Sartorius Sartolab RF 50 User manual

Instructions for Use
Sartolab®RF | BT
RF 50 – 1000 | BT150 – 1000
Filtration Unit forVacuum Filtration
1000096582

Sartolab®RF | BTInstructions for Use 3
Contents
Contents
1 About these Instructions............................................................. 5
1.1 Validity .............................................................................5
1.2 Target Groups......................................................................5
1.3 Symbols Used......................................................................6
1.3.1 Warnings in Operation Descriptions........................................6
1.3.2 Other Symbols..............................................................6
2 Safety Instructions ................................................................... 6
2.1 General Function ..................................................................6
2.2 Significance of these Instructions..................................................7
2.3 Functionality of the Product .......................................................7
2.4 Spilled Liquids......................................................................7
3 Product Description ................................................................. 8
3.1 Product Overview..................................................................8
3.2 Vacuum Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
3.3 Vacuum Tube Adapter .............................................................9
3.4 Vacuum Filtration ..................................................................9
3.5 Product Symbols...................................................................9
4 Process Preparation.................................................................10
4.1 Scope of Delivery .................................................................10
4.2 Unpacking ........................................................................10
4.3 Assembling the Receiver Bottle (Sartolab®BT 150 – 1000 Only) .................10
4.4 Inserting Product into a Rack (Sartolab®RF 50 Sterile Only) .....................11
4.5 Connecting the Vacuum Source ..................................................11
4.5.1 Inserting the Product Into the Support Manifold ..........................11
4.5.2 Connecting the Product to theVacuum Source via the Vacuum Tube ....12
5 Use...................................................................................12
5.1 Filling the Funnel..................................................................12
5.2 Performing Filtration..............................................................13
5.3 Ending Filtration ..................................................................13
5.4 Preparing Filtrate for Storage (Sartolab®RF 50 | RF 150 – 1000 Only) ...........13
6 Storage ..............................................................................13
6.1 Storing the Product ...............................................................13
7 Disposal..............................................................................14
7.1 Decontaminating the Product ....................................................14
7.2 Disposing of the Product..........................................................14

4 Sartolab®RF | BTInstructions for Use
Contents
8 Technical Data .......................................................................15
8.1 Dimensions and Weights..........................................................15
8.2 Ambient Conditions...............................................................16
8.3 Storage Conditions ...............................................................16
8.4 Operating Conditions.............................................................16
8.4.1 Operating Pressure forVacuum Source ...................................16
8.4.2 Filtration Applications .....................................................16
8.4.3 Liquids.....................................................................17
8.4.4 Filtration Capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
8.5 Membrane Filter ..................................................................19
8.6 Sterility ...........................................................................20
8.7 Approved Products ..............................................................20
8.7.1 Receiver Bottle (Sartolab® RF | BT 150 – 1000 Only) .....................20
8.7.2 Support Manifold forVacuum Filtration Unit .............................20
8.8 Materials ..........................................................................21
9 Accessories .........................................................................22

Sartolab®RF | BTInstructions for Use 5
About these Instructions
1 About these Instructions
1.1 Validity
These instructions are part of the product. These instructions apply to the product in the following versions:
Pore Size
0.10 µm 0.22 µm 0.45 µm
Product Type Type Type
With collection tube
Sartolab®RF 50 sterile – 180E01---------2 180F01---------2
Sartolab®RF 50 non-sterile – 180E01--------E8 180F01--------E8
With receiver bottle
Sartolab®RF 150 – 180E02---------E 180F02---------E
Sartolab®RF 250 180D03---------E 180E03---------E 180F03---------E
Sartolab®RF 500 – 180E04---------E 180F04---------E
Sartolab®RF 1000 180D05---------E 180E05---------E 180F05---------E
Without receiver bottle
Sartolab®BT 150 – 180E12---------E –
Sartolab®BT 250 – 180E13---------E –
Sartolab®BT 500 – 180E14---------E –
Sartolab®BT 1000 – 180E15---------E 180F15---------E
1.2 Target Groups
These instructions are designed for the following target groups. The target groups must possess the knowledge
listedbelow.
Target Group Knowledge and Qualifications
User The user is familiar with how to use the product and with the associated work processes.The user
is familiar with the hazards that may arise when working with the product, and is able to avoid
these hazards. The user has received training on how to use the product.
Operator The operator of the product is responsible for ensuring compliance with workplace health and
safety regulations.The operator must ensure that anyone working with the product has access to
the relevant information and is trained to work with the product.

