https://www.avient.com/sites/default/files/2021-02/mevopur-needle-one-pager-case-study.pdf
H Y P O D E R M I C N E E D L E
M A N U FAC T U R E R
N E E D L E H U B , C O V E R A N D
S H I E L D
• Compliance to ISO 6009 color coding for single use hypodermic
needle
• Biocompatibility of all component materials
• Good mechanical and visual properties after sterilization (e.g.
ETO / Gamma radiation)
• Facilitated 510(k) submission with formulations
registered under Device Master File MAF 1833
• Pre-tested raw materials to biocompatibility
ISO10993, US and Eu Pharmacopeia, ICH-Q3D
extractable metals
• Enhanced stability with gamma stabilizing
package
• Minimized risk of change with change control
beyond CAS number level
• Ensured uninterrupted supply from multiple ISO
13485-2016 certified sites
• MEVOPURTM ISO 6009 Standard / Customized
Solutions
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2024-02/Suzhou (SEM) ISO 14001.pdf
https://www.avient.com/sites/default/files/2025-01/ISO 16949 Tossiat%2C France.pdf
https://www.avient.com/sites/default/files/resources/Polyolefins%2520Product%2520Selection%2520Guide.pdf
This product selection guide provides
detailed information to help you select
the Maxxam product that’s right for
your application.
4
INJECTION MOLDING POLYPROPYLENE
Product Code - - - PP5113 B44 F5134T2-4 PP5130 B63 F5134T4-1
Filler Percentage - % - 13 20 30 40
Tensile Strength Yield psi ASTM D638 5000 4800 4600 4500
MPa ISO 527 33 33 32 31
Tensile Elongation Yield % ASTM D638 6 4 3 2
ISO 527
Break % ASTM D638 60 30 15 10
ISO 527
Flexural Modulus 73°F (23°C) psi ASTM D790 300,000 360,000 400,000 460,000
MPa ISO 178 2300 2450 2900 3300
Notched Izod
Impact
73°F (23°C) ft-lb/in ASTM D256 0.65 0.60 0.55 0.50
kJ/m2 ISO 180 3.50 3.3 3.00 2.75
Heat Deflection 66 psi °F ASTM D648 230 240 260 275
°C ISO 75 110 116 127 135
264 psi °F ASTM D648 130 140 150 175
°C ISO 75 54 60 66 79
Specific Gravity 73°F (23°C) - ASTM D792 0.99 1.04 1.15 1.25
ISO 1183
Linear Shrinkage
Range
1/8 in wall % - 1.2–1.6 1.0–1.4 0.8–1.2 0.6–1.0
3.2 mm wall % - 1.2–1.6 1.0–1.4 0.8–1.2 0.6–1.0
Product Code - - - PP6113 A77-SM
PP6120
B16-2
PP6130
B11
PP6135
B40-UV
Filler Percentage - % - 13 20 30 35
Tensile Strength Yield psi ASTM D638 4350 3500 2600 3700
MPa ISO 527 30 24 18 26
Tensile Elongation Yield % ASTM D638 5 4 7 6
ISO 527
Break % ASTM D638 35 70 150 70
ISO 527
Flexural Modulus 73°F (23°C) psi ASTM D790 290,000 280,000 280,000 390,000
MPa ISO 178 2000 1950 1750 2700
Notched Izod
Impact
73°F (23°C) ft-lb/in ASTM D256 0.7 2.7 4.5 0.65
kJ/m2 ISO 180 4.0 14 24 3.5
Heat Deflection 66 psi °F ASTM D648 239 215 225 250
°C ISO 75 115 102 107 123
264 psi °F ASTM D648 140 125 130 150
°C ISO 75 60 52 54 60
Specific Gravity 73°F (23°C) - ASTM D792 0.99 1.05 1.15 1.18
ISO 1183
Linear Shrinkage
Range
1/8 in wall % - 1.1–1.5 .9–1.3 0.7–1.1 0.5–0.9
3.2 mm wall % - 1.1–1.5 .9–1.3 0.7–1.1 0.5–0.9
Maxxam™ Talc-Filled
Copolymer Polypropylene
• Scratch & mar resistant
• UL approved
• FDA certifiable
• Natural, black or colors
• High flow grades
• UV stabilized
• UL approved
• FDA certifiable
• Natural, black or colors
• High flow grades
• UV stabilized
• Recycled content
Maxxam™ Talc-Filled
Homopolymer Polypropylene
Offers a moderate level of impact
strength and improved stiffness
and heat deflection performance.
