VG TuFlux SLO5705-e12043_85032-540-28.indd - Sartorius AG

Validation Guide
TuFlux® SIL – Silicone Tubing

Table of Contents
1. Introduction 4
1.1 Security of Supply 5
1.2 cGMP Quality Assurance from
Sartorius Stedim Biotech 5
1.3 Quality Assurance 5
1.4 Complete Traceability 5
1.5 Quality Management System 5
1.6 Human Resources 5
1.7 Infrastructure 5
1.8 Purchasing 6
2. Technical Specifications 7
2.1 Tubing Manufacturing 7
2.2 Tubing Dimensions 7
2.3 Type and Part Numbers Overview 7
2.4 Material of Construction 8
2.5 Physical Properties 9
2.6 Physico Chemical Test 10
2.7 Chemical Compatibility 12
2.8 Biocompatibility 14
2.9 Tubing Printing 15
2.10 Extractable Profile 15
2.11 FT-IR and DSC Profiles 16
2.12 Sterilization Compatibility 17
2.13 Shelf Life and Recommended
Storage Conditions 17
3. Functional Qualification Tests 18
3.1 Burst Pressure Test 18
3.2 Pumping Life Time 19
3.3 Clamping Test 19
3.4 Clamping Force 19
3.5 Barrier Properties to Water Vapor 20
3.6 Oxygen Permeability 21
3.7 Flow Rate Data 21
| 3

1. Introduction
4 |
Sartorius Stedim Biotech bags and
systems are widely used in biopharmaceutical
processes for a variety of
unit operations of the commercial
production of drug products such as
vaccines, recombinant proteins and
monoclonal antibodies and for the
development of future biomolecules
in clinical phases.
Buffers and media are increasingly
formulated, sterile filtered
and stored in single-use Fluid
Management Systems (FMS) that
involve Flexel® and Flexboy® Bags
integrated with filters, impeller
mixers, tubing, connectors and
monitoring tools. Product intermediates
are also filtered and stored
between UF|DF and chromatography
purification steps in Gamma sterile
Fluid Management Systems.
Fluid Management Systems are
also adopted for the formulation,
filtration and aseptic processing of
final drug products.
From buffer media preparation,
cell culture operations, purification
operations up to final formulation,
filtration and transfer, the silicone
tubing TuFlux® SIL is a key element
for the successful implementation
of disposable manufacturing
processes.
The TuFlux® SIL, Sartorius Stedim
Biotech silicone tubing, is qualified,
manufactured and released
according to stringent product
validation protocols and Quality
Control testing to offer safe and
robust single-use processes to the
end users of the biopharmaceutical
industry.
Validation includes testing and
inspection of final products with
the goal of ensuring that the
finished products can be reliably
and reproducibly manufactured in
the respect with the established
production and quality control
procedures.
We have compiled this validation
guide so that users of TuFlux® SIL
can plan, implement and document
their own validation procedures.
This validation guide is applicable
for both TuFlux® SIL sold
as a stand-alone product and
pre-assembled on Sartorius Stedim
Biotech single-use systems.

1.1 Security of Supply
Sartorius Stedim Biotech offers
the most secured manufacturing
resources and capabilities on the
market to ensure the strongest
security of supply. We hold
the most modern facilities in
Europe, America, North Africa for
production of pharmaceutical and
medical plastic Fluid Management
Systems with a total of 4800 m 2
(48.000 sq ft) of ISO 7 clean room
(Class 10.000 or Grade C).
Our manufacturing plants operate
under a common information
system in order to offer flexibility
and reliable product transfer
from one location to the other.
Consistent process performance
is ensured by the on-going qualification
of all components and
assemblies, manufacturing processes
and personnel.
1.2 cGMP Quality Assurance from
Sartorius Stedim Biotech
Consistent high quality of the
TuFlux® SIL silicone tubing is
assured by careful selection of the
raw material by Raumedic, wellplanned
and validated production
technologies and an exceptionally
efficient Quality Assurance
Department, all of which result in
high batch-to-batch reproducibility.
1.3 Quality Assurance
For quality assurance, all materials
are carefully selected and validated
in accordance with Sartorius Stedim
Biotech in-house guidelines and
the specifications of our Research
and Development Department
including product performance
and security of supply. TuFlux®
SIL as a component undergoes
quality controls. This involves
100 % non-destructive testings of
each individual component. A lot
is not released until all in-process
and final quality control data are
available.
1.4 Complete Traceability
The type and lot number are printed
on the label of the protective
plastic bag and on the label of
the box in which the TuFlux®
SIL silicone tubing is packed. The
traceable lot number allows convenient
retrieval of all data compiled
on the materials used, production
steps and QC tests.
1.5 Quality Management System
Sartorius Stedim Biotech implemented
Quality Management
Systems to assure consistent high
quality of the TuFlux® SIL tubing.
Exemplary Quality Systems Certificates:
Quality Management System
ISO 13485
The complete Quality Systems
Certificates are continuously
updated and can be downloaded on
our website
www.sartorius-stedim.com.
Raumedic is also certified according
to ISO 13485
1.6 Human Resources
Sartorius Stedim Biotech recognizes
that human resources and personnel
competency are of utmost importance
and have therefore established
a comprehensive human resources
management program. Stringent
selection, motivation, initial and
continuous training and qualification
of personnel at all levels
of the company assure that every
employee is at his or her best at all
times for each step of the manufacturing
and control processes.
Comprehensive training records are
kept for all employees.
1.7 Infrastructure
The buildings, equipment and
work environment at Sartorius
Stedim Biotech have been designed
to maximize employee comfort
and safety while responding to
current GMP requirements for the
manufacture of single-use FMS
destined to the pharmaceutical
industry and medical applications.
All infrastructure (equipment,
utilities, etc.) that has an impact on
the product quality is inventoried
and undergoes an appropriate
qualification.
| 5

