
SOP - 3D Printer Preparation and Use
Preface: We are leveraging 3d printing technology in our operation to create molds. First, we create a solid reusable negative mold with the 3d printer. We then use biocompatible silicone to create the final mold which we then inject with a final biocompatible resin. Although none of the printed pieces come in contact with the final implant, it's important to use appropriate resins as the silicone can become contaminated which can then contaminate the final implant. This system is a work in progress and we'll continue to add to it as we go.Â
Standard Operating Procedure
Title: Preparation, Operation, and Cleaning of Resin 3D Printer for Biocompatible Printing
SOP Number: SOP-R3DP-01
Effective Date: 10/10/24
Review Date: In review
Author: Cassox
Approver:Â
Table of Contents
- Purpose
- Scope
- Responsibilities
- Definitions
- Materials and Equipment
- Safety Precautions
- Procedure
- 7.1 Preparation
- 7.2 Printing
- 7.3 Cleaning
- References
- Appendices
- Purpose
This SOP describes the process for preparing, calibrating, using, and cleaning a resin 3D printer for the fabrication of biocompatible pieces, ensuring quality and safety standards are upheld.
- Scope
This procedure applies to all personnel involved in the 3D printing of biocompatible resin materials in Symbiont Labs.
- Responsibilities
- Operator: Responsible for executing the procedure and ensuring compliance with safety protocols. Ensures equipment functionality and performs routine maintenance.
- Quality Assurance: Verifies prints meet biocompatibility standards post-production.
- Definitions
- Biocompatible Resin: Resin material validated to be compatible with living tissue and not induce an immune response once appropriately cured.Â
- Materials and Equipment
- Resin 3D printer
- Biocompatible resin
- Plate and FEP tray for specific resin used
- Personal protective equipment (PPE): gloves, safety goggles, lab coat
- Isopropyl alcohol (IPA)Â
- UV curing stationÂ
- Cleaning tools and materialsÂ
- Safety Precautions
- Always wear appropriate PPE to avoid skin contact with resin.
- Ensure the work area is well-ventilated.
- Follow manufacturer safety instructions for handling resin and solvents.
- Procedure
7.1 Preparation
- Workspace Preparation:
- Ensure the printer is on a stable and level surface.
- Confirm availability of adequate ventilation within the workspace.
- Clean area using IPA spray and wiping
- Printer Setup:
- Check printer calibration and adjust as needed.
- Use plate and FEP tray for specified Resin.
- Clean plate and FEP using IPA and allow it to dry completely.
- Fill the resin vat with the appropriate biocompatible resin, taking care to avoid spills.
- Material Handling:
- Wear gloves to avoid skin contact with resin.
- Cap the resin bottle immediately after pouring to prevent contamination.
- Close lid of 3d printer immediately after pouring to minimize light exposure
7.2 Printing
- File Preparation:
- Load the STL or other compatible file into the slicing software.
- Configure specific printing parameters suitable for the biocompatible resin, such as layer thickness and exposure time.
- Start Print:
- Begin the printing process and monitor the initial layers for proper adhesion.
- Regularly check print progress and machine performance.
7.3 Cleaning
- Post-Print Processing:
- Allow the print to drip dry over the resin vat to minimize resin waste.
- Carefully remove the print from the build platform using appropriate tools to avoid damage.
- Cleaning the Print:
- Rinse the print using isopropyl alcohol in cure/wash unit to remove uncured resin.
- Cure the print under UV light as specified by resin manufacturer for final material properties.
- Printer Cleaning:
- Clean excess resin from the build platform with IPA.
- Ensure that the resin vat is free of cured debris by filtering.
- Perform routine checks of the printer’s optical components for cleanliness and condition.
- References
- Resin 3D Printer User Manual
- Material Safety Data Sheets (MSDS) for biocompatible resins
- Appendices
- Appendix A: Printer Calibration Checklist
- Appendix B: Safety Protocols and Emergency Contacts
- Appendix C: Detailed Cleaning Procedure
Â