Phthalate-Free PVC options for medical device manufacturers
- Alphagary, an Orbia business
- Jun 27
- 2 min read
Plasticizers are the key ingredient that makes flexible polyvinyl chloride (PVC) able to bend without breaking or cracking. This flexibility is essential for medical device products such as oxygen tubing and blood bags as well as a variety of other products such as wires & cables, flooring, wallcovering and other common items that enhance the quality of our lives.
There are many different types of plasticizers to choose from. The type of plasticizer used in a formulation depends on cost, performance, and reporting requirements. Phthalate plasticizers based on phthalic acid such as DOP/DEHP are widely used. However, the use of non-phthalate type plasticizers such as DOTP are growing because of increased reporting requirements under RoHS, REACH, Prop 65 and other regulations.
Terms like “phthalate-free” and “non-phthalate” are often used interchangeably as manufacturers seek to comply with reporting requirements. These terms can be misleading if they don’t accurately identify the reportable phthalate content in a compound. At Alphagary, we have taken the approach to provide transparency on both our Technical Data Sheets (TDS) and Safety Data Sheets (SDS) about reportable phthalate content so that customers are able to make informed decisions about the materials they choose.
The following are restrictions on phthalates as of January 2023:
*January 2023 Status of Reporting Requirements | |
Listed below are the restricted phthalates as of January 2023* When we state, “This product is not intentionally formulated with restricted phthalates”, we are referring to this list. | |
ORGANIZATION | REPORTABLE PHTHALATES |
EU Toy Industry Restricted Phthalates (7) | BBP, DBP, DIBP, DOP/DEHP, DNOP, DINP, DIDP |
US Toy Industry Restricted Phthalates (8, CPSIA) | BBP, DBP, DIBP, DOP/DEHP, DINP, DCHP, DNHP, DNPP |
RoHS Restricted Phthalates (4) | BBP, DBP, DIBP, DOP/DEHP |
REACH SVHC Restricted Phthalates (12) | BBP, DBP, DIBP, DOP/DEHP, DIHP, DCHP, DNHP, DNPP, DIPP, n-Pentyl-isopentyl Phthalate, Bis(2-methoxyethyl) Phthalate, Di(C6-C10) Phthalates |
Prop 65 Phthalates requiring labeling (6) | BBP, DBP, DOP/DEHP, DINP, DIDP, DHP |
EU Medical Device Regulation (12, EU MDR) | BBP, DBP, DIBP, DOP/DEHP, DCHP, DNHP, DNPP, DIPP, DHNUP, n-Pentyl-isopentyl Phthalate, Bis(2-methoxyethyl) Phthalate, Di(isoheptyl) Phthalates |
*Please confirm with Alphagary personnel that the reporting status is updated to the latest information, and the most appropriate compound(s) are recommended. |
Compounds formulated without restricted phthalates
Flexible PVC compounds formulated without restricted phthalates are available from Alphagary. Depending on the application requirements (for example, what sterilization method will be utilized), we offer materials plasticized with DOTP (Dioctyl Terephthalate), Adipate, Trimellitate, and bio-based Citrate.
We also offer flexible TPE materials that do not contain plasticizers:
Plasticizers for PVC compounds
Under the brand name MEXIFLEX, Alphagary produces plasticizers for PVC compounds at our facility in Altamira (Mexico). Vertical integration allows us the flexibility to manage the supply chain. It also gives us the innovative ability to create materials to our exact specifications.
The current offering includes:
MEXIFLEX DOP
MEXIFLEX DOTP – including grades manufactured with recycled PET
MEXIFLEX DOA
MEXIFLEX TOTM
And more
Our technical sales team is happy to help with product selection based on the performance criteria of the finished device. Feel free to contact us with questions:
ALPHAMED, EVOPRENE, MEXIFLEX, and SUPERKLEEN are registered tradenames
