https://www.avient.com/sites/default/files/2023-03/Mevopur Healthcare Functional Additives Antistatic Application Bulletin_0.pdf
APPLICATIONS
• Medical devices
• Drug delivery devices
• Labware
KEY CHARACTERISTICS
• Manufactured at four ISO 13485 certified sites,
providing global consistency and increased
security of supply
• Documented change control beyond CAS
number level, reducing risk of change
REGULATORY SUPPORT
• Raw materials tested to:
- ISO 10993-1 and USP
biological evaluation
- European Pharmacopeia 3.1.3/3.1.5
(polyolefin)
- USP (polyethylene)
- ICH Q3D elemental impurities
• Registered Drug Master File (Type III) and/or
Device Master File
• Food contact established with FDA/EU*
* FDA/EU compliance information available upon request
Copyright © 2023, Avient Corporation.
https://www.avient.com/sites/default/files/2023-01/Mevopur Healthcare Functional Additives Chemical Foaming Agents Application Bulletin.pdf
KEY CHARACTERISTICS
• Manufactured under ISO 13485 procedures
• Documented change control beyond
CAS number, reducing risk of change
• Can be used on common injection molding
and extrusion machines—set-up support by
a technical assistance team
• Available for use in polyolefins, styrenics
and copolymers
• Can be combined with colorants
REGULATORY SUPPORT
• Raw materials tested to:
- ISO 10993-1
- USP and (incl. class VI)
- European Pharmacopeia, monograph 3.1.3/
3.1.5 (polyolefin packaging materials)
- USP (polyethylene)
- Elemental impurities as per ICH Q3D
• Registered Drug Master File (Type III) and/or
Device Master File
• Food contact according to USA FDA and
EU norms
APPLICATION BULLETIN
Sustainability Spotlight
Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2022-02/Sustainability ESG Disclosures_Silicon Dioxide.pdf
CATEGORY DETAIL
EC Number 231-545-4
CAS Number 7631-86-9
Chemical Name Silicon Dioxide (SiO2)
Structural Formula
CHEMICAL IDENTITY
Si
O O
HEALTH EFFECTS
HUMAN HEALTH SAFETY ASSESSMENT
Consumer No human health hazard has been identified relating to this substance.
https://www.avient.com/sites/default/files/2021-06/inscripcion-registro-santiago-cambio-razon-social-performance-masterbatches618874v1.pdf
Santiago, 3 Junio 2021
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012-2106-0309-1142
Documento incorpora Firma
Electronica Avanzada
Código de Verificación: cec_1c0abd-0 pagina 2 de 2
EDUARDO JAVIER DIEZ MORELLO
2021-06-03T10:28:54-0600
Santiago
Firma Electrónica Notario
2021-06-04T10:37:47-0400
https://www.avient.com/sites/default/files/2025-02/case study snapshot-Ostomy bag-G2705.pdf
PowerPoint Presentation
MEDICAL DEVICE
MANUFACTURER
O S T O M Y B A G S E A L S
• Comply with ISO 10993 and FDA Class II medical device
regulations
• Offer Good sealing performance
• Provide technical supports for processing
recommendations
• Deliver a high compression set materials to improve
comfort
• Provided a medical-grade TPE to help the
customer meet necessary regulatory
specifications and gain market share
• Provided technical support during design
and the manufacturing process for EVA
bonding
• Delivered soft-touch feel and excellent
sealing performance
Versaflex HC Thermoplastic Elastomers -
G2705 Formulation
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/industries/consumer/consumer-discretionary/home-household/office-supplies
BOS - Battery S Frame
Engineered Materials for EV Batteries
Engineered Polymer Materials for EV Batteries
https://www.avient.com/sites/default/files/resources/HIGH_PERFORMANCE_CLEAR_THERMOPLASTICS_ELASTOMER.pdf
II.
Major requirements for medical tubing
are listed:
Transparent or translucent
Kink resistance
Peristaltic pump life
Autoclavable/Gamma Sterilizable
Low extractable
Hardness and modulus requirement
The comparison of properties of SBC
compound, PVC and TPV are listed in Table II.
Gravity 1.15 0.89
Ratio of specific gravity 1.29 1
Hardness, A 50 54
Tensile, Pa, 106 (psi) 8.96 (1300) 7.01 (1029)
Tear, N/M, 104 (lb/in) 3.20 (182) 3.22 (183)
Elongation, % >500 690
Clarity transparent transparent
British tear test passed passed
Boiling water/dish washer passed passed
Table II Comparison of properties of SBC compound, PVC and TPV
PVC-60 A TPV-67A SBC-59A SBC-74A
Hardness, A 60 67 59 74
Specific gravity 1.20 0.97 0.90 0.90
100% modulus, Pa, 106 (psi) 7.07 (1025) 5.67 (822) 2.03 (295) 3.63 (527)
Tensile, Pa, 106 (psi) 9.65 (1400) 6.21 (900) 6.94(1007) 11.7(1700)
Tear, N/M, 104 (lb/in) 3.25 (185) 2.14 (122) 3.36 (192) 4.38 (250)
Elongation 250 150 650 550
Clarity transparent opaque semi-transparent transparent
3040 / ANTEC 2003
https://www.avient.com/sites/default/files/2024-07/Ballistic Resistant Composite Panels Product Selection _ Install Guide.pdf
Panels are available for protection to UL 752
levels 1, 2, & 3 and NIJ Levels I, II, & IIIA test
standards for ballistic resistance.
