Dow Corning Healthcare

Innovative Solutions for Healthcare Applications

Dow Corning’s commitment to providing you with the solutions you need to improve patient health and comfort is stronger than ever. We are not only expanding the use of our products into new applications. We are also investing in totally new areas and technologies. At Dow Corning, the future of healthcare is bright and exciting. It is a future we look forward to sharing with you. Gary E. Anderson Chairman Dow Corning Corporation Stephanie A. Burns President and CEO Dow Corning Corporation

Dow Corning Healthcare Selection Guide

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Providing Solutions to Improve the Quality of Life Dow Corning was an early pioneer in the use of performanceenhancing materials in a broad range of healthcare applications … from medical devices to pharmaceuticals. Dow Corning continues to be the acknowledged industry expert and technology leader for healthcare applications that demand the unique benefits silicon-based materials can provide. From the Americas to Europe to Asia and beyond, the people of Dow Corning are dedicated to providing solutions to improve the quality of life. Our commitment to the healthcare industry is ongoing. We are here today. We will be here tomorrow.

Focusing on What Matters Most to You Dow Corning is a responsive and flexible global supplier with the material and service support you need to succeed: • Consistent Quality

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• A Reliable Source of Supply • Innovative Solutions • Supportive Regulatory Practices AV06852

• Supportive Services • A Range of Beneficial Materials It has never been easier to do business with Dow Corning … no matter where in the world that business takes you.

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Dow Corning Healthcare Selection Guide

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“We know our healthcare customers require exacting quality. Through the dedication of our employees, we are able to achieve the strict control of contaminants, consistent product quality and batch traceability needed to meet our customers’ quality expectations.” Debora S. Ackerman Healthcare Industries Quality Assurance Manager

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Consistent Quality From batch to batch, year after year, you can be sure the products you order from Dow Corning will live up to their

Innovative Solutions

specifications. Dow Corning materials for healthcare are manufactured in a

Since our early days, Dow Corning has been a healthcare

dedicated, FDA-registered (CFN 1816403) and inspected

innovator … not for innovation’s sake, but for the sake of our

facility that uses appropriate Good Manufacturing Practices

customers and the patients they serve.

(GMPs) for the intended applications.

When the industry began exploring the use of silicones in

At the Healthcare Industries Materials Site, special attention

healthcare, Dow Corning provided the materials and technical

is given to produce products that meet the highest quality

expertise needed to turn ideas into solutions.

standards. This is achieved through:

• In medical devices, Dow Corning pioneered the use of silicone in hydrocephalic shunts, as a coating for pacemaker leads and in wound dressing materials.

• An integrated supply chain and full documentation (from raw material testing through production, to final testing and lot sample retention) to ensure complete

• In pharmaceuticals, our technology has proved its worth in the development of antigas products, transdermal drug delivery systems and contamination-free tubing for drug processing.

traceability of our materials. • Meticulous control and documentation of change as well as a policy of notifying customers of all significant changes.

Today, Dow Corning is meeting the market’s need for • Rigorous procedures for cleanliness to ensure high

excipients that improve the aesthetics and bio-availability of

product purity.

topical pharmaceuticals. And we’re helping customers expand the use of silicone elastomers, adhesives and tubing into new

A Reliable Source of Supply

areas, such as wound and oral care.

With a manufacturing site dedicated exclusively to the

to help pharmaceutical and medical device companies

production of silicon-based products for healthcare, you can

worldwide improve the quality of life.

What will tomorrow bring? Countless opportunities for Dow Corning to use its proven materials and service expertise

depend on Dow Corning for appropriately manufactured and tested materials. Additional performance-enhancing materials are manufactured at qualified sites. Our global SAP installation enables us to provide you with best-in-class manufacturing, service and supply chain capabilities. Sales offices, channel partners, customer service facilities and/or distribution centers on five continents work together to bring you the materials you need, precisely when, where and how you need them. Dow Corning’s use of e-business solutions enables us to AV06849

create a fully integrated supply chain network that is both efficient and adaptive.

