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Product Information
Healthcare
DOW CORNING® Pharma Tubing

FEATURES Pharmaceutical grade silicone tubing for transferring of

" Excellent flexibility ultra-pure liquids, air or steam in pharmaceutical and
" Low extractables biotechnological manufacturing processes
" Contains no peroxide by-products,
chlorophenyls or PCBs
APPLICATION
" No organic plasticizers, phthalates or
" DOW CORNING Pharma Tubing is designed for applications that require the
latex additives
" Easily sterilized transfer of high purity fluids where contamination is a concern.
" Available in three durometers to match TYPICAL PROPERTIES
performance requirements
Specification Writers: These values are not intended for use in preparing specifications. Please
" Stable over a wide temperature range
contact your local Dow Corning sales representative or your global Dow Corning connection
" High resiliency
prior to writing specifications on this product.
" No imparted taste or odor
" Non-wetting (hydrophobic) surface CTM* ASTM* Test Unit Value
" Made from SILASTIC® BioMedical Pharma- Pharma- Pharma-
Grade elastomer that exceeds United 501 652 803
States Pharmacopeia (USP®) Class VI 0099 D2240 Durometer hardness, shore A4 50 65 80
Plastics Test requirements 0137A D412 Tensile strength at break, die D5 MPa 8.7 6.8 7.0
psi 1265 990 1025
" Meets European Pharmacopoeia
0137A D412 Elongation at break, die D5 % 795 775 570
monograph 3.1.9. Silicone elastomer for 0137A D412 Modulus at 200%, die D5 MPa 2.1 2.8 3.9
closures and tubing psi 310 415 570
" Manufactured to the principles of FDA 0159A D624 Tear strength, die B 4
kN/m 47.3 45.5 42
ppi 270 260 240
21 CFR 210/211 cGMPs for
Pharmaceutical products 1. 9.53mm x 15.875mm (ID x OD; 0.375 x 0.625).
2. 3.35mm x 4.65mm (ID x OD; 0.132 x 0.183).
" Produced in an FDA-registered 3. 1.63 mm x 2.21 mm (ID x OD; 0.064 x 0.087).
(CFN 1816403) and inspected healthcare 4. Typical properties for the elastomer.
facility 5. Typical properties of the extruded tubing.
* CTM: Corporate Test Method, copies of CTMs are available on request.
* ASTM: American Society for Testing and Materials.
BENEFITS
" Reduces risk of contaminating ultra-pure
liquids DESCRIPTION DOW CORNING Pharma Tubing is
" Complete traceability DOW CORNING Pharma Tubing is a available in three durometers
" Consistent performance translucent silicone tubing made from (hardnesses) to meet burst or
" Rigorous change control tear-resistant SILASTIC® brand processing requirements:
BioMedical Grade platinum-cured " 50 Shore A: Medium
COMPOSITION elastomer. It is designed for use in " 65 Shore A: Medium-High
pharmaceutical and biotechnological " 80 Shore A: High
" Platinum-cured silicone tubing manufacturing processes.
For more demanding applications, the
increased hardness of
DOW CORNING® Pharma-65 and
Pharma-80 Tubing offers greater
pressure and kink resistance.
MANUFACTURING Gamma Radiation USABLE LIFE AND
ENVIRONMENT Sterilization STORAGE
DOW CORNING Pharma Tubing is Gamma radiation studies of the effects When stored in the original unopened
manufactured under quality control on the physical properties of the containers, DOW CORNING Pharma
guidelines. The Healthcare Industries silicone elastomer used to produce Tubing has a usable life of 36 months
Materials Site in Hemlock, Michigan, DOW CORNING Pharma Tubing have from the date of production.
is dedicated to the production of shown that doses of radiation up to
silicone materials for healthcare 2.5 Mrad (25kGy) do not adversely TUBING SIZE
applications. It is registered with the affect durometer, elongation, modulus, CAPABILITIES AND
U.S. Food and Drug Administration tensile or tear strength. Repeated PACKAGING
