Merck Pellicon Capsule Manuel utilisateur

The life science business of Merck KGaA, Darmstadt,

Germany operates as MilliporeSigma in the U.S. and Canada.

Pellicon® Capsule

Pellicon® Capsule Stand

User Guide

Pellicon®Capsule and Pellicon®Capsule Stand User Guide 2

Introduction

Pellicon® capsules are a family of single-

use tangential flow filters available in

three linearly scalable device sizes: 0.1,

0.5 and 1.5 m2, and as pre-assembled

manifolds of multiple capsules connected

via tubing assemblies to enable membrane

area installations of 1, 3, 4.5, 6, 7.5 and

9 m2. Manifolded sizes 1, 3 and 4.5 m2

are provided fully assembled with aseptic

connectors. Sizes 6, 7.5 and 9 m2are

achieved by aseptically connecting two

manifold assemblies of 3 or 4.5 m2at the

user site (refer to Manifold Installation).

Capsule

Size (m2)Available Connection Type

Device

0.1, 0.5 ¾ in. Sanitary Flange or

AseptiQuik® G Connector

1.5 AseptiQuik® G Connector

Manifold

1, 3, 4.5 AseptiQuik® G Connector

6, 7.5, 9 AseptiQuik® L Connector

Contents

Introduction ......................................... 2

Pellicon® Capsules ................................ 3

Before Use ....................................... 3

Unpacking ........................................ 3

Installation Materials ......................... 5

Operation Mode................................. 5

Device Installation............................. 5

Manifold Installation .......................... 8

Integrity Testing ................................ 11

Conditioning Flush.............................. 12

Product Processing............................. 13

Concentration ................................. 13

Diafiltration .................................... 13

Recovery........................................ 13

Pellicon® Capsule Stand ...................... 14

Installation ..................................... 14

Troubleshooting ................................. 15

The capsules are self-contained and do not

require a compression holder. Sizes 0.1,

0.5 and 1 m2may be clamped on a user-

supplied fixture or mounted onto a Pellicon®

capsule stand for support (refer to Pellicon®

Capsule Stand for installation). Sizes 1.5 m2

and above are provided with a self-standing

feature.

Feed Port

Retentate Port

Permeate Port

Pellicon® capsule

(shown 0.5 m2with ¾ in. Sanitary Flange)

Pellicon®Capsule and Pellicon®Capsule Stand User Guide 3

Pellicon® Capsules

Before Use

Pellicon® capsules are wetted with

preservative-free reverse osmosis water,

double bagged, packaged and gamma

sterilized. The radiation exposure label on

the inner bag will be red to indicate gamma

irradiation has been performed.

Store the product at ambient temperature

and keep protective packing materials

in place until installation. To prevent

contamination, the capsule should be

removed from the inner bag just prior to

installation.

Visually inspect capsules to ensure no

damage occurred during shipping. Pellicon®

capsule manifolds should not be lifted or

carried by the tubing assemblies.

Cleaning and sanitizing before use are not

required.

Refer to the Certificate of Quality supplied in

the box with each product for specifications.

Unpacking

Pellicon® capsules are individually packaged. The packaging includes double bags, foam

pouches or foam frames, and a corrugated box. Pellicon®capsule manifolds in sizes 3 and 4.5

m2are palletized to provide additional protection during shipment.

CAUTION The 3 and 4.5 m2packages are heavy. Two people or a lifting aid may

be required to move the package. Follow internal SOPs to ensure operator

safety.

1. Cut sealing tape at the base on all

four sides.

CAUTION Do not cut box open from top.

3. Using the handles, lift the assembly

up and out of the bottom tray. Place

the assembly on a stable surface.

2. Lift and remove the top portion of the

box.

4. Lift and remove the top foam piece.

Pellicon®Capsule and Pellicon®Capsule Stand User Guide 4

5. Securely grasp the outer plastic bag

assembly by its edges and lift free

from the bottom foam piece and place

on stable surface.

8. Place the bagged manifold on a flat

surface, cut the inner bag at the seal

and remove the foam assembly.

