TECHNICAL NOTES

From defined requirements to recorded validation.

Understand the development stages, the information recorded at each stage and the relationship between product evaluation and process checks.

Product researchers reviewing laboratory materials

01 / WORKFLOW

Four stages of development.

The TOWIN development guides describe a route from requirement definition through development, evaluation and scale-up. The overview below focuses on the technical records at each stage.

  1. 01

    Requirement definition

    Record the intended application, format and reference properties. A defined requirement record provides the basis for development and later comparisons.

  2. 02

    Formulation and specification

    The development stage brings together formulation work and a technical specification. Diameter, mass, appearance and force criteria are recorded alongside the evaluation method.

  3. 03

    Evaluation and review

    Evaluate development material against the defined requirements. Record observations, test results and revisions so that each evaluation refers to an identifiable version.

  4. 04

    Production validation

    The final stage connects the evaluated specification with production checks. The documented process includes forming, drying, sorting and finished-product inspection.

02 / TECHNICAL RECORD

Keep the evaluation basis clear.

A useful technical record separates dimensional requirements, mechanical criteria and document identity. The fields below help explain what an evaluation is based on.

Application geometry

Available space, intended format and positioning constraints.

Dimensions

Nominal diameter and tolerance, with the reference document identified.

Mass

Whole-capsule mass; shell and core mass when stated in the specification.

Mechanical criteria

Force unit, acceptance range, test method and whether a criterion refers to a mean or a proportion of results.

Appearance reference

Color and appearance descriptions linked to the applicable reference.

Version and traceability

Document version, material identifier, evaluation date and recorded revisions.

Equipment research team examining a production assembly

03 / VALIDATION

Product and process records work together.

The corporate brochure describes product development alongside in-house equipment research. Product evaluation addresses the material specification; equipment and process work support production validation and maintenance.

Quality documentation covers incoming materials, process checks and finished-product inspection. A dimensional reference, a test result and a safety information sheet each answer a different technical question.

Read the specification and testing notes

SOURCE DOCUMENTS

Read the original development guides.

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