Raw materials tested to ISO 10993-1, USP and (class VI), USP , European Pharmacopeia monographs 3.1.3 and 3.1.5, ICH Q3D

Like all Mevopur products, Mevopur Healthcare Bio-based Polymer Solutions use raw materials pre-tested to ISO 10993-1, USP and , EP 3.1.3 / 3.1.5 (polyolefin packaging materials), USP (polyethylene) and ICH Q3D (elemental impurities).

Avient follows the ISO 14067:2018 standard to calculate PCF values and utilizes global formulation expertise, green manufacturing processes, and sourcing & logistics competence to achieve such low or negative values.  

They are tested to ISO 10993 standards, and can be customized with the addition of functional additives to enhance product performance.

PCF values are calculated using Avient’s PCF Calculator, certified by TÜV Rheinland according to ISO 14067

MEVOPUR medical-grade materials are produced according to ISO13485-2016 protocols and supported by testing to ISO 10993-1, USP, European Pharmacopeia and ICH Q3D guidelines.

No. 0562.01) Revised 05/31/2022 Page 1 of 1 SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 AVIENT CORPORATION 733 East Water Street North Baltimore, OH 45872 Claire Holman Phone: (419) 257-1327 MECHANICAL Valid To: October 31, 2023 Certificate Number: 0562.01 In recognition of the successful completion of the A2LA evaluation process, accreditation is granted to this laboratory to perform the following automotive plastics tests: Test Method: Test Name: ASTM D412 Tensile ASTM D523 Specular Gloss ASTM D618 (A) Conditioning of Plastics ASTM D624 (Die C) Tear Strength ASTM D638 Tensile Properties ASTM D792 (A) Density and Specific Gravity by Displacement ASTM D1004 Initial Tear Resistance ASTM D1203 (A) Volatile Loss ASTM D1895 (A) Apparent Density, Bulk Factor, Pourability ASTM D1921 Particle Size (Sieve Analysis) ASTM D2240 Durometer Hardness (Shore A and D) ASTM E1331 Color by Spectrophotometry Using Hemispherical Geometry FMVSS 571.302 Flammability FORD BN-102-01 (A) Low Temperature Flexibility FORD BO-131-03 Interior Odor ISO 3795 Determination of Burning Behavior of Interior Materials SAE J323 (A) Cold Cracking (Mandrel Bend) SAE J1351 Hot Odor for Insulation Materials SAE J1545 Instrumental Color Difference Measurement SAE J1756 Fogging Characteristics of Interior Automotive Materials (Photometric Only) DOC-058151 Angle of Repose 1 Laboratory Developed Method For the tests to which this accreditation applies, please refer to the laboratory’s Mechanical Scope of Accreditation. Accredited Laboratory A2LA has accredited AVIENT CORPORATION North Baltimore, OH for technical competence in the field of Mechanical Testing This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories. This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system (refer to joint ISO-ILAC-IAF Communiqué dated April 2017).

ISO 13485 certified manufacturing sites ISO 10993 and USP Class VI compliant solutions

Mevopur™ Healthcare Colorants, Functional Additives, and Bio-based Formulations: Manufactured across a global network of ISO 13485 facilities, this broad portfolio is pre-tested to United States Pharmacopeia (USP) Class VI, ISO 10993, USP 661, European Pharmacopeia 3.1, and International Conference on Harmonization (ICH) Q3D protocols.

Limited PO Box 2137, Jeddah 22758, Saudi Arabia Has been assessed and found to meet the requirements of ISO 45001:2018 This certificate is valid for the following scope of operations: Production and Supply of Color and Additive Master Batches Authorised by: Stan Wright Director Date of Certificate Issue: 30 December 2021 Certificate Valid Until: 29 December 2024 Recertification audit before 30 November 2024.