Biesterfeld Spezialchemie LifeScience Pharma. Product Portfolio Siliconisation / Adhesives / Silicone Elastomers. Vers. 3

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1 Biesterfeld Spezialchemie LifeScience Pharma Product Portfolio Siliconisation / Adhesives / Silicone Elastomers Vers. 3

2 Our Principals

3 Content Silicones for Parenteral Components 4 Dow Corning 4 Non-Curing Siliconisation Fluid 4 Curing Siliconisation Fluid 4 Solvent for Siliconisation 4 DuPont 5 Solvent for Siliconisation 5 Silicone Skin Adhesives 5 Dow Corning Silicone Adhesive 5 Pressure Sensitive Adhesives (PSA) 5 Soft Skin Adhesives (SSA) 5 Device Adhesives and Encapsulants 6 Dow Corning BioMedical Grade Low Consistency Rubber 6 Dow Corning RTV Adhesive 6 Dow Corning Soft Filling Elastomer 6 Cyberbond Cyanoacrylat Adhesives 7 Cyberbond UV-Curing Adhesives 8 Silicone Elastomers 8 Dow Corning Silicone Elastomers 8 High Consistency Rubber (HCR) 8 Liquid Silicone Rubber (LSR) 9 Silicone Tubing 10 Dow Corning Medical Grade Tubing 10 3

Dow Corning BioMedical Grade Low Consistency Rubber 6 Dow Corning RTV Adhesive 6 Dow Corning Soft Filling Elastomer 6 Cyberbond Cyanoacrylat Adhesives 7 Cyberbond UV-Curing

4 Silicones for Parenteral Components Silicones for Parenteral Components Dow Corning Non-Curing Siliconisation Fluid 360 Medical Fluid 20 cst 100 cst 350 cst 1000 cst cst Polydimethylsiloxane Dimeticones in various viscosities Bacterial endotoxins controlled Dimethicone NF Dimeticone/Silicone Oil EP Certificate of Suitability (CEP) US-DMF 365, 35% Dimethicone NF Emulsion Emulsion containing 35 % of Dow Corning 360 Medical Fluid 350 cst TF Lubricants for medical device components, glass, metals, plastics and rubbers Hydrophobic: Dow Corning 360 Medical Fluid Water-dilutable: Dow Corning 365, 35% Dimethicone NF Emulsion Siliconisation of syringes, vials, ampoules, stoppers, filaments and medical device components Curing Siliconisation Fluid MDX % Medical Grade Dispersion 50 % dispersion of an amino functional dimethylsiloxane copolymer US-DMF Cures at room temperature to form a dry coating Lubricant for cutting edges, hypodermic needles and cannulas Solvent for Siliconisation Q Silicone Fluid 0.65 cst 1.0 cst Hexamethyldisiloxane Octamethyltrisiloxane High purity, volatile silicone fluids US-DMF, TF Solvent for Dow Corning 360 Medical Fluid and MDX % Medical Grade Dispersion 4

containing 35 % of Dow Corning 360 Medical Fluid 350 cst TF Lubricants for medical device components, glass, metals, plastics and rubbers Hydrophobic: Dow Corning 360 Medical Fluid Water-dilutable:

5 Silicones for Parenteral Components DuPont Solvent for Siliconisation Vertrel X-Si specialty fluid Blend of Vertrel XF hydrofluorocarbon and hexamethyldisiloxane Solvent for Dow Corning 360 Medical Fluid and MDX % Medical Grade Dispersion Silicone Skin Adhesives Silicone Skin Adhesives Dow Corning Silicone Adhesive Pressure Sensitive Adhesives (PSA) Product Description Application MD Silicone Adhesive Solvent-based pressure-sensitive adhesive Non-sensitizing, non-irritating Medium tack 65 % solid content Medical device TF/DMF MD Silicone Adhesive Solvent-based pressure-sensitive adhesive Non-sensitizing, non-irritating High tack 60 % solid content Medical device TF/DMF Adhesion of dressings, prosthetics and other devices to the body Adhering ileostomy and colostomy appliances to the skin Patient monitoring Hairpiece adhesion Soft Skin Adhesives (SSA) Product Description Application Soft Skin Adhesive MG Soft Skin Adhesive MG Soft Skin Adhesive MG Soft Skin Adhesive Two-part, platinum-catalyzed adhesive, unfilled silicone elastomer Clear and solventless Medical device For scar therapy, wound dressing and pharmaceutical topical or transdermal applications Gentle skin adhesion Low peel release force Adhesion properties are maintained after several applications 5

MD7-4502 Silicone Adhesive Solvent-based pressure-sensitive adhesive Non-sensitizing, non-irritating Medium tack 65 % solid content Medical device TF/DMF MD7-4602 Silicone Adhesive Solvent-based

6 Device Adhesives and Encapsulants Device Adhesives and Encapsulants Dow Corning BioMedical Grade Low Consistency Rubber SILASTIC MDX Medical Grade Elastomer Two-part, platinum-catalyzed, room-temperature-curing and pourable silicone elastomer EP Silicone elastomer for closures and tubing Meets USP Class VI, 90-day implant Medical device encapsulating and mold making prototyping Drug matrix for pharmaceutical applications Dow Corning RTV Adhesive Silastic Medical Adhesive Silicone, Type A One-part, low-slump, translucent silicone material, solventless Cures at room temperature between % relative humidity USP Class VI, 90-day implant Assembling and sealing of medical device components Encapsulating of electrical components for medical devices Dow Corning Soft Filling Elastomer Soft Filling Elastomer Two-part, platinum-catalyzed unfilled silicone elastomer DMF Filling material for external form prostheses and pressure cushions 6

Silicone elastomer for closures and tubing Meets USP Class VI, 90-day implant Medical device encapsulating and mold making prototyping Drug matrix for pharmaceutical applications Dow Corning RTV

