Sartorius 16274 User manual

80260-000-50
Operating Instructions | Betriebsanleitung
Stainless Steel In-Line Filter Holder |
Edelstahl-Druckfiltrationsgerät
Type | Typ 16274
80260-000-50

English page 
Deutsch Seite 37

Contents
Operating Instructions Stainless Steel In-Line Filter HolderType 16274 3
Contents
1 About these Instructions............................................................. 5
1.1 Scope ..............................................................................5
1.2 Accompanying Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
1.3 Target Groups......................................................................5
1.4 Symbols Used......................................................................6
1.4.1 Warnings in Operation Descriptions........................................6
1.4.2 Other Symbols..............................................................6
2 Safety Instructions ....................................................................7
2.1 Intended Use.......................................................................7
2.2 Personnel Qualification ............................................................7
2.3 Proper Working Order of the Device...............................................7
2.4 Components Under Pressure ......................................................8
2.4.1 Overpressure ...............................................................8
2.5 Compatibility of Media and Materials ..............................................8
2.6 Hot Surfaces .......................................................................8
2.7 Conduct in an Emergency .........................................................8
2.8 Accessories, Consumables, and Spare Parts .......................................9
2.9 Personal Protective Equipment....................................................9
3 Device Description..................................................................10
3.1 Device Overview ..................................................................10
3.2 Device Connections ..............................................................11
3.3 Functionality ......................................................................12
4 Installation ...........................................................................13
4.1 Scope of Delivery .................................................................13
4.2 Selecting an Installation Site ......................................................13
4.3 Unpacking ........................................................................14
4.4 Mounting the Device..............................................................14
5 Getting Started ......................................................................16
5.1 Preparing Device Connection.....................................................16
5.1.1 Dismantling the Device....................................................16
5.1.2 Cleaning the Device .......................................................17
5.1.3 Reassembling the Device..................................................17
5.2 Inserting a Membrane Filter.......................................................18
5.3 Sealing the Device ................................................................18
5.4 Sterilizing the Device..............................................................19
6 Operation...........................................................................20
6.1 Performing an IntegrityTest......................................................20
6.2 Filtering Liquids ...................................................................21
7 Maintenance Schedule..............................................................22
8 Malfunctions........................................................................22
9 Decommissioning ...................................................................23

Contents
4 Operating Instructions Stainless Steel In-Line Filter HolderType 16274
10 Storage and Shipping ...............................................................24
10.1 Storage...........................................................................24
10.2 Returning the Device and Parts .................................................. 24
11 Disposal.............................................................................25
11.1 Information on Decontamination ................................................25
11.2 Dismantling the Device ..........................................................25
11.3 Disposing of the Device and Parts ...............................................26
11.3.1 Information on Disposal ..................................................26
11.3.2 Disposal...................................................................26
12 Technical Data ......................................................................27
12.1 General Data......................................................................27
12.2 Dimensions and Weight...........................................................27
12.3 Ambient Conditions at the Installation Site .......................................27
12.4 Operating Conditions.............................................................27
12.5 Device Connections ..............................................................27
12.6 Materials .........................................................................28
12.7 Compatibility of Media and Materials ............................................28
13 Accessories and Spare Parts ........................................................34
13.1 Accessories ......................................................................34
13.1.1 Seals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
13.1.2 Connectors, Pressure Tubes and Adapters ...............................34
13.1.3 Recommended Filters ....................................................34
13.1.4 Pressure Vessels with TC 50.5 Connection ...............................35
13.1.5 Other .....................................................................35
13.2 Spare Parts .......................................................................35
14 Sartorius Service ....................................................................36

Operating Instructions Stainless Steel In-Line Filter HolderType 16274 5
About these Instructions
1 About these Instructions
1.1 Scope
These instructions are part of the device. These instructions apply to the
device in the following version:
Device Model
Stainless steel pressure filtration device 16274
1.2 Accompanying Documents
t In addition to these instructions, observe the following documentation:
— Certificates on the device or its components
— Certificate of manufacture and pressure test
1.3 Target Groups
These instructions are addressed to the following target groups. The target
groups must possess the specified knowledge.
Target group Knowledge and responsibilities
User The user is familiar with the operation of the
device and the associated work processes. They
understand the hazards which may arise when
working with the device and know how to
prevent them.
The user is trained in the operation of the device.
The training is carried out by the operating
engineer | laboratory manager or the operator of
the device.
Operating engineer |
laboratory manager
The operating engineer | laboratory manager
makes decisions about the use and operating
conditions of the device.
Operator The operator of the device is responsible for
ensuring compliance with workplace health and
safety regulations.
The operator must ensure that all persons who
work with the device have access to the relevant
information and are trained in working with the
device.