6. Cut the outer bag at the seal and

remove the inner-bagged manifold

unit.

CAUTION

Do not cut open the inner bag

until ready to use the product

to prevent contamination.

9. Remove the top foam piece.

7. Follow SOP prior to bringing it into a

cleanroom.

10. Hold the bottom foam piece down and

lift the manifold unit by the handles.

11. For E manifolds only, pull the foam

insert out to remove the center

unification bracket.

Once all packaging materials have been

removed, the product is ready to use.

Pellicon®Capsule and Pellicon®Capsule Stand User Guide 5

Installation Materials

Below is a list of recommended materials for Pellicon® capsule

installation:

Component Use

Diaphragm or Peristaltic Pump Feed Pump

Diaphragm or Peristaltic Pump

Head Feed Pump Head

Sanitary Gaskets

(not required with AseptiQuik®

Connectors)

Feed, Retentate, Permeate Ports

Sanitary Clamps

(not required with AseptiQuik®

Connectors)

Feed, Retentate, Permeate Ports

Sanitary to Barb Fittings or hose

barb AseptiQuik® Connectors

Feed, Retentate, Permeate Tubing

Connections to Ports

Tubing Feed, Retentate, Permeate,

Recovery Lines

Pinch Clamps/Valves Feed, Retentate, Permeate,

Recovery Lines

Barb Tee Recovery Line

Pressure Transducers Feed, Retentate, Permeate Lines

Pressure Monitor Pressure Sensor Monitor for

Feed, Retentate, Permeate

Tank Feed

Stirrer Feed

Capsule Stand (sizes 0.1, 0.5 and

1 m2only) Capsule support

Use tubing compatible with solvents and pressures expected in the

application.

The pump must have adequate capacity for the installation. The

optimal feed flow rate will depend on the application and solution

being filtered.

Operation Mode

Product installation and system setup is defined by the TFF operation

mode:

Parameter Operation Mode

Batch TFF Single-pass TFF

Feed Flow Path Recirculation Pumped through the

system once

Feed Flow Rate

(L/min/m2)4 to 8 ≤ 1

Multiple Capsule

Installation Parallel Series

Device Installation

Pellicon® capsule devices are supplied with port twist caps on

sanitary flanges for sizes 0.1 and 0.5 m2only, or with AseptiQuik®

G connectors for all three sizes. Capsules supplied with port caps

require fractional sanitary fittings, gaskets, and clamps to connect the

tubing to the capsule feed, retentate and permeate ports.

Capsules supplied with AseptiQuik® G connectors are provided pre-

assembled with sanitary gaskets and clamps, and require user

supplied AseptiQuik® G connector halves to connect the system

flowpath to the capsule feed, retentate and permeate ports.

During installation and use, avoid stress such as impact, pulling or

stretching at connection points.

Pellicon®Capsule and Pellicon®Capsule Stand User Guide 6

Batch TFF Installation

Batch TFF installations allow the feed to pass through the filter assembly multiple times. If installing multiple devices, assemble for parallel flow

using tubing to connect shared feed, retentate, and permate lines.

Pump

Feed

Pellicon®

Capsule

Feed

Tank

Retentate

Permeate

to Drain

or Waste

Recovery

Pump

Feed

Pellicon

Capsules

Feed

Tank

Retentate

Permeate

to Drain

or Waste

Recovery

Batch TFF installation with one Pellicon® capsule Batch TFF installation with multipe Pellicon® capsules

1. Install the Pellicon® capsule(s) vertically with the permeate and

retentate ports on top.

2. Capsules supplied with port caps:

Remove the permeate, feed and retentate port caps by twisting

the caps counterclockwise. Remove the port O-rings.

NOTE O-rings are not reusable.

Insert sanitary gaskets and connect tubing to the feed, permeate

and retentate ports, securing fittings with sanitary clamps.

Capsules supplied with AseptiQuik® Connectors:

Aseptically connect the capsule to the corresponding TFF system

flowpath lines using genderless AseptiQuik® connectors. Refer to

the manufacturer's instructions.

Multiple capsule installations require shared feed, permeate and

retentate lines as shown.

