DOP grades: technical specifications and batch traceability
The names DOP and DEHP identify a chemical, not every quality requirement of a commercial grade. Purchasing products from the same chemical family requires separate assessment of specifications, batch documents and intended use.
The names DOP and DEHP identify a chemical, not every quality requirement of a commercial grade. Purchasing products from the same chemical family requires separate assessment of specifications, batch documents and intended use.
Separate the commercial code from the chemical name
Versafleks DOP and Med-X DOP are different commercial grades in the Plastay portfolio. The Med-X product page describes a medical grade. This description alone does not establish grade equivalence or automatic compliance of a finished device. State the complete product code in purchasing documents.
Compare specification fields
Review published properties such as ester content, residual alcohol, water, acidity, colour and viscosity using matching units and methods. Do not transfer one grade's limit to another grade. Where typical information differs from acceptance limits, agree a written technical specification with the supplier. Preserve previous delivery records when document revisions change.
Establish batch traceability
- Match the packaging product code and batch number to the delivery.
- Archive the CoA against the relevant batch.
- Link the sample, production order and finished-product batch.
- Apply change control to supplier or grade changes.
- Define record-retention requirements in the company procedure.
This chain helps identify which raw material was used in each production run when a deviation appears later. Filing only by supplier name can lose the distinction between grades and batches.
Evaluate a grade change
Do not accept the candidate as an automatic substitution. Determine its implications for formulation, processing and finished-product assessment with the relevant quality team. This article is not clinical-use advice or a regulatory compliance opinion; assessments required by a specific application remain separate. Share the current product code, critical quality fields and required document list in the technical request.
Related products and technical evaluation
Versafleks DOP — DOP / DEHP PVC plasticizer
Check current requirements for the destination country and finished-product category before selecting DOP / DEHP. Processing performance does not establish permitted use or product compliance. Compare alternative plasticizers for formulation cost, hardness and migration under identical test conditions.
Discuss your application with the technical team →Med-X DOP — Medical-grade DOP plasticizer
A medical-grade raw material designation is not approval of a finished device. The device manufacturer must assess contact type and duration, extraction, sterilisation, biocompatibility and destination-market requirements together. Confirm current product documents with the technical team.
Discuss your application with the technical team →