6 Operating Instructions Stainless Steel In-Line Filter HolderType 16274
About these Instructions
1.4 Symbols Used
1.4.1 Warnings in Operation Descriptions
WARNING
Denotes a dangerwith the risk that death or severe injury may result if it is
not avoided.
CAUTION
Denotes a hazard that may result in moderate or minor injury if it is not
avoided.
NOTICE
Denotes a dangerwith the risk that property damage may result if it is not
avoided.
1.4.2 Other Symbols
t  Required action: Describes actions which must be carried out.
y Result: Describes the result of the actions carried out.

Operating Instructions Stainless Steel In-Line Filter HolderType 16274 7
Safety Instructions
2 Safety Instructions
2.1 Intended Use
The device was developed for sterile filtration of difficult-to-filter liquids
(e.g. serum) and particle removal from solvents or viscous liquids (e.g.
photoresist) and is intended for general laboratory use.
The device is exclusively designed for use in accordance with these
instructions. Any further use beyond this is considered improper.
If the device is not used properly:The device’s protective systems may be
impaired. This can lead to unforeseeable personal injury or property
damage.
Operating conditions for the device
Do not use the device in potentially explosive environments. Only use the
device indoors.
The device may only be used with the equipment and under the operating
conditions described in the Technical Data section of these instructions and
on the device’s type plate.
Modifications to the device
You may not modify or repair the device or make any technical changes.
Any retrofitting or technical changes to the device are only permitted with
prior written permission by Sartorius Stedim Biotech.
2.2 Personnel Qualification
Persons who do not possess adequate knowledge about how to use the
device safely may injure themselves and other persons.
If a particular qualification is required for an activity: The target group will be
specified. If no qualification is specified: The activity may be carried out by
the “operator” target group.
2.3 Proper Working Order of the Device
A damaged device or worn parts may lead to malfunctions or cause hazards
which are difficult to recognize.
t Only operate the device when it is safe and in proper working order.
t Complywith the maintenance intervals (for intervals and maintenance
work, see Chapter “7 Wartungsplan”, page 56).
t Have any malfunctions or damage repaired immediately by Sartorius
Service.

8 Operating Instructions Stainless Steel In-Line Filter HolderType 16274
Safety Instructions
2.4 Components Under Pressure
2.4.1 Overpressure
If the device is subjected to excessive pressure: The device may be
damaged. Liquids or gases may escape uncontrollably and cause serious
injuries to personnel.
t Stay within the permitted temperature ranges (for the permitted ranges,
Chapter “12 Technical Data”, page 27).
t Before the device is pressurized: Check all detachable connections are
fitted securely.
t Connect devices for pressure monitoring, e.g. a pressure gage.
2.5 Compatibility of Media and Materials
The media used must be suitable for the device, accessories, and
consumables. The media must not corrode the device and seals.
If the materials are corroded: Parts of the device may be damaged, e.g.
seals. Damaged seals can lead to the leakage of media.
t Only use accessories, consumables, and spare parts that are compatible
with the media used (for the device materials, see Chapter “12.6
Materials”, page 28, for the chemical resistance of the materials, see
Chapter “12.7.1 Chemical Resistance of the Device Materials”,
page 28 and Chapter “12.7.2 Chemical Resistance of the Seal
Materials”, page 30).
t Only use accessories, consumables, and spare parts that are in proper
working order.
t For special applications or ambiguities, request written approval for the
compatibility from Sartorius Stedim Biotech.
t When using chemical cleaning agents: Observe the manufacturer’s
material safety data sheets and the applicable legislation and accident
prevention laws.
2.6 Hot Surfaces
Depending on the application, parts of the device may heat up so much
during operation that surfaces become hot. There is a risk of burning if body
parts touch these surfaces.
t Avoid contact with hot surfaces.
t Before working on the device: Leave the device to cool down.
t Wear personal protective equipment.
2.7 Conduct in an Emergency
If there is immediate danger of personal injury or equipment damage, e.g.
due to malfunctions or dangerous situations, the device must be immedi-
ately taken out of operation.