Chemically coupled
• Natural or black
• High flow grades
• Provides heat stabilization
• Excellent balance of properties
• Natural, black or custom colors
Product Code - - - PX5430 B1 PX5435 B1 PX5440 B1 PX5450 B1
Reinforcement Type - - - Glass Glass Glass Glass
Reinforcement % - % - 30 35 40 50
Specific Gravity 73°F (23°C) - ISO 1183 1.13 1.18 1.23 1.35
Tensile Strength Yield MPa ISO 527 102 105 113 130
Flexural Modulus 73°F (23°C) MPa ISO 178 6500 8000 9400 11,500
Notched Izod Impact 73°F (23°C) kJ/m2 ISO 180 9.4 9.3 11.0 12.0
Heat Deflection 264 psi °C ISO 75 152 152 153 154
Product Code - - - PP5120 B270-LO
MFR g/10 min ISO 1133 12
Tensile Modulus MPa ISO 527 3320
Tensile Stress Yield MPa ISO 527 32
Tensile Elongation Yield % ISO 527 4.6
Tensile Elongation Break % ISO 527 17
Flexural Modulus MPa ISO 178 3000
Charpy Impact 73°F (23°C) kJ/m2 ISO 179/1eU 38
Heat Aging 150°C h VW 44045 700 hr
VOC µg/g VDA 278 23.5
Fog µg/g VDA 278 30.5
Carbon Emissions µgC/g VDA 277 18
Odor Grade VDA 270 B3 3
• High flow grades
• UV stabilized
PROPERTY CONDITION UNITS METHOD PRODUCT EXAMPLES
INJECTION MOLDING POLYPROPYLENE
PROPERTY CONDITION UNITS METHOD PRODUCT EXAMPLES
10
Maxxam™ Filled
& Reinforced
Polypropylene
A range of melt flows to process well in
sheet extrusion, thermoforming, profile
extrusion and blow molding operations
FDA certifiable
• Natural, black or colors
• UV stabilized
Product Code - - - PE4125 B1
Reinforcement
Type
- - - Talc
Reinforcement
%
- % - 25
Specific
Gravity
73°F (23°C) - ASTM D792 1.15
ISO 1183
Tensile
Strength
Yield psi ASTM D638 4050
MPa ISO 527 28
Tensile
Elongation
Yield % ASTM D638 10
ISO 527
Break % ASTM D638 40
ISO 527
Flexural
Modulus
73°F (23°C) psi ASTM D790 270,000
MPa ISO 178 1850
Notched
Izod Impact
73°F (23°C) ft-lb/in ASTM D256 3.5
kJ/m2 ISO 180 20.0
Heat
Deflection
66 psi °F ASTM D648 190
°C ISO 75 88
264 psi °F ASTM D648 115
°C ISO 75 46
PROPERTY CONDITION UNITS METHOD PRODUCT EXAMPLES
12
www.polyone.com
Copyright © 2019, PolyOne Corporation.
https://www.avient.com/sites/default/files/2023-10/ISO 13485-2016 cert_expire 28Feb2025_Avient%5B28%5D.pdf
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Certificate
Avient Colorants Singapore Pte Ltd
8 Third Chin Bee Road
Jurong Industrial Estate
618684 Singapore
Singapore
Scope
Administration, Site management, Manufacture,
Laboratory, Procurement, Maintenance,
infrastructure, Warehouse and Transport
Normative base
EN ISO 13485:2016 Medical devices – Quality Management System
Reg. no. 45483 Validity 01. 03. 2022 – 28. 02. 2025
Issue 01. 03. 2022
A.Grisard, President SQS F.
