Pacote de Validação Do Mangote Silicone

November 2009 issue 9.
Validation pack
Watson-Marlow Pumpsil 913.A and 913.B series platinum cured silicone tubing
1
November 2009 issue 9.0
Validation pack - Watson-Marlow Pumpsil 913.A and 913.B series platinum cured silicone tubing.
Contents Page
1. Introduction 3
1.1. Company 3
1.2. Product and production facilities 3
2. Mission statement 4
2.1. ISO9001:2000 certificate 5
2.2. ISO14001:2004 policy and certificate 6
3. Product description and specification 8
3.1. Animal origin / TSE statement 8
3.2. Post-cure 8
3.3. Sample certificate of conformance 10
3.4. Specification 11
3.5. Traceability 12
3.6. Physical properties 12
3.7. Sterilisation 12
3.8. Working temperature range 12
3.9. Gas permeability 12
3.10. Tube structure 13
3.11. Control systems 13
3.12. Packaging 14
3.13. Shelf life, storage conditions 14
3.14. Material data sheet 15
4. Systemic injection - ISO test result certificate. 16
5. Intracutaneous injection – ISO test for irritation and delayed-type hypersensitivity test result 17
certificate.
6. European Pharmacopoeia 3.1.9 silicone elastomer for closures and tubing (ISO10993) test result 18
certificate.
7. Hemocompatibility (Hemolysis test - Autian method test result certificate. 26
8. Kligman Maximisation - test for irritation and delayed-type hypersensitivity test result certificate. 28
9. In-vitro cytotoxicity test (quantitative MEM elution) test result certificate. 29
10. Elution test – ISO. Biological reactivity part 5, in vitro cytotoxicity test result certificate. 30
11. Physiochemical tests on elastomeric closure materials test result certificate. 31
12. Short term intramuscular test result certificate. 38
13. USP class VI summary certificate test result certificate. 45
14. Limulus Amebocyte Lysate (LAL) Kinetic-QCL method. Bacterial Endotoxin Assay test result 46
certificate.
15. Total extractables as per 21CFR 177.2600 test result certificate. 47
16. USP Particulate / Microscopic particulate count analysis test result certificate. 48
17. Total Organic Carbon test result certificate. 49
18. Residual platinum test result certificate. 50
This document is uncontrolled and updates will not be automatically included. For the current issue of the
validation pack, please contact your local Watson-Marlow representative.
Change history
Issue Change Date
8.0 Change history introduced 2004.04.22
'Uncontrolled document' comment on contents page introduced
Product ID expanded to include 913.B series throughout sections 1,2,3
ISO 9001: certificate updated in section 2
Certificate of conformance updated in section 3
Updated USP VI certificate in section 11
9.0 Sections 1-3 updated to reflect the introduction of the T2 cleanroom. 2009.11.30
ISO 9001:2000, ISO14001:2004, certificate of conformance all updated.
ISO14401:2004 section updated.
All test certificates in sections 4-17 updated.
Contents page expanded.
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1) Introduction
1.1 Company
Watson-Marlow was founded in 1956, producing the first successful peristaltic pump. In 1969 the company moved
to Falmouth, Cornwall, England in to a facility which now comprises over 7,500 square metres (80,000 square feet)
of production and office space. Watson-Marlow is a wholly owned subsidiary of Spirax-Sarco Engineering plc.
Spirax-Sarco's headquarters are in Cheltenham, England and is listed on the London Stock Exchange.
1.2 Product and production facilities

