About Lot numbers
Lot numbers and traceability
All 3Dresyns® materials are supplied with lot numbers as part of the Company's quality-control and traceability system.
A lot number identifies a particular manufacturing or supply batch of a Product configuration and enables the Company to correlate the supplied material with relevant internal manufacturing, quality-control, and traceability records.
Lot identification is particularly important for multivariable photopolymer and functional material systems, where the supplied formulation must be distinguished from the printing, post-processing, post-curing, conditioning, and testing conditions subsequently applied by the customer.
Product, version, SKU, and lot
Product, version, SKU, and lot numbers perform different functions.
- Product identifies the general material system or formulation platform.
- Version identifies a controlled technical configuration of that Product system.
- SKU identifies the relevant commercial supply configuration.
- Lot number identifies a particular manufacturing or supply batch of the relevant configuration.
Multiple lots may therefore correspond to the same Product version and SKU.
A lot number does not, by itself, identify a different Product version or formulation. Where a material change results in a different Product version, SKU, specification, or documentation revision, the applicable version-control system should be considered together with the lot information.
Further information is available in Product versions and SKUs.
Traceability and quality control
Lot numbers allow the Company to trace a supplied batch through the relevant internal records maintained for quality-control and investigation purposes.
Depending on the Product and applicable manufacturing records, this may allow correlation with information such as:
- Product and Product version;
- SKU or supply configuration;
- manufacturing batch;
- relevant raw-material or component records;
- production and preparation records;
- internal quality-control information;
- applicable Product documentation or revision;
- retention samples, where applicable; and
- other internal traceability information relevant to the supplied batch.
The exact scope of traceability records depends on the Product, manufacturing process, applicable quality procedures, and information reasonably required for the relevant purpose.
Controlled batch-to-batch consistency
The Company's lot-control system is intended to support controlled batch-to-batch consistency within the formulation, manufacturing, and quality framework applicable to the relevant Product version.
Different production lots of the same Product version are not expected to be numerically identical in every measurable characteristic. Normal manufacturing and measurement variability may exist within the applicable specifications, tolerances, or technical performance envelope.
Accordingly, lot control supports controlled reproducibility and traceability but should not be interpreted as a guarantee that every analytical measurement, printed specimen, or final-part property will be numerically identical between lots.
Final properties remain process-dependent
A lot number identifies the supplied material batch. It does not control the customer's printing and processing workflow.
Mechanical, physical, thermal, optical, dimensional, electrical, dielectric, conductive, and other properties measured on printed or cured parts may depend on variables including:
- printer make and model;
- printing technology;
- exposure conditions;
- printer calibration;
- layer thickness;
- material temperature;
- mixing or homogenization;
- part geometry and orientation;
- cleaning;
- drying;
- post-processing;
- post-curing;
- conditioning;
- specimen preparation; and
- testing methodology.
Consequently, two customers using material from the same lot may obtain different final-part results if their printers, processing, post-curing, conditioning, or testing conditions differ.
Likewise, a difference between customer-generated results from two lots does not, by itself, establish a batch-to-batch manufacturing difference unless the relevant processing and testing conditions are sufficiently comparable.
Further information is available in the Company's Guarantee of properties policy.
Lot numbers and Product specifications
Lot identification does not replace the specifications, tolerances, test methods, or other requirements applicable to the relevant Product version.
Where an express Product specification applies, conformity of a supplied lot should be assessed according to the applicable specification, conditions, tolerances, test methods, contractual requirements, and mandatory law.
The existence of a valid lot number does not, by itself, prove that a Product is conforming or non-conforming.
Lot numbers and technical documentation
Customers should retain the lot number together with the Product name, version, SKU, order information, and documentation applicable to the material received.
Where Technical Data Sheets (TDSs), Safety Data Sheets (SDSs), Instructions for Use (IFUs), Curing Rate Tables (CRTs), specifications, or other technical documents are version-specific, the relevant documentation should be interpreted according to the Product version to which it applies.
A lot number may assist in determining which Product version or documentation was applicable when a particular batch was supplied, but the lot number does not replace the document's own version or revision information.