1.8 Purchasing
6 |
Supplier and Raw Material
Qualification
All our suppliers are carefully
selected according to internal
standards and applicable regulations.
Each raw material and|or
component used in FMS is put
through prior qualification. This
qualification includes a list of
required statements from the
supplier that is dependent on the
final use of the component and|or
raw material. Typical requirements
for components that are in contact
with the product flow are the
following (not exhaustive list):
USP Class VI and|or ISO10993
conformity
TSE|BSE statement
EP conformity (if applicable)
Change notification statement
Beyond these requirements,
Sartorius Stedim Biotech performs
a qualification of the proposed
component and|or raw material
internally. For raw materials, the
internal qualification will include
machinability and physical performance
of the products made with
this raw material. For components,
the qualification will be centered
around the testing of the assembly
of the new component with other
components and|or bags that will
be attached.
Disclaimer
TuFlux® SIL has not been tested
and approved for patient cure and
hospital, such as for temporary
insertion or any in vivo procedure.
Supplier Evaluation
Suppliers are periodically evaluated
on the basis of the following
performance metrics:
Delivery conformity
Conformity of products on
reception
Compliance with delivery deadlines
Suppliers audit is performed
periodically
Verification of Purchased Product
(Incoming QC)
All raw materials, components
and sub-contracted products are
inspected upon arrival at Sartorius
Stedim Biotech against approved
control specifications. Typical
testing requirements applied at
incoming quality inspection are
listed below:
Supplier documentation controls
(Certificates)
Packaging identification and
integrity
Material identification by Infra Red
(FT-IR) spectroscopy
Visual inspection
Dimensional check
Only approved materials will be
allowed to be used in production
of single-use FMS manufactured by
Sartorius Stedim Biotech.

2. Technical Specifications
2.1 Tubing Manufacturing
TuFlux® SIL is produced by
Raumedic (Germany) under clean
room conditions according to ISO
14644, ISO class 7. The production
site of Raumedic is certified
according to ISO 13485:2003.
2.2 Tubing Dimensions
Dimensions Dimensions
[mm] [inch]
(ID ƒ OD) (ID ƒ OD)
3.2 ƒ 6.4
1/8" ƒ 1/4"
6.4 ƒ 9.5
1/4" ƒ 3/8"
6.4 ƒ 11.1
1/4" ƒ 7/16"
9.5 ƒ 15.9
3/8" ƒ 5/8"
12.7 ƒ 19.1 1/2" ƒ 3/4"
19.1 ƒ 25.4 3/4" ƒ 1"
19.1 ƒ 28.6 3/4" ƒ 1 1/8"
2.3 Type and Part Numbers Overview
Tubing coils made of TuFlux® SIL
are of dimensions between 1/8" ƒ
1/4" (ID ƒ OD) and 3/4" ƒ 1 1/8" (ID
ƒ OD). Tubing coils are provided
in a double PE bags packaged in a
cardboard box.
Part Number Dimensions [mm] Dimensions [inch] Tubing Coil Length
(ID ƒ OD) (ID ƒ OD) [m|ft]
FSA117425 3.2 ƒ 6.4 1/8" ƒ 1/4" 100|328
FSA117426 6.4 ƒ 9.5 1/4" ƒ 3/8" 50|164
FSA117427 6.4 ƒ 11.1 1/4" ƒ 7/16" 50|164
FSA117428 9.5 ƒ 15.9 3/8" ƒ 5/8" 25|82
FSA117429 12.7 ƒ 19.1 1/2" ƒ 3/4" 25|82
FSA117430 19.1 ƒ 25.4 3/4" ƒ 1" 15|49
FSA117431 19.1 ƒ 28.6 3/4" ƒ 11/8" 15|49
| 7