https://www.avient.com/sites/default/files/2023-12/Jeddah%2C Saudia Arabia ISO 14001.pdf
Limited
PO Box 2137, Jeddah 22758
Saudi Arabia
Has been assessed and found to meet the requirements of
ISO 14001:2015
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: 20 December 2022
Certificate Valid Until: 19 December 2025
Recertification audit before 20 November 2025.
https://www.avient.com/sites/default/files/2023-02/PH - 15701960 AVIENT ASSESSE ISO 14001.pdf
AVIENT BELGIUM
2, RUE MELVILLE WILSON
5330 ASSESSE- BELGIUM
Bureau Veritas Certification France certify that the Management System of the above
organization has been audited and found to be in accordance with the requirements of the
management system standard detailed below:
Standard
ISO 14001 : 2015
Scope of certification
DESIGN AND MANUFACTURE OF COLOUR AND ADDITIVE
CONCENTRATES, THERMOPLASTIC RESINS AND
SPECIALITY COMPOUNDS.
https://www.avient.com/sites/default/files/2020-07/PH -AVIENT LUXEMBOURG - 15608678 - ISO 14001.pdf
POLYONE FRANCE TOSSIAT
43, PLACE DE LA GARE
01250 TOSSIAT
FRANCE
Bureau Veritas Certification France certify that the Management System of the above
organization has been audited and found to be in accordance with the requirements of the
management system standard detailed below:
Standard
ISO 14001:2015
Scope of certification
THE DESIGN AND MANUFACTURE OF COLOUR AND ADDITIVE CONCENTRATES FOR
THERMOPLASTICS
Certification/Recertification Cycle Start Date: 03 May 2023
Subject to the continued satisfactory operation of the organization’s Management System,
this certificate expires on: 02 May 2026
Expiry date of previous cycle: NA
Certification/Recertification Audit date: 08 March 2023
Original Cycle Start Date: 15 July 2011
Certificate n°: FR081968-1
File n°:15608678 Revision date:24 April 2023
Laurent CROGUENNEC - President
Local Office: Bureau Veritas Certification France
Le Triangle de l'Arche - 9 Cours du Triangle - 92937 Paris La Défense
Further clarifications regarding the scope of this certificate the applicability of the management system
requirements may be obtained by consulting the organization.
https://www.avient.com/sites/default/files/2020-07/ISO 45001 14 March 2026.pdf
F-27, MIDC,
Ranjangaon, Shirur,
Pune, Maharashtra 412 220
India
ISO 45001:2018
The Occupational Health and Safety Management is applicable to:
Certificate No: 55689
Certification Date: 15 March 2017
Effective Date: 09 March 2023
Expiration Date: 14 March 2026
Revision Date: 15 March 2023 Dominic Townsend, President
DESIGN MANUFACTURE OF COLOR MASTER BATCHES, ADDITIVES CONCENTRATES AND SPECIALTY
COMPOUNDS.
https://www.avient.com/sites/default/files/2020-07/ISO 14001 - 14 March 2026.pdf
F-27, MIDC,
Ranjangaon, Shirur,
Pune, Maharashtra 412 220
India
ISO 14001:2015
The Environmental Management System is applicable to:
Certificate No: 55688
Certification Date: 15 March 2017
Effective Date: 09 March 2023
Expiration Date: 14 March 2026
Revision Date: 21 March 2023 Dominic Townsend, President
DESIGN MANUFACTURE OF COLOR MASTER BATCHES, ADDITIVES CONCENTRATES AND SPECIALTY
COMPOUNDS
This certificate may be found on the ABS QE Website (www.abs-qe.com).