formLabs BioMed White Resin Instruction Manual

formLabs BioMed White Resin

Product Information

• Product Name: BioMed White Resin
• Manufacturer: Formlabs Ohio Inc.
• Manufacturer Address: 27800 Lemoyne Rd, Millbury, OH 43447 USA Manufacturer Contact: +1 617 855 0762

Instructions for Printing

1. Shake cartridge: Prior to use, shake the cartridge well. If the cartridge is not shaken sufficiently, deviations in color and opacity may be observed. 2.

2. Set up: Insert the BioMed White Resin cartridge into a compatible Formlabs SLA 3D printer.

3. Printing:

   • Prepare a print job using PreForm software. Import the desired part STL file and orient it accordingly. Generate supports as required. For recommendations on print orientation and support placement, visit support.formlabs.com.
   • Send the print job to the printer. Select the print job from the print menu and follow any prompts or dialogs shown on the printer screen. The printer will automatically complete the print.

4. Part removal:

   • Remove the build platform from the printer.
   • Printed parts can be removed from the build platform before or after washing. To remove, wedge the part removal tool under the printed part raft and rotate the tool. For detailed techniques, visit support.formlabs.com.

5. Rinsing:

   • Required:
     Place the printed parts in a Formlabs validated wash unit filled with Isopropyl Alcohol (IPA, 99%) and wash for 5 minutes or until clean.

Hazards And Precautions:

• Hazards:
  BioMed White Resin (uncured) contains polymerizable monomers which may cause skin irritation.

• Precautions:

  • When washing the printed part in solvents, this should be done in a properly ventilated environment with proper protective gloves and equipment.
  • Expired or unused BioMed White Resin shall be disposed of in accordance with local regulations.
  • IPA shall be disposed of in accordance with local regulations. Please note that for more detailed safety and environmental information, refer to the Safety Data Sheet available at formlabs.com. For further information regarding the use of the material, please contact Formlabs directly.

Instructions for Printing

The following printing instructions are for Formlabs biocompatible photopolymer BioMed White Resin. Basic information about safety and environmental concerns are also included. For more detailed safety and environment information please refer to the Safety Data Sheet, available at formlabs.com. For further information regarding the use of the material, please contact Formlabs.
Prepared: 02/07/2022 PRNT-0078 Rev 00

Symbols & Manufacturer Information

Introduction

APPLICATIONS

• BioMed White Resin is a light-curable polymer based material for the additive manufacturing of biocompatible, medical grade, white parts that are robust and extremely versatile. With USP Class VI certification and additional biocompatibility safety, BioMed White Resin is suitable for a wide range of applications, including functional prototyping and manufacturing of end use parts for healthcare applications, production floor accessories, and consumer goods.
• Users should independently verify the suitability of the printed materials for their particular application and intended purpose.
• BioMed White Resin is a photopolymer resin made of a mixture of methacrylic esters and photoinitiators.

Specific Manufacturing Considerations

NOTIFICATION
The device specifications have been validated using the printer process parameters indicated below.

REQUIREMENTS
Use dedicated accessories for BioMed White Resin. For biocompatibility compliance, BioMed White Resin requires a dedicated resin tank, build platform, Formlabs validated wash units, and finishing kit which should not be mixed with any other resins.

RECOMMENDED 3D PRINTER AND PRINTING PARAMETERS

1. Hardware: Formlabs SLA 3D Printer
   Laser wavelength : 405 nm

2. Software: Formlabs PreForm

   •  STL file import
   •  Manual/Automatic rotation and placement
   • Manual/Automatic generation of supports

3. Recommended Post-Processing Equipment:

   • Formlabs validated Wash Units
   •  Isopropyl alcohol (IPA) ≥ 99%
   •  Formlabs validated Post Curing Units

Hazards And Precautions

HAZARDS

1. BioMed White Resin (uncured) contains polymerizable monomers which may cause skin irritation (allergic contact dermatitis) or other allergic reactions in susceptible persons. If resin contacts skin, wash thoroughly with soap and water. If skin sensitization occurs, discontinue use. If dermatitis or other symptoms persist, seek medical assistance.
2. Eye contact: High vapor concentration may cause irritation.
3.   Skin contact: May cause sensitization by skin contact. Irritating to skin. Repeated and/or prolonged contact may cause dermatitis.
4. Inhalation: Irritating to the respiratory system. Prolonged or repeated exposure may cause: headache, drowsiness, nausea, weakness (severity of effects depends on the extent of exposure).
5. Ingestion: Low oral toxicity, but ingestion may cause irritation of the gastrointestinal tract.
6.   Protection: Protective glasses and nitrile gloves should be worn while handling BioMed White Resin. Detailed information about the handling of BioMed White Resin can be found in the Safety Data Sheets at formlabs.com.

