Thermoforming for Medical Devices
Explore our medical device thermoforming services for customized packaging solutions that ensure protection and compliance.
LSO offers medical package thermoforming services to achieve the customization level, protection, and regulatory requirements your medical device needs to safely reach your end user.
Visual Inspection Testingfor Medical Device Packaging Integrity
Tailored thermoforming solutions to meet your packaging design and production needs. From sterile trays to custom blisters, our advanced in-line and offline capabilities ensure precision, protection, and compliance. With in-house tooling and quick turnarounds, we streamline your packaging process for efficiency and quality.
What is thermoforming?
Thermoforming is a part of the medical device manufacturing process that produces sterile barriers such as trays, blisters, and clamshells that protect devices from contamination and physical damage.
At Life Science Outsourcing, we specialize in offering cutting-edge thermoforming services as part of our comprehensive manufacturing solutions for the medical device industry. We understand the critical role thermoforming plays in medical device manufacturing, and we’re proud to offer this essential service as part of our wide range of capabilities.
Thermoforming is important for:
Sterility maintenance
It ensures that medical devices remain sterile until use
Protection
Thermoforming shields devices from physical damage during transportation and storage.
Compliance
Thermoforming meets regulatory standards for packaging and sterility.
Customization
The thermoforming process allows for package creation tailored to the specific shape and size of a medical device.
Cost-effectiveness
Thermoforming is efficient for large-scale production and can reduce overall packaging costs.
Who needs thermoforming?
Thermoforming is a useful process for medical device manufacturers to ensure products remain sterile and protected; for hospitals and clinics to receive devices in sterile, ready-to-use condition; and distributors to transport medical devices without compromising device sterility or integrity.
How does thermoforming work?
The thermoforming process is performed by heating a plastic sheet to a pliable forming temperature. The plastic is then formed to a specific shape in a mold, then trimmed to create a usable product.
High-speed thermoforming
LSO is equipped with in-line, high-speed roll-fed thermoforming and die-cutting capabilities. We run these operations in Class 8 cleanrooms to guarantee a contamination-free environment, with multiple machines always at your service.
Offline thermoforming
We also cater to low-volume and complex designs with our offline single-sheet thermoforming and die-cutting capabilities. This flexible approach is ideal for customized production and small-batch runs.
Deep draw trays, material thickness, width, and usage
LSO excels at creating deep draw trays that accommodate intricate device designs. We seamlessly manage a wide range of material thicknesses and sheet widths. We also work with diverse materials such as PETG, PVC, and Styrene, while for single-sheet (offline) thermoforming we broaden our scope to include additional materials like RPET, TPU, and Lexan/Polycarbonate.
What standards apply?
Thermoforming can meet FDA regulations for medical device packaging:
- 21 CFR Part 820 (Quality system regulation) requires that manufacturers establish and maintain procedures for packaging to meet specific requirements.
- ISO 11607-1 and ISO 11607-2 is the international standard recognized by the FDA for materials requirements, sterile barrier systems, and packaging systems for terminally sterilized medical devices.
Why LSO?
LSO offers thermoforming as part of our end-to-end solutions, allowing us to streamline the process for our clients. Our integrated approach means you only deal with a single supplier for supply, manufacturing, packaging, and sealing, ensuring seamless communication and enhanced efficiency throughout the production process.
In-house machine shop
Our in-house machine shop allows us to produce custom tooling, offering unmatched flexibility and speed in manufacturing.
Operation capacity
We are capable of meeting high demand or tight deadlines. We can often go from drawing to first article in as little as eight weeks.
Versatility
We use automated and manual operations to guarantee high precision for all product sizes. Smaller trays can be automated, while larger trays benefit from the accuracy of manual operation.
Design assistance
We have a team of highly skilled engineers ready to contribute our expertise and assist with design optimization during product development.
Full EtO Validation
Comprehensive packages for regulatory compliance.
Flexible Sterilization Cycles
From fractional to full cycles with EtO residual testing.
Robust Qualification
Secure with 2X qualification.
Choice of PCDs
Tailored to your sterilization needs.
FDA-Registered
Manufacturing Facility
ISO 13485
Certified Quality System
12 Cleanrooms
Class 5–8
125,000+ Sq Ft
Regulated Manufacturing
3 Facilities
CA | NH | Costa Rica
Ready to get started?
Talk to a specialist about thermoforming for medical devices.