Watson-Marlow's Pumpsil 913.A and 913.B series platinum cured tubing is a high purity, 'addition cured' silicone
which is produced from a USP class VI raw material. It is produced in one of two ISO 14644-1 class 7 (class
10,000 / class J) cleanrooms located on the same campus in Falmouth, Cornwall. The first cleanroom (T1) started
operations in 2001, the second (T2) in 2009. Both cleanrooms are operated according to cGMP principles,
operating within the same ISO9001:2000 quality system. Both cleanrooms are air conditioned to ensure that
temperature and humidity are controlled to ensure a stable extrusion environment.
The new T2 cleanroom on the Falmouth campus was built to provide business continuity for our customers and to
expand production capacity. For business continuity reasons T2 is housed in a purpose-built facility which is
physically separated from the existing facility with its primary utility supplies and enterprise computing all
duplicated.
The same raw material is used in T1 and T2 for the production of 913.A and 913.B series tubing (i.e. there has
been no change in the raw material used to produce 913.A and 913.B series Pumpsil tubing). The same cold
extrusion / hot cure process is used in T1 and T2, with appropriate process conditions set to optimise product
consistency within the established ranges. Tubing from both cleanrooms is post-cured using the same 4 hour /
200C process. The campus-wide services which include the receipt of materials, traceability, equipment calibration
and maintenance clothing regimes, etc. apply equally to both cleanrooms.
The tests in this validation pack have been carried out on tubing extruded in T2. A material data sheet summarising
the results is in section 3.14. The reports are included in sections 4 to 17. The test results – taken with those in the
previous edition of the validation pack which were carried out on T1 extruded tubing - demonstrate the equivalence
of tubing produced in T1 and T2. Test 18 (residual platinum) has not been repeated for T2 extruded tubing as it
relates to the raw material composition rather than production conditions.
Performance equivalence of T1 and T2 tubing has been established following like-for-like pump testing of three
batches of three different sizes of tubing. The three sizes chosen (3.2mm bore x 1.6mm wall, 9.6mm bore x 3.2mm
wall and 19.0mm bore x 4.8mm wall) ensured that the range of standard tubing sizes was covered, three different
wall thicknesses were tested and three different pump ranges were used in the testing. The tests results show that
life and flow drop of T1 and T2 tubing are equivalent to within +/-2SD.
Pumpsil 913.A and 913.B series tubing:

• Meets or exceeds FDA regulations CFR 177.2600 for contact with food.
• Meets or exceeds USP XXVII class VI requirements
• Meets or exceeds European Pharmacopoeia 3.1.9 requirements
• Meets or exceeds ISO10993 requirements
• Meets or exceeds USDA standards
Where relevant test reports are included as part of this validation pack.
Watson-Marlow Pumpsil 913.A and 913.B series platinum cured tubing exhibits a number of key features:
• LaserTraceability • No PCB's (Poly Chlorinated Biphenyls)
• Full post-cure • Good clarity, no odour
• Very low extractables • Non-toxic
• Animal free • A low tendency to discolour at higher temperatures
• Very tight surface cure • No 2,4 DCBA residues
LaserTraceability is the laser etching of the part number, lot number and use by date on to the surface of the tube.
The etch is repeated along the length of the tubing at approximately 500mm centres (subject to tube and hence
text size). LaserTraceability ensures complete traceability of the tubing even when it is removed from the
packaging, uses no inks or solvents and does not contaminate the tube, is indelible and cannot be removed from
the tube, does not affect the performance of the tube. Full details are included in section 3.5.
Post-cure (sometimes referred to as post-baking) is the extended heating of the tubing – in Watson-Marlow's 4
hours at 200C - case after the extrusion and primary cure has been completed. Post cure removes unwanted
volatiles and ensures full cross linking. Full details are included in section 3.2.
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2) Mission statement
Watson-Marlow business policy
Is the world leader in solving fluid handling problems with peristaltic pumping technology.
Is approved to BS EN ISO 9001, BS EN ISO 14001 and OHSAS 18001.
Strives to provide its customers with nothing less than the best products, service and knowledge.
Is committed to continual improvement in every area of its business.
Conducts its business ethically, and stands by its word, its recommendations and its products.
Provides a safe working environment, open communications, and opportunities for advancement for all
employees.
Managing Director, Watson-Marlow

