This document summarizes published scientific research on sterilization and food safety methods for 3D printed objects, particularly those made with common FDM (Fused Deposition Modeling) materials like PLA, PETG, and ABS. The research demonstrates that 3D printed objects can be made food safe and even sterile for medical use with proper material selection, printing parameters, and sanitization protocols.
Authors: Dautzenberg, P., Volk, H.A., Huels, N., Cieciora, L., Dohmen, K., Lüpke, M., Seifert, H., & Harms, O.
Institution: University of Veterinary Medicine Hannover, Germany
DOI: 10.1186/s12917-021-03065-8
Published: December 23, 2021
This study investigated the morphological effects of steam sterilization on different 3D printable materials intended for surgical use in veterinary medicine. The research focused on creating patient-specific sawing templates for performing corrective osteotomies.
Test specimens were 3D-printed using the FDM method with five different materials:
Sterilization Parameters:
PC, PA, and ABS: Showed great morphological deviations (>1%)
PLA: Demonstrated fewer morphological deviations but still showed some changes:
GreenTEC Pro® (100% infill): Best performer overall
GreenTEC Pro® with 100% infill is the most suitable material for steam sterilization, fulfilling requirements of autoclavability, biocompatibility, and economic viability for clinical use.
Authors: Ramos, C.H., Wild, P.M., & Martins, E.C.
Institution: Hospital XV, Curitiba, Brazil
Published: July 22, 2022
This study compared the efficacy of autoclave and ethylene oxide (EO) methods for sterilization of PLA objects. The research addressed the challenge that PLA is thermosensitive with melting beginning at 120°C.
Forty cubic-shaped PLA objects were printed:
Group 1: Autoclave sterilization at 121°C ("fast cycle")
Group 2: Ethylene oxide "cold" sterilization
Solid Objects:
Hollow Objects:
Solid Objects:
Hollow Objects:
Bacteria Isolated: Non-coagulase-producing Staphylococcus (Gram positive) in all contaminated samples.
Authors: Thomas, M., Seibi, A., Jaafar, I., & Amin, M.
Institution: Utah Valley University, United States
DOI: 10.1109/IETC57902.2023.10152238
Published: May 2023
This comprehensive 7-month study investigated sanitization efficacy for safe use of 3D-printed parts for food and medical applications. The study examined methods to reduce or eliminate pathogens and biofilms from defects and interstitial spaces in FFF printing.
Comprehensive panel of common food and medical pathogens:
3D Print Imperfections:
Bacterial Dimensions:
Conclusion: Layer lines are NOT the primary concern. Bacteria are generally larger than imperfections and need room to grow.
Study addressed concerns about lead from brass nozzles:
Protocol:
Results: 90% reduction in Colony Forming Units (CFU)
Protocol:
Results:
Protocol:
Results:
Protocol: 70% or higher IPA, applied after washing
Results:
| Item | CFU Reduction |
|---|---|
| Glass Plate | 99% |
| Standard Spoon | 91% |
| 3D Printed Parts (cleaned) | 90%+ |
| Plastic Cutting Board | 80% |
| Fingernails (washed) | 40% |
Properly cleaned 3D printed parts perform comparably to or better than standard kitchen equipment.
Study addressed concerns about color additives:
Authors: Oth, O., Dauchot, C., Orellana, M., & Glineur, R.
Institution: Hôpital Erasme, Université Libre de Bruxelles, Belgium
DOI: 10.2174/1874210601913010410
Published: December 5, 2019
This groundbreaking study investigated morphological effects of hydrogen peroxide low-temperature sterilization on surgical objects 3D-printed in PLA and PETG. This is the first study regarding morphologic deformation of 3D-printed objects in PLA and PETG after sterilization for medical use.
Two series of 21 identical surgical guides:
Sterilization:
T0 vs T2 (Design vs Sterilized):
T1 vs T2 (Printed vs Sterilized):
T0 vs T2 (Design vs Sterilized):
T1 vs T2 (Printed vs Sterilized):
Although differences were statistically significant, they had NO impact on clinical use because:
Hydrogen peroxide low-temperature sterilization is strongly recommended for sterilization of 3D printed objects in PLA and PETG for medical and surgical use. This technique can be extrapolated to any 3D printed medical object.
Step 1: Wash
Step 2: Scrub
Step 3: Rinse
Step 4: Sanitize
Step 5: Optional Final Sanitization
Equipment: STERRAD® or equivalent
Parameters:
Advantages:
Suitable for: Solid (100% infill) PLA objects only
Advantages: 100% sterilization for solid objects, cold method
Disadvantages: Requires aeration, may affect polymer properties, NOT effective for hollow objects
Unique Capability: ONLY common FDM material that can withstand steam autoclave
Requirements:
Food Safety: Generally safe, verify manufacturer certification
Sterilization: Hydrogen peroxide gas plasma ONLY (or ethylene oxide for solid objects)
NOT Suitable: Steam autoclave
Best For: Single-use or limited-use food contact, medical models with proper sterilization
Food Safety: Preferred material - FDA-approved, ISO10993 certified
Sterilization: Hydrogen peroxide gas plasma (best method)
NOT Suitable: Steam autoclave
Best For: Repeated food contact, medical devices, professional applications
Food Safety: Food safe, biodegradable, environmentally friendly
Sterilization: Can withstand steam autoclave (121°C) - UNIQUE capability
Also Compatible: Hydrogen peroxide gas plasma
Best For: Medical devices requiring repeated sterilization, professional food service
Use Only For: Non-food, non-medical applications
| Material | Food Safe | Autoclave | H₂O₂ Plasma | Best Use |
|---|---|---|---|---|
| PETG | ✓ FDA-approved | ✗ No | ✓ Yes | Repeated food contact, medical |
| GreenTEC Pro® | ✓ Yes | ✓ Yes (unique) | ✓ Yes | Medical, repeated sterilization |
| PLA | ✓ Generally safe | ✗ No | ✓ Yes | Single-use, limited food contact |
| ABS | ✗ No | ✗ No | ✗ No | Non-food, non-medical only |
This is the single most critical factor for food safety and sterilization:
Biofilms are protective layers that bacteria create when stressed. They act as a shield that makes bacteria resistant to standard cleaning methods.
