View PDF The SQS herewith attests that the organisation named below has a management system that meets the requirements of the normative base mentioned. 7 0 0 1 _1 /A p ri l 2 0 2 2 /V er si o n 2 .0 Certificate Avient Colorants Germany GmbH Hohenrhein 1 56112 Lahnstein Germany Scope Production of Color Concentrates and Compounds Normative base ISO 50001:2018 Energy Management System Reg. no. 46089 Page 1 of 1 Validity 17. 12. 2023  – 16. 12. 2026 Issue 17. 12. 2023  A.Grisard, President SQS F.

Like other Mevopur formulations, they are produced in dedicated facilities according to ISO 13485-2016 protocols and supported by testing to ISO 10993-1, USP, European Pharmacopeia and ICH Q3D guidelines.

– June 24, 2014 – PolyOne GLS Thermoplastic Elastomers, a global leader in high-performance, custom-formulated thermoplastic elastomer (TPE) solutions, today announced that its Versaflex™ CE 3620 material meets all ISO 10993-10:2010 testing requirements with no signs of irritation. Several Versaflex CE materials have been used in wearable electronics applications without irritation for a number of years, and the recent ISO testing results underscore this track record.

These expanded offerings add medical-grade LDPE, nylon, PEBA, PS and PVC to the globally available palette of specialty healthcare colorants, and are pre-certified to meet or exceed biocompatibility requirements for ISO 10993 and/or USP Class VI protocols. All thirteen medical-grade carrier materials in the portfolio are pre-certified to meet or exceed ISO 10993 and/or USP Class VI requirements for applications ranging from medical packaging to device housings. 

Avient’s PCF calculation method follows the ISO 14067:2018 standard and is certified by TÜV Rheinland.   Certified for USP Class VI and ISO 10993, the new Versaflex HC BIO BT218 grade is manufactured in the United States with global commercial availability.  

Biocompatibility: Our PEEK solutions have passed ISO 10993 biocompatibility testing, ensuring safety and reliability for medical applications. Passed ISO 10993 biocompatibility testing, suitable for medical use

In the event of a conflict between this Quality Commitment and any mutually agreed specifications or quality agreement that is executed by NEU, the mutually agreed specifications or signed quality document shall control. 1.0 PRODUCT DESCRIPTION Thermoplastic material in pellet form. 2.0 TEST METHODS NEU test methods are modeled after ASTM testing standards, where applicable. 3.0 OPERATIONAL DEFINTIONS 3.1 Lot (Batch): Material manufactured at one time. 3.2 Blend: No more than three lots of a specific raw material, combined together to form a homogeneous mixture. 3.2.1 Full lot tractability of non-proprietary formulations will be reflected on the COC 3.3 Certification: “Certificate of Conformance” or “Certificate of Analysis” based material requirements 3.4 Certificate of Analysis: Document containing information that the product conforms to the established Product Specifications. 3.5 Certificate of Conformance: Document containing confirmation that the product conforms to the defined formulation. 3.6 Finished Product Form: Finished product shape (Cylindrical, Spherical) 3.7 Product Specification: the product specifications that are contained in a written document signed by NEU, or if such document does not exist, the Certificate of Analysis or Certificate of Conformance issued by NEU. 4.0 PACKAGING 4.1 Standard product packaging options include: 4.1.1 Drum 4.1.2 Gaylord 4.1.3 Pail 4.1.4 Individual bag in box Approved Plant/Local : Reference Document Document #: DOC-10815 Revision: 3 Document Owners: Dean Clark Effective Date: Oct 29, 2020 Title: NEU Quality Commitment Page 2 of 4 Only the electronic version of this document in ETQ is the controlled version of the document. as applicable) 4.2.2 Customer Description 4.2.3 Manufacturer’s Product Code 4.2.4 Manufacturer's Lot Number 4.2.5 Quantity and Units (Example 25 lbs.) 4.2.6 Company Name 4.2.7 Date of Manufacture 4.2.8 Expiration Date (as applicable) 5.0 SUPPORTING DOCUMENTATION 5.1 Certification: Each shipment of product will be accompanied by a Certification that, at the time of shipment, the material conforms to the Product Specifications. 5.1.1 Certification document will include: 5.1.1.1 Customer Part Number 5.1.1.2 Customer Purchase Order Number 5.1.1.3 Customer Material Description 5.1.1.4 Manufacturer's Lot Number 5.1.1.5 Total quantity shipped (with units) 5.1.1.6 Test values (as applicable) 5.1.2 Certification will be sent with each product shipment, addressed to the Customer’s shipping location and/or electronically sent to appropriate Customer contact. 5.1.3 The Certification document may contain test values conducted by NEU on the product for those characteristics listed under certification. 5.2 Safety Data Sheets: A Safety Data Sheet will be made available upon request or may be available on NEU’s website. In the event that the NEU determines that it is the root cause of the Customer complaint, a corrective action will be issued, and preventive actions will be developed to address the root cause. 10.0 MANAGEMENT OF SUPPLIERS 10.1 NEU will maintain and ensure oversight and monitoring of applicable suppliers in accordance with the requirements of ISO 13485 Quality Management System. 11.0 TRACABILITY, RECORDS & RETENTION 11.1 NEU is responsible for establishing and maintaining controlled documentation of product and raw material component traceability during all stages of production and shipment. 11.2 An electronic record of the manufacturing conditions and raw materials (vendor ID and lot number) used to manufacture each batch is retained and preserved for a period of at least 7 years from the manufacture date or as specified by applicable Regulatory Requirements. 11.3 An electronic record of the Customer purchase order and NEU sales order confirmation will be retained and for a period of at least 7 years from order acceptance date. 11.4 A representative sample of the product manufactured will be retained for a period of at least 1 year from manufacture date. 12.0 EXPIRATION 12.1 NEU’s obligations contained in this Quality Commitment will automatically expire if the Customer does not purchase product from NEU for a period of one year.

PHARMACEUTICAL PACKAGING OEM V I A L S , B O T T L E S & C O N T A I N E R S • Raw materials pre-tested to USP 661.1 and ICHQ3D guidelines • Stabilization during molding and sterilization processes for both opaque and transparent polymer materials • Certified formulations available globally • Offered pre-tested raw materials and produced in an ISO 13485 certified site, minimizing risk across the pharmaceutical value chain • Delivered specialized formulated solutions to meet stringent pharmaceutical packaging requirements • Provided global formulations transferrable from our three ISO 13485 certified facilities Mevopur™ Healthcare Concentrates KEY REQUIREMENTS WHY AVIENT? AVIENT SOLUTION CERTIFICATION + AVAILABILITY LEARN MORE © 2021, Avient Corporation, All Rights Reserved https://www.avient.com/products/polymer-colorants/solid-color-masterbatches/mevopur-custom-colors-and-formulations

C e rt if ie d M an ag ement System s by Sw itze rla nd Certificate The SQS herewith attests that the organisation named below has a management system that meets the requirements of the normative base mentioned. Martorell no.124 08740 Sant Andreu de la Barca Spain 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. 46388 Validity 25. 02. 2021 – 24. 02. 2024 Issue 25. 02. 2021 Swiss Made sqs.ch F.

View PDF The SQS herewith attests that the organisation named below has a management system that meets the requirements of the normative base mentioned. 7 0 0 1 _1 /A p ri l 2 0 2 2 /V er si o n 2 .0 Certificate Avient Colorants Spain S.A. Martorell no.124 08740 Sant Andreu de la Barca Spain 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. 46388 Page 1 of 1 Validity 25. 02. 2024  – 24. 02. 2027 Issue 25. 02. 2024  A.Grisard, President SQS F.