Issue 6 May 2009
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2.1) ISO9001-2000
Watson-Marlow is an ISO9001-2000 accredited company.
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2.2) ISO14001
Scope of Watson-Marlow business

With over one million peristaltic pumps designed, manufactured and sold around the world Watson-Marlow has
identified the importance of its environmental aspects and impacts. The company aims to continually improve its
environmental performance in the design, development, manufacture and in-house repair of peristaltic pumps and
accessories, the supply of associated products and development and manufacture of tubing.
To achieve improvement we operate an Environmental Management System that as a minimum meets the
requirements of ISO14001 and have set the following general aims:
• Identify the significant environmental impacts of our company's activities.
• Aim to continually improve the environmental performance of our company by setting environmental
objectives, targets and processes.
• Promote optimum and efficient use of resources and energy.
• Work towards the reduction or elimination of any potential or actual pollution.
• Raise the awareness and understanding of all staff about the company's environmental policy and
maintain awareness of environmental issues and related matters.
• Provide interested parties with relevant and appropriate information and establish open and on-going
dialogue.
• Ensure these aims are achieved by the use of appropriate processes that will be monitored, audited,
reviewed and improved if necessary.
It is the responsibility of directors and managers to be aware of environmental risks and regulations and to identify
and implement best practice.
The Operations Manager has specific responsibility to monitor and implement our environment system.
Specifically:
Legislation: We meet or, where practical, exceed all UK legislative, regulatory and other requirements
appropriate to our business.
Product design: We select materials to eliminate hazardous substances (RoHS), ensure resource saving and
make continual improvement in energy efficiency, keeping 'end of life' in mind.
Manufacturing: Ensuring efficient processes we reduce material use, minimise waste and emissions and
ensure energy efficiency within our processes.
Use: Our designs ensure controllability to reduce energy consumption and our increased tube life
and controlled waste minimises risk of contamination throughout the world.
Applications: Environmental applications, Water treatment, Control of hazardous substances. Contributing
to a cleaner environment.
End of Life: Where practical Watson-Marlow pumps are produced from recyclable materials and simple
disassembly ensures end of life issues are minimised.
Managing Director, Watson-Marlow

Issue 7 May 2009
6
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3) Product description and specification
Watson-Marlow Pumpsil 913.A and 913.B series 'addition cured' silicone tubing is a high purity product which is
produced in state-of-the-art facilities.
The term 'addition cured' signifies that a platinum catalyst is used to trigger the cross-linking reaction which
produces a uniformly vulcanised product without curative by-products.
The cleanrooms and process equipment used to produce the tubing are dedicated to the production of 'addition
cured' silicone tubing and are therefore entirely clear of the 2,4 DCBA residues found in peroxide cured silicones.
Likewise all tubing produced in the cleanrooms is entirely clear of 2,4 DCBA residues.
Watson-Marlow Pumpsil 913.A and 913.B series platinum cured tubing exhibits lower surface tack, a tighter
surface structure and no decomposition by-products when compared with peroxide cured silicones. It is also free
from the surface 'bloom' of 2,4 DCBA which can occur in peroxide cured silicone after a period of storage.
Watson-Marlow Pumpsil 913.A and 913.B series platinum cured silicone tubing is produced from entirely virgin
material. No product is re-worked during the production process.
3.1) Animal origin / TSE statement