How to Break Down Biofilms:
Research shows that ethanol and isopropyl alcohol can INCREASE biofilm formation in Staphylococcus species:
Common Misconception: Layer lines are the biggest threat to food safety.
The Truth:
Conclusion: Layer lines are NOT the primary concern. The real concerns are:
1. Protein Residue Testing (Most Accurate):
2. ATP Monitoring:
3. Petri Dish Cultures:
Visual inspection alone cannot detect microscopic contamination or verify sterilization effectiveness. Must be combined with testing methods.
Based on comprehensive published research from multiple institutions, 3D printed objects can be made food safe and even sterile for medical use with proper:
Fact: Layer lines (1 micron average) are smaller than bacteria (2-5 microns). Cleaning solutions can penetrate 0.1 micron spaces.
Fact: Lead transfer is negligible (0.007g potential contact). No measurable loss after 1000 hours of printing.
Fact: Hydrogen peroxide gas plasma achieves effective sterilization with <0.2mm deformation.
3D printed objects CAN be food safe and sterile. Success requires proper material selection, 100% infill, and appropriate protocols. Research-backed methods exist and are proven effective. Always use 100% infill and follow verified cleaning/sterilization protocols - this is not optional, it's essential for safety.
This comprehensive review is based on peer-reviewed published research from leading institutions including:
Dautzenberg, P., Volk, H.A., Huels, N., Cieciora, L., Dohmen, K., Lüpke, M., Seifert, H., & Harms, O. (2021).
"The effect of steam sterilization on different 3D printable materials for surgical use in veterinary medicine."
BMC Veterinary Research, 17(1), 389.
DOI: 10.1186/s12917-021-03065-8
Published: December 23, 2021
Available at: https://bmcvetres.biomedcentral.com/articles/10.1186/s12917-021-03065-8
Ramos, C.H., Wild, P.M., & Martins, E.C. (2022).
"Effectiveness in Sterilization of Objects Produced by 3D Printing with Polylactic Acid Material: Comparison Between Autoclave and Ethylene Oxide Methods."
Revista Brasileira de Ortopedia, 58(2), 284-289.
Published: July 22, 2022
Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC10212635/
Thomas, M., Seibi, A., Jaafar, I., & Amin, M. (2023).
"Study on the Sanitization Efficacy for Safe Use of 3D-Printed Parts for Food and Medical Applications."
2023 Intermountain Engineering, Technology and Computing (IETC), pp. 1-6.
DOI: 10.1109/IETC57902.2023.10152238
Published: May 2023
Available at: ResearchGate
Oth, O., Dauchot, C., Orellana, M., & Glineur, R. (2019).
"How to Sterilize 3D Printed Objects for Surgical Use? An Evaluation of the Volumetric Deformation of 3D-Printed Genioplasty Guide in PLA and PETG after Sterilization by Low-Temperature Hydrogen Peroxide Gas Plasma."
The Open Dentistry Journal, 13, 410-419.
DOI: 10.2174/1874210601913010410
Published: December 5, 2019
Available at: https://opendentistryjournal.com/VOLUME/13/PAGE/410/
Luther, M.K., Bilida, S., Mermel, L.A., & LaPlante, K.L. (2015).
"Ethanol and Isopropyl Alcohol Exposure Increases Biofilm Formation in Staphylococcus aureus and Staphylococcus epidermidis."
Infectious Diseases and Therapy, 4(2), 219-226.
Dobay, O., Laub, K., Stercz, B., et al. (2018).
"Bicarbonate Inhibits bacterial growth and biofilm formation of prevalent cystic fibrosis pathogens."
Frontiers in Microbiology, 9, 2245.
Kondrashov, V., McQuirter, J.L., Miller, M., & Rothenberg, S.J. (2005).
"Assessment of lead exposure risk in locksmiths."
International Journal of Environmental Research and Public Health, 2(1), 164-169.
U.S. Food and Drug Administration.
"Code of Federal Regulations Title 21, Volume 3 - Food and Drugs."
Available at: FDA CFR Database
International Organization for Standardization.
"ISO 10993 - Biological evaluation of medical devices."
Available at: ISO Website
Taulman3D. "guidel!ne Material Specifications - ISO10993 and FDA Approved."
Available at: Taulman3D Website
All primary research articles cited in this review are published in open-access journals and are freely available online. Links to full-text versions are provided in the citations above.