6 Sartolab®RF | BTInstructions for Use
Safety Instructions
1.3 Symbols Used
1.3.1 Warnings in Operation Descriptions
CAUTION
Denotes a dangerwith risk of moderate or minor injury may result if it is not
avoided.
1.3.2 Other Symbols
t Required action: Describes activities that must be carried out.
The actions in the sequence must be carried out in succession.
y Result: Describes the result of the activities carried out.
2 Safety Instructions
2.1 General Function
The product is used for vacuum filtration of liquids, e.g. cell culture media.
The filtration applications, the liquids used, and the filling volume must be
suitable for the product.
The product must be connected to a vacuum source during filtration.
Theliquid to be filtered must be poured into the funnel.
The product can be inserted into a support manifold. In this way, the
support manifold applies a vacuum to the product and filtration can be
performed simultaneously. The support manifold must be suitable for
theproduct.
If the product is used without a support manifold: The product must be
connected to a vacuum source, e.g. a vacuum pump, via a vacuum tube.
Thevacuum source must be suitable for the product.
The product is intended for single use and must be disposed of after
oneuse.
The product is intended exclusively for use in accordance with these
instructions. Any further use beyond this is considered improper.
Operating Conditions for the Product
The product may only be used for research purposes. The product is not
suitable for diagnostic applications.
The product may only be used with the equipment and under the operating
conditions described in the Technical Data section of these instructions.

Sartolab®RF | BTInstructions for Use 7
Safety Instructions
2.2 Significance of these Instructions
Failure to follow the instructions in this manual may have serious
consequences, e.g., danger to individuals.
t Read the instructions carefully and in full. The required actions in the
instructions build on each other.
t Ensure that the information contained in these instructions is available
to all individuals working with the product.
2.3 Functionality of the Product
A damaged product orworn parts can lead to malfunctions or cause hazards
that are difficult to identify.
t Only operate the product when it is safe and in perfect working order.
2.4 Spilled Liquids
If liquids are spilled, e.g., due to the product falling over or sudden
movement of the support manifold: People could come into contact with
the spilled liquids, or work surfaces could be contaminated.
t Use the lid to close the funnel.
t Do not cause any sudden movements to the product that could tip it
over or destabilize it, e.g., when pulling out the vacuum tube or when
working on the support manifold.
t Do not exceed the permitted temperatures for the product. When using
outside the permitted temperature range, the product may be damaged,
e.g., due to the collection container bursting.

8 Sartolab®RF | BTInstructions for Use
Product Description
3 Product Description
3.1 Product Overview
11
2
3
3
5
2
3
4
2
1
Fig.1: Product (with collection tube, with receiver bottle,without receiver bottle, example)
Pos. Name Description
1 Lid Removable.
2 Funnel −For pouring in the liquid to be
filtered.
−Contains the membrane filter.
3 Adapter −Connects the funnel to the
collection tube or the receiver
bottle vacuum-tight.
−For attaching the product to a
support manifold.
4 Collection tube Collection container for the filtrate.
5 Receiver bottle Collection container for the filtrate.

Sartolab®RF | BTInstructions for Use 9
Product Description
3.2 Vacuum Connection
The vacuum connection is intended to connect the product to a vacuum
source, e.g., a vacuum pump.
1
1
Fig.2: Vacuum connection (example)
Pos. Name
1 Vacuum connection
3.3 Vacuum Tube Adapter
The vacuum tube adapter (1) is intended for direct connection of the
vacuum filtration unit to a vacuum source. The vacuum tube adapter holds
the vacuum tube of the vacuum source.
3.4 Vacuum Filtration
The vacuum draws the liquids through the membrane. Particles that are
larger than the pore size of the membrane are removed from the liquid. The
liquid is collected as the filtrate in the collection tube.
3.5 Product Symbols
Symbol Description
Quantity
Order number
Batch number
Use by
Sterilized through irradiation
Do not re-use
Consult the Instructions for Use
1

