Keeping Up With 3D-Printed Medical Devices Manufacturing

Quality Control and Testing

Nov 30, 2022 | 4 min read

Advances in 3D printing technology have revolutionized the field of medical devices by making it faster, easier, and cheaper to produce surgical instruments, personalized prosthetics and implants, all of which outperform standard options in many ways. All these devices must satisfy a stringent regulatory process before landing in the clinic.

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3D Printing in Medical Devices

Medical 3D printers are used to manufacture a variety of medical devices, such as scaffolds , implants, dental implants, contact lenses, and surgical instruments. The type of printing technology used depends on the application of the medical device. Powder bed fusion is one popular printing method due to its compatibility with materials commonly used to manufacture medical devices, such as aluminum or titanium alloys.

The development of advanced biomaterials is another enabling factor in the medical devices field. Biodegradable or bioresorbable polymer materials, for example, can enhance safety and biocompatibility of medical implants.

Personalized Medical Devices

While printers can be used to create identical copies of medical devices, they can also create custom pieces that meet the unique requirements of patients. Personalized medical devices use data and anatomical information from the patient to create custom pieces that are not only more functional, but also more comfortable for the patient.

Some medical devices are personalized during the design phase before they are manufactured, while others are adapted to the patient after manufacturing (e.g., a prosthetic limb). The combination of personalization and advanced biomaterials is seen in new medical devices being developed for soft tissue regeneration. For example, new technologies for breast reconstruction allow patient-derived fat cells to regenerate over a custom 3D-printed bioresorbable lattice.

Medical Device Manufacturing

Globally, regulators are adapting their guidelines for the rapidly evolving field of 3D-printed medical devices. Manufacturers must comply with strict quality and safety guidelines, which start in the design phase and continue through the whole product life cycle.

To start, the raw materials used to produce or print medical devices must be tested for purity and stability. In-process controls performed at regular intervals ensure quality and required specifications prior to final release.

Sartorius offers a variety of solutions for medical device manufacturing and quality control processes, including ultrapure water for rinsing during production, as well as bioburden testing.

Rinsing and Sterile Preparation

Highly pure water (DI, RO, DI Ultrapure) that is free from impurities like microbes and particulates is a critical requirement during medical device production. Water is used to rinse newly printed devices prior to sterilization. Ultrapure water also feeds a range of vital lab equipment, like washing machines, steam sterilizers or autoclaves for sterile preparation of instruments, parts and assemblies.

To keep costs down and processes flowing smoothly, the ideal water system should be reliable, easy to use and hassle-free to maintain. The Sartorius Arium^® Comfort II, for example, provides both ASTM Type 1 ultrapure and Type 2 pure water in one system, with an additional filter option for removing endotoxins. The system also stores purified water in an exchangeable Bagtank, which makes cleaning easy.

Sterility and Bioburden Testing

Microbial contamination is a big concern when it comes to the safety of medical devices. Contamination can originate from the raw materials, or it can be introduced during impression. One way to prevent biofilms is by using water that is deionized and free from bacteria.

Continuous microbiological testing before and after rinsing is also crucial to ensure product quality and patient safety. Sartorius has membrane filtration solutions for standard microbial enumeration protocols to detect potentially pathogenic or spoilage microorganisms.

Explore all of Sartorius’ solutions for medical devices quality control and manufacturing.