Product Information
`Healthcare
`
`DOWCOHNING
`
`FEATURES & BENEFITS
`• Excellent lubricating and release
`characteristics
`• Good wetting characteristics
`• The silicone fluid is tested
`according to and complies with all
`National Formulary (NF)
`requirements for dimethicone and
`European Pharmacopeia (EP)
`requirements for dimeticone
`
`COMPOSITION
`• Polydimethylsiloxane emulsion
`• Dimethicone fluid viscosity: 350 cs
`
`Dow Corning® 365, 35%
`Dimethicone NF Emulsion
`
`Hydrophobic lubricant for medical devices.
`
`APPLICATIONS
`• Water-borne 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.
`
`Test*
`
`Property
`
`CTM 0176
`
`Appearance
`
`Unit
`
`Result
`
`White liquid
`
`CTM0806
`
`Dimethicone NF content
`
`%
`
`CTM000lA
`
`Specific gravity at 25°C (77°F)
`
`CTM0007
`
`pH
`
`*CTM: Corporate Test Method, copies ofCTMs are available on request.
`
`35
`
`0.99
`
`5.0
`
`DESCRIPTION
`Dow Corning® 365, 35% Dimethicone
`NF Emulsion is a water-dilutable
`emulsion containing non-ionic
`emulsifiers and 35% National
`Formulary dimethicone.
`
`The emulsion is not manufactured
`or tested to be pyrogen free.
`
`Advantages of this product include:
`•
`Excellent lubricating and release
`characteristics
`• Good wetting characteristics
`•
`The silicone fluid meets the
`current National Formulary
`dimethicone and European
`Pharmacopeia dimeticone
`requirements
`
`Dow Corning 365, 35% Dimethicone
`NF Emulsion may be used in a variety
`of applications where it is
`advantageous to deliver a lubricating
`silicone fluid in a water-dilutable
`delivery system.
`
`REGULATORY STATUS
`The dimethicone component is
`qualification tested to requirements of
`the National Formulary and the
`European Pharmacopeia.
`
`Dow Corning 365, 35% Dimethicone
`NF Emulsion is formulated with an
`emulsifier (Triton X-100, CAS #9036-
`19-5) which has been added to the
`REACh (Registration, Evaluation,
`Authorisation and Restriction of
`Chemicals) Authorisation List
`administered by the EChA (European
`Chemical Agency). Dow Corning does
`not intend to file with EChA for
`authorisation. Effective 04 July 2019,
`no new applications for such material
`in the European Union shall occur
`without EChA authorisation. EChA
`has communicated a sunset date of 04
`January 2021 for the surfactant. In
`anticipation of these regulatory
`circumstances, Dow Corning has
`developed and made available a
`
`NOVITC(US)00000792
`
`Novartis Exhibit 2153.001
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`similar product, Dow Corning® 366
`35% Dimethicone NF Emulsion
`which is intended to replace
`Dow Corning 365, 35% Dimethicone
`NF Emulsion in most applications.
`
`In any application involving the U.S.
`Food and Drug Administration or any
`other regulatory agency, it is the
`user's responsibility to ensure that use
`of the product complies with the
`requirements of these agencies.
`
`IMPORTANT
`INFORMATION
`Dow Corning neither represents nor
`tests this material for specific medical
`device or pharmaceutical
`applications. Purchaser is fully
`responsible to determine end-use
`suitability.
`
`MANUFACTURING
`ENVIRONMENT
`Dow Corning 365, 35% Dimethicone
`NF Emulsion is manufactured, tested
`and packaged under strict quality
`control guidelines at the Healthcare
`Industries Materials Site (HIMS).
`The HIMS (Hemlock, Michigan) is
`dedicated to the production of
`silicone materials for healthcare
`applications. It is registered with the
`U.S. Food and Drug Administration
`(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.
`
`HOW TO USE
`Before use, Dow Corning 365,
`35% Dimethicone NF Emulsion must
`be mixed thoroughly to ensure that the
`emulsion is homogeneous. Depending
`on application, the product may be
`diluted to around 15% silicone with
`ambient temperature Water For
`Injection (WFI) water. The resulting
`solution may be applied to articles by
`spraying, brushing, wiping or using a
`dipping bath. After the water has
`evaporated, which can be accelerated
`with heat, the resultant coating is a
`
`lubricious, hydrophobic film of
`polydimethylsiloxane fluid.
`
`If the treated article can tolerate heat,
`the durability of the coating may be
`enhanced by baking; this step can be
`combined with the water evaporation
`step. Recommended baking conditions
`include a temperature less than 200°C
`(392°F) to avoid the possibility of
`oxidation and formaldehyde
`formation. A cloudy appearance on
`the surface of a treated article after
`baking may indicate excessive
`application or over-baking.
`
`HANDLING
`PRECAUTIONS
`PRODUCT SAFETY
`INFORMATION REQUIRED FOR
`SAFE USE IS NOT INCLUDED IN
`THIS 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 the original unopened
`container between 5°C and 40°C
`( 41 °F and 104 °F), this product has a
`usable life of 36 months from the date
`of production.
`
`Avoid freezing.
`
`Separation/settling may occur during
`storage. Therefore, it is necessary that
`all containers be thoroughly mixed
`prior to use.
`
`PACKAGING
`INFORMATION
`This product is supplied in 16 and 190
`kg (35 and 419 lb) containers, net
`weight.
`
`A certification that the product
`specifications have been met will be
`supplied upon request.
`
`SHIPPING LIMITATIONS
`This product should not be shipped
`below 0°C (32°F). Freeze/thaw
`cycling may break emulsion.
`
`LIMITATIONS
`This product is neither tested nor
`represented as suitable for medical or
`pharmaceutical uses.
`
`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.
`®TM Trademark of The Dow Chemical Company ("Dow") or an affiliated company of Dow
`Dow Coming is a registered trademark of Dow Coming Corporation. The Coming portion of the Dow Corning trademark is a trademark of Corning, Incorporated, used llllder license
`We help you invent thefature is a trademark of Dow Corning Corporation
`XIAMETER is a registered trademark of Dow Coming Corporation
`© 20022017 Dow Coming Corporation, a wholly owned subsidiary of The Dow Chemical Company. All rights reserved
`2
`
`2017, July 13
`Form No. 51-0232P-01
`
`NOVITC(US)00000793
`
`Novartis Exhibit 2153.002
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`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.
`
`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
`
`2017, July 13
`Form No. 51-0232P-01
`
`®TM Trademark of The Dow Chemical Company ("Dow") or an affiliated company of Dow
`Dow Coming is a registered trademark of Dow Coming Corporation. The Coming portion of the Dow Corning trademark is a trademark of Corning, Incorporated, used llllder license
`We help you invent thefature is a trademark of Dow Corning Corporation
`XIAMETER is a registered trademark of Dow Coming Corporation
`© 20022017 Dow Coming Corporation, a wholly owned subsidiary of The Dow Chemical Company. All rights reserved
`3
`
`NOVITC(US)00000794
`
`Novartis Exhibit 2153.003
`Regeneron v. Novartis, IPR2021-00816
`
`