2.4 Material of Construction
Silicone rubber, grade TuFlux®
SIL, addition cross-linked hot
vulcanisate based on vinyl methyl
dimethyl polysiloxane using silicic
acid fillers and platinum catalyst.
8 |
The surface is coated in a plasma
process. This coating provides a
less sticky surface of these silicone
tubing (Low Tack) in comparison
with common non-coated silicone
products.
TuFlux® tubing is colourless transparent
or translucent.
The tubings are delivered within the
following dimensions specifications:
Dimensions Dimensions Internal Dimensions Tubing Wall Thickness
[inch] [mm] [mm] [mm]
(ID ƒ OD) (ID ƒ OD) (ID)
1/8" ƒ 1/4" 3.2 ƒ 6.4 3.2 ± 0.2 1.6 ± 0.2
1/4" ƒ 3/8" 6.4 ƒ 9.5 6.4 ± 0.3 1.6 ± 0.2
1/4" ƒ 7/16" 6.4 ƒ 11.1 6.4 ± 0.3 2.4 ± 0.3
3/8" ƒ 5/8" 9.5 ƒ 15.9 9.5 ± 0.5 3.2 ± 0.4
1/2" ƒ 3/4" 12.7 ƒ 19.1 12.7 ± 0.8 3.2 ± 0.4
3/4" ƒ 1" 19.1 ƒ 25.4 19.1 ± 0.8 3.2 ± 0.4
3/4" ƒ 1 1/8" 19.1 ƒ 28.6 19.1 ± 0.8 4.8 ± 0.5
According to the current state-ofthe-art
individual fisheyes due to
raw material and processing, foreign
material, dirt inclusions and air
bubbles as well as contamination
on the tubing surface, like intrinsic
particles and fluff, cannot be
completely excluded.
Contamination with asbestos
particles is excluded due to purity
of raw materials used and due to
manufacturing process.
TuFlux® SIL is free from any
substances defines as SVHC -
Substances of Very High Concern –
by the European REACH regulation,
Annex XIV.
The material grade meets the
requirements of heavy metals limits
according to EC directive 94/62/EEC.
During vulcanisation of TuFlux®
SIL no low-molecular decomposition
products will evolve, so that
this grade is chemically especially
clean and can be recommended for
applications where decomposition
products of a peroxidic crosslinking
system would represent a
disadvantage. Such applications will
mainly be found in pharmaceutical
and drugs production. TuFlux® SIL
is made of a special Platinum-cured
silicone material from Raumedic
that is registered with the FDA
under Master File No. 1341.

2.5 Physical Properties
The following values are determined
on standard test specimens punched
from a press plate.
Material Hardness
Purpose and Test Method
A measure of the indentation resistance
of elastomeric or soft plastic
materials based on the depth of
penetration of a conical indentor.
Hardness values range from 0 (for
full penetration) to 100 (for no
penetration).
Tensile Properties
Purpose and Test Method
A tensile test consists in applying an
elongation to a tubing specimen and
measuring the resulting strength.
Mechanical properties can then be
defined from the stress-strain curve.
Ultimate Tensile Strength (UTS):
The maximum stress a material
can withstand is calculated by
dividing the maximum load by the
original cross sectional area of the
specimen. The tensile strength test
is performed with a tensile machine
in stretching or elongation mode.
Elongation at Break:
The elongation is recorded at the
moment of specimen rupture and
often expressed as a percentage of
the original length. Materials with
high elongation at break withstand
a high deformation before rupture.
A high elongation at break means
often high flexibility.
Resistance to Tearing
Purpose and Test Method
Tear resistance is a complex result
of other basic properties, such as
modulus and tensile strength. It is a
measure of the ability of the tubing
materials to resist tearing.
Thermal Stability:
The material can be used continuous-
ly in a temperature range from
-60 °C (-76 °F) to +200 °C
(+392 °F) without loosing its
integrity or deterioration of its
chemical|physiological properties.
Test Results
Properties Standards Units Value
Material Hardness ISO 868 Shore A 60 ± 5
Test Results
Properties Standards Units Value
Ultimate Tensile Strenght ISO 527 MPa > 8.0
Elongation at Break ISO 527 % > 500
Test Results
Properties Standards Units Value
Initial Tear Resistance ASTM D624B N/mm 2 > 35
| 9

