https://www.avient.com/sites/default/files/2023-03/Mevopur Healthcare Functional Additives Nucleating Application Bulletin.pdf
The nucleating agents also foster constant process
settings throughout part manufacturing with a
higher crystallization temperature for improved
crystallization speed.
REGULATORY SUPPORT
• Drug delivery devices
• Pharmaceutical packaging
• Medical equipment
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 the risk of change
• Allows crystallization in semi-crystalline
polymers to begin faster and complete earlier
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*
APPLICATION BULLETIN
* FDA/EU compliance information available upon request
Healthcare use limitations apply—see below.
It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device with all applicable laws and regulations, including
the suitability of all raw materials and components used for its manufacture.
https://www.avient.com/sites/default/files/2023-05/Cesa Light Diffusion Additives for Automotive - Product Overview.pdf
Cesa™
Light Diffusion Additives enable manufacturers to
develop consumer-pleasing automotive lighting
systems that also meet OEM’s demands for
manufacturability and cost management.
Our expertise is in
understanding a designer’s idea and developing
the appropriate formulation to turn it into a
manufacturing reality.
Information we may require includes:
• Which material will be used to manufacture the lens?
https://www.avient.com/sites/default/files/2020-09/case-study-one-pager-hybrid-5g-cable.pdf
OFC
MANUFACTURER
5 G H Y B R I D C A B L E
J A C K E T I N G & I N S U L A T I O N
• Fire performance: reduce smoke and fume production,
high flame and char resistance
• Reduce development time
• Meet required standards: UL 1581 (Class XL) mechanical
properties , UL 1685 (flame test/smoke parameters), FT2
& FV2 (VW1)
• Accelerated speed to market, reducing
development time to three months
• Instilled confidence and proved material
expertise as solutions passed extensive
testing ahead of competition
• Optimized cable manufacture process and
line speed following trials at customers
facility
ECCOH 5549/1 LDD & Syncure™ S100FH
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/products/engineered-polymer-formulations/eco-conscious-formulations/eccoh-low-smoke-and-fume-non-halogen-formulations
OFC Manufacturer
https://www.avient.com/sites/default/files/2022-04/Ext Building Products OEM Application Snapshot.pdf
Ext Building Products OEM Application Snapshot
EXTERIOR BUILDING
PRODUCTS OEM
S H E E T / P R O F I L E E X T R U S I O N
• Source a cost competitive and effective chemical foaming
additive (CFA) with prompt availability
• Incorporate a CFA lightweighting solution with consistent
cell structure and density for better overall operational
performance
• Improve material usage while manufacturing on both
single and twin screw processing equipment
• Met customer needs and timing with
effective and efficient CFA solutions
• Provided formulations that improved the
dispersion and efficacy for optimized
performance and control in manufacturing
• Offered application and processing
expertise focused on specific customer
manufacturing assets and operations,
allowing improved material usage and
reduced operational costs
Hydrocerol™ and Excelite™ CFAs
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2022-05/Pipe Mfg Liquid Color App Snapshot final NEW.pdf
Pipe Mfg Liquid Color App Snapshot final (1)
PIPE MANUFACTURER
P R E S S U R E / N O N - P R E S S U R E P I P E S
• Provide a safe and compliant manufacturing environment
for all team members
• Improve weatherability and outdoor exposure longevity in
field and yard environments
• Increase color consistency and enhance pipe appearance
• Reduce scrap rates and eliminate order rejections
• Meet required compliance and regulatory approvals
• Incur no capital expense for dosing & handling equipment
• Provided a customer-centric approach focused on
gaining operational efficiencies to support an
improved manufacturing environment
• Offered formulation expertise and problem-solving
experience to upgrade pipe performance
• Attained finely dispersed TiO2 and color distribution
throughout the pipe, meeting quality requirements
while reducing scrap rates
• Delivered solutions with extensive NSF, UL and pipe
industry approvals
• Supplied dosing equipment to eliminate capital
costs, backed with on-call technical support
ColorMatrix™ Liquid Colorant + Dosing Equipment
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2022-10/5_PolyOne GMP Certificate%5B97%5D.pdf
Pune, Maharashtra - 412 220
India
Hold this Opinion Statement No. 770146 / 2022
The Organization has demonstrated that they have followed the Good Manufacturing
Practices with reference to IPEC -PQG-GMP requirements applicable to Excipients used in
pharma products for the following Business activity:
“Research and Development, Manufacture of Color additives, Concentrates and
Specialty Formulations for intended use in pharma and other industries”.