Watson-Marlow Pumpsil 913.A and 913.B series tubing, and the plastic packaging in immediate contact with it, is
entirely free of any animal products or by-products. No animal products or by-products are used in the production
of Watson-Marlow Pumpsil 913.A and 913.B series tubing.
3.2) Post-cure
All Watson-Marlow Pumpsil 913.A and 913.B series tubing is fully post-cured at 200C for four hours. During the
post-cure cycle two key changes take place:
1) Volatile cyclic siloxanes (silicone oligomers) are driven off that would otherwise remain in the finished
tube as leachables. Cyclic siloxanes are cytotoxic and therefore, if left in the tubing, could leach into the
product flow and either contaminate the product or affect cell culture.
2) The physical properties of the tubing are stabilised by completing the crosslinking and condensing of
any residual functional groups. Full crosslinking ensures a more stable structure resulting in lower
hysteresis and more stable flow in a peristaltic pump.
In production of the silicone polymer—the raw material for the silicone tube—a cyclic siloxane/oligomer mixture is
introduced as a process aid. As the siloxane performs no function in the finished polymer it is vacuum devolatilised
at high temperature. The result is high molecular weight polymer but with a residual 0.5 to 2 weight percent
residual oligomer. If the tubing is not post-cured, the residual 0.5 to 2 weight percent remains in the tubing as an
extractable. As can be seen in the graph below, the level of extractables in fully post-cured tubing is dramatically
lower than in non-post-cured tubing.
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The continued crosslinking between vinyl and hydride groups occurs because some of the functional groups are
less reactive than others and can only be made accessible with increased heat and time. This type of cross-linking
cannot be achieved in so-called 'in-line' post-cure which does not allow sufficient time for the process to take place.
All of the physical property changes are the result of a tighter network and an increased crosslink density. In the
case of peristaltic pump tubing, the more stable network structure will result in fewer chemical changes over time
that would lead to changes in flow rate. Decreasing the number of defects in the network structure will lower the
hysteresis and in turn this will lengthen tubing life. Lower hysteresis will also improve restitution and maximise the
flow rate.
Cyclic siloxanes are cytotoxic. In a test carried out by Toxicon, an independent test laboratory, a mix of three cyclic
siloxanes was tested using the MEM Elution test (ISO 10993–5, 1999: (Biological Evaluation of Medical Devices
Part 5: Tests for In- Vitro Cytotoxicity) and USP 29 NF 24, 2006 (87) Biological reactivity test, in vitro). The test
sample showed a severe reactivity (grade 4) at the 48 hour observation and therefore the mix of cyclic siloxanes
was cytotoxic. Grade 4 / severe reactivity means a reduction in viable cell count of approximately 70%. The cyclic
siloxane mix was equal parts of octamethyl cyclotetrasiloxane, decamethyl cyclopentasiloxane and dodecamethyl
cyclohexasiloxane. The test was carried out at 25% dilution of this mix.
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3.3) Sample certificate of conformance
A certificate of conformance is supplied in every box or reel of tubing. A sample certificate is shown below:
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3.4) Specification
The raw material used in the production of Watson-Marlow Pumpsil 913.A and 913.B series platinum cured silicone
tubing complies with the requirements of FDA CFR 177.2600 and USP class VI. Further tests (as detailed in
section 3.14) have been carried out on the finished product. There has been no change to the raw material with the
introduction of the T2 cleanroom facility on the Falmouth campus.
The tolerance of the wall and bore for all standard sizes is shown below (other sizes are available on request). In
practice, much tighter tolerances are maintained during production (see note under 'control').
Bore Wall
Diameter (mm) Tolerance (± mm) Thickness (mm) Tolerance (± mm)
0.5 0.13 1.6 +0.2, +0.05
0.8 0.13 1.6 +0.2, +0.05
1.6 0.13 1.6 +0.2, +0.05
2.4 0.13 1.6 +0.2, +0.05
3.2 0.13 1.6 +0.2, +0.05
4.8 0.25 1.6 +0.2, +0.05
6.4 0.25 1.6 +0.2, +0.05
8.0 0.25 1.6 +0.2, +0.05
0.5 0.20 2.4 0.20

0.8 0.20 2.4 0.20
1.6 0.20 2.4 0.20
3.2 0.25 2.4 0.20
4.8 0.25 2.4 0.20
6.4 0.25 2.4 0.20
8.0 0.30 2.4 0.20
9.6 0.30 2.4 0.20
4.8 0.25 3.2 0.20

6.4 0.25 3.2 0.20
9.6 0.25 3.2 0.20
12.7 0.40 3.2 0.40
15.9 0.40 3.2 0.40
8.0 0.30 4.0 0.40