2.6 Physico Chemical Test
European Pharmacopoeia: 3.1.9 &
FDA regulation 21CFR, § 177.2600.
10 |
Purpose and Test Method
With regard to their basic material,
additives and properties, TuFlux®
SIL tubing in silicone rubber has
been tested in compliance with the
recommendations and guidelines on
health assessment of plastics within
the scope of Food and Drug Act,
sections A XV and B II XV, European
Pharmacopoeia (E.P.) 3.1.9. as well as
FDA regulation 21 CFR, § 177.2600.
USP - Containers,
Physicochemical Tests – Plastic
Purpose
Physicochemical tests are designed
to determine physical and chemical
properties of TuFlux® SIL tubing and
their extracts. They are performed
on TuFlux® SIL samples before and
after irradiation and accelerated
ageing conditions.
Test Method
Samples of the TuFlux® SIL cut in
small portions previously Gamma
irradiated (50 kGy) were extracted
(ratio of 30 g per 150 mL) in Ultra
Pure water at 70 °C (158 °F) for
24 hours. The tests are conducted
in order to determine physical and
chemical properties of the test
article and its extracts. The same
test have been performed on tubing
Gamma irradiated (50 kGy) stored
during a period corresponding to
a shelf life of 3 years (accelerated
conditions).
Test Results
TuFlux® SIL tubing in silicone
rubber meets the requirements of
the European Pharmacopoeia 3.1.9.
and regulation 21 CFR, § 177.2600.
The test methods, limits and results
are those described by the E.P.
monograph and listed in the table
below.
Test Description E.P. 3.1.9 Limits Results on TuFlux® SIL:
Pass or Fail
Appearance of Solution Colourless Pass
Acidity < 2.5 mL NaOH 0.01M Pass
Alkalinity < 1.0 mL HCl 0.01M Pass
Reducing Substances < 1 mL Pass
Substances Soluble in Hexane < 3 % Pass
Volatile Matter < 2 % Pass
Mineral Oils < 1 ppm Pass
Platinium < 30 ppm Pass
Test Results
The silicone tubing TuFlux® SIL
meets the USP requirements
when sterilized at 50 kGy with and
without aging conditions corresponding
to a shelf life of 3 years.
Test Description USP Limits Results on TuFlux® SIL:
Pass or Fail
Non Volatile Residue < 15 mg Pass
Residue on Ignition < 5 mg Pass
Heavy Metals < 1 ppm Pass
Buffering Capacity < 10 mL Pass

USP - Elastomeric Closures
for Injections
Purpose and Test Method
Elastomeric closures for containers
are made of materials obtained
by vulcanization (cross-linking)
poly merization, polyaddition,
or polycondensation of macromolecular
organic substances
(elastomers). Elastomeric closures
shall conform to biological, physicochemical,
and functionality requirements.
The tests are performed according
to USP recommendations.
Japanese Pharmacopoeia
Test Method
The tests are performed according
to JP recommendations.
Test Results
The silicone tubing TuFlux® SIL
meets the USP requirements
if non sterile and sterile (50 kGy).
Test Description USP Limits Results on TuFlux® SIL:
Pass or Fail
Cheerlessness Pass
Reducing Substances 0 Pass
Lead 0 ppm Pass
pH Value Change 5-7 Pass
Dry Residue < 2 mg Pass
Test Results
Test Description JP Limits Results on TuFlux® SIL:
Pass or Fail
Inspection Colourless Pass
Transmission at 430 and 650 nm < 1% Pass
pH Value 5-7 Pass
Reducing Substances < 2 mL Pass
Dry Residue < 2 mg Pass
UV Adsorption < 0.2 Pass
TuFlux® SIL meets the physical
chemical requirements of the
Japanese Pharmacopoeia
“Test for Rubber Closure for
Aqueous Infusions”.
| 11

2.7 Chemical Compatibility
12 |
Purpose
A chemical resistance study is
conducted to assess the resistance
of TuFlux® SIL to a variety of
chemical solutions.
Test Method
In compliance with DIN 53 521
each vulcanizate was immersed for
7 days and variations in Shore A,
tear strength, elongation at break
and volume have been evaluated to
assess the chemical resistance.
Test Results
The compatibility test results are
classified as follows:
R for Resistant: the product is
unaffected in any way for the
duration of the test.
N for Not Resistant: changes in
critical quality properties to severe
attack, unusable chemical with this
product.
T for Testing recommended before
use: chemical resistance studies
can be proposed upon customer’s
request according to specific
process conditions (i.e. time,
temperature, exposure time and
type of solution).
Chemical Resistance of TuFlux® SIL:
Entry # Chemical R|N|T
1 Acetamide R
2 Acetic acid T
3 Acetic anhydride R
4 Acetone T
5 Ammonia conc. R
6 Ball bearing grease T
7 Benzyl alcohol R
8 Brake fluid R
9 Butanol T
10 Butylacetate N
11 Calcium hydorxide sat. R
12 Chloroform N
13 Coconut butter R
14 Cyclohexane N
15 Detergent solution 1% R
16 Diacetone alcohol R
17 Dibutylether N
18 Diesel oil N
19 Dimethyl formamide R
20 1,4 Dioxan N
21 Ethanol R
22 Ethyl acetate N
23 Formic acid conc. R
24 Gasoline 90/110 N
25 Gear oil SAE 90 T
26 Glycerine R
27 Glycol R
28 Hexane N
29 Hydrochloric acid 10 % R
30 Hydrochloric acid 30 % T
31 Hydrogen peroxide 10 % R
32 Hydrogen peroxide 30 % R
33 Isopentyl alcohol N
34 Isopropyl alcohol R