Operating Instructions Stainless Steel In-Line Filter HolderType 16274 9
Safety Instructions
2.8 Accessories, Consumables, and Spare Parts
Unsuitable accessories, consumables, and spare parts can adversely affect
functionality and safety, and have the following consequences:
— Risk of injury to persons
— Damage to the device
— Device malfunctions
— Device failure
t You should only use approved accessories, consumables, and spare parts
supplied by Sartorius Stedim Biotech.
t Only use accessories, consumables, and spare parts that are in proper
working order.
2.9 Personal Protective Equipment
Personal protective equipment protects against risks arising from the device
and the material being processed. If the personal protective equipment is
missing or unsuitable: Personnel may be injured.
Protective Equipment
Designation Explanation/examples
Protective work clothing Tight-fitting work clothing with low tear
resistance, tight sleeves, and without any
projecting parts./ Protects against getting
caught in moving parts or chemicals, heat and
injuries.
Safety gloves Protect against chemicals, heat, and injuries.
Safety glasses Protect against substances escaping under
high pressure, and liquid spray and splashes.
t Wear appropriate personal protective equipment.
t If the workplace or the process in which the device is used requires
additional safety precautions: Additionally wear the appropriate personal
protective equipment.

10 Operating Instructions Stainless Steel In-Line Filter HolderType 16274
Device Description
3 Device Description
3.1 Device Overview
Fig.1: Stainless steel pressure filtration device
Pos. Designation Description
1 Upper part of device With lasered data (order number, serial number, pressure, volume)
2 O-ring Silicone
3 Backflow prevention device PTFE coated
4 Filter support PTFE coated
5 O-ring Silicone
7
8
9
1
2
3
4
5
6

Operating Instructions Stainless Steel In-Line Filter HolderType 16274 11
Device Description
Pos. Designation Description
6 Perforated sheet
7 Lower part of the device
8 Locking clamp
9 Device leg Stainless steel
3.2 Device Connections
1
5
4
2
3
Fig.2: Stainless steel pressure filtration device
Pos. Designation Description
1 Filler opening Receives the medium to be filtered.
2 Filler opening cap With PTFE coating
3 Outlet With tube nozzle, directs the medium out of the device.
4 Valve with tube nozzle Fluoroelastomer O-ring and PTFE gasket
5 Inlet With tube nozzle, to connect the pressure tube.

12 Operating Instructions Stainless Steel In-Line Filter HolderType 16274
Device Description
3.3 Functionality
Pressure filtration devices are used with the appropriate membrane filter for
clear filtration, ultrapurification or sterile filtration of liquids and the filtration
of air or other gases.
Depending on the objective of the filtration, the volume and the viscosity of
the medium to be filtered, the wide range of different filter types and
devices offers a suitable filtration system for almost every application.
All the pressure filtration devices are autoclavable and, due to their
construction, enable easy, effective cleaning.

Operating Instructions Stainless Steel In-Line Filter HolderType 16274 13
Installation
4 Installation
4.1 Scope of Delivery
Item Quantity
Lower part of device with 3 locking clamp screws 1
Lower part of the device 1
Stainless steel device leg 3
Filler opening cap 1
Valve 1
O-ring 2
Tube nozzle 2
Backflow prevention device 1
Filter support 1
Perforated sheet 1
Locking clamps 3
4.2 Selecting an Installation Site
Procedure
t Make sure that the following conditions are met at the installation site:
Condition Characteristics
Ambient conditions — Suitability tested (see Chapter “12.3
Ambient Conditions at the Installation
Site”, page 27 for ambient conditions)
Setup surface — Sufficiently dimensioned for the device and
the peripheral devices (for the space
requirements of the device, see
Chapter “12.2 Dimensions and Weight”,
page 27; for the peripheral device
space requirements, see instructions for
the peripheral devices, e.g. pressure tanks)
— Sufficient load-bearing capacity for the
device and the peripheral devices even
when full (for the device weight, see
Chapter “12.2 Dimensions and Weight”,
page 27; for the weight of the
peripheral devices, see the instructions for
the peripheral devices, e.g. pressure tanks)
Access to parts
relevant to operation
— Barrier-free

