Product Information
`Healthcare
`
`DOWCORNING
`
`Dow Corning® 360 Medical Fluid
`
`FEATURES & BENEFITS
`• Available in five standard
`viscosities
`• High water
`repellency/hydrophobicity
`• Good stability over a broad range
`of temperatures
`• Excellent lubricating
`characteristics
`• Low surface tension
`• Low order of toxicity and skin
`sensitization
`• Tested according to and complies
`with all National Formulaiy (NF)
`requirements for Dimethicone and
`European Pharmacopeia (EP)
`requirements for Dimeticone or
`Silicone Oil Used as a Lubricant,
`depending on viscosity
`
`COMPOSITION
`• Clear, colorless
`polydimethylsiloxane fluid
`
`Hydrophobic lubricant for medical devices
`
`APPLICATIONS
`• Silicone fluid for lubrication and siliconization of glass, metals, plastics and
`rubber.
`
`TYPICAL PROPERTIES
`Specification Writers: These values are not intended for use in preparing
`specifications. Please contact your local Dow Corning sales office or your Global
`Dow Corning Connection before writing specifications on this product.
`
`CTM1
`
`ASTM2
`
`Property
`
`Unit
`
`Result
`
`Visual appearance
`
`Clear as water
`
`0176
`
`0005
`
`0044
`
`D1209
`
`Color (APHA)
`
`D70 Specific gravity at 25°C
`
`D1217
`
`20 est
`
`100 est
`
`350 cSt, 1000 cSt
`
`< 15
`
`0.951
`
`0.967
`
`0.972
`
`1.4018
`
`1.4032
`
`1.4042
`
`1.4046
`
`1.4047
`
`0002
`
`D1218 Refractive index
`
`20 est
`
`100 est
`
`350 est
`
`1000 est
`
`12,500 est
`
`0004
`
`D445 Viscosity at 25°C
`
`D21 62
`
`D2515
`
`20 est
`
`%of nominal
`
`± 10
`
`100 and 350 cSt
`
`%of nominal
`
`±5
`
`0050
`
`D1084 Viscosity at 25°C
`
`D4287
`
`1000 est
`
`12,500 est
`
`0051
`
`D664
`
`Acid number
`
`0079
`
`D974
`
`Infrared identification
`
`%of nominal
`
`%of nominal
`
`±5
`
`±5
`
`BPB
`(Bromophenyl
`Blue)
`
`< 0.02
`
`Matches reference
`spectrum for specific
`viscosity
`
`1CTM: Corporate Test Method, copies ofCTMs are available on request.
`2ASTM: American Society for Testing and Materials
`
`NOVITC(US)00000788
`
`Novartis Exhibit 2152.001
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`DESCRIPTION
`Dow Corning® 360 Medical Fluid is a
`clear, colorless polydimethylsiloxane
`liquid that is available in five
`standard viscosities.
`
`IMPORTANT NOTICE
`Dow Corning neither represents nor
`tests this material for specific medical
`device or pharmaceutical
`applications. Purchaser is fully
`responsible to determine end-use
`suitability.
`
`REGULATORY AND
`PHARMACOPEIAL
`STATUS
`Dow Corning 360 Medical Fluid is
`not to be used as a new drug or new
`device as defined by regulatory
`authorities (e.g., the U.S. Food and
`Drug Administration) until the user
`has obtained appropriate approval
`from those regulatory authorities.
`This fluid is not approved by the
`FDA for tissue augmentation and
`Dow Corning does not support this
`use.
`
`Each lot of Dow Corning 360
`Medical Fluid is tested and complies
`with the current monograph
`requirements for Dimethicone NF,
`Dimeticone EP, or Silicone Oil Used
`as a Lubricant EP, depending on the
`fluid viscosity.
`
`A certification of these test results is
`available upon request.
`
`Dow Corning also maintains a Drug
`Master File with the U.S. FDA and
`holds a Certificate of Suitability to
`support European registrations.
