Quality, Traceability and Controlled Manufacturing at 3Dresyns

This page describes the quality, traceability and manufacturing control framework applied by 3Dresyns® to the development and supply of photopolymer materials for additive manufacturing.

3Dresyns supplies materials as raw materials and formulation systems. Quality is therefore defined in terms of formulation control, process consistency, traceability and reproducibility within qualified tolerances.

Quality in photopolymer materials is formulation- and process-driven

In photopolymer additive manufacturing, quality is not defined by a single test result or certification. It emerges from the controlled interaction between formulation design, raw material selection, manufacturing procedures, storage conditions and qualified Instructions for Use.

For this reason, quality must be understood as a system property rather than a static label.

Quality Assurance (QA): controlled design and manufacturing

Quality Assurance at 3Dresyns focuses on ensuring that each formulation system is designed, produced and supplied according to defined internal specifications and controlled procedures.

This includes:

• controlled sourcing of raw materials

• formulation design under defined recipes

• controlled manufacturing procedures

• defined acceptance criteria and tolerances

• documentation and version control

QA activities are designed to ensure consistency and reproducibility across production lots within the expected variability of photopolymer systems.

Quality Control (QC): verification and release

Quality Control activities are implemented to verify that each production lot conforms to the defined formulation and manufacturing specifications.

QC may include:

• verification of critical formulation parameters

• visual and physical checks

• process consistency checks

• release controls prior to shipment

QC does not replace application-specific testing by the user and does not certify final part performance under all conditions.

ISO certification in the correct context

Some manufacturing steps may be performed under ISO-certified environments through qualified partners when required by contractual or regulatory context.

However, ISO certification at the material supplier level does not by itself certify the final printed product or the user’s manufacturing process. Certification and regulatory compliance ultimately apply to the finished device and its validated production workflow.

Lot numbers and traceability

Each supplied material is associated with a lot number to ensure traceability.

Lot numbers enable:

• identification of the manufacturing batch

• traceability of formulation versions and configurations

• correlation with internal production and QC records

Traceability supports controlled reproducibility, change management and issue investigation when required.

Expiration dates and validated shelf life

Expiration dates define the validated time window during which the material is expected to perform reliably when stored and handled according to specifications.

Expired materials may exhibit changes in viscosity, reactivity or performance and should not be used for qualified or regulated applications without revalidation.

Relationship to Instructions for Use (IFU)

Quality, reproducibility and safety depend strongly on adherence to the applicable Instructions for Use.

IFUs define qualified workflows for printing, cleaning and post-curing. Deviations from IFUs may compromise surface quality, mechanical properties, biocompatibility or long-term stability.

Transparency and realistic expectations

3Dresyns is committed to transparent communication regarding quality and traceability. Material data and specifications describe typical behavior under reference conditions and controlled workflows.

Final part performance must always be validated by the user under their specific process conditions and intended application.

Governing principle

Quality in photopolymer additive manufacturing is system-dependent. 3Dresyns ensures controlled formulation, manufacturing and traceability of raw materials. Final product quality and regulatory compliance depend on the validated manufacturing process implemented by the user.