Chemical Resistance of TuFlux® SIL:
Entry # Chemical R|N|T
35 Linseed oil T
36 Margarine R
37 Methanol R
38 Methyl ethyl ketone N
39 Methylene dichloride N
40 Mineral oil ASTM 1 R
41 Mineral oil ASTM 2 T
42 Mineral oil ASTM 3 N
43 Motor oil SAE 20 T
44 Nitric acid 10 % T
45 Nitric acid 65 % N
46 Olive oil R
47 Petrolium ether N
48 Phosphoric acid 30 % T
49 Phosphoric acid 85 % T
50 Phtalic anhydride R
51 Potassium chromate 20 % R
52 Potassium hydroxide solution 50 % N
53 Silicone fluid AK 350 N
54 Sodium carbonate sat. R
55 Sodium chlorate 20 % R
56 Sodium hydroxide solution 10 % R
57 Sodium hydroxide solution 50 % N
58 Sodium perchlorate 20 % R
59 Solution of sodium chloride 10 % R
60 Stearic acid N
61 Styrol N
62 Sulphuric acid 10 % T
63 Tetrahydrofuran N
64 Toluene N
65 Turpentine N
66 Vaseline T
67 Xylol N
R: resistant
N: not resistant
T: testing recommended before use
| 13

2.8 Biocompatibility
14 |
Purpose and Test Method
Biocompatibility tests are performed
to demonstrate that TuFlux® SIL
is biocompatible and meets or
exceeds the current USP and ISO
requirements. Tests are carried out
on TuFlux® SIL samples before and
after Gamma irradiation (50 kGy).
TuFlux® SIL tubing samples were
supplied to an independent testing
facility for evaluation under the
current USP and ISO 10993-5
biocompatibility standards.
USP Class VI
TuFlux® SIL material is implant
tested, meets the requirements of
implant test to USP Class VI as
well as the intracutaneous test and
the acute toxicity test to USP
Class VI, meaning that biological
neutrality has been proven via these
animal experiment tests on sterile
and Gamma or autoclave sterilized
samples. The following tests were
performed on samples with and
without ink:
Cytotoxicity test
Intracutaneous test
Systemic injection test
Implantation test (7 days)
Test Results of USP Class VI
All material used in the construction
of the silicone tubing TuFlux® SIL
meet or exceed the requirements
of the USP Class VI– 121 °C
Plastics tests and are considered as
non cytotoxic and non haemolytic.
ISO 10993-5
Test Results of ISO 10993-5
Within the context of a cytotoxi city
test according to ISO 10993-5
no substances with cytotoxicity
effects were detected. The test has
been performed on non sterile and
autoclaved samples (>3 ƒ 20 min at
121 °C).
Summary Table of USP Class VI and ISO 10993-5 Biocompatibility Standards:
Samples: TuFlux® SIL
Test Non sterile Sterile Sterile Non sterile
(without ink) (without ink) (with ink) (with ink)
USP Conform Conform (50 kGy) Test on going N/A
ISO 10993-5 Conform Conform (autoclaving) Test on going conform
For the ongoing tests the results will be updated when available.
ADCF Certified
TuFlux® SIL formulation does not
contained any animal derived
components.
LAL Endotoxin Test
TuFlux® SIL passed a pyrogen test
(LAL Endotoxin test).

2.9 Tubing Printing
TuFlux® SIL is delivered printed with
the following printing:
“Sartorius Stedim Biotech –
TuFlux® SIL a/b" ƒ c/d” – made
by Raumedic” , where a/b is the
Internal Dimension and c/d the
Outer Dimension of the tubing in
inch.
The inocuity of the ink is proven by
the tests performed according to
ISO 10993-5.
2.10 Extractable Profile
Purpose
Extractables are substances that can
be extracted from a bioprocessing
containment, such as a tubing,
using extraction solvents and conditions
that are more aggressive than
the usual conditions of use. The
goal of this extractable profile test
is to supply worse case extractable
data to support process developers
and toxicologists in their validation
studies.
Method
A 2 g of sample of TuFlux® SIL was
immersed for 90 days at 40 °C in
200 mL of the test solutions:
Deionised water
Buffer solution pH 2
Buffer solution pH 3
Buffer solution pH 7
Buffer solution pH 10
1M Sodium hydroxide
1M Hydrochloric acid
20% Ethyl alcohol
After the incubation period, a
portion of the test solution is
extracted with 3% dichloromethane.
The dried organic phase is analyzed
by gas chromatograph with mass
selective detector in the scan mode.
Test results
In the migrats of the sample of
tubing no foreign substances could
be proven with a detection limit at
0.3 mg/L. The detection limit was
0.6 mg/L for the siloxane.
| 15

2.11 FT-IR and DSC Profiles
16 |
Purpose
DSC analyziz has been conducted
to measure the thermal phenomena
which are directly linked to the
polymer nature and its history.
FT-IR analyzis has been conducted
in order to highlight the chemical
fingerprint of the polymer including
additives.
Method and Test Results
FT-IR Tests Performed on TuFlux® SIL Samples:
Samples Non Sterile Sterile 50 kGy
TuFlux® SIL, lot A ✓ ✓
TuFlux® SIL, lot B ✓ ✓
FR-IR spectrum of TuFlux® SIL lot A, sterile. The 3 other spectra are identical.
Method and Test Results
The TG-DSC analyses have been
performed under N2 atmosphere
with a heating rate of 20 K/min
from RT up to 250 °C (482 °F).
No peak was detected on the thermograms of the non sterile and irradiated tube during the
heating and the cooling phases.
Regarding the DSC results, the
50 kGy sterilization has no influence
on the TuFlux® SIL on the thermal
characteristics in the studied
temperature range.