(FDA) as a Drug Establishment (CFN gamma sterilization or processing at To serve our customers better, we can
1816403). The site quality system is higher doses of radiation and for longer provide DOW CORNING
based on principles of current Good dosing periods may change some of the Pharma Tubing in a variety of
Manufacturing Practices for both Bulk physical properties of the elastomer. dimensions, including the most
Pharmaceutical Products and Medical commonly used sizes shown in
Devices. The site is ISO 9001- Ethylene Oxide Sterilization Table 1. Standard package is a
registered. Ethylene oxide (ETO) has been used to 15-meter (50 foot) coil, double bagged
sterilize silicone tubing with no in separately sealed polyethylene bags
QUALITY ASSURANCE degradation of physical properties. contained in a cardboard box.
Dow Corning manufactures Sterilization by this method is only
DOW CORNING Pharma Tubing in a recommended if procedures allow SPECIAL NEEDS
totally integrated process from raw sufficient time for complete out- Dow Corning has the capabilities to
materials to the final extruded tubing. gassing of residual ETO and ETO by- customize products to your
The tubing is manufactured in an ISO products. specifications. Customization includes
registered facility, requiring sizes, tolerances, cut lengths, bulk
appropriate documentation and REGULATORY STATUS packaging and spooling. For easy
traceability. Critical properties are DOW CORNING Pharma Tubing is identification, DOW CORNING
controlled all along the complete manufactured using SILASTIC Pharma Tubing is also available
manufacturing process, to provide BioMedical Grade silicone elastomer marked with product name and size.
quality of the raw materials, the that meet or exceed the test Please contact your Dow Corning
elastomer, and the finished tubing. requirements of USP Class VI Plastics representative to discuss your specific
)87* and )88*. requirements.
STERILIZATION
CONSIDERATIONS DOW CORNING Pharma Tubing LIMITATIONS
It is the users responsibility to validate meets the requirements of 21 CFR This product has not been tested or
a sterilization process for silicone 177.2600 and USP )661* (Physico- approved for any hospital or patient
tubing. The user should conduct testing chemical Tests - Plastics), and its care use such as for temporary
if sterilization conditions vary and/or if elastomer stock complies with selected insertion or any in vivo procedures.
minor property changes could affect 3-A Sanitary Standards. The tubing
application performance. Common meets the requirements of European This product is not to be used in human
sterilization procedures include: Pharmacopoeia (Ph. Eur. or EP) implantation, or human contraceptive,
3.1.9. Silicone elastomer for closures reproductive, obstetrical or
Autoclave and tubing. gynecological applications. The user
(Steam Sterilization) shall hold Dow Corning harmless from
Silicone tubing can be effectively To support use in validated processes, any and all damages resulting from use
sterilized by steam in an autoclave. contact Dow Corning to obtain a of this product. It is the sole
Silicone materials are more difficult to Qualifications Guide for Dow Corning responsibility of the user to determine
heat than materials such as thermo- Pharma Tubing. This manual the safety and efficacy of this product
plastics because they have thermal summarizes key tubing performance for any specific use.
insulating properties. Steam and regulatory data.
sterilization has been accomplished in
a standard gravity steam sterilization
cycle (30 minutes at 1 bar /15 psi and
121ºC/250ºF) and in a high-speed flash
steam sterilization cycle (15 minutes at
2 bar/30 psi and 132ºC/270ºF).