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Dow Corning Healthcare Selection Guide

“By applying the appropriate level of GMPs (Good Manufacturing Practices) for the products we make, our customers can be assured that the products they purchase from us will meet applicable global regulations and have the quality attributes they require.” Katherine L. Ulman Regulatory Affairs Quality Manager Healthcare Industries Materials Site

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Supportive Services Whether you’re considering an existing product for a current application or looking for a co-development partner willing to

Supportive Regulatory Practices

custom formulate materials to meet your unique processing

When Dow Corning develops performance-enhancing

about the suitability of our materials for your application

and performance needs, you can depend on Dow Corning for: Information Support – to help you make informed choices

materials for healthcare, we take into account the properties

• Comprehensive product literature

and purity level your applications require, as well as the

• Information-on-demand from our healthcare web site: www.dowcorning.com/healthcare

environment of safety and security you need to comply with

– Detailed product, application and properties

the industry’s stringent regulatory demands.

information The way a material is produced and tested can seriously affect

– Product and industry news

its quality, suitability and performance in critical healthcare

– Technical library

applications. When you choose silicon-based materials for

– Electronic product finder

healthcare from Dow Corning, you are selecting products that

– Multi-language Material Safety Data Sheets

are manufactured and tested appropriately so they comply

– Direct e-mail links to Dow Corning customer

with global regulations. For example:

and technical service

• Pharmaceutical: Dow Corning’s product offerings meet

Technical and Manufacturing Support

or exceed guidelines established in several national and

• Worldwide network of technical assistance centers

international pharmacopeial standards. FDA Drug

• Custom formulation and research and development

Master Files and/or European Technical Files have been

support

established and maintained for select materials, provid-

• Toxicology testing and analysis

ing you valuable support for your pharmaceutical

• Materials analysis and chemical engineering services

regulatory filings. Regulatory Support – to help speed and simplify the regula• Medical Devices: Dow Corning materials for medical

tory process

device applications are tested according to a program

• FDA Drug Master Files

based on FDA guidelines and ISO 10993 standards

• European Technical Files

for medical devices. FDA Material Application Files

• FDA Material Application Files

are available for select materials to help support your Global Business Support – including system-to-system and

medical device regulatory filings.

web-based e-business solutions • Multi-language/multi-currency transactions • 24-hour, 7-day electronic access to order information: historical purchase summary, order and delivery status

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and online retrieval of business documents

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Dow Corning Healthcare Selection Guide

“When you buy from Dow Corning, you receive a high level of baseline service and support. We can also provide a number of optional services designed to help you meet unique requirements. We want to be more than just another raw material supplier – our goal is to use our technology, as well as our valued service and support capabilities, to help you invent the future.” Brian L. Jones Healthcare Global Market Manager

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A Range of Beneficial Materials Among qualified materials used in healthcare applications, silicones are generally recognized for their biocompatibility. Dow Corning’s healthcare products have a long history of

Silicone Adhesives – Used in transdermal drug delivery

pre-clinical and clinical use to support their biocompatibility.

systems (TDDS), medical devices (surgical tape, ostomy

Dow Corning continues to invest in ongoing toxicological

bags, drapes), specialty cosmetic and hair replacement

research. And Dow Corning provides an expanded solution

materials, prosthetic devices and wound care products,

set that includes non-silicone biocompatible materials.

silicone adhesives from Dow Corning offer optimum The chemistry associated with performance-enhancing

skin adhesion properties that remain constant for

materials offers a broad range of performance characteristics

extended periods, even under high-humidity conditions.

that make Dow Corning materials suitable for use in many

With appropriate and versatile tissue adhesion, there is

types of processes and applications ranging from multifunc-

no adhesive build-up; and skin adhesive devices

tional excipients … to active pharmaceutical ingredients …

(patches, ostomy bags, etc.) can be easily and comfort-

to medical device components.

ably removed. Silicone chemistry does not generate unwanted by-products that can irritate the skin.