2.12 Sterilization Compatibility
The TuFlux® SIL may be unsterile
when sold as a stand-alone product
or sterile when sold pre-assembled
on Sartorius Stedim Biotech bags.
The tubing TuFlux® SIL is coiled in
the relevant specified supply length
and are supplied welded in double
PE-bags, however non-sterile.
TuFlux® SIL tubing can be sterilized
according the well-known methods
of sterilization technique, while we
especially recommend sterilization
via Gamma rays (up to 50 kGy) and
water vapour (up to 134 °C).
It is the responsibility of the user to
validate a sterilization process with
autoclave for TuFlux® SIL.
2.13 Shelf Life and Recommended
Storage Conditions
Shelf Life for Tubing Coils
The shelf life of TuFlux® SIL is
5 years. There is no substantial
change of the specified physical,
chemical and physiological
parameters of the tubing material
after that period of time.
The following storage conditions
shall apply:
Temperature:
5 °C (41 °F) to 40 °C (104 °F)
No exposure of the tubing material
to direct sun-light or UV-irradiation
sources.
Specific Shelf Life for
Components
Sartorius Stedim Biotech does not
redo the ageing studies performed
by its qualified suppliers. We require
certification for any claim that a
supplier makes on the shelf life of
their components.
Shelf Life for Assemblies
Beyond the requirements from the
suppliers, Sartorius Stedim Biotech
will perform ageing studies on all
new assemblies that require this to
be done. This process will guarantee
that the assemblies will perform in
an identical manner after the stated
shelf life as they did just after
sterilization. Shelf life under accelerated
conditions for T1 year, T2
years, T3 years and natural ageing
for T3 years are ongoing and shelf
life statement will be updated after
receipt ot the results.
| 17

3. Functional Qualification Tests
18 |
The qualification of the silicone
tubing TuFlux® SIL was performed
according to Sartorius Stedim
Biotech standard methods. The
qualification tests were performed
at ambiant temperature.
3.1 Burst Pressure Test
Purpose
The goal of the burst pressure test is
to assess the pressure resistance of
the tubing depending on the tubing
dimensions (inside and outside
diameter).
Test Method
The test method is described in the
scheme below. Three measurements
of the pressure were taken for
each tubing reference on Gamma
sterilized samples at 50 kGy at
burst.
Test Results
Air Manometer
Dimensions Dimensions TuFlux® SIL
[mm] [inch] Typical Value of Burst Pressure
(ID ƒ OD) (ID ƒ OD) [bar]
3.2 ƒ 6.4 1/8" ƒ 1/4" 4.5
6.4 ƒ 9.5 1/4" ƒ 3/8" 3.1
6.4 ƒ 11.1 1/4" ƒ 7/16" 3.4
9.5 ƒ 15.9 3/8" ƒ 5/8" 3.8
12.7 ƒ 19.1 1/2" ƒ 3/4" 4.6
19.1 ƒ 25.4 3/4" ƒ 1" 3.0
19.1 ƒ 28.6 3/4" ƒ 1 1/8" 4.6
1 bar = 0.1 MPa
Reinforced tubing
TuFlux® SIL
sample
Metalic
clamp

3.2 Pumping Life Time
Purpose
The goal of the pumping life time
test is to assess the mechanical
resistance of the tubing under
pumping conditions.
Test Method
The tubing is placed in a peristaltic
pump and speed is set up to
maximum (> 300 rpm). The tubing
was pumping water at ambiant
temperature between 2 tanks
mimicing recirculation conditions.
The test was stopped and time
measured at tubing break resulting
in leak.
3.3 Clamping Test
Purpose
The goal of the claping test is to
evaluate the permanent deformation
induced by clamping.
Test Method
Tubes are clamped in several
positions and sterilized at 50 kGy.
Atfer the sterilization, the first clamp
is removed. The opening of the
tubing is therefore checked (internal
surfaces must not be definitely
sealed). The system keeping clamped
is stored at 60 °C (140 °F) for an
accelarated ageing. Every 6 months,
one clamp is removed and the tube
was checked up to 3 years under
accelerated conditions.
3.4 Clamping Force
Purpose and Test Method
Clamps are necessary to close the
fluid path when necessary. The
purpose of this test is to evaluate
the strengh needed to close the
clamp. This strenght is measured with
a tensile machine in compression
mode.
Test Results
Dimensions Dimensions TuFlux® SIL
[mm] [inch] Pumping Life Time
(ID ƒ OD) (ID ƒ OD) [h]
6.4 ƒ 11.1 1/4" ƒ 7/16" ongoing
9.5 ƒ 15.9 3/8" ƒ 5/8" ongoing
12.7 ƒ 19.1 1/2" ƒ 3/4" > 130
19.1 ƒ 25.4 3/4" ƒ 1" ongoing
19.1 ƒ 28.6 3/4" ƒ 1 1/8" > 70
For the ongoing experiments data will be updated when available
Test Results
TuFlux® Clamping at 60 °C (140 °F)
Sample T0 T 6 T 1 T 1,5 T2 T 2,5 T 3
SIL Months Year Year Years Years years
1/2" ƒ 3/4" + + + + + + +
++: tube is in its original state
+ : tube returns to its original state easily
- : tube is sealed
Test Results
Test Description Specification Results on TuFlux® SIL:
Pass or Fail
Clamping force < 80 N for 1/8" ƒ 1/4" tubing Pass
< 330 N for 1/2" ƒ 3/4" tubing Pass
| 19