10 Sartolab®RF | BTInstructions for Use
Process Preparation
4 Process Preparation
4.1 Scope of Delivery
Item Quantity
Product
Sartolab®RF 50 sterile 24
Sartolab®RF 50 non-sterile 96
Sartolab®RF 150 – 1000 | Sartolab®BT 150 – 1000 12
Vacuum tube adapter (sterile versions only) 24 or 12
Screw cap
Sartolab®RF 50 sterile 24
Sartolab®RF 50 non-sterile 96
Sartolab®RF 150 – 1000 12
Quality certificate 1
Instructions for Use 1
4.2 Unpacking
The screw caps are packaged individually in sterile packaging. Exception:
For the non-sterile versions, the screw caps are included in the product
packages. The sterile screw cap must be unpacked immediately before use.
Procedure
XCheck the usability of the product (see specification on packaging).
Dispose of products forwhich the usability has been exceeded.
XUnpack the product.
4.3 Assembling the Receiver Bottle
(Sartolab®BT 150 – 1000 Only)
The product must be attached to a receiver bottle. The receiver bottle must
be suitable for the product (see Chapter 8.7.1, page 20).
Material: Receiver bottle of a suitable size x1
Procedure
XScrew the product adapter onto the receiver bottle.

Sartolab®RF | BTInstructions for Use 11
Process Preparation
4.4 Inserting Product into a Rack
(Sartolab®RF 50 Sterile Only)
The product must be positioned upright during filtration. The product can
be inserted into a rack in order to ensure this. The bracket is not included in
the scope of delivery. The non-sterile versions of the products can only be
used with the Sartolab®Multistation because they are supplied without a
vacuum tube adapter.
1
Fig.3: Product placed in a rack (example)
Pos. Name
1 Rack
Material: 1 rack or 1 holder for 50mL centrifuge tubes
Procedure
t Insert the product into the chosen bracket.
4.5 Connecting the Vacuum Source
4.5.1 Inserting the Product Into the Support Manifold
The product can be inserted into a support manifold. In this way, the
support manifold applies a vacuum to the product during filtration and
multiple filtrations can be performed simultaneously.
1
2
4
5
1
Fig.4: Product inserted in support manifold (example: Sartolab®Multistation)
Pos. Name
1 Support manifold

12 Sartolab®RF | BTInstructions for Use
Use
Requirements
−The support manifold is suitable for the product (see Chapter 8.7.2,
page 20).
−The product is equipped with a collection tube or a receiver bottle or is
connected to a receiver bottle.
Procedure
t Insert the product adapter into the bracket of the support manifold
(seeinstructions for the support manifold).
4.5.2 Connecting the Product to the Vacuum Source via the
Vacuum Tube
Requirements
The product is not inserted in a support manifold.
Procedure
t Attach the tube adapter (1) to the vacuum connection (2).
t Attach the vacuum tube of the vacuum source to the tube adapter.
Thevacuum tube must not come loose during filtration.
5 Use
5.1 Filling the Funnel
CAUTION
Danger of injury due to contamination of the vacuum source!
Excess liquid in the funnel can cause the liquid to be aspirated into the
vacuum source or the support manifold:
t Do not exceed the maximum filling volume (see Chapter 8.4.4,
page 17).
Procedure
t Make sure the funnel is securely attached to the collection tube or the
receiver bottle.
t If required:Tighten the funnel.
t Remove the lid from the funnel.
t Pour the required quantity of liquid into the funnel.
t If diatomaceous earth is used as a filter aid for clarifying filtration:
Observe the handling specifications (see instructions for the
diatomaceous earth filter aid).
t Place the lid on the funnel.
1
2