Dow Corning brings you one of the broadest lines of

Enhanced drug permeation properties also improve

performance-enhancing materials for healthcare in the

drug bio-availability.

industry … materials that are safe and beneficial in a

Acrylic and Rubber-Based Pressure Sensitive Adhesives – Adhesives from Dow Corning find

multitude of applications. What follows is only a sampling of the many potential applications for our products and benefits they deliver:

application in adhering medical devices to skin, such as in wound care and transdermal drug delivery. These

Qualified Topical Excipients – Among Dow Corning®

adhesive systems are available with these properties:

brand Silky Touch excipients for topical pharmaceuti-

various tacks, non-cytotoxic, non-irritating and non-

cals, you will find unique material offerings with

sensitizing.

enhanced drug permeation properties that allow a high drug diffusion rate, which can improve the efficacy of

Polyurethane Potting Compounds – These compounds

your formulation. Silky Touch silicone excipients for

can be used to seal medical devices such as medical

skin-contact applications can improve patient comfort

filters in blood oxygenators and dialysers. Gel time can

as well as the aesthetics of pharmaceutical formulations,

be controlled by selection of the catalyzed polyol.

providing them with a non-greasy, silky-smooth feel and

Rubber/Elastomers – Silicone rubber and elastomeric

a non-glossy finish. Ease of processing is another key

materials from Dow Corning are utilized in medical

benefit of these materials.

devices, as well as veterinary applications throughout the world. These materials are employed in devices in all US and European regulatory classifications (Class I, II & III), used as excipients for implants and inserts, and used in other applications that benefit from our products’ consistent high quality and purity.

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Dow Corning Healthcare Selection Guide

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Dispersions – Dow Corning offers a silicone dispersion primarily used to lubricate medical devices, cutting edges and surfaces. It provides a durable, cured coating ®

®

Our Silastic BioMedical grade and Dow Corning

with good lubrication characteristics.

Class VI grade materials are qualified to ensure compli-

Antifoams and Antifoam Emulsions – Used in

ance with various international, European, US and other

antiflatulent/antigas products, as fermentation aids,

national regulations, standards and guidelines. These

process aids/excipients and contrast media, and in blood

products are manufactured to ISO 9001 quality standards

oxygenation and veterinary applications, Dow Corning®

utilizing appropriate principles of Good Manufacturing

brand antifoams are known for their excellent defoaming

Practice (GMP) regulations. These materials do not

properties.

contain plasticizers, animal-derived ingredients or natural rubber latex. Further, they generate no unwanted

If you are looking for a healthcare supplier/partner with safe,

by-products, enabling you to use them with confidence

effective materials, global resources and expert people

in applications where purity is essential.

dedicated to your success, look to Dow Corning.

Tubing – Dow Corning offers silicone tubing for a wide Dow Corning … We help you invent the future.™

range of medical device, pharmaceutical, laboratory and veterinary uses, including critical applications such as life-saving pharmaceutical drug delivery systems for patients … cardiac pacemaking leads … and tubing used in the manufacture of pharmaceutical and biological

How to read the selector guide charts

drugs. The key benefit of silicone tubing from

The charts on pages 12 through 27 of this brochure contain three or four of the following sections:

Dow Corning is that it is manufactured specifically for

Regulatory Status: This section includes select governmental regulations and organizational standards to which the various materials comply as indicated by the presence of the • symbol. The compliance may have been achieved through testing or by other regulation-specified provision.

healthcare applications in accordance with your need for purity. Silicone tubing does not support microorganism growth, so it reduces the chance of infection, and it is easily sterilized. Additionally, custom sizes, packages

Biocompatibility Tests: This section includes select biological qualification biotests. The presence of the • indicates the material (or equivalent) was tested and passed the respective test. Qualification Data Summaries containing more information are available upon request. The absence of the • symbol for a particular material indicates that such qualification testing is not applicable to, or provided for, that material.

and delivery options are available to meet your specific processing and application needs.

Fluids and Emulsions – Key applications for Dow Corning® brand healthcare fluids and emulsions include siliconization (parenteral packaging components, needle lubrication, medical device lubrication),

Processes: This section includes several generic manufacturing processes believed applicable to the materials as indicated by the • symbol. The user is responsible to validate the applicability of any material for their process and application.

excipients, antiflatulent/antigas products, wound care and oral care. These materials offer high water repellency, good lubrication characteristics and low surface tension.

