https://www.avient.com/sites/default/files/2020-10/neu-quality-commitment.pdf
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.
https://www.avient.com/resource-center?document_subtype=0&document_type=59&form_id=resource_filter_form&industry=0&op=FILTER RESULTS&product_family=0&product_name=0&page=0
NEU™ Custom Capabilities and NEUSoft™ Thermoplastic Polyurethanes are developed for short-term in-vivo applications that offer good elasticity, radiopacity, excellent UV stability and protection against moisture and oxygen while meeting ISO 10993 & USP Class VI standards.
Edgetek™ Engineered Polymer Formulations achieved a UL 94 V-0 flammability rating certification for server cabinets
Mevopur™ formulations for PCR well plates prevent 'cross-talk' and minimize phosphorescence with optimally dispersed TiO2, while balancing melt flow and physical properties, and ensuring quality through ISO 13485:2016 certification.
https://www.avient.com/resource-center?document_type=59&document_subtype=0&industry=0&product_family=0&product_name=0&op=FILTER RESULTS&form_id=resource_filter_form&page=0
NEU™ Custom Capabilities and NEUSoft™ Thermoplastic Polyurethanes are developed for short-term in-vivo applications that offer good elasticity, radiopacity, excellent UV stability and protection against moisture and oxygen while meeting ISO 10993 & USP Class VI standards.
Edgetek™ Engineered Polymer Formulations achieved a UL 94 V-0 flammability rating certification for server cabinets
Mevopur™ formulations for PCR well plates prevent 'cross-talk' and minimize phosphorescence with optimally dispersed TiO2, while balancing melt flow and physical properties, and ensuring quality through ISO 13485:2016 certification.
https://www.avient.com/resource-center?document_type=59
NEU™ Custom Capabilities and NEUSoft™ Thermoplastic Polyurethanes are developed for short-term in-vivo applications that offer good elasticity, radiopacity, excellent UV stability and protection against moisture and oxygen while meeting ISO 10993 & USP Class VI standards.
Edgetek™ Engineered Polymer Formulations achieved a UL 94 V-0 flammability rating certification for server cabinets
Mevopur™ formulations for PCR well plates prevent 'cross-talk' and minimize phosphorescence with optimally dispersed TiO2, while balancing melt flow and physical properties, and ensuring quality through ISO 13485:2016 certification.
https://www.avient.com/sites/default/files/2021-07/mevopur-pharma-packaging-1-page-case-study.pdf
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
https://www.avient.com/company/policies-and-governance-0/supplier-code-conduct
Global ISO Certificate Library
https://www.avient.com/sites/default/files/2024-02/Sant Andreu_ISO22000.pdf
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Sw
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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.
https://www.avient.com/sites/default/files/308837_en_46388.pdf
View PDF
The SQS herewith attests that the organisation named below has a management system that meets the requirements of
the normative base mentioned.
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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.
https://www.avient.com/sites/default/files/resources/Tangerang_ISO22000.pdf
C
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by
Sw
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Certificate
The SQS herewith attests that the organisation named below has a management system that meets
the requirements of the normative base mentioned.
Cibodas
Kecamatan Cibodas, Tangerang 15138
Indonesia
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. 46391 Validity 25. 02. 2021 – 24. 02. 2024
Issue 30. 06. 2021
Swiss Made
sqs.ch
F.
https://www.avient.com/sites/default/files/resources/Jurong_ISO22000.pdf
C
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M
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s
by
Sw
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Certificate
The SQS herewith attests that the organisation named below has a management system that meets
the requirements of the normative base mentioned.
Avient Colorants Singapore Pte Ltd
8 Third Chin Bee Road
Jurong Industrial Estate
Singapore 618684
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 Validity 25. 02. 2021 – 24. 02. 2024
Issue 30. 06. 2021
Swiss Made
sqs.ch
F.