12.0 0.30 4.0 0.40
16.0 0.40 4.0 0.40
17.0 0.40 4.0 0.40
9.6 0.30 4.8 0.40

12.7 0.30 4.8 0.40
15.9 0.40 4.8 0.40
19.0 0.40 4.8 0.40
25.4 0.40 4.8 0.40
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3.5) Traceability
All Pumpsil 913.A and 913.B series tubing features LaserTraceability, the laser etching of the part number, lot
number and use by date along the length of the tube. Full traceability is therefore assured even when the tubing is
removed from the bag.
The format of the date code is to ISO8601:2000: YYYY.MM.DD (e.g. 2009.09.25)
All tubing is also labelled on the bag, the certificate of analysis and the box (where used) with the part number,
product description, lot number, use by date and a barcode of this information.
As part of the Watson-Marlow ISO9001 system, lot records and process data are stored for all tubing produced.
Full lot traceability to raw material supply is therefore assured. For security, the paper production records are
scanned and the .pdf files held on backed-up drive. All records are kept for at least the shelf life of the tubing.
The lot number of the tubing enables the raw material lot numbers, key equipment production equipment and
production personnel to be identified for any batch of tubing extruded.
The plastic packaging used in direct contact with the tubing is also lot traceable and, as with the tubing, all lot
records are kept for the shelf life of the tubing.
In addition to the production record, a sample piece of every production batch of tubing is retained for reference.
3.6) Physical properties

Elongation at break: 550 - 1500
Shore hardness: 55-57 shore A.
Specific gravity 1.135 – 2.37
Compression set 5.0 - 42.5
Tear strength, die B (PPI) 200 - 500
3.7) Sterilisation
Watson-Marlow Pumpsil 913.A and 913.B series platinum cured tubing may be sterilised using:
• Gamma radiation (maximum 35 kGy / 3.5 MRads)
• Autoclave (1 bar / 14.5psi, 121deg C / 250deg F)
• EtO (ethylene oxide).
Further details on the properties and performance of tubing after gamma irradiation will be included in a
subsequent issue of this validation pack.
3.8) Working temperature range

The working temperature range of Watson-Marlow Pumpsil 913.A and 913.B series silicone tubing is -20 deg C to
+80 deg C. For static (i.e. non-pumped) applications these limits can be exceeded, but it is recommended that
testing is carried out to ensure suitability.
3.9) Gas permeability

Gas Permeability
O 3.8 - 4.6 x 10-6
-6
H2 1.9 x 10
H2O 4.2 x 10-6
CO2 2.3 x 10-5
-4
C2H2 1.7 x 10
C2H4 8.8 x 10-6
n-C4H10 5.8 x 10-5
-4
n-C5H12 1.3 x10
n-C6H14 6.0 x 10-5
n-C10H22 2.7 x 10-5
-5
Benzene 6.8 x 10
Toluene 5.8 x 10-5
3
Permeability = cm gas (RT) . cm thick
sec . cm . atm . Δr
2
For example – H2 Permeability = 1.9x10-6cm³ Hydrogen gas (RT) will move across a 1 cm thick silicone sheet
every second for every cm² surface area and for every 1 atm difference in pressure.
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3.10) Tube structure
The structure of the tube is a poly (dimethyl) siloxane or PMDS structure with a high surface area silica filler to
provide enhanced physical characteristics. The tube contains less than 1% catalyst residue, which itself is primarily
a silicone carrier for the platinum catalyst. The residual level of platinum in the finished tube is less than 5ppm, the
detection level of the test used (see section 18).
The tubing contains some methylpolysiloxanes which when heated to 150 deg C or above can generate
formaldehyde. Therefore heating to 150 deg C or above is not recommended (this is well in excess of the
recommended operating temperature and the recommended autoclave temperature detailed above).
No special handling precautions are required, there are no potential health effects (other than when the tubing is
heated as outlined above).
On combustion, the following products will be released:

Carbon monoxide
Carbon dioxide
Silicon dioxide
Formaldehyde
Fumes of vinyl compounds
Any/all standard firefighting media can be used.
3.11) Control systems

As part of Watson-Marlow's ISO90001 system, key processes including raw material weighing, mixing and
extruding through to finished product packaging are detailed in a Business Processes with additional detail in
Manufacturing Procedures to eliminate batch-to-batch variability. In addition, all key production variables are
monitored by a process control system to ensure consistently high quality tubing.
The T1 and T2 extrusion lines use closed loop feedback control from an on-line laser micrometer to ensure that
very tight dimensional tolerances – much tighter than those outlined in the table above - are maintained throughout
every batch of tubing produced. The sample graph below is taken from a recent batch of 6.4mm bore x 1.6mm wall
tubing. The solid lines show the minimum and maximum diameters taken from the table in section 3.4. The yellow
(middle) line shows the actual tubing diameter through the production run.
6.4mm bore x 1.6mm wall Pumpsil (sample lot 1027SJ03)
10.4
10.2
Outside diameter (mm)
10
9.8
9.6
Tubing OD
Specification minimum OD
9.4 Specification maximum OD
9.2
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Date / time
In addition, individual closed loop controls on key production variables (such as oven temperatures, etc.) ensure
that process conditions remain constant within a batch. Equipment calibration – controlled as one of our business
procedures - ensures that batch-to-batch conditions remain consistent.
Following receipt raw materials are transferred in to the clean room as soon as possible. The cleanroom is air
conditioned to maintain a stable temperature and humidity 24 hours/day, 365 days/year. The control of
atmospheric conditions ensures that the physical properties of the raw material are consistent batch-to-batch,
which in turn maximises the consistency of the extruded tubing.
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3.12) Packaging
Tubing is double bagged in heat-sealed polythene bags in a number of different standard lengths. The bags can be
either shrink-wrap or a looser fit. The lengths available vary according to the tube size, as detailed below:
Tube bore Tube wall Part number / length Part number / length Part number / length
mm inch mm inch
0.5 1/50 1.6 1/16 913.AJ05.016 / 5m 913.A005.016 / 15m 913.B005.R16 / 152m
0.8 1/32 1.6 1/16 913.AJ08.016 / 5m 913.A008.016 / 15m 913.B008.R16 / 152m
1.2 3/64 1.6 1/16 913.AJ12.016 / 5m 913.A012.016 / 15m
1.6 1/16 1.6 1/16 913.AJ16.016 / 5m 913.A016.016 / 15m 913.B016.R16 / 152m
2.4 3/32 1.6 1/16 913.AJ24.016 / 5m 913.A024.016 / 15m
3.2 1/8 1.6 1/16 913.AJ32.016 / 5m 913.A032.016 / 15m 913.B032.R16 / 152m
4.8 3/16 1.6 1/16 913.AJ48.016 / 5m 913.A048.016 / 15m 913.B048.R16 / 152m
6.4 1/4 1.6 1/16 913.AJ64.016 / 5m 913.A064.016 / 15m 913.B064.R16 / 152m
8.0 5/16 1.6 1/16 913.AJ80.016 / 5m 913.A080.016 / 15m 913.B080.R16 / 152m
0.5 1/50 2.4 3/32 913.AJ05.024 / 5m 913.A005.024 / 15m 913.B005.R24 / 152m

