Sartorius Stedim Biotech Sartocube Manuel utilisateur

User Manual | Bedienungsanleitung

Sartocube®|Sartocon®|Sartocon®Slice|

Sartocon®Slice 200 Cassettes

White Silicone | Weißes Silikon

1000035949 Vers. 11 | 2018

2Contents

English page 3

Deutsch Seite 31

Contents

1. About this Document .............................................................4

1.1 Accompanying Documents...................................................5

1.2 Symbols Used.................................................................5

2. Shelf Life of unused Filtration Units.............................................6

3. Safety Instructions ................................................................7

4. Components of a Crossflow System ............................................ 10

5. Start up of cassettes ............................................................ 11

5.1 Installing Filter Cassettes in a Holding Device.............................. 11

5.2 Clamping Forces ............................................................ 12

5.3 Rinsing Cassettes ........................................................... 13

5.4 Integrity Test ............................................................... 13

5.4.1 Manual Integrity Test .............................................. 14

5.4.2 Automatic Integrity Test (Pressure Decay) ......................... 14

5.5 Determining Clean Water Flux for Filter Cassettes (CWF) .................. 15

5.6 Thermal Sterilization of Filter Cassettes.................................... 16

5.6.1 In-Line Steam Sterilization of Sartocon®Microfilter Cassettes .... 16

5.6.2 In-Line Steam Sterilization of Sartocon®Ultrafilter Cassettes..... 18

5.6.3 Autoclaving the Filter Cassette .................................... 20

5.7 Filtration.................................................................... 21

5.8 Cassette Cleaning........................................................... 22

5.9 Cassette Storage............................................................ 24

5.9.1 Short Term Storage ................................................ 24

5.9.2 Long Term Storage ................................................. 24

5.10 Cassette Return Instructions ............................................... 25

5.11 Disposal..................................................................... 25

6. Technical Data................................................................... 26

6.1 Technical Specifications Sartocon®Slice 200............................... 26

6.2 Technical Specifications Sartocon®Slice ................................... 27

6.3 Technical Specifications Sartocon®......................................... 28

6.4 Technical Specifications Sartocube®........................................ 29

4About this Document

1. About this Document

This user manual provides you with all the information necessary to install

the Sartocube®, Sartocon®, Sartocon®Slice and Sartocon®Slice 200 Cassettes.

These cassettes will also hereinafter be referred to as product or cassette.

− The user manual informs you about how to operate the product according

to the safety requirements.

The user manual must be read, understood and used by all persons entrusted with the

installation and use of the product. This applies particularly to the safety instructions

listed.

− Please read this user manual carefully and completely before working with

the cassette.

− This user manual is part of the product. Keep it in a safe and easily accessible place

near the device's site of installation.

− If the manual should be lost or misplaced, please contact Sartorius for a

replacement or download the latest version from our website: www.sartorius.com

In addition to the user manual, all generally valid, legal and otherwise binding

regulations for accident protection and environmental protection of the country of

use must be observed.

This user manual must always be kept at the place of use of the cassette.

− Any guarantees and warranties shall apply to manufacturing-related defects and

malfunctions.

− The device is designed for standard laboratory conditions and techniques.

This user manual describes the product at the time of printing stated in the revision

number.

All data has been compiled with care, although no guarantee can be given for the

data provided. Sartorius Stedim Biotech GmbH reserves the right to make technical

changes to the design and equipment of its products or to make changes to the

associated documentation without any prior notice or specific mention.

Because Sartorius' products are constantly undergoing further development, some

components and their operation may not be described in this manual.

This manual may also contain information that does not apply to setup. Please notify

us if any information is missing that is important to you, if you find any errors in the

content or require more extensive information on specific components.

If you have any questions about our product program or the use of the cassette

which are not dealt with in this manual, please contact:

Sartorius Stedim Biotech GmbH

Crossflow Business Unit

August-Spindler-Strasse 11

37079 Goettingen, Germany

Phone +49.551.308.0

Fax +49.551.308.289

[email protected]

www.sartorius-stedim.com

About this Document

1.1 Accompanying Documents

This user manual describes how to install the product along with the standard

equipment intended for this purpose.

In addition to these instructions, please observe the user manual for the filter holder.

1.2 Symbols Used

As a means of instruction and direct warning against hazards, all text statements to

be particularly noted in this user manual will be marked as follows:

This instruction denotes a possible danger with medium risk that death or severe

injury may result if it is not avoided.

This symbol denotes a possible danger with risk that moderate or minor injury

may result if it is not avoided.

This symbol denotes a danger with the low risk

that could result in property damage if the risk is not avoided.

This symbol indicates that the preservative is not suitable for consumption.

This symbol

− is an indication of a function or setting on the device.

− that caution should be exercised while working.

− identifies useful information.

The following presentations will also be used:

–Texts that follow this mark are lists.

tTexts that follow this mark describe activities that must be carried out

in the specified order.

yTexts that follow this mark describe the result of an action.

“ ” Texts in quotes are references to other chapters or sections.

[Æ]Texts following this symbol make reference to other chapters, sections

or documents.

6Shelf Life of unused Filtration Units

2. Shelf Life of unused Filtration Units

The latest date of usage is 3 years from date of manufacture.

The following conditions have to be maintained during storage in order

to guarantee full cassette functionality:

Cassettes must be stored in a closed dry area.

Temperature has to be between 5°C to 40°C and absolutely frost free.

No direct solar radiation.

No direct contact with moisture.

Any mechanical influence or damage must be prevented.

Products with damaged packaging should be discarded.

Safety Instructions

3. Safety Instructions

The preservative is not suitable for consumption.