14 Operating Instructions Stainless Steel In-Line Filter HolderType 16274
Installation
4.3 Unpacking
Procedure
t Unpack the device.
t Check the completeness of the device and all its components (see
Chapter “4.1 Scope of Delivery”, page 13).
t Keep all the parts of the original packaging, e.g. to return the device.
4.4 Mounting the Device
Procedure
t Screw a valve onto the bottom of the lower part of the device.
t Screw on a tube nozzle or the filling device with manual operation
(accessory) at the bottom of the lower part of the device.
t Tighten the tube nozzle with a spanner.
t Screw the three device legs into the threads on the bottom of the lower
part of the device.
t Position the device on the three legs.
t Place the perforated sheet centrally on the lower part of the device with
the outer edge facing upwards.
t Push one of the two O-rings into the groove provided on the filter
support.

Operating Instructions Stainless Steel In-Line Filter HolderType 16274 15
Installation
t Place the filter support on the perforated sheet.
t Screw the other tube nozzle into the thread on the side of the upper part
of the device.
t Push the second O-ring into the groove on the inside of the upper part
of the device.
t Place the upper part of the device on a stable surface, e.g. a table, with
the inside facing upwards.
t Insert the backflow prevention device so that the lugs face downwards
and one of the lugs is in line with the valve.
t Push the backflow prevention device down onto the inside of the upper
part of the device and turn it until the lugs are in the recesses provided
for that purpose.
t Seal the filler opening with the filler opening cap.

16 Operating Instructions Stainless Steel In-Line Filter HolderType 16274
Getting Started
5 Getting Started
5.1 Preparing Device Connection
Before the initial commissioning and after each use, the device and all of its
components must be dismantled, cleaned and reassembled.
5.1.1 Dismantling the Device
Procedure
t Loosen the locking clamps.
t Remove the upper part of the device from the lower part of the device.
t Unscrew the filler opening cap.
t Place the upper part of the device on a stable surface, e.g. a table, with
the inside facing upwards.
t When a membrane filter and, if applicable, a prefilter are inserted into
the device: Remove all inserted filters.
t To remove the backflow prevention device from the upper part of the
device: Rotate the backflow prevention device until the recesses in the
upper part of the device and the lugs of the backflow prevention device
overlap.
t Remove the O-ring from the groove on the inside of the upper part of
the device.
t Remove the tube nozzle from the upper part of the device.
t Remove the filter support from the perforated sheet.
t Remove the O-ring from the groove on the filter support.

Operating Instructions Stainless Steel In-Line Filter HolderType 16274 17
Getting Started
t Remove the perforated sheet from the lower part of the device.
t Remove the three device legs from the lower part of the device.
t Remove the valve from the lower part of the device.
t Remove the tube nozzle from the lower part of the device.
5.1.2 Cleaning the Device
Requirement
The device is dismantled.
Procedure
t NOTICE Corrosion or damage to the device due to unsuitable cleaning
agents! Clean the device and all disassembled device components with
warm water, a soft brush and gentle, commercially available laboratory
cleaning agents. The cleaning agent must be suitable for metal, glass,
and plastic.
t Rinse the device and all device components with hot water after cleaning
them.
t Rinse the device and all device components with distilled water.
t NOTICE Fiber residues on the device due to the use of cloths! Dry the
device and all device components in the compressed-air flow or leave to
air dry, do not drywith cloths.
5.1.3 Reassembling the Device
Procedure
t Assemble the device (see Chapter “4.4 Mounting the Device”,
page 14).

18 Operating Instructions Stainless Steel In-Line Filter HolderType 16274
Getting Started
5.2 Inserting a Membrane Filter
Procedure
t Take the membrane filter out of the packaging, e.g. with tweezers, and if
necessary moisten it with distilled water.
t When inserting a cellulose nitrate filter in a dry device: Do not wet the
membrane filter. Only use dry cellulose nitrate filters.
t When inserting a cellulose nitrate filter in a wet device: Only use a wet
cellulose nitrate filter.
t When inserting a cellulose acetate filter or a nylon filter (polyamide)
into the device: Only use a wet membrane filter.
t Place the membrane filter centrally on the filter support without tension.
t If staged filtration is to be carried out: Insert up to three membrane
filters. Place polyester fabric (accessory) between the membrane filters.
t If a prefilter is used: Place the filter centrally on the membrane filter.
t The diameter of the prefilter must not be larger than 130 mm.
t WARNING Risk of injury due to medium escaping uncontrollably. If
the prefilter is under the O-ring:The device may leak and media may
escape uncontrollably. Make sure that the prefilter is not under the
O-ring.
t If staged filtration is to be carried out: Insert up to three membrane
filters. Place polyester fabric (accessory) between the membrane filters.
t Place the upper part of the device with an exact fit on the lower part of
the device.
5.3 Sealing the Device
Procedure
t If the device is sterilized prior to use:
t Lightly tighten the locking clamps by hand.
t If the device is not sterilized prior to use:
t Firmly tighten the locking clamps by hand.
y If the device is not sterilized prior to use: The device is ready for use.