For and on behalf of BSI
Theuns Kotze, Managing Director – IMETA Assurance
Last Assessment Date: 2022/06/25
Latest issue Date: 2022/08/24
Expiry Date: 2023/08/17
BSI Group India Private Limited T: +91 11 2692 9000
(CIN U74899DL1999PTC101381 info.in@bsigroup.com
The Mira Corporate Suites bsigroup.com/en-IN
Plot 1&2, Ishwar Nagar,
Mathura Road New Delhi-110065, India
Good Manufacturing Practices
mailto:info.in@bsigroup.com
https://www.avient.com/sites/default/files/2024-09/CCG Application Snapshot PTFE dispersed pigment tubing.pdf
PTFE Wire insulation
TUBING
MANUFACTURER
P T F E C A T H E T E R T U B I N G
• Food contact compliance
• Avoid contamination risks resulting from dry pigments
• Powder paste extrusion process
• High quality dispersion
• Availability of custom color options
• Supplied pigments with FDA clearance
• Optimized pigment particle size and distribution to
achieve high-quality dispersion
• Provided a technology based on high-quality
pigments and ready-to-use formulations
• Offered a standard liquid pigment portfolio in a
wide range of shades with color-matching
capabilities
• Improved manufacturing process stability and
efficiency
Colorant Chromatics PTFE Dispersed
Pigment Solutions
KEY REQUIREMENTS
WHY AVIENT?
Slide 1: Tubing manufacturer
https://www.avient.com/sites/default/files/2021-04/shanghai-9001.pdf
Park, Pudong, Shanghai China, 201203
and the sites as mentioned in the appendix accompanying this certificate
has been found to conform to the Quality Management System standard:
GB/T 19001-2016/ISO 9001:2015
This certificate is valid for the following scope:
Design and Manufacture of Masterbatch
Certificate No: 7071-1998-AQ-RGC-RvA
Place and date: Shanghai, 19 March, 2021
Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
TEL:+31(0)102922689. www.dnvgl.com/assurance
Page 2 of 2
Appendix to Certificate
PolyOne-Shanghai, China
Locations included in the certification are as follows:
Site Name Site Address Site Scope
PolyOne Polymer (Tianjin)
Company Limited
No.28#C, Jin Bin Hi-Tech
Industrial Park, 156 Nan Hai Road,
Tianjin Economic-Technological,
Tianjin, China, 300457
Manufacture of Masterbatch
PolyOne-Shanghai, China No. 88, Guo Shou Jing Road, Z.
Park, Pudong,
Shanghai, China, 201203
Design and Manufacture of Masterbatch
https://www.avient.com/sites/default/files/2020-10/photovoltaic-floating-power-station-case-study.pdf
This manufacturer is using Avient’s Smartbatch™
Concentrates, an integrated colorant and anti-UV
solution.
In addition, the company’s expertise and Smartbatch
anti-UV concentrate extends the manufacturer’s
pontoon part’s ability to withstand outdoor exposure.
Finally, the manufacturer reported it was able to win
market share and increase profitability as a result of the
Smartbatch concentrate
https://www.avient.com/sites/default/files/2024-12/ISO-9001_English_Shanghai Zhangjiang.pdf
Park, China (Shanghai) Pilot Free Trade Zone,
Shanghai, China 201203
and the sites as mentioned in the appendix accompanying this certificate
has been found to conform to the Quality Management System standard:
GB/T 19001-2016 / ISO 9001:2015
This certificate is valid for the following scope:
Design and Manufacture of Colour and Additive Concentrates
http://www.dnv.com/assurance
Certificate no.: 7071-1998-AQ-RGC-RvA
Place and date: Shanghai, 20 March 2024
Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
ACCREDITED UNIT: DNV Business Assurance B.V., Zwolseweg 1, 2994 LB, Barendrecht, Netherlands - TEL: +31(0)102922689. www.dnv.com/assurance
Page 2 of 2
Appendix to Certificate
PolyOne-Shanghai, China
Locations included in the certification are as follows:
Site Name Site Address Site Scope
PolyOne Polymer (Tianjin) Company
Limited
No. 28#C, Jin Bin Hi-Tech Industrial Park,
No. 156, Nan Hai Road, Tianjin Economic-
Technological Development Area, Tianjin,
China 300457
Manufacture of Colour and Additive
Concentrates
PolyOne-Shanghai, China No. 88, Guo Shou Jing Road, Z.
Park, China (Shanghai) Pilot Free
Trade Zone, Shanghai, China 201203
Design and Manufacture of Colour and
Additive Concentrates
http://www.dnv.com/assurance