3.5 Barrier Properties to Water Vapor
20 |
Purpose
The aim of this test is to evaluate
the permeability of silicon tubes
irradiated at 50 kGy to WIFI at
60 °C (140 °F) for 2, 7 and 14 days
representing 1, 3 and 6 months
respectively in normal room
temperature conditions.
Test Method
Figure No 1 Assembly:
Test Results
Usefull part = 250 mm
First Second
Tube length: 400 mm, or 17.75 inch
pH and conductivity are measured
at t = 0 and after 14 days of
storage at 60 °C (140 °F).
The mass of each assembly is
controlled at start and after 2, 7
and 14 days the samples being
stored at 60 °C (140 °F). The
percentage of mass loss is calculated
from the weight at start of
the test compared to the weight
after storage time.
Tubing Sample Mass Loss at 60 °C [%]
t = 2d t = 7d t = 14d
TuFlux® SIL 1/2" ƒ 3/4" 5.4 19.0 38.0

3.6 Oxygen Permeability
Purpose
This property is important when
the product inside the TuFlux®
SIL is sensible to oxidation and
will be stored. The permeation
phenomenon being driven by the
partial pressure equilibrium on both
sides of the tubing wall, no oxygen
will enter the container if it is not
consumed by the solution. The
values displayed in this table are the
maximum.
Method
The test has been conducted on
TuFlux® SIL 1/2" ƒ 3/4" with a wall
thickness of 3.2 mm or 0.126 inch
as following:
Oxygen External
Side
T° = 21 °C
tubing wall
Internal
Side
T° = 21 °C
3.7 Flow Rate Data
Purpose
The objective of this test was to
assess the maximum flow rate of
some TuFlux® SIL dimensions.
Test Method
The time to transfer 100 L of water
at room temperature with non
sterile tubing using a peristaltic
pump set up at the maximum
speed (310 rpm) was measured in
duplicates.
Test Results
Test Description Units Value
Oxygen Transmission Rate dm 3 /m 2 /24h < 15
Test Results
TuFlux® SIL Dimensions [inch] Flow Rate [L/min]
1/4" ƒ 7/16" > 1.2
3/8" ƒ 5/8" > 6.0
1/2" ƒ 3/4" > 8.9
3/4" ƒ 1" > 16.5
3/4" ƒ 1 1/8" > 20.0
| 21