`
`MANUFACTURING
`ENVIRONMENT
`Dow Corning 360 Medical Fluid is
`manufactured, tested and packaged
`under strict quality control guidelines
`at the Healthcare Industries Materials
`Site (HIMS). The HIMS (Hemlock,
`Mich.) is dedicated to the production
`of silicone materials for healthcare
`applications. It is registered with the
`U.S. Food and Drug Administration
`
`20 15. August 10
`Form No. 51-03740-01
`
`(FDA) as a drug establishment (CFN
`1816403). The site quality system for
`active pharmaceutical ingredients
`(APis) is in compliance with current
`Good Manufacturing Practices for
`Bulk Pharmaceutical Products. The
`site is also ISO registered by BSI.
`
`HOWTOUSE1
`Dow Corning 360 Medical Fluid can
`be applied directly to surfaces by
`techniques such as dipping, spraying
`or wiping to provide a lubricious
`and/or hydrophobic coating.
`
`When a very thin film of fluid is
`desired, Dow Corning 360 Medical
`Fluid can be diluted to the desired
`silicone fluid concentration (such as
`0.1 to 2%) in a nonpolar solvent. After
`Dow Corning 360 Medical Fluid has
`been applied, allow sufficient time to
`permit the solvent to evaporate.
`Solvents that can be used with
`Dow Corning 360 Medical Fluid are
`discussed in the Compatibility section.
`
`Although Dow Corning 360 Medical
`Fluid possesses excellent lubricant
`characteristics, the fluid may not
`provide satisfactory lubrication when
`used in situations such as metal
`against metal. On temperature
`resistant materials, such as glass,
`ceramic and metal, this fluid film can
`be heated to provide a more durable
`hydrophobic film.
`
`Dow Corning 360 Medical Fluid can
`be applied to silicone elastomers for
`temporary lubricity. Before exposing a
`silicone elastomer to a silicone fluid,
`the user should evaluate the effect of
`the exposure on the performance.
`
`Sterilization
`Sterilization of the bulk fluid is not
`recommended. If sterilization is
`necessary for a given application, the
`sterilization process should be done on
`the treated article.
`
`Steam autoclaving sterilization of bulk
`fluid by steam autoclaving is not
`recommended. Excess water diffuses
`into the fluid, causing the fluid to
`become hazy. Thin films of fluid may
`
`be satisfactorily sterilized by this
`method.
`
`Gamma irradiation the exl)osure of
`polydimethylsiloxane fluids, such as
`Dow Corning 360 Medical Fluid, to
`25 kGy of cobalt-60 radiation has the
`effect of introducing small levels of
`cross-linking into the fluid and is
`observed as an increase in fluid
`viscosity. This effect is most
`noticeable in the higher-viscosity
`fluids (e.g. , 12,500 cSt). As with any
`exposure of a product to radiation, one
`should evaluate product performance
`after exposure to determine if such
`treatment has detrimental effects.
`
`Dry heat sterilization of bulk fluid is
`not recommended. Thin films of fluid
`may be satisfactorily sterilized by this
`method. The temperature of the fluid
`should not exceed 200°C because
`small amounts of formaldehyde may
`be generated.
`
`COMPATIBILITY
`Dow Corning 360 Medical Fluid is
`soluble in all proportions in nonpolar
`solvents:
`
`• Aliphatic hydrocarbon (e.g.,
`hexane, heptane, mineral spirits)
`• Aromatic hydrocarbon (e.g.,
`toluene, xylene)
`
`Several ozone-safe, volatile organic
`compound (VOC)-exempt solvents are
`compatible with Dow Corning 360
`Medical Fluid:
`
`• Dow Corning® Q7-9180 Silicone
`Fluids
`• Dow Corning® OS-10 Fluid,
`Dow Corning® OS-20 Fluid,
`Dow Corning® OS-30 Fluid
`• Vertrel®2 XSi Cleaning Agent
`Lenium®3 DF
`•
`
`1For additional information on uses, toxicity,
`analysis and methods of applying
`polydimethylsiloxane fluids in parenteral
`applications, read Technical Report No. 12,
`Siliconization of Parenteral Drug Packaging
`Components, Jou rnal of Parenteral Science
`and Technology, Volume 42, No. 4S, 1988 .