3. Install pressure transducers and pinch valves where required on

the feed, retentate and permeate lines.

4. Connect the feed line to the pump.

5. Install a recovery line and pinch valve after the feed pump and

before the capsule feed port, if needed for product recovery.

6. Direct the permeate line to drain or to waste container.

7. Direct the retentate line to the feed tank.

Pellicon®Capsule and Pellicon®Capsule Stand User Guide 7

Single-pass TFF Installation

Single-pass TFF installations allow the feed to pass through each filter once to generate permeate and concentrated retentate without

recirculation.

Single-pass TFF installations use either one or mutiple Pellicon® capsules. Mutiple capsule installations require the capsules be assembled in

series, with the total membrane area equally distributed in the serialized sections. For example, a process requiring a total of 0.3 m2of filter area would

consist of three 0.1 m2 capsules in series.

Pump

Feed

Tank

Retentate

Permeate

to Drain

or Waste

Pellicon®

Capsule

to Collection Vessel

for Product Recovery

to Next Step for

Continuous Processing

Pump

Feed

Pellicon

Capsule

Feed

Tank

Retentate

Permeate

to Drain

or Waste

Pellicon

Capsule

Pellicon

Capsule

to Collection Vessel

for Product Recovery

to Next Step for

Continuous Processing

Single-pass TFF installation with one Pellicon® capsule Single-pass TFF installation with multiple Pellicon® capsules

1. Install the Pellicon® capsule vertically with the permeate and

retentate ports on top.

2. Capsules supplied with port caps: Remove the

permeate, feed and retentate port caps by twisting the caps

counterclockwise. Remove the port O-rings.

NOTE O-rings are not reusable.

Insert sanitary gaskets and connect tubing to the feed,

permeate and retentate ports, securing fittings with sanitary

clamps.

Capsules supplied with AseptiQuik® Connectors:

Aseptically connect the capsule to the corresponding TFF system

flowpath lines using genderless AseptiQuik®connectors. Refer to

the manufacturer's instructions.

For multiple capsule installations, connect the feed/retentate port

of the prior capsule to the feed/retentate port of the next capsule.

3. Install a pressure transducer on the feed tubing of the first

capsule and connect the feed line to the pump.

4. Install a pressure transducer in the retentate tubing of the final

capsule in the series then install a pinch valve downstream of

the sensor.

5. Direct permeate lines to waste container or drain.

6. Direct retentate tubing of the final capsule to a collection

vessel for product recovery or to the next step for continuous

processing.

Pellicon®Capsule and Pellicon®Capsule Stand User Guide 8

Manifold Installation

Pellicon® capsule manifold assemblies are

standard units of multiple capsule devices

(2 or 3) connected via single-use tubing

assemblies that are terminated with

AseptiQuik® G or L connectors. There are

three manifold formats available as follows:

Format* Description

GCapsule Manifolds with

AseptiQuik® G Connectors

LCapsule Manifolds with

AseptiQuik® L Connectors

Capsule Extender Manifolds with

AseptiQuik® L Connectors on

both ends

*Refer to the last digit of the catalog number.

Each unit is pre-assembled during

manufacturing, mounted on a stainless-steel

plate (3 and 4.5 m2only) for convenience

during use, then individually packaged and

gamma sterilized.

The product must not be lifted or carried by

the tubing assemblies.

Provide adequate tubing length from the

system to avoid stretching of the tubing that

could lead to stress at connection points as

well as prevent kinking of tubing that could

restrict flow.

Installation of 1, 3 or 4.5 m2of Membrane Area

Pellicon® capsule manifold assemblies of 1, 3 and 4.5 m2of membrane area (manifold formats

G) are shipped fully assembled with AseptiQuik® G connectors ready to connect to your TFF

smart system. Refer to the manufacturer's instructions for details on making the aseptic

connections.

The 1 m2manifold may be installed onto the Pellicon® capsule stand for vertical support during

use.