Sales and Service Contacts
For further contacts, visit www.sartorius-stedim.com
Europe
Germany
Sartorius Stedim Biotech GmbH
August-Spindler-Strasse 11
37079 Goettingen
Phone +49.551.308.0
Fax +49.551.308.3289
www.sartorius-stedim.com
Sartorius Stedim Systems GmbH
Schwarzenberger Weg 73–79
34212 Melsungen
Phone +49.5661.71.3400
Fax +49.5661.71.3702
www.sartorius-stedim.com
France
Sartorius Stedim Biotech S.A.
ZI Les Paluds
Avenue de Jouques – BP 1051
13781 Aubagne Cedex
Phone +33.442.845600
Fax +33.442.845619
Sartorius Stedim France SAS
ZI Les Paluds
Avenue de Jouques – CS 71058
13781 Aubagne Cedex
Phone +33.442.845600
Fax +33.442.846545
Austria
Sartorius Stedim Austria GmbH
Franzosengraben 12
A-1030 Vienna
Phone +43.1.7965763.18
Fax +43.1.796576344
Belgium
Sartorius Stedim Belgium N.V.
Leuvensesteenweg, 248/B
1800 Vilvoorde
Phone +32.2.756.06.80
Fax +32.2.756.06.81
Denmark
Sartorius Stedim Nordic A/S
Hoerskaetten 6D, 1.
DK-2630 Taastrup
Phone +45.7023.4400
Fax +45.4630.4030
Hungary
Sartorius Stedim Hungária Kft
Kagyló u. 5
2092 Budakeszi
Phone +36.23.457.227
Fax +36.23.457.147
Italy
Sartorius Stedim Italy S.p.A.
Via dell’Antella, 76/A
50012 Antella-Bagno a Ripoli (FI)
Phone +39.055.63.40.41
Fax +39.055.63.40.526
Netherlands
Sartorius Stedim Netherlands B.V.
Edisonbaan 24
3439 MN Nieuwegein
Phone +31.30.6025080
Fax +31.30.6025099
Poland
Sartorius Stedim Poland Sp. z o.o.
ul. Wrzesinska 70
62-025 Kostrzyn
Phone +48.61.647.38.40
Fax +48.61.879.25.04
Russian Federation
OOO "Sartorius ICR"
Rasstannaya str. 2, b.2, lit.A,
p/b 134,
192007, Saint-Petersburg
Phone +7.812.6100821
Fax +7.812.6100821
Spain
Sartorius Stedim Spain SA
C/Isabel Colbrand 10,
Oficina 70
Polígono Industrial de Fuencarral
28050 Madrid
Phone +34.90.2110935
Fax +34.91.3589623
Switzerland
Sartorius Stedim Switzerland AG
Ringstr. 24 a
8317 Tagelswangen
Phone +41.52.354.36.36
Fax +41.52.354.36.46
U.K.
Sartorius Stedim UK Limited
Longmead Business Park
Blenheim Road, Epsom
Surrey KT19 9 QQ
Phone +44.1372.737159
Fax +44.1372.726171
www.sartorius-stedim.com
America
USA
Sartorius Stedim North America Inc.
5 Orville Drive
Bohemia, NY 11716
Toll-Free +1.800.368.7178
Fax +1.631.254.4253
Sartorius Stedim SUS Inc.
1910 Mark Court
Concord, CA 94520
Phone +1.925.689.6650
Toll-Free +1.800.914.6644
Fax +1.925.689.6988
Argentina
Sartorius Argentina S.A.
Int. A. Avalos 4251
B1605ECS Munro
Buenos Aires
Phone +54.11.4721.0505
Fax +54.11.4762.2333
Brazil
Sartorius do Brasil Ltda
Av. Dom Pedro I, 241
Bairro Vila Pires
Santo André
São Paulo
Cep 09110-001
Phone +55.11.4451.6226
Fax +55.11.4451.4369
Mexico
Sartorius de México S.A. de C.V.
Circuito Circunvalación Poniente No. 149
Ciudad Satélite
53100 Naucalpan, Estado de México
Phone +52.5555.62.1102
Fax +52.5555.62.2942
Asia|Pacific
Australia
Sartorius Stedim Australia Pty. Ltd.
Unit 5, 7-11 Rodeo Drive
Dandenong South Vic 3175
Phone +61.3.8762.1800
Fax +61.3.8762.1828
China
Sartorius Stedim Beijing
Representative Office
No. 33, Yu’an Road,
Airport Industrial Zone B, Shunyi District
Beijing 101300
Phone +86.10.80426516
Fax +86.10.80426580
Sartorius Stedim Shanghai
Represantative Office
Room 618, Tower 1, German Centre,
Shanghai, PRC., 201203
Phone +86.21.28986393
Fax +86.21.28986392.11
Sartorius Stedim Guangzhou Office
Room 704, Broadway Plaza,
No. 233–234 Dong Feng West Road
Guangzhou 510180
Phone +86.20.8351.7921
Fax +86.20.8351.7931
India
Sartorius Stedim India Pvt. Ltd.
#69/2-69/3, Jakkasandra
Kunigal Road, Nelamangala Tq
Bangalore – 562 123
Phone +91.80.4350.5361
Fax +91.80.4350.5253
Japan
Sartorius Stedim Japan K.K.
KY Building, 8–11
Kita Shinagawa 1-chome
Shinagawa-ku
Tokyo 140-0001
Phone +81.3.3740.5407
Fax +81.3.3740.5406
South Korea
Sartorius Korea Biotech Co., Ltd.
8th Floor, Solid Space B/D,
PanGyoYeok-Ro 220,
BunDang-Gu
SeongNam-Si, GyeongGi-Do,
463-400
Phone +82.31.622.5700
Fax +82.31.622.5799
Malaysia
Sartorius Stedim Malaysia Sdn. Bhd.
Lot L3-E-3B, Enterprise 4
Technology Park Malaysia
Bukit Jalil
57000 Kuala Lumpur
Phone +60.3.8996.0622
Fax +60.3.8996.0755
Singapore
Sartorius Stedim Singapore Pte. Ltd.
1 Science Park Road,
The Capricorn, #05-08A,
Singapore Science Park 2
Singapore 117528
Phone +65.6872.3966
Fax +65.6778.2494
Specifications subject to change without notice. Printed in Germany on paper that has been bleached without any use of chlorine.
Publication No.: SLO5705-e12043 · Order No.: 85032-540-28|Ver. 04/2012