0.8 1/32 2.4 3/32 913.AJ08.024 / 5m 913.A008.024 / 15m 913.B008.R24 / 152m
1.6 1/16 2.4 3/32 913.AJ16.024 / 5m 913.A016.024 / 15m 913.B016.R24 / 152m
3.2 1/8 2.4 3/32 913.AJ32.024 / 5m 913.A032.024 / 15m 913.B032.R24 / 152m
4.8 3/16 2.4 3/32 913.AJ48.024 / 5m 913.A048.024 / 15m 913.B048.R24 / 122m
6.4 1/4 2.4 3/32 913.AJ64.024 / 5m 913.A064.024 / 15m 913.B064.R24 / 91m
8.0 5/16 2.4 3/32 913.AJ80.024 / 5m 913.A080.024 / 15m 913.B080.R24 / 61m
9.6 3/8 2.4 3/32 913.AJ96.024 / 5m 913.A096.024 / 15m 913.B096.R24 / 46m
4.8 3/16 3.2 1/8 913.A048.I32 / 3m 913.A048.032 / 15m 913.B048.R32 / 91m

6.4 1/4 3.2 1/8 913.A064.I32 / 3m 913.A064.032 / 15m 913.B064.R32 / 61m
8.0 5/16 3.2 1/8 913.B080.R32 / 46m
9.6 3/8 3.2 1/8 913.A096.I32 / 3m 913.A096.032 / 15m 913.B096.R32 / 46m
12.7 1/2 3.2 1/8 913.A127.I32 / 3m 913.A127.032 / 15m 913.B127.R32 / 30m
15.9 5/8 3.2 1/8 913.A159.I32 / 3m 913.A159.032 / 15m
8.0 5/16 4.0 - 913.A080.I40 / 3m 913.A080.040 / 15m

12.0 - 4.0 - 913.A120.I40 / 3m 913.A120.040 / 15m
16.0 - 4.0 - 913.A160.I40 / 3m 913.A160.040 / 15m
9.6 3/8 4.8 3/16 913.A096.I48 / 3m 913.A096.048 / 15m

12.7 1/2 4.8 3/16 913.A127.I48 / 3m 913.A127.048 / 15m
15.9 5/8 4.8 3/16 913.A159.I48 / 3m 913.A159.048 / 15m
19.0 3/4 4.8 3/16 913.A190.I48 / 3m 913.A190.048 / 15m
25.4 1 4.8 3/16 913.A254.I48 / 3m 913.A254.048 / 15m
All 3m and 5m lengths are double bagged and supplied complete with a certificate of conformance.
All 15m lengths are double bagged and supplied in a card box complete with a certificate of conformance.
All reels (913.B***.R**) are double bagged and supplied in a card box complete with a certificate of conformance.
Other tube sizes (bore / wall) and lengths are available on request. Custom laser coding is also available on
request. Please contact your local Watson-Marlow representative for details.
3.13) Shelf life

The use by date of the tubing is included on the bag and box label. To maintain the performance of the tubing
throughout its life, tubing should be stored in a cool, dry environment away from direct sunlight. Normal room
temperature (circa 18-21ºC, 65-70ºF) is ideal, normal warehouse conditions (circa 5-30ºC, 40-86ºF) are
acceptable. Wherever possible, original packaging should be maintained. Stock should be rotated on a FIFO (first
in, first out) basis.
The performance of any tubing beyond its use by date, or which has not been stored according to the
recommendations outlined above, cannot be assured.
14
3.14) Material data sheet - Watson-Marlow Pumpsil 913.A and 913.B series platinum cured silicone tubing.
The tubing has been tested as outlined in the tests below. Full test results are included in the validation pack.
Section Test description Test reference Result

