View PDF The SQS herewith attests that the organisation named below has a management system that meets the requirements of the normative base mentioned. 70 01 _1 /A pr il 20 22 /V er si on 2 .0 Certificate Avient Colorants Singapore Pte Ltd 8 Third Chin Bee Road Jurong Industrial Estate 618684 Singapore Singapore Scope Category I Production of customer specific Masterbatches for Food packaging materials on the dedicated extrusion lines Normative base ISO 22000:2018 Food Safety Management Systems - Requirements for any organization in the food chain Reg. no. 46390 Page 1 of 1 Validity 25. 02. 2024  – 24. 02. 2027 Issue 25. 02. 2024  A.Grisard, President SQS F.

MEDICAL DEVICE DISINFECTION—HOW TO PREVENT CRACKING AND CRAZING Understanding polymer performance is key to minimizing disinfectant-related failures DISINFECTANT-RELATED DAMAGE ON POLYMER HOUSINGS Strong chemicals used to reduce hospital- acquired infections can damage equipment and result in material failures, such as: • Stress cracking • Crazing • Discoloration CHEMICAL RESISTANCE REQUIREMENTS VARY BY ENVIRONMENT • Patient/exam rooms • Operating and radiology rooms • Reception areas • Home (patient equipment & devices) Healthcare devices must perform flawlessly in a myriad of challenging environments and engineers must be certain their devices can withstand increasingly potent disinfectants, which have begun to outstrip the performance of traditional polymers. Additionally, the wide variability of environments that medical devices might see, which can range from home to hospital, mean devices must be able to withstand varying disinfectant strengths, exposure levels and frequencies. Whether you are designing for a medical device housing or a surgical device in the operating room, we offer solutions to meet a wide variety of performance specifications and application needs.

These customizable color solutions enhance brand value and promote product differentiation for medical device, cosmetic, or pharmaceutical polymer applications. OnColor HC Plus Colorants have been tested across a wide range of medical polymers to provide added confidence in meeting these critical bio- compatibility standards. KEY CHARACTERISTICS • Polymer colorants formulated specifically for healthcare product applications • Meets and exceeds various material performance requirements including FDA 21 CFR, ISO 10993 and USP Class VI • HC Plus colorants certified for bio-compatibility • Available as pre-color, concentrate, masterbatch or Smartbatch™ combined colorant/additive solution • Wide range of colors, striking special effects and custom color matching MARKETS AND APPLICATIONS OnColor™ HC and HC Plus Colorants are an excellent choice for medical devices and parts, pharmaceutical or cosmetic packaging, and many other healthcare related polymer applications.

It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device with all applicable laws and regulations, including the suitability of all raw materials and components used for its manufacture.

Lewiston, ME, 04240 United States of America Scope Avient CAI Design and manufacture of colour and additive concentrates and specialty compounds for the Healthcare and Medical device market. Normative base EN ISO 13485:2016 Medical devices – Quality Management System Reg. no. 45484 Validity 01.03.2022 – 28.02.2025 Issue 01.03.2022 Swiss Made Swiss Association for Quality and Management Systems (SQS) Bernstrasse 103, 3052 Zollikofen, Switzerland sqs.ch F.

Ltd. 30, Hsing Pang Road 33068 Taoyuan Taiwan Scope Design and manufacture of colour and additive concentrates and specialty compounds for the Healthcare and Medical device market. Normative base EN ISO 13485:2016 Medical devices – Quality Management System Reg. no. 46154 Validity 12.01.2022 – 11.01.2025 Issue 12.01.2022 Swiss Made Swiss Association for Quality and Management Systems (SQS) Bernstrasse 103, 3052 Zollikofen, Switzerland F.

A material is shear dependent when its viscosity is higher at low shear rates (such as extrusion) and lower at high shear rates (as in injection molding). To aid in release, the cavity or core may be coated with a release coating such as PTFE impregnated nickel after it has been given a sandblast or EDM finish. 8 Sprue and Sprue Puller Design The sprue should have sufficient draft, from 1º to 3º to minimize drag and sprue sticking. Hot Runner System Gates Valve Gates Valve gates offer the best solution for high production parts where surface quality is critical, such as medical and cosmetic products.

WOOD PLASTIC COMPOSITE (WPC) MFG S H E E T A N D D E C K I N G • Lightweighting solution offering energy savings and manufacturing efficiencies • Reduced downtime associated with poor quality rejections • Consistent and uniform cell structure in decking material • Compatibility with mono-core extrusion formula (rice hull bio-filler and virgin PVC) when used with a chemical foaming additive • Density control of 0.60-0.65 g/cc in production • Provided a CFA solution that offered energy savings, process optimization, and extended manufacturing run times • Enabled improved performance results and enhanced process control • Allowed tighter tolerance control with uniform cell structure, eliminating voids and surpassing density target ($100K savings) • Increased productivity and aesthetic finish with secondary operations (sanding) KEY REQUIREMENTS Excelite™ Chemical Foaming Additives (CFA) WHY AVIENT?

Plasticos 28, int B102 Santa Clara Coatitla 55540 Ecatepec de Morelos, Estado de México Mexico Scope Category I Production of customer specific Masterbatches for Food packaging materials on the dedicated extrusion lines.

To add better particle blocking capabilities to this layer, fibers can be modified with an additive during extrusion before undergoing an electret charging process.