Sartolab®RF | BTInstructions for Use 13
Storage
5.2 Performing Filtration
Procedure
t Connect the vacuum source so that a vacuum is applied to the product
(See instructions for the vacuum source or support manifold).
y The filtrate is collected in the collection tube or receiver bottle.
5.3 Ending Filtration
CAUTION
Danger of injury due to spilled liquids!
t Do not cause any sudden movements to the product that could tip it
over or destabilize it.
Procedure
t Shut off the vacuum source (see instructions for the vacuum source or
support manifold).
t Remove the product from the support manifold (see instructions for the
support manifold) or pull the vacuum tube out off the tube adapter.
t Unscrew the funnel with adapter from the collection tube or receiver
bottle and dispose of it.
5.4 Preparing Filtrate for Storage
(Sartolab®RF 50 | RF 150 – 1000 Only)
The filtrate can be stored in the collection tube or receiver bottle. The
receiver bottle must be sealed with the appropriate screw cap.
Procedure
t Unpack the screw cap and screw onto the collection tube or receiver
bottle.
6 Storage
6.1 Storing the Product
Procedure
t Store the product in accordance with the storage conditions (see
Chapter 8.3, page 16).

14 Sartolab®RF | BTInstructions for Use
Disposal
7 Disposal
7.1 Decontaminating the Product
If the product has come into contact with hazardous substances: Steps must
be taken to ensure proper decontamination and declaration. The operator
of the product is responsible for adhering to local government regulations
on the proper decontamination and declaration for transport and disposal.
Procedure
t If the product has come into contact with hazardous substances:
Decontaminate the product.
7.2 Disposing of the Product
The product must be disposed of properly. The packaging is made of
environmentally friendly materials that can be used as secondary raw
materials.
Procedure
t Dispose of the product in accordance with local government regulations.
t Dispose of the packaging in accordance with local government
regulations.

Sartolab®RF | BTInstructions for Use 15
Technical Data
8 Technical Data
8.1 Dimensions and Weights
Sartolab®RF 50 – 250
Sartolab®RF 50 Sartolab®RF 150 Sartolab®RF 250
Unit Value Value Value
Height mm 116 142 180
Outer diameter, max. mm 78 100 100
Product weight g51 100 114
Sartolab®RF 500 – 1000
Sartolab®RF500 Sartolab®RF 1000
Unit Value Value
Height mm 206 318
Outer diameter, max. mm 124 124
Product weight g 115 257
Sartolab®BT 150 – 250
Sartolab®BT 150 Sartolab®BT 250
Unit Value Value
Height mm 88 103
Outer diameter, max. mm 100 100
Funnel to fit bottle neck size mm 45 45
Product weight g61 68
Sartolab®BT 500 – 1000
Sartolab®BT 500 Sartolab®BT 1000
Unit Value Value
Height mm 114 171
Outer diameter, max. mm 124 124
Funnel to fit bottle neck size mm 45 45
Product weight g 102 135

16 Sartolab®RF | BTInstructions for Use
Technical Data
8.2 Ambient Conditions
Unit Value
Temperature
During use, max. °C 70
During transport, max. °C 60
8.3 Storage Conditions
Unit Value
Collection tube or collection
container filled with filtrate
and sealed with screw cap
Temperature
Sartolab®RF 50 °C -80 – +100
Sartolab®RF 150 – 10001°C -20 – +70
1Storage at temperatures of -20°C–0°C is dependent on the liquid type and the storage conditions.
We recommend conducting a storage test for the solution before use.
8.4 Operating Conditions
8.4.1 Operating Pressure forVacuum Source
Unit Value
Operating pressure of vacu-
um source
mbar -350 – -750
8.4.2 Filtration Applications
Membrane Filter Pore Size Recommended Filtration Application
0.10 µm Retention of mycoplasma
0.22 µm Sterile filtration
0.45 µm Clarification

