Offset

TangenX™ PRO Holder (TX002, TX003)

Pall – Centramate Holder (CM018LV, FS001K10)

o0.756in (19.21mm) Offset

Millipore – Pellicon Mini Holder (XX42PMINI)

Sartorius – Sartocon Slice Holder (17525—01, 17521—02)

GE – Kvick Lab Holder (KLPH01SSU, KLHR0105000SS)

FIGURE 1

•Once the cassette holder’s offset bolt pattern has been identified, confirm the

cassette matches the bolt pattern and continue to the next section for the

supplemental guide to the standard user guide.

•Only use the gaskets provided by Repligen that are supplied with each

TangenX™ PRO PD cassette.

TANGENX™ PRO PD CASSETTE | SUPPLEMENTAL INSTALLATION

•Pall Centramate Cassette Holder

Reference TangenX™ User Guide

IF.PUG.003 for basic cassette installation

instructions, further details are below.

The Pall Centramate cassette holder

uses 0.850in (21.59mm) notch pattern

and is compatible with all TangenX™

PRO PD cassettes with the part number

xxxxxAxxx. There are two points of

interest to be aware of when installing

TangenX™ PRO cassette in the

Centramate holder.

The TangenX™ PRO PD cassette must be placed in the cassette holder with

the cassette’s identification label facing “down” or towards the lower flow-

path manifold and away from the brass retaining nuts.

The Centramate cassette holder has four bolts (vs. two), thus reducing the

required torque required to seal the TangenX™ PRO PD cassette. The

corrected torque values are shown in Table 1 below. Tighten the two center

bolts and then the two outer bolts in ¼ turn increments until the

recommended torque is achieved.

Table 1 Recommended Torque Values | Pall Centramate 4-Bolt Holder

Holder Part Number

Torque Range (in-lbs)

Torque Range (Nm)

CM018LV 60 - 90 7 - 10

FS001K10 60 - 90 7 - 10

•GE Kvick Lab Cassette Holder

Reference TangenX™ User Guide IF.PUG.003

for basic cassette installation instructions,

further details are below.

The Kvick packet holder uses the 0.756in

(19.21mm) notch pattern while using 4 bolts

to secure the assembly. The Kvick lab

cassette holder uses the same bolt pattern,

but uses only 2 bolts to secure the

assembly. Both are compatible with all

TangenX™ PRO PD cassettes with the part

number xxxxxWxxx.

The TangenX™ PRO cassette must be placed in the cassette holder with the

identification label facing away from the feed/retentate ports and towards

the brass retaining nuts. The recommended torque values are shown below.

Table 2 Recommended Torque Values | GE Kvick Holder

Holder Part Number

Torque Range (in-lbs)

Torque Range (Nm)

KLPH001SSU (4 Bolt)

60 - 90

7 - 10

KLHR0105000SS (2 Bolt)

120 - 180

14 - 20

•Millipore Pellicon Mini Cassette Holder

Reference TangenX™ User Guide IF.PUG.003 for

basic cassette installation instructions. The

Millipore Pellicon Mini cassette holder uses the

0.756in (19.21mm) notch pattern and is

compatible with all TangenX™ PRO PD cassettes

with the part number xxxxxWxxx.

The TangenX™ PRO PD cassette must be placed in

the cassette holder with the identification label

facing away from the feed/retentate ports and

towards the brass retaining nuts. The

recommended torque values are shown below.

Table 3 Recommended Torque Values | Millipore Pellicon Mini 2-Bolt

Holder Part Number

Torque Range (in-lbs)

Torque Range (Nm)

XX42PMINI 120-180 14-20

•Sartorius Sartocon Slice Cassette Holder

Reference TangenX™ User Guide IF.PUG.003 for

basic cassette installation instructions, further

details are below.

The Sartorius Sartocon cassette holder uses the

0.756in (19.21mm) notch pattern and is

compatible with all TangenX™ PRO PD cassettes

with the part number xxxxxWxxx. The TangenX™

PRO PD cassette must be placed in the cassette

holder with the identification label facing away

from the feed/retentate ports and towards the

brass retaining nuts. The recommended torque

values are shown in Table 4.

Table 4 Recommended Torque Values | Sartorius Sartocon Slice 2-Bolt

Holder Part Number

Torque Range (in-lbs)

Torque Range (Nm)

17525-- 01

120 - 180

14 - 20

17521-- 02

120 - 180

14 - 20

•TangenX™ PRO Cassette Holder

Follow the instructions outlined in

the TangenX™ User Guide

IF.PUG.003 for cassette installation

procedures. A copy is included in

the box of every TangenX™ PRO

cassette.

Every TangenX™ PRO PD cassette

holder uses the 0.850in (21.59mm)

bold pattern and are ideally

compatible with all TangenX™ PRO

PD cassettes with the part number xxxxxAxxx.