https://www.avient.com/sites/default/files/2021-07/neu-quality-commitment-2021.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.
3.1.1 Full Raw Material tractability of non-proprietary formulations will be reflected on
the COC
3.2 Certification: “Certificate of Conformance” or “Certificate of Analysis” based material
requirements
3.3 Certificate of Analysis: Document containing information that the product conforms to
the established Product Specifications.
3.4 Certificate of Conformance: Document containing confirmation that the product
conforms to the defined formulation.
3.5 Finished Product Form: Finished product shape (Cylindrical, Spherical)
3.6 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
4.1.5 Packaging may include a liner or pallet based on the configuration.
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.
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https://www.avient.com/sites/default/files/2020-07/versaflex-hc-syringe-plunger-english.pdf
Versaflex HC - Syringe Plunger - English
SYRINGE
MANUFACTURER
D I S P O S A B L E S Y R I N G E
P L U N G E R
• USP VI and ISO 10993-4,5 compliant
• Sterilize by gamma & EtO
• Long-term sealing performance
• Low coefficient of friction (COF)
• Consistent performance across barrel sizes
• Provided a formulated solution that met
rigorous medical application requirements
• Improved global supply continuity
• Increased process efficiency by replacing
previous thermoset material with TPE
Versaflex™ HC 2110-57B
KEY REQUIREMENTS
WHY AVIENT?
AVIENT SOLUTION
COMPLIANCE + PERFORMANCE
LEARN MORE
Copyright © 2020, Avient Corporation.
https://www.avient.com/sites/default/files/2022-01/Dynaflex-Disposable syringe tip cap-Application snapshot.pdf
SYRINGE
MANUFACTURING
D I S P O S A B L E S Y R I N G E T I P
C A P
• Excellent sealing and resealing performance
• No DEHP or natural rubber latex added during processing
• Can be sterilized by EtO
• Compliance with ISO 10993-4&5, USP Class VI
Dynaflex™ Thermoplastic Elastomer
KEY REQUIREMENTS
WHY AVIENT?
AVIENT SOLUTION
COMPLIANCE + EASY PROCESSING
Copyright © 2022, Avient Corporation.
Formulated a solution that met rigorous
medical application requirements
• Leveraged global footprint to ensure supply
continuity
• Increased process efficiency by replacing
previous thermoset material with TPE
LEARN MORE
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