Operating Instructions Stainless Steel In-Line Filter HolderType 16274 19
Getting Started
5.4 Sterilizing the Device
NOTICE
Damage to the device from improper use!
The coating of PTFE-coated device components may come away from the
base material if the device is operated with superheated steam or highly
diffusive substances, or if device surfaces are damaged.
t Do not operate the device with superheated steam or highly diffusive
substances.
t Avoid damage to the device surfaces.
Material: 1 silicone tube approx. 30 cm long
Aluminum foil or waterproof paper
Requirements
— The device is cleaned and mounted.
— A membrane filter is used.
Procedure
t Pull the silicone tube onto the valve.
t Open the valve by half a turn.
t Place aluminum foil or waterproof paper at the inlet and outlet of the
device and at the end of the silicone tube. Make sure that the vapor
permeability of the connections and valve is guaranteed.
t If no membrane filter made of cellulose acetate 111..., PFTE 118... and no
glass fiber filter 134... is used: Sterilize the device as follows:
t Autoclave the device for 30 minutes at 121 °C and 1 bar.
t If a membrane filter made of cellulose acetate 111..., PFTE 118... or a glass
fiber filter 134... is used: Sterilize the device in one of the following ways:
t Autoclave the device for 30 minutes at 121 °C and 1 bar.
t Alternatively: Sterilize the device for 2.5 hours at 180 °C or for 3 hours
at 160 °C with dry heat (depending on the filter material). To do so,
insert the filter dry.
t Alternatively: Sterilize the device by gassing it with ethylene oxide.
t CAUTION Risk of injury due to hot surfaces!The surfaces of the
device may become very hot during operation. There is a risk of burning
if body parts touch these surfaces. When sterilization is complete: Leave
the device to cool down.
t Remove the silicone tube and aluminum foil or waterproof paper.
t Firmly tighten the locking clamps by hand.
t Close the valve.
y The device is ready for use.

20 Operating Instructions Stainless Steel In-Line Filter HolderType 16274
Operation
6 Operation
NOTICE
Damage to the device from improper use!
The coating of PTFE-coated device components may come away from the
base material if the device is operated with superheated steam or highly
diffusive substances, or if device surfaces are damaged.
t Do not operate the device with superheated steam or highly diffusive
substances.
t Avoid damage to the device surfaces.
6.1 Performing an IntegrityTest
Ensure the integrity of the device before and after each sterile filtration
using the bubble-point-test.
Material: 1 silicone tube approx. 30 cm long
Pressure tubes
Requirement
The device is ready for use.
Procedure
t With a pressure tube, connect the inlet of the device to a pressure
source with a pressure gage.
t Insert the silicone tube on the valve on the lower part of the device.
t Immerse the other end of the silicone tube approx. 1 cm deep in water or
alcohol.
t Make sure that the valve is closed.
t Introduce a small amount of water or liquid to be filtered into the filler
opening.
t Seal the filler opening with the filler opening cap.
t To wet the membrane filter completely: Filter the liquid that was
introduced.
t If possible, seal the outlet of the device, e.g. with a stopcock:
t Seal the outlet of the device.
t Open the valve on the lower part of the device.
t If it is not possible to seal the outlet of the device:
t Make sure that the valve on the lower part of the device is closed.
t Push the end of the silicone tube not immersed in water or alcohol
onto the outlet of the device.
t Pressurize the device until 70% — 80% of the expected minimum bubble
point of the membrane filter is reached.
t Keep the pressure constant for 2 – 5 minutes.
t Then increase the pressure by approx. 0.1 bar every 5 seconds while
watching the end of the silicone tube that is immersed in water or
alcohol.