Shots Composite Panel Nominal
Thickness
Nominal
Weight
Level
1
9mm full metal
copper jacket
with lead core
1175 ft/sec
358 m/sec 3 GlasArmor
Level 1
0.256 in
6.5 mm
2.7 lb/ft2
13.2 kg/m2
2
Level
II-A
.357 magnum
jacketed
lead soft point
1250 ft/sec
381 m/sec 3 GlasArmor
Level 2
0.384 in
9.8 mm
4.0 lb/ft2
19.5 kg/m2
Level
3
Level
III-A
.44 magnum lead
semi-wadcutter
gas checked
1350 ft/sec
411 m/sec 3
GlasArmor
Level 3
0.500 in
12.7 mm
5.1 lb/ft2
24.9 kg/m2
ThermoBallistic
Level 3
0.440 in
11.2 mm
3.9 lb/ft2
19.0 kg/m2
Level
4 .30 cal. rifle lead core 2450 ft/sec
747 m/sec 1
Customized solutions
are available.
Level
5
7.62mm rifle lead core
full metal copper jacket,
military ball
2750 ft/sec
838 m/sec 1
Level
6
Level
II
9mm full metal jacket
with lead core
1400 ft/sec
427 m/sec 5
Level
7
5.56mm rifle full metal
copper jacket with
lead core
3080 ft/sec
939 m/sec 5
Level
8
Level
III
7.62mm rifle lead core
full metal copper jacket,
military ball
2750 ft/sec
838 m/sec 5
Width Length Thickness Color
LEVEL 1
0.256 in/6.5 mm Natural
36 in/91 cm 120 in/305 cm
48 in/122 cm 108 in/274 cm
48 in/122 cm 120 in/305 cm
LEVEL 2
0.384 in/9.8 mm Natural
36 in/91 cm 120 in/305 cm
48 in/122 cm 108 in/274 cm
48 in/122 cm 120 in/305 cm
LEVEL 3
0.500 in/12.7 mm
Natural
36 in/91 cm 120 in/305 cm Natural
48 in/122 cm 96 in/244 cm Natural, Grey, White, Tan
48 in/122 cm 108 in/274 cm Natural, Grey
48 in/122 cm 120 in/305 cm Natural, Grey, White
ThermoBallistic Panels
24 in/61 cm 96 in/244 cm
0.44 in/11.2 mm White, Grey, Blue
24 in/61 cm 144 in/366 cm
48 in/122 cm 144 in/366 cm
BALLISTIC PANEL SELECTION GUIDE
Customized panel sizes and colors available.
https://www.avient.com/sites/default/files/2024-12/Terms and Conditions of Sale for Indonesia %28English translation%29.pdf
Buyer
assumes all risks and liabilities (i) arising out of unloading,
discharge, storage, handling and use of the Product, or (ii) arising
out of compliance or non-compliance with national, state,
provincial, or local laws and regulations governing or controlling
such activity.
Except in the case of a force
majeure, if not satisfied with Seller’s determination, Buyer as its sole
remedy shall have a right to terminate this contract without further
obligation upon: (i) 10 (ten) calendar days’ written notice; and (ii)
payment for all Product received to date.
14.
Buyer shall be exclusively responsible for (i) ensuring
compliance with all Laws and Standards associated with its intended
use of Product; and (ii) obtaining all necessary approvals, permits or
clearances for such use.
https://www.avient.com/sites/default/files/2024-03/Terms and Conditions of Sale for Finland %28Finnish Translation%29.pdf
Ostaja kantaa kaikki riskit ja vastuut (i) jotka syntyvät
Tuotteen purkamisesta kuljetuksesta, säilytyksestä, käsittelystä ja
käytöstä (ii) tai tällaista toimintaa koskevien sovellettavien lakien ja
säädösten noudattamisesta tai noudattamatta jättämisestä.
Pois lukien tilanteet, johon liittyy ylivoimainen este,
ellei Ostaja tyydy Myyjän päätökseen, tällä on, ilman
lisävelvoitteita, ainoana oikeussuojakeinonaan oikeus irtisanoa tämä
sopimus: (i) tekemällä kirjallinen irtisanomisilmoitus 10 päivän
irtisanomisajalla ja (ii) maksamalla kaikista siihen asti
vastaanottamistaan Tuotteista.
14.
Ostaja on
yksinomaisesti vastuussa (i) sen Tuotteen aiottuun käyttöön
liittyvien Lakien ja standardien noudattamisen varmistamisesta ja
(ii) kaikkien tarvittavien hyväksyntöjen tai lupien hankkimisesta
tällaista käyttöä varten.