Quality & Certifications

Compliance-capable grades

Standards we work to

FDA 21 CFR 177.2600

Rubber articles intended for repeated food contact.

USP Class VI

Biological reactivity testing for platinum-cured medical grades.

ISO 10993

Biocompatibility evaluation for medical-device components.

EU 1935/2004

Materials and articles intended to come into contact with food.

RoHS / REACH

Substance declarations for restricted and hazardous materials.

Batch traceability

Material certificates and production records per lot.

Applicable certifications depend on the silicone grade selected for your part. Confirm the declarations you require with your quote request and we will issue them with the order.

Quality assurance & testing

Quality parameters checked

Every batch of silicone extrusion at Makvin Polymer undergoes a complete analysis before dispatch, so each lot meets the required mechanical, dimensional and visual standards. Our in-house quality team tests every production lot for:

Physical Properties

Tensile Strength (ASTM D412)
Elongation at Break (ASTM D412)
Hardness (ASTM D2240)
Compression Set (ASTM D395)
Specific Gravity (ASTM D792)

Dimensional Accuracy

Inner diameter, outer diameter and wall thickness measured by precision gauges and calipers
Profile and cross-section verification as per approved drawings

Visual & Surface Checks

Surface finish and colour uniformity
No bubbles or stickiness
Dimensional consistency across the full coil length

Documentation & Traceability

Each batch is issued with a unique Lot Number and COA recording all inspection results
Any batch outside tolerance is quarantined for review and corrective action before release

In practice

How we hold
quality.

Controlled compounding: Recipes and cure systems fixed per grade, mixed in-house for batch-to-batch consistency.
In-line & final inspection: Dimensional checks during extrusion and at despatch against the approved drawing.
Documentation pack: Material certificates, compliance declarations and dimensional reports on request.
Sampling & validation: Evaluation samples before commitment, with first-article review for custom parts.