Sartolab®RF | BTInstructions for Use 17
Technical Data
8.4.3 Liquids
Liquid type
Aqueous solutions, e.g., buffer or cell culture media
−It is not advisable to use the following fluids: Acids, aldehydes, aliphatic amines, aromatic amines, alkalis,
esters, hydrocarbons, and ketones
−Fluids and temperatures may impair the properties of the product, e.g., mechanical strength, color,
appearance, and dimensional stability
Alcohols may be suitable for some applications.We recommend testing the product with the solution
beforeuse.
8.4.4 Filtration Capacity
Sartolab®RF 50 – 250
Sartolab®RF 50 Sartolab®RF 50 Sartolab®RF 50
Unit Value Value Value
Type 180E01---------2 180F01---------2 180E01--------E8
Filling volume, max. mL 50 50 50
Funnel volume mL 50 50 50
Receiver bottle volume mL 50 50 50
Hold-up volume mL 1.2 1.2 1.2
Sartolab®RF 50 Sartolab®RF 150 Sartolab®RF 150
Unit Value Value Value
Type 180F01--------E8 180E02---------E 180F02---------E
Filling volume, max. mL 50 150 150
Funnel volume mL 50 150 150
Receiver bottle volume mL 50 150 150
Hold-up volume mL 1.2 2.7 2.7
Sartolab®RF 250 Sartolab®RF 250 Sartolab®RF 250
Unit Value Value Value
Type 180D03---------E 180E03---------E 180F03---------E
Filling volume, max. mL 250 250 250
Funnel volume mL 250 250 250
Receiver bottle volume mL 250 250 250
Hold-up volume mL 2.7 2.7 2.7

18 Sartolab®RF | BTInstructions for Use
Technical Data
Sartolab®RF 500 – 1000
Sartolab®RF 500 Sartolab®RF 500 Sartolab®RF 1000
Unit Value Value Value
Type 180E04---------E 180F04---------E 180D05---------E
Filling volume, max. mL 500 500 1000
Funnel volume mL 500 500 1000
Receiver bottle volume mL 500 500 1000
Hold-up volume mL 4.1 4.1 4.1
Sartolab®RF 1000 Sartolab®RF 1000
Unit Value Value
Type 180E05---------E 180F05---------E
Filling volume, max. mL 1000 1000
Funnel volume mL 1000 1000
Receiver bottle volume mL 1000 1000
Hold-up volume mL 4.1 4.1
Sartolab®BT 150 – 250
Sartolab®BT 150 Sartolab®BT 250
Unit Value Value
Type 180E12---------E 180E13---------E
Funnel volume mL 150 250
Hold-up volume mL 2.7 2.7
Sartolab®BT 500 – 1000
Sartolab®BT 500 Sartolab®BT 1000 Sartolab®BT 1000
Unit Value Value Value
Type 180E14---------E 180E15---------E 180F15---------E
Funnel volume mL 500 1000 1000
Hold-up volume mL 4.1 4.1 4.1

Sartolab®RF | BTInstructions for Use 19
Technical Data
8.5 Membrane Filter
Sartolab®RF 50 – 250
Sartolab®RF 50 Sartolab®RF 150 Sartolab®RF 250
Unit Value Value Value
Membrane diameter mm 58.5 80 80
Effective filtration surface cm221 43 43
Pore size µm 0.22
0.45
0.22
0.45
0.10
0.22
0.45
Membrane type: PES
Sartolab®RF 500 – 1000
Sartolab®RF 500 Sartolab®RF 1000
Unit Value Value
Membrane diameter mm 100 100
Effective filtration surface cm269 69
Pore size µm 0.22
0.45
0.10
0.22
0.45
Membrane type: PES
Sartolab®BT 150 – 250
Sartolab®BT 150 Sartolab®BT 250
Unit Value Value
Diameter mm 80 80
Effective filtration surface cm243 43
Pore size µm 0.22 0.22
Membrane type: PES

20 Sartolab®RF | BTInstructions for Use
Technical Data
Sartolab®BT 500 – 1000
Sartolab®BT 500 Sartolab®BT 1000
Unit Value Value
Diameter mm 100 100
Effective filtration surface cm269 69
Pore size µm 0.22 0.22
0.45
Membrane type: PES
8.6 Sterility
Sterilized before delivery (beta irradiation) and packaged individually in sterile packaging
Exception (non-sterile versions):
Sartolab®RF 50 non-sterile (180E01--------E8 and 180F01--------E8)
Product not suitable for autoclaving
8.7 Approved Products
8.7.1 Receiver Bottle (Sartolab®RF | BT 150 – 1000 Only)
Unit Value
Bottle neck size mm 45
Receiver bottle volume is
equal to or greater than funnel
volume
Suitable for:
Vacuum
8.7.2 Support Manifold forVacuum Filtration Unit
Sartolab®Multistation
Suitable for:
Sartolab®RF 50 – 1000
Sartolab®BT 150 – 1000, attached to a suitable receiver bottle