CREATING TOMORROW S SOLUTIONS HEALTHCARE I WOUND CARE SILICONES FOR WOUND CARE

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1 CREATING TOMORROW S SOLUTIONS HEALTHCARE I WOUND CARE SILICONES FOR WOUND CARE

2 A SUCCESSFUL FUTURE WITH WACKER Regardless of the challenges the future holds, offers you a future-proof solution that satisfies the highest medical standards. The average age of the population is increasing progressively. As more and more people gain access to modern healthcare, statutory requirements for medical products and services are becoming stricter. As a result, the health care industry faces ever-increasing demands with regard to the safety and efficiency of its solutions. WACKER s contribution to this development is : the future-proof, pure silicone that meets the most rigorous medical demands. A European pioneer in the field of silicone chemistry, WACKER s strength lies in its unique expertise and future-oriented research, and additionally, in its integrated raw-materials systems. Consequently, customers can place their confidence in future-proof solutions that are compliant with the highest German quality standards. WACKER Clean Operations guarantees outstanding purity for the medical requirements of today and tomorrow. WACKER s cleanrooms comply with the medically required Cleanroom Class 8 and are certified to ISO Much More Than Just a Product makes the best service available to you, ensuring your success. Always at the ready, our teams of experts help you optimally adapt s virtually unlimited scope and innovative strength to your needs, thus creating customized product solutions which contribute to your long-term business success. Manufacturing Process for Wound Dressings Step 1 The silicone adhesive is applied to the carrier by doctor blade, slot die or similar tool in a coating process. Step 2 The adhesive already cures at room temperature, but the process can be accelerated by increasing the temperature up to 120 C. Step 3 After the silicone adhesive layer has been covered, finishing of the material composite can proceed. 2

3 Silicones for Wound Care WACKER silicones satisfy the highest medical standards and offer unique processing advantages. With properties that promote wound healing, is ideal for both woundcare applications and scar treatment. The product range thus sets new benchmarks in wound and scar care. Highest Medical Standard The product range fulfills the most rigorous medical demands. It is free of organic plasticizers, can be sterilized and carries a number of certificates. Selected tests according to ISO and USP Class VI certification ensure biocompatibility and the highest safety levels for both users and processors. Less Trauma, Less Pain Better Quality of Life 40% of patients who live with a chronic wound described the pain of changing the dressing as their greatest problem.* Silicone wound dressings can be changed atraumatically, so removing the dressing is associated with less pain, significantly reducing the patients stress that is triggered by the anticipation of pain. At the same time, their permeability to water vapor and gases creates an ideal environment for healing. Every one of these advantages can, in turn, lead to faster wound healing. With less trauma and less pain, as well as a shorter healing time, wound-care applications based on adhesives can enhance a patients quality of life. Adhesives: Safe Application Characteristics Biocompatibility (e.g. USP Class VI and ISO 10993) Silicones do not support microbial growth (due to their hydrophobicity) Biodurability: low surface tension, thermal stability and chemical stability Good media resistance to a large number of solvents and chemicals Sterilizable for single and repeated use (ethylene oxide) Good weathering, UV and aging resistance High transparency Cleanroom dispensing and packaging in accordance with WACKER Clean Operations standards ensure consistently high product quality. Optimal Wound Healing Modern wound dressings must meet specific requirements, such as breathability, to provide an optimal healing environment for wounds and protection from external influences like bacteria and moisture. Since they are soft and flexible, silicones are ideal as skin adhesives. Their pleasant adhesive properties make atraumatic dressing changes possible. This allows the healing process to proceed unhindered. Adhesives from WACKER Offer: Selected tests according to ISO and USP Class VI certification. FDA Master Files for Devices (MAF) are available for our adhesives. Efficient curing processes Economical processing Excellent bonding properties Stable at temperatures from -50 to +200 C Long shelf life Enhanced performance For further information on wound care products, please contact your local WACKER SILICONES distributor. * Meaume S et al., Ostomy Wound Management,

4 Performance Overview of 21xx Series in Peel Adhesion Measurement on Steel and Human Skin Stainless Steel Substrate Peel adhesion on stainless steel Tack adhesives cover a wide range of initial tack, and adhesion. This allows us to offer individually tailored product lines for three sectors: Traditional wound care Advanced wound care Stoma care Peel adhesion on stainless steel Tack [N] Human Skin Substrate Peel adhesion on skin Peel adhesion on skin Tack [N] Tack Silicone wound contact layer from KET Liegau 4

5 for scar dressings for wound dressings for non-adhering wound dressings Silicones for Wound Care Silicones for Scar Treatment Description Color Viscosity A* Hardness Shore A* Hardness Shore 00* Tensile Strength* [N/mm²] Elongation at Break* [%] Tear Strength* [N/mm] 2400 Translucent 1,800 1, /25 Translucent 3,300 2,000 < Translucent 2,500 3, ,100 1, Mixing ration A:B = 1:1 Silicones for Advanced Wound Care ,000 35, ,600 11, ,000 10, ,100 1, Silicones for Stoma Care ,000 40, Silicones for Traditional Wound Care and Medical Tape ,000 13, ,200 2, * For standard specifications and technical parameters, refer to the technical data sheet ** On stainless steel All figures are intended as a guide and should not be used in preparing specifications. Measurement conditions for penetration: hollow cone 62.5 g, 60 sec. 5

6 Wacker Chemie AG Hanns-Seidel-Platz Munich, Germany Tel info.silicones@wacker.com D e/04.16 supersedes 6365D e/10.13 is a registered trademark of Wacker Chemie AG The data presented in this brochure are in accordance with the present state of our knowledge, but do not absolve the user from carefully checking all supplies immediately on receipt. We reserve the right to alter product constants within the scope of technical progress or new developments. The recommendations made in this brochure should be checked by preliminary trials because of conditions during processing over which we have no control, especially where other companies raw materials are also being used. The information provided by us does not absolve the user from the obligation of investigating the possibility of infringement of third parties rights and, if necessary, clarifying the position. Recommendations for use do not constitute a warranty, either express or implied, of the fitness or suitability of the product for a particular purpose.