DOW CORNING Pharma Tubing

2
Ref. no. 51-0985D-01
ORDERING LIMITED WARRANTY
DOW CORNING Pharma Tubing is INFORMATION - PLEASE
available direct from Dow Corning or READ CAREFULLY
through many pharmaceutical or The information contained herein is
laboratory distributors. For order offered in good faith and is believed
information or to discuss specific to be accurate. However, because
requirements, please contact conditions and methods of use of our
Dow Corning at 1-800-248-2481 products are beyond our control, this
(USA) or +44-(0)1676-528000 information should not be used in
(Europe & Middle East) or consult substitution for customers' tests to
www.dowcorning.com. ensure that Dow Corning's products are
safe, effective, and fully satisfactory
HEALTH AND for the intended end use. Suggestions
ENVIRONMENTAL of use shall not be taken as
INFORMATION inducements to infringe any patent.
To support Customers in their product
safety needs, Dow Corning has an Dow Corning's sole warranty is that the
extensive Product Stewardship product will meet the Dow Corning
organization and a team of Product sales specifications in effect at the time
Safety and Regulatory Compliance of shipment.
(PS&RC) specialists available in each
area. Your exclusive remedy for breach of
such warranty is limited to refund of
For further information, please see our purchase price or replacement of any
website, www.dowcorning.com or product shown to be other than as
consult your local Dow Corning warranted.
representative.
DOW CORNING SPECIFICALLY
DISCLAIMS ANY OTHER
EXPRESS OR IMPLIED
WARRANTY OF FITNESS FOR
A PARTICULAR PURPOSE OR
MERCHANTABILITY.

DOW CORNING DISCLAIMS

LIABILITY FOR ANY
INCIDENTAL OR
CONSEQUENTIAL DAMAGES.

We help you invent the future."

www.dowcorning.com

DOW CORNING Pharma Tubing

3
Ref. no. 51-0985D-01
Table 1: Common tubing product sizes. Capability exists for these and many other sizes.
Imperial (inches) Metric (mm)
Inside diameter Outside diameter Wall Inside diameter Outside diameter Wall
0.125 0.250 0.063 3.175 6.350 1.588
0.188 0.313 0.063 4.775 7.950 1.588
0.188 0.375 0.094 4.775 9.525 2.375
0.250 0.375 0.063 6.350 9.525 1.588
0.250 0.438 0.094 6.350 11.113 2.381
0.250 0.500 0.125 6.350 12.700 3.175
0.313 0.500 0.094 7.950 12.700 2.375
0.375 0.500 0.063 9.525 12.700 1.588
0.375 0.563 0.094 9.525 14.300 2.388
0.375 0.625 0.125 9.525 15.875 3.175
0.500 0.688 0.094 12.700 17.463 2.381
0.500 0.750 0.125 12.700 19.050 3.175
0.625 0.875 0.125 15.875 22.225 3.175
0.750 1.000 0.125 19.050 25.400 3.175

Table 2: Burst Properties.

Values stated are typical values only and are not intended for writing specifications. The user is responsible for validating the
suitability of DOW CORNING Pharma Tubing for their process.
Imperial (inches) Metric (mm) Burst pressure1
Inside diameter Outside diameter Inside diameter Outside diameter Pharma-50 Pharma-65 Pharma-80
psi (bar) psi (bar) psi (bar)
0.125 0.250 3.175 6.350 80 (5.5) 123 (8.5) 191 (13.2)
0.188 0.375 4.775 9.525 101 (7.0) 157 (10.8) 246 (17.0)
0.250 0.500 6.350 12.700 85 (5.9) 147 (10.1) 254 (17.5)
0.375 0.625 9.525 15.875 59 (4.1) 112 (7.7) 192 (13.2)
0.500 0.750 12.700 19.050 48 (3.3) 90 (6.2) 147 (10.1)
0.625 0.875 15.875 22.225 37 (2.6) 67 (4.6) 123 (8.5)
0.750 1.000 19.050 25.400 33 (2.3) 63 (4.3) 107 (7.4)
1. Test method described in Dow Corning Form 52-1047-01, Burst Strength Testing of DOW CORNING Pharma Tubings.

DOW CORNING Pharma Tubing We help you invent the future. is a trademark of Dow Corning Corporation.
4 05/09/2003 SILASTIC and DOW CORNING are registered trademarks of Dow Corning Corporation.
Ref. no. 51-0985D-01 DC 4420 USP is a registered trademark of The United States Pharmacopeial Convention.
©2003 Dow Corning Corporation. All rights reserved.