PRECAUTIONS

1. When washing the printed part in solvents, this should be done in a properly ventilated environment with proper protective gloves and equipment.
2. Expired or unused BioMed White Resin shall be disposed of in accordance with local regulations.
3. IPA shall be disposed of in accordance with local regulations.

Manufacturing Procedure With BioMed White Resin

PRINTING AND POST-PROCESSING

1. Shake cartridge: Prior to use, shake the cartridge well. If the cartridge is not shaken sufficiently, deviations in color and opacity may be observed.
2. Set up: Insert resin cartridge into a compatible Formlabs 3D printer.
3. Printing :
   • Prepare a print job using PreForm software. Import the desired part STL file. Orient and generate supports. For recommendations on print orientation and support placement, visit support.formlabs.com.
   • Send the print job to a printer. Begin print by selecting the print job from the print menu. Follow any prompts or dialogs shown on the printer screen. The printer will automatically complete the print.
4. Part removal:
   • Remove the build platform from the printer.
   • Printed parts can be removed from the build platform before or after washing. To remove, wedge the part removal tool under the printed part raft and rotate the tool. For detailed techniques visit support.formlabs.com.
5. Rinsing: Required – Place the printed parts in a Formlabs validated wash unit filled with Isopropyl Alcohol (IPA, ≥99%) and wash for 5 minutes or until clean.
6. Drying:
   • Leave parts to air dry for at least 30 minutes or use compressed air to remove excess IPA off of the printed part surfaces. Note: Ambient conditions and printed part geometry may affect drying time.
   • Inspect printed parts to ensure that surfaces are clean and dry. No residual alcohol, excess liquid resin or residue particles must remain on the surface before proceeding to subsequent steps.
7. Post cure: Required – Place the dried printed parts in a Formlabs validated post-curing unit and cure at 60°C for 60 minutes. Note: For best results and biocompatibility compliance, post-cure in accordance with these validated recommendations.
8. Support removal:
   • Remove supports using a cutting plier or other part removal tools. If needed, carefully smoothen the support remnants on surfaces with a bur and handpiece.
   •  Attention: Inspect the parts for any cracks. Discard if any damage or cracks are detected.

DISINFECTION AND STERILIZATION

1. The parts may be cleaned, disinfected, and sterilized according to facility protocols. The manufacturer is responsible for validation of part performance depending on the application requirements post disinfection and/or sterilization. Note: If alcohol-based disinfectants are used, do not leave parts in alcohol solution for an extended time.
2.  For additional information, visit support.formlabs.com
3.  Attention: After disinfection and/or sterilization, inspect the parts for cracks to ensure that the integrity of the designed part meets performance requirements.

STORAGE

1. When not in use, place printed parts in closed, opaque or amber containers.
2. Store in a cool, dry place out of direct sunlight. Excess light exposure overtime may affect the color of printed parts.
3. Store the cartridges at 10°C – 25°C (50°F – 77°F).
4. Do not exceed 25°C (77°F) when in storage.
5. Keep cartridges closed and away from ignition sources.

DISPOSAL

1. Any cured resin is non-hazardous and may be disposed of as regular waste.
2. Follow facility protocols for waste that may be considered biohazardous.
3. Liquid resin should be disposed of in accordance with government regulations (community, regional, national).
   • Contact a licensed professional waste disposal service to dispose of liquid resin.
   •  As with all foreign substances, avoid release into the environment and do not allow waste to enter storm or sewer drainage systems.
   • Contaminated packaging: Dispose of cartridge or any unused product per local waste management guidelines.

References

• High Resolution SLA and SLS 3D Printers for Professionals | Formlabs
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