4 Systemic injection – ISO / USP ISO 10993-11, Pass
2006, USP NF 27,
2009, <88>
5 Intracutaneous injection – ISO test for irritation and delayed-type ISO10993-10, Pass
hypersensitivity. 2002, USP NF 27,
2009, <88>
6 European Pharmacopoeia 3.1.9 silicone elastomer for closures and European Pass
tubing Pharmacopoeia
6.5, 2009 chapter
3.1.9
7 Hemocompatibility (Hemolysis test - Autian method ISO 10993-4, Pass
ASTM F756-00
8 Kligman Maximisation - test for irritation and delayed-type ISO 10993-10, Pass
hypersensitivity. 2002, 2006
9 In-vitro cytotoxicity test (quantitative MEM elution) ISO 10993-5, 2009 Pass
10 Elution test – ISO. Biological reactivity part 5, in vitro cytotoxicity ISO 10993-5, 2009 Pass
USP 32, NF 27,
2009, <87>
11 Physicochemical tests on elastomeric closure materials USP 32 NF27, Pass
2009: <381>
12 Short term intramuscular test ISO 10993-6, Pass
2007, USP 32, NF
27, 2009, <88>
13 USP class VI summary certificate USP 32 Pass
14 Limulus Amebocyte Lysate (LAL) Kinetic-QCL method. Bacterial USP-NF 27, 2009, Report
Endotoxin Assay <85>
15 Total extractables as per 21CFR 177.2600 21 CFR part Pass
177.2600
16 USP Particulate / Microscopic particulate count analysis test USP 32, NF 27, Report
2009, <788>
17 Total Organic Carbon USP 32, NF 27, Report
2009, <643>,
<381>
18 Residual platinum content by ICP-AES N/A Report
15
4. Systemic injection – ISO / USP.
Note: The amended report was issued to include the USP references. There was no change to the study. Original
report available on request.
16
5. Intracutaneous injection – ISO / USP test for irritation and delayed-type hypersensitivity.
17
6. European Pharmacopoeia 3.1.9 silicone elastomer for closures and tubing (ISO10993).
18
19
20
21
22
23
24
25
7. Hemocompatibility (Hemolysis test - Autian method.
26
27
8. Kligman Maximisation - test for irritation and delayed-type hypersensitivity.
28
9. In-vitro cytotoxicity test (quantitative MEM elution).
29
10. Elution test – ISO. Biological reactivity part 5, in vitro cytotoxicity.
30
11. Physiochemical tests on elastomeric closure materials
31
32
33
34
35
36
37
12. Short term intramuscular test
38
39
40
41
42
43
44
13. USP class VI summary certificate
45
14. Limulus Amebocyte Lysate (LAL) Kinetic-QCL method. Bacterial Endotoxin Assay.
46
15. Total extractables as per 21CFR 177.2600 test result certificate.
47
16. USP Particulate / Microscopic particulate count analysis test result certificate.
48
17. Total Organic Carbon test result certificate.
49
18. Residual platinum test result certificate.
50

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November 2009 issue 9.

1.2 Product and production facilities

Pumpsil 913.A and 913.B series tubing:

Watson-Marlow business policy

Managing Director, Watson-Marlow

Watson-Marlow is an ISO9001-2000 accredited company.

Scope of Watson-Marlow business

Managing Director, Watson-Marlow

3) Product description and specification

3.1) Animal origin / TSE statement

0.5 0.20 2.4 0.20

4.8 0.25 3.2 0.20

8.0 0.30 4.0 0.40

9.6 0.30 4.8 0.40

The format of the date code is to ISO8601:2000: YYYY.MM.DD (e.g. 2009.09.25)

3.6) Physical properties

3.8) Working temperature range

3.9) Gas permeability

On combustion, the following products will be released:

3.11) Control systems

6.4mm bore x 1.6mm wall Pumpsil (sample lot 1027SJ03)

0.5 1/50 2.4 3/32 913.AJ05.024 / 5m 913.A005.024 / 15m 913.B005.R24 / 152m

4.8 3/16 3.2 1/8 913.A048.I32 / 3m 913.A048.032 / 15m 913.B048.R32 / 91m

8.0 5/16 4.0 - 913.A080.I40 / 3m 913.A080.040 / 15m

9.6 3/8 4.8 3/16 913.A096.I48 / 3m 913.A096.048 / 15m

3.13) Shelf life

Section Test description Test reference Result

4. Systemic injection – ISO / USP.

9. In-vitro cytotoxicity test (quantitative MEM elution).

10. Elution test – ISO. Biological reactivity part 5, in vitro cytotoxicity.

11. Physiochemical tests on elastomeric closure materials

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