7 Device Adhesives and Encapsulants Cyberbond Cyanoacrylat Adhesives Elastomer and Plastic Ethylester Cyanoacrylate with extremely good ageing properties Fluorescence optional Excellent adhesives for Rubber to Rubber, Rubber to Plastic and Plastic to Plastic applications Viscosity range from mpa*s ISO , -10, -11 Powerdrop Ethylester Carefully stabilised, fast bonding Cyanoacrylates Viscosity range from 7-85 mpa*s ISO Xtraflex (rubber toughened) modified Ethylester Partly flexible respectively rubber toughened Cyanoacrylates For dynamic and temperature loaded bonds A certain shock resistance is guaranteed Very good results for Metal to Plastic and Metal to Rubber combinations Viscosity range from mpa*s ISO Low Odour Alkoxyester Low odour, low blooming, low outgassing characteristics Viscosity range from mpa*s ISO One component systems Solvent free Fast curing High bonding strength Excellent substrate compatibility Temperature tolerance Economic efficiency LINOP dosing equipment offered as product periphery 7

Viscosity range from 7-85 mpa*s ISO 10993-5 Xtraflex (rubber toughened) modified Ethylester Partly flexible respectively rubber toughened Cyanoacrylates For dynamic and temperature loaded bonds A

8 Device Adhesives and Encapsulants Cyberbond UV-Curing Adhesives Medical UV Products One component, solvent free and cold curing systems Fast curing Viscosity range from mpa*s ISO Recommended for needle bonding LINOP dosing and curing equipment offered as product periphery Silicone Elastomers Silicone Elastomers Dow Corning Silicone Elastomers High Consistency Rubber (HCR) QP1-xx Silicone Elastomer C6-1xx Silicone Elastomer C6-2xx Silicone Elastomer Silastic Q7-47xx BioMedical Grade HCR Uncatalysed silicone rubber base Processable by peroxide or addition cure For addition cure cross linkers, catalysts and cure inhibitors are offered separately (30, 50, 60, 70) Two-part, platinum catalyzed HCR (35, 50, 65, 80) One-part, enhanced tear resistant HCR HCR for peroxide cure Peroxide initiator selected by customer (35, 50, 65) Two-part, platinum-catalyzed, enhanced tear-resistant silicone elastomers (20, 35, 50, 65, 80) Appropriate quality principles EP Silicone elastomer for closures and tubing - Volatile matter - Subst. soluble in hexane FDA Regulation 21 CFR EP Silicone elastomer for closures and tubing - Volatile matter - Subst. soluble in hexane FDA Regulation 21 CFR EP Silicone elastomer for closures and tubing - Volatile matter - Subst. soluble in hexane TF FDA Regulation 21 CFR Fabrication of medical/surgical/diagnostic devices and components Fabrication of extruded parts 8

QP1-xx Silicone Elastomer C6-1xx Silicone Elastomer C6-2xx Silicone Elastomer Silastic Q7-47xx BioMedical Grade HCR Uncatalysed silicone rubber base Processable by peroxide or addition cure For

9 Silicone Elastomers Liquid Silicone Rubber (LSR) QP1-xx Liquid Silicone Rubber Two-part, platinum catalyzed liquid silicone rubbers (20, 30, 40, 45, 50, 60, 70, 75) Excellent mechanical properties: - High tear strength, - Low compression set - Reduced mold fouling Appropriate quality principles QP1-2xx Liquid Silicone Rubber Two-part, platinum catalyzed liquid silicone rubbers 2 (30, 40, 50, 60, 70) Optimized formulation for: - Reduced processing cycles - Improved pot life (72 hours at 25 C after mixing) - Improved rheological profile for intricate parts Appropriate quality principles C6-5xx Elastomer Two-part, platinum catalyzed liquid silicone rubbers (30, 40, 50, 60, 70) EP Silicone elastomer for closures and tubing - Volatile Matter - Subst. soluble in hexane FDA Regulation 21 CFR Silastic Q7-48xx BioMedical Grade LSR Two-part, platinum-catalyzed liquid silicone rubbers (40, 50, 60, 70) EP Silicone elastomer for closures and tubing - Volatile matter - Subst. soluble in hexane TF FDA Regulation 21 CFR Injection molding of precision and intricate parts of medical devices (O-rings, stoppers and closures) Designed for fully automatic molding systems Fabric coating 9

10 Silicone Tubing Silicone Tubing Dow Corning Medical Grade Tubing Silastic Medical Grade Tubing Rx-50 Rx-65 Rx-80 Rx Pump Platinum-cured silicone tubing Extruded from Silastic brand Bio Medical Grade Elastomer EP Silicone elastomer for closures and tubing USP Class VI FDA and ISO criteria cgmp Infusion therapy (drug delivery, nutritional therapy/feeding tubes) Medical catheters (urology catheters, respiration catheters) 10

1.9. Silicone elastomer for closures and tubing USP Class VI FDA and ISO criteria cgmp Infusion therapy

12 Biesterfeld Spezialchemie GmbH Ferdinandstraße Hamburg / Germany [email protected] Patrizia Wenzel Product Manager Tel: [email protected] Robert Radsziwill Product Line Manager Tel: [email protected] Dr. Andreas Lekebusch Marketing Manager Pharma Tel: [email protected]

wenzel@biesterfeld.com Robert Radsziwill Product Line Manager Tel: +49 40 32008-601 r.

Peroxide or Platinum? Cure System Considerations for Silicone Tubing Applications

Peroxide or Platinum? Cure System Considerations for Silicone Tubing Applications Regina M. Malczewski, Ph. D., Donald A. Jahn, and William J. Schoenherr Dow Corning Healthcare Introduction Silicone tubing