Installation of 6, 7.5 or 9 m2of Membrane Area

Pellicon® capsule manifold formats E and L are individual assemblies of either 3 or 4.5 m2of

membrane area. The E format is an extender assembly that enables increased membrane

area installations when aseptically connected to an L assembly. To achieve installations of 6,

7.5, or 9 m2of membrane area, Pellicon® capsule manifold formats E and L are paired during

installation as follows:

Membrane Area (m2)Catalog Number Required

EManifold LManifold

6 PCC----30E PCC----30L

7.5 PCC----30E PCC----45L

9 PCC----45E PCC----45L

NOTE Each Eand Lmanifold unit must be ordered separately.

AseptiQuik®L Connectors

EManifold Assembly LManifold Assembly

System Connection:

Retentate

System Connection:

Permeate

System Connection:

Feed

Carry Handles

Manifold

Connection:

Retentate

Manifold

Connection:

Permeate

Manifold

Connection:

Feed

Center

Unification

Bracket (CUB)

Pellicon®

Capsules 1.5 m2

4.5 m2E manifold (left) and 4.5 m2L manifold (right), shown for a 9 m2installation

Pellicon®Capsule and Pellicon®Capsule Stand User Guide 9

The following procedure requires various connections of AseptiQuik®

L connectors. Refer to the manufacturer's instructions for details on

making the aseptic connections.

1. To position E and L manifolds adjacent to the TFF smart system,

lift each manifold individually by the handles on the plate of the

filtration unit and place on a flat even surface near the system.

NOTE Do not lift or carry the product by the tubing

assemblies.

2. Align the three (3) AseptiQuik® L connectors on one side of the

E manifold labeled To System (refer to tag attached to each

tubing line) to the corresponding feed, retentate, and permeate

AseptiQuik® L connectors on the TFF system flow path.

EManifold Assembly

To TFF

System

Alignment of AseptiQuik® L connectors between system and E manifold

3. Align the three (3) AseptiQuik® L connectors on the opposite side

of the E manifold labeled To Filter to the three (3) AseptiQuik®

L connectors of the L manifold. Ensure the tubeset tags

opposite to each other match according to the intended flow

path direction: Feed to Feed, Retentate to Retentate, and

Permeate to Permeate.

System

To TFF

System

EManifold Assembly LManifold Assembly

Filter

Alignment of AseptiQuik® L connectors between E and L manifolds

4. To pair the E manifold to the TFF smart system, push the

feed side AseptiQuik® L connector on the E manifold to the

TFF system feed side AseptiQuik® L connector (refer to the

manufacturer's instructions). Then repeat for the retentate line,

and finally the permeate line.

Pellicon®Capsule and Pellicon®Capsule Stand User Guide 10

NOTE Do not pull the membrane tabs on the connectors at

this step as the flow path installation is not complete.

EManifold Assembly

Pairing E manifold to TFF system

5. To pair the L manifold to the E manifold already coupled to the

TFF system, push the feed side AseptiQuik® L connector (refer

to the manufacturer's instructions) on the opposite side of the

E manifold (opposite to the TFF system) to the L manifold feed

side AseptiQuik® L connector. Then repeat for the retentate line,

and finally the permeate line.

NOTE Do not pull the membrane tabs on the connectors at

this step as the flow path installation is not complete.

EManifold Assembly

LManifold Assembly

Pairing E and L manifolds

6. Insert the center unification bracket provided with the E

manifold into the space on the inner handles of each manifold

plate and push the center unification bracket down until it clicks

into place, securely inter-locking the E and L manifolds. The

center unification bracket should self-align in the features used

to position it.

NOTE Both manifolds must be on the same flat surface to

allow the center unification bracket to seat correctly

and the four tabs on the bottom corners of the center

unification bracket must lock under the plate inner

handles, securely locking together the two manifold

units.

Gently push the center

unification bracket down:

Center unification bracket clicks

and secures manifolds:

Inserting the center unification bracket

7. Once all connectors have been paired between the manifolds

and to the TFF smart system and the center unification bracket

is in place, pull the membrane tabs from the AseptiQuik® L

connectors by following the manufacturer's instructions to

complete the flow path through the filtration unit.

Ce manuel convient aux modèles suivants

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