`2Vertrel is a registered trademarlc The Chemours
`Company.
`3Lenium is a registered trademark of Vantage
`Specialties Inc.
`
`Dow Corning is a registered trademark of Dow Coming Corporation
`We help y ou invent th efuh1re is a trademark of Dow Corning Corporation
`XIAMETER is a registered trademark of Dow Coming Corporation
`© 2002 - 201 5 Dow Coming Corporation. All rights reserved.
`
`2
`
`NOVITC(US)00000789
`
`Novartis Exhibit 2152.002
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`Solvents selected from this list are
`frequently used to dilute
`Dow Corning 360 Medical Fluid as
`a means of applying the fluid to
`articles by dipping or spraying. As
`the polarity of the solvent
`increases, the solubility of the
`silicone fluid decreases.
`
`For example, Dow Corning 360
`Medical Fluid is, for all practical
`purposes, insoluble in glycerin,
`ethylene glycol, stearyl alcohol,
`methanol, ethanol and water.
`Limited solubility ofless than 0.5%
`may be obtained for 20 and 100 cSt
`fluid in anhydrous isopropanol.
`Lower- viscosity (molecular
`weight) Dow Corning 360 Medical
`Fluid will tend to have a slightly
`increased solubility in the more
`polar solvents. Moderate solubility
`(approximately 10%) is obtained in
`some ethers (e.g., ethyl ether,
`esters; amyl acetate and ketones;
`methyl ethyl ketone).
`
`BLENDING
`Although the fluid is available in a
`number of standard viscosities,
`occasionally an application calls for a
`fluid of an intermediate viscosity.
`Blending of different viscosities of
`Dow Corning 360 Medical Fluid
`permits any desired viscosity between
`20 and 12,500 cSt.
`
`The blending chart (Figure 1) is a
`guideline for preparing intermediate
`fluid viscosities. To use the blending
`chart:
`
`1. Draw a line between two points
`one on the left-hand scale
`representing the higher-viscosity
`fluid available, and one on the
`right, the lower-viscosity fluid;
`2. Draw another line horizontally
`across the chart at the desired
`viscosity rating;
`3. Draw a third line vertically
`through the intersection of the
`first two lines;
`4. Read from the top and bottom
`scales the proportions of the
`available fluids to blend to obtain
`the desired viscosity.
`
`20 15. August 10
`Form No. 51-03740-01
`
`Figure 1: Blending chart for Dow Corning 360 Medical Fluid
`
`l'erv..:ntby w,:igh1. ,YfHi gh,·1~\/is-·o·;j;y Flu id
`
`iuo.oon --<......,~ ........ ---'-----i----i---....;...-..,J.._-i..._...L--J wn,ooo
`
`HJO
`
`'!O
`
`80
`
`70
`
`61>
`
`5!?
`
`40
`
`30
`
`:.'U
`
`J tl
`
`0
`
`12;500 Y
`:.'i
`IO.GOO
`
`l.OGO
`
`35iJ
`
`Hi !'--.--..........,,..........---,-~---~-~-~--.............J iO
`l()()
`
`Accuracy is increased by blending the
`two fluids that immediately bracket
`the desired viscosity. If a very
`accurate blend is required, it may be
`necessary to adjust the viscosity of the
`mixture by a second blending.
`
`The example shown in Figure 1 is as
`follows: 150 cSt fluid is desired. The
`standard viscosities immediately
`bracketing 150 cSt are 100 and 350
`cSt. Draw line A connecting 350 cSt
`on the left-hand scale with 100 cSt on
`the right-hand scale. Draw line B
`horizontally at the desired viscosity of
`150. Atthe point of intersection, AB,
`draw vertical line C. The proportion of
`100 cSt viscosity fluid (67%) is read
`on the bottom scale; the proportion of
`350 cSt viscosity fluid (33%) is read
`on the top scale.
