https://www.avient.com/sites/default/files/308837_en_46388.pdf
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/2024-04/CCG Application Snapshot_Endoscope.pdf
Surgical instrument oem
SURGICAL
INSTRUMENT OEM
E N D O S C O P E C O M P O N E N T S
• Functional differentiation
• ISO 10993 compliance
• Excellent resistance to steam sterilization
• Excellent chemical resistance
• Delivered a variety of bright, distinguishing color
choices for functional differentiation
• Minimized color deviation
• Provided a biocompatible solution
• Offered low MOQ with flexible supply
Transcend Premier PPSU Healthcare Pre-
colored Solutions
KEY REQUIREMENTS
WHY AVIENT?
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?
https://www.avient.com/sites/default/files/2020-07/versaflex-bvm-resuscitator-bag.pdf
Versaflex - BVM Resuscitator Bag
BAG-VALVE-MASK (BVM)
MANUFACTURER
R E S U S C I T A T O R B A G
• Compatible gamma sterilization process
• Achieve desired elastomeric properties
• PVC-free formulation
• FDA, ISO 10993, USP VI compliant
• Repeatable injection molding process
• Complemented customer expertise with
technical support in material selection, part &
tool design, and process development
• Customized TPE offered customer an
alternative to vinyl without sacrificing
performance
• Improved process efficiency and overall
system costs through injection molding method
Customized Versaflex™ TPE
KEY REQUIREMENTS
WHY AVIENT?
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?
https://www.avient.com/sites/default/files/2023-10/reSound BIO TPE -Underwire-case study snapshot.pdf
FAMOUS
UNDERWEAR
BRAND
U N D E R W I R E
• Formulated a 40% bio-derived material to
help meet customer’s sustainable goals with
good rigidity and supporting strength
• Improved comfort and softness compared to
a normal steel underwire design
• Passed ISO 105-X18 textile test with good
chemical resistance, durability, and wash
fastness
Customized reSound™ BIO TPE
WHY AVIENT?
https://www.avient.com/sites/default/files/2021-02/custom-gls-tpe-touriquet-band-case-study-one-pager.pdf
GLOBAL ELASTIC &
RUBBER PRODUCT
MANUFACTURER
T O U R N I Q U E T B A N D
• Hardness 45, shore A
• Thickness 0.5mm and Tensile set
https://www.avient.com/sites/default/files/2022-06/Malmoe 308840_en_13485_22.pdf
Normative base
EN ISO 13485:2016 Medical devices –
Quality Management System
Reg. no. 37081 Validity 01.03.2022 – 28.02.2025
Issue 01.03.2022
Swiss Made
Swiss Association for Quality
and Management Systems (SQS)
Bernstrasse 103, 3052 Zollikofen, Switzerland
sqs.ch
F.
https://www.avient.com/sites/default/files/2024-02/Sant Andreu_ISO22000.pdf
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 Madesqs.ch
F.
https://www.avient.com/sites/default/files/resources/Ahrensburg_ISO50001.pdf
Avient Colorants Germany GmbH
Kornkamp 50
22926 Ahrensburg
Germany
Scope
Production of Color- and Additives Concentrates,
Compounds and Foaming Agents
Normative base
ISO 50001:2018 Energy Management System
Reg. no. 46090 Validity 20. 01. 2021 – 19. 01. 2024
Issue 12. 04. 2021
Swiss Made
Swiss Association for Quality
and Management Systems (SQS)
Bernstrasse 103, 3052 Zollikofen, Switzerland
sqs.ch
F.