Lot numbers and regulatory identifiers
The Company's lot number is a traceability identifier and should be distinguished from other Product, safety, classification, or regulatory identifiers that may be required for a particular Product or market.
Where a Product requires specific regulatory identification, labelling, Safety Data Sheet information, Unique Formula Identifier (UFI), or other legally required information, those requirements apply independently according to the relevant regulatory framework.
Customer responsibilities
Customers should preserve the original Product label and lot information for as long as reasonably necessary for Product identification, internal records, quality control, and potential technical investigation.
Where a Product is transferred into another container, subdivided, mixed with another material, modified, or incorporated into a downstream formulation, the customer should maintain sufficient records to preserve appropriate traceability within its own process.
Customer modification, repackaging, subdivision, blending, or downstream processing does not create a new 3Dresyns lot number unless expressly assigned by the Company.
Product complaints and technical investigations
Customers reporting a suspected Product issue should provide the applicable lot number whenever available.
Depending on the nature of the reported issue, the Company may also reasonably request:
- order reference;
- Product name and version;
- SKU;
- photographs of the Product and label;
- remaining Product quantity;
- storage conditions;
- transport or delivery observations;
- mixing or homogenization procedures;
- printer and printing parameters;
- cleaning and post-processing conditions;
- post-curing conditions;
- test methodology and results; and
- other information materially relevant to the investigation.
The lot number allows the Company to investigate the relevant manufacturing batch, but a technical assessment may also require evaluation of transportation, storage, handling, printing, processing, post-curing, testing, and other circumstances affecting the customer's material or final result.
Retention samples
Where applicable, the Company may maintain retention samples associated with production lots for internal quality-control, traceability, and investigation purposes.
A retention sample may assist in evaluating the original manufactured material under the Company's reference storage conditions.
However, retention samples do not reproduce the transportation, Customs handling, storage, opening, contamination, resealing, temperature history, mixing, printing, cleaning, post-curing, post-processing, or application history experienced by a customer's Product after shipment.
A retention sample therefore forms one possible element of a technical investigation and is not, by itself, conclusive evidence that the customer's material was or was not conforming.
Different observations within the same lot
Different customer observations involving Products from the same lot do not necessarily establish inconsistent manufacturing.
Differences may arise from variations in storage, transport, homogenization, printer configuration, processing, cleaning, post-curing, conditioning, geometry, measurement, or application conditions.
Conversely, the fact that another customer or retention sample has performed as expected does not, by itself, invalidate a legitimate claim concerning another unit from the same lot.
Claims should be assessed using the available evidence and the circumstances relevant to the particular Product supplied.
Lot traceability does not extend Product guarantees
Assignment of a lot number does not create an additional warranty or guarantee beyond the specifications, contractual commitments, Product documentation, Legal Terms, and mandatory obligations applicable to the relevant Product.
Lot traceability is intended to support quality control, investigation, and controlled supply. It does not make final printed properties independent of the customer's manufacturing and testing workflow.
Consumers and mandatory conformity rights
Where the Buyer qualifies as a Consumer, the use of lot numbers, retention samples, internal quality-control records, or technical investigations does not exclude, restrict, transfer, or modify mandatory statutory conformity rights or applicable rules concerning evidence and burden of proof.
The Company's internal batch investigation does not give the Company unilateral authority to determine conclusively whether a Consumer's statutory conformity claim is legally valid.
Governing principle
Lot numbers provide traceability to a specific supplied batch and support controlled batch-to-batch consistency within the applicable Product configuration. They do not imply that final printed or cured properties are independent of printer, processing, post-processing, post-curing, conditioning, or testing conditions.
Relationship with other Legal Terms
This policy must be read together with the Company's Product versions and SKUs, Guarantee of properties, applicable Product documentation, Terms & Conditions, and Legal Terms.
Mandatory rights
Nothing in this policy excludes, restricts, or modifies an express Product specification, contractual conformity requirement, Consumer right, or other obligation that cannot lawfully be excluded or limited.