`
`HANDLING
`PRECAUTIONS
`PRODUCT SAFETY
`INFORMATION REQUIRED FOR
`SAFE USE IS NOT INCLUDED IN
`TIDS DOCUMENT. BEFORE
`HANDLING, READ PRODUCT
`AND SAFETY DATA SHEETS
`
`AND CONTAINER LABELS FOR
`SAFE USE, PHYSICAL AND
`HEALTH HAZARD
`INFORMATION. THE SAFETY
`DATA SHEET IS AVAILABLE ON
`THE DOW CORNING WEBSITE
`AT DOWCORNING.COM, OR
`FROM YOUR DOW CORNING
`SALES APPLICATION
`ENGINEER, OR DISTRIBUTOR,
`OR BY CALLING
`DOW CORNING CUSTOMER
`SERVICE.
`
`USABLE LIFE AND
`STORAGE
`When stored in original, unopened
`containers this product has a usable
`life of 60 months from the date of
`production.
`
`PACKAGING
`INFORMATION
`Dow Corning 360 Medical Fluid is
`available in five standard viscosities:
`20, 100, 350, 1000 and 12,500 cSt.
`The material is supplied in 0.45, 18,
`and 200 kg (1, 40, and 440 lbs)
`containers, net weight.
`
`Dow Corning is a registered trademark of Dow Coming Corporation
`We help y ou invent th efuh1re is a trademark of Dow Corning Corporation
`XIAMETER is a registered trademark of Dow Coming Corporation
`© 2002 - 201 5 Dow Coming Corporation. All rights reserved.
`
`3
`
`NOVITC(US)00000790
`
`Novartis Exhibit 2152.003
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`SHIPPING LIMITATIONS
`None
`
`ORDERING
`Dow Corning requires a signed
`affidavit detailing information on the
`intended use of Dow Corning 360
`Medical Fluid before acting upon a
`request for a sample or sales order.
`
`To obtain additional information or to
`place an order, contact your local
`Dow Corning representative.
`
`HEALTH AND
`ENVIRONMENTAL
`INFORMATION
`To support customers in their product
`safety needs, Dow Corning has an
`extensive Product Stewardship
`organization and a team of Product
`Safety and Regulatory Compliance
`(PS&RC) specialists available in each
`area.
`
`For further information, please see our
`website, dowcorning.com or consult
`your local Dow Corning
`representative.
`
`LIMITED WARRANTY
`INFORMATION - PLEASE
`READ CAREFULLY
`The information contained herein is
`offered in good faith and is believed to
`be accurate. However, because
`conditions and methods of use of our
`products are beyond our control, this
`information should not be used in
`substitution for customer's tests to
`ensure that our products are safe,
`effective, and fully satisfactory for the
`intended end use. Suggestions of use
`shall not be taken as inducements to
`infringe any patent.
`
`Dow Corning' s sole warranty is that
`our products will meet the sales
`specifications in effect at the time of
`shipment.
`
`Your exclusive remedy for breach of
`such warranty is limited to refund of
`purchase price or replacement of any
`product shown to be other than as
`warranted.
`
`201 5. August 10
`Form No. 51-03740-01
`
`TO THE FULLEST EXTENT
`PERMITTED BY APPLICABLE
`LAW, DOW CORNING
`SPECIFICALLY DISCLAIMS
`ANY OTHER EXPRESS OR
`IMPLIED WARRANTY OF
`FITNESS FOR AP ARTICULAR
`PURPOSE OR
`MERCHANTABILITY.
`
`DOW CORNING DISCLAIMS
`LIABILITY FOR ANY
`INCIDENTAL OR
`CONSEQUENTIAL DAMAGES.
`
`We help you invent the future. TM
`
`dowcoming.com
`
`Dow Corning is a registered trademark of Dow Coming Corporation
`We help y ou invent the fu h1re is a trademark of Dow Corning Corporation
`XIAMETER is a registered trademark of Dow Coming Corporation
`© 2002 - 201 5 Dow Coming Corporation. All rights reserved.
`
`4
`
`NOVITC(US)00000791
`
`Novartis Exhibit 2152.004
`Regeneron v. Novartis, IPR2021-00816
`
`