Typical Properties: This section provides typical data for select properties of the listed materials. Additional typical property data may be available in the Product Data Sheets. These values are not intended for use in preparing specifications. Please contact your local Dow Corning sales office prior to writing specifications on these products.

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Dow Corning Healthcare Selection Guide

Qualified Topical Excipients (Silky Touch) The Silky Touch products are qualified silicon-based excipients that can improve the bio-availability of the active drug, the aesthetics and the processability of topical pharmaceutical formulations (creams, emulsions, gels, ointments, lotions, sprays and stick formulations).

Regulatory Status EP (Ph. Eur.) Monograph - Dimeticonum NF Monograph Toxicological Summary European Technical File1

To assure consistent quality in pharmaceutical formulations, Dow Corning® brand topical excipient products are packaged and tested at the Healthcare Industries Materials Site utilizing principles of GMP guidelines for Active Pharmaceutical Ingredients (APIs).

Biocompatibility Tests Skin Sensitization Mutagenicity/Genotoxicity

Volatiles

Description

Typical Applications

High-purity, volatile silicone fluid (hexamethyldisiloxane and octamethyltrisiloxane) Clear liquid

• Carrier for sprays • Spreading agent

Volatile silicone, decamethylcyclopentasiloxane (NF Cyclomethicone) Clear, 4 cSt liquid

• Volatile excipient • Solvent

High-purity, non-volatile silicone fluid (NF Dimethicone, EP Dimeticone) Colorless, odorless liquid

• Lubricant • Emollient • Skin protectant

A short, hydroxy-terminate Dimethicone fluid Colorless, odorless, 40 cSt liquid

• Excipient for hydrophilic actives • Lubricant

A unique blend of silicone gum (6%) in Dimethicone Colorless, odorless liquid

• Lubricant • Emollient

Dow Corning® Dimethiconol Blend 20

•

•

•

Blend of silicone gum (1%) in hexamethylsiloxane Clear liquid

• Substantive carrier for sprays • Spreading agent

Dow Corning® Silmogen Carrier

•

•

•

A blend of unique silicone elastomer in volatile silicone Translucent gel

• Unique, silky aesthetics (smooth, dry feel) • Rheology modifier • Thickener for silicone-containing formulations

Dow Corning® ST-Elastomer 103

•

•

•

Semi-occlusive, low-meltingpoint (53°C/127°F) silicone wax Soft, white to light-straw, semicrystalline wax

• Semi-occlusive formulation • Lubricant • Detackifier • Emollient • Water-repellent

Dow Corning® Silky Wax 103

•

•

•

An occlusive, alkylmethyl silicone wax White to off-white flake; melting point 75°C (167°F)

• Replacement for petrolatum • Detackifier • Thickener • Emollient • Moisturizer

Dow Corning® ST-Wax 303

•

•

•

Alkylmethyl silicone polyglycol Transparent Clear to light-straw liquid of approximately 2500 cSt

• Emulsifier for water-in-oil and water-in-silicone emulsions (up to 80% water content) • Room temperature emulsification

•

•

•

1

2 3

Dow Corning® Q7-9180 Silicone Fluid

• • •

•

Dow Corning® Q7-9120 Silicone Fluid 20, 100, 350, 1000 and 12,500 cSt

•

•

Dow Corning® ST-Dimethiconol 40

•

1.0 cSt Dow Corning® ST-Cyclomethicone 5 – NF

Fluids2

Blends

Waxes •

Emulsifier Dow Corning® Emulsifier 10

Dow Corning can provide Technical Files (or Certificates of Suitability) as needed to meet requirements. Not intended for human injection. These products are tested at the Healthcare Industries Materials Site utilizing principles of GMP regulations for Active Pharmaceutical Ingredients (APIs).

Dow Corning Healthcare Selection Guide

• • •

0.65 cSt

12

•

•

Typical Properties* Match Reference IR Spectrum Nonvolatile Content Melting Point Heavy Metals Relative Density Refractive Index Kinetic Viscosity Dynamic Viscosity mPa.s

cSt

0.59-0.71

0.65

1.3750

0.760

0.9-1.1

1.0

1.3840

0.816

4.0

1.397

0.95

1.40181.4047

0.9510.973