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Post-Processing, Inspection & Packaging Guidelines

This document describes the required post-processing, inspection, dimensional verification, documentation, and packaging steps after 3D printing is completed. Following these steps ensures consistency, quality, and readiness for clinical use.

Updated over a month ago

1. Post-Processing Workflow (After Printing)

Follow the printer and material manufacturer’s instructions at all times.

The steps below reflect the standard workflow for Formlabs systems and equivalent technologies.

1. Remove From Build Platform

  • Carefully remove the printed part from the printer build platform.

  • Avoid applying excessive force to prevent damage.

  • Ensure the build platform is cleaned before the next print job, according to manufacturer guidelines.

2. Wash

  • Place the build platform with the attached part into:

    • Form Wash / Form Wash L

  • Wash duration:

    • 10 minutes

  • Use the approved solvent and follow manufacturer instructions.

3. Air Dry

  • Remove the part from the wash unit.

  • Place the part in a designated drying basket.

  • Allow to air dry for a minimum of 30 minutes.

  • Ensure all solvent residue has fully evaporated before curing.

4. Cure

  • Transfer the dried part to:

    • Form Cure / Form Cure L

  • Cure parameters:

    • 60 °C

    • 20 minutes

  • Confirm curing settings match the resin manufacturer’s recommendations.

5. Remove Supports

  • Remove all support structures using:

    • Flush cutters or appropriate post-processing tools.

  • Take special care to avoid damaging:

    • Contact surfaces

    • Drill holes

    • Mating or anatomical fit areas

2. General Inspection Guidelines

Each printed part must undergo a thorough visual and physical inspection.

Visual & Structural Inspection

Confirm that:

  • All support and resin residues are fully removed (internal and external surfaces).

  • No cracks, fractures, warping, or deformation are present.

  • The part is complete and free of missing features.

  • Surface finish matches the expected quality for the specific device or model.

Functional Inspection

Verify that:

  • All holes, slots, and channels are fully open and pass-through.

  • No internal blockages or leftover support material remain.

  • Critical interfaces are clean and undamaged.

Geometry Verification

  • The printed part must match the intended geometry of the approved design.

  • Any deviation that could affect fit or function must be documented and escalated.

3. Dimensional Verification

Approved tolerance: ±0.1 mm

Measurement Procedure

  • Measure the three critical dimensions defined for the device (as shown in the reference diagram or planning documentation).

  • Use a calibrated electronic caliper.

  • Record each measured value.

Acceptance Criteria

  • All measured dimensions must fall within the specified tolerance range.

  • Any out-of-tolerance measurement results in non-conformance and requires review before release.

4. Anatomical Model Fit Verification

As part of the personalized set:

  • A patient-specific anatomical model is printed alongside the PSI.

  • The anatomical model is used to:

    • Verify correct PSI fit

    • Confirm alignment with the planned anatomy

  • The model is produced from biocompatible material and:

    • May be sterilized by the hospital

    • Can be used intraoperatively for fit and placement verification

This step provides an additional physical confirmation that the customized PSI meets the clinician’s requirements.

5. Documentation & Quality Control Records

All inspections and measurements must be recorded in the Quality Control (QC) documentation.

Required Records

Document the following:

  • File name and version

  • Printer model

  • Printer firmware version

  • Resin type and lot number

  • Measured dimensions

  • Pass / Fail status

  • Inspector name and date

  • Any observations or deviations

These records must be retained according to the applicable quality management system (QMS).

6. Packaging & Delivery

Release Conditions

  • Parts are released only after final plan approval by the requesting clinician.

Packaging Method

  • Parts are packaged in a small cardboard box with protective bubble wrap.

  • Each package is labeled with:

    • Surgeon’s name

    • Surgery date

    • Patient identifier

      • Provided by the treating physician

      • Applied in compliance with confidentiality, data protection, and medical device regulations

Package Contents

Each delivery includes:

  • Unsterilized patient-specific instrument (PSI)

  • Unsterilized anatomical model (if applicable)

  • Counting form

  • Suggestion for Use (SFU)

  • Approved clinician disclaimer documentation

  • Prescription

Labeling

  • Package labels include standardized medical device symbols as required.

  • No claims of sterility are made.

7. Final Notes & Responsibilities

  • CustoMED does not perform or provide sterilization.

  • Sterilization timelines must be factored into surgical scheduling by the receiving facility.

  • The final decision to use the printed PSI or model is made intraoperatively by the surgeon.

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