During in-line sterilization of the holding device with hot steam, the entire

system becomes very hot. Do not touch any part of the system with your bare

hands. If you need to handle any part of the system, wear heavy safety gloves

to avoid getting severely burned.

During in-line steam sterilization, hot steam exits from the feed inlet and

from the permeate outlets. Keep a safe distance to these outlets and do not try

to reach inside them; as there is a serious risk of severe burns.

Do not apply more than the torque given in [ÆChapter “5.2 Clamping Forces”,

page 12]. Torquing the filter cassettes too tightly will damage them.

The maximum inlet pressure must not be exceeded

[ÆChapter “6. Technical Data”, page 26].

Over pressurizing will damage the filter cassettes.

Before thermal sterilization, exchange the torque nuts for normal operation

to the torque nuts for pressure compensation. These pressure compensation

torque nuts keep the torque constant even when the temperature fluctuates.

If the pressure compensating torque nuts are not used, the torque will increase

beyond the maximum allowable compression during thermal sterilization,

causing irreversible damage to the filter cassettes.

Do not allow any type of filter cassette to dry out to avoid loss of filtration

properties.

Make sure that the filter cassettes you plan to use have the required chemical

compatibility before beginning a filtration run in order to avoid damaging the

membranes. If you are not sure about the compatibility of a filter cassette with

a certain chemical, please consult your nearest Sartorius Stedim Application

specialist.

Do not combine cassettes with white and gray silicone encapsulation in one

holding device.

Avoid abrupt changes in pressure (approximately > 1 bar/sec), such as those that

can occur when the pump is switched on or when the valves settings are

changed.

Keep vibration to the lowest level that is technologically possible.

The effective torque on hydraulic holding devices should be kept constant, espe-

cially when the holding device is installed in a large filtration system.

The maximum allowable back pressure on the permeate side must not exceed

0.5 bar for Hydrosart®UF and 1 bar for PESU max and Hydrosart®open channel

cassettes.

The outer silicone sealing of cassettes should be washed of with DI water, after

submerged storage, before installation into a cassette holding device.

8Safety Instructions

Retentate backpressure is defined as follows:

Permeate pressure is higher than the Retentate pressure

Pperm > P ret ;

P back = Pperm - P ret .

Hydrostatic pressure on the permeate side (height and the inner diameter of the

filtrate tubing) has an impact on backpressure.

Please make sure that the maximum backpressure is never exceeded.

Note

This has to be distinguished from Transmembrane Pressure.

− Transmembrane pressure (TMP):

TMP = [(pfeed + pret)/2] - pperm

− and from Differential Pressure:

Δp = pfeed - pret

Feed pressure (pfeed) and retentate pressure (pret), both measureable with a gauge.

Permeate pressure (pperm) is the average pressure on the permeate side, measureable

with a gauge.

If the possibility of crystalline particles entering the cassettes cannot be

completely ruled out (for example, due to abrasion in the pumps), a prefilter

must be used.

Make sure that crystallization caused by changes in temperature or

concentration cannot occur during operation or storage.

Do not combine cassettes that have a different feed inlet design.

Sartocon®cassettes have alternating oval and round ports.

Install the filter cassettes in the appropriate holding device only. You will need

either a Sartocon®Slice, Sartocon®2 plus or a Sartoflow®holding device,

depending on the type and amount of filter cassette you plan to use. If you wish

to use holding devices supplied by other manufacturers, you may need to apply a

different torque pressure when installing cassettes. To avoid damaging the cas-

settes, please contact our application specialist.

Make sure that the correct crossflow conditions are maintained during

filtration. Otherwise, the flux rate of the filter cassettes will decrease rapidly

during filtration under static conditions (dead-ended filtration) [ÆChapter “5.7

Filtration”, page 21].

Sartocon®Slice 200

Cassette

Sartocon®Slice Cassette Sartocon®Cassette Sartocube®Cassette

Safety Instructions

The temperature of the retentate must not exceed that given for continuous

operation, which is listed in the “Specifications.” During crossflow filtration, the

temperature will increase over time because the kinetic energy of the pump is

transferred to the liquid undergoing filtration. If the temperature increases

beyond that indicated in the “Technical Specifications,” the pressure resistance

of the crossflow system will decrease.

You should use a prefilter. This will enhance the flux rate and increase

the service life of the filter cassettes.

You should clean the filter cassettes after every filtration run. During filtration

a layer caused by fouling builds up on the membranes. Over time, this layer

becomes compacted, making it difficult to remove completely. As a result, the

flux rate of your filter cassettes will decrease.

All filter cassettes used in one holding device must have identical membranes.

If you do not need to use filter cassettes for a relatively long period, you should

store them in a solution that contains a preservative. This will protect the filter

cassettes from microbial contamination and from drying out.

Do not attempt to operate the filtration system with accessories or spare parts

other than those supplied by the original manufacturer. In the event that

the filtration system is tampered with in any way, we cannot guarantee or take

any responsibility for the performance or safety of the system. This may also

endanger the safety of the operator.

Use only materials recommended by the manufacturer (e.g. gaskets, tubing

or hoses).

10 Components of a Crossflow System

4. Components of a Crossflow System

Holding Device

Sartocon®Slice 200

(Holder for max. 2 Slice 200

Cassettes)

Mat. No. #17525---01

Sartocon®Slice

(for 1-3 Slice Cassette Holder)

Mat. No. #17521---001

Need for No. #: 1ZLI-V0001

additional longspacers to run

a Slice 200 cassette

Sartocon®Slice

(for 1-5 Slice Cassette Holder

[Sartoflow®Alpha])

Mat. No. #17521---002

Sartocon®2 plus

1–10 Cassettes

[Order Nr.: 17546*]

Sartoflow®10 Holder

1–10 Cassettes

Sartoflow®20 Holder

2–20 Cassettes

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