Medical Device Contract Packaging
QUALIFICATIONS
We are ISO 13485 certified and FDA registered. We have been developing packaging for the medical device industry for over 40 years and have expertise in all areas of packaging design, development and production.
We have facilities in Santa Fe Springs, CA; Arlington, TX; and St. Paul, MN, with redundant capabilities to protect your supply chain.
Please contact us for a free Packaging Consult to kick off your next project.
PACKAGING TO MATCH YOUR MEDICAL DEVICE
You may not have thought about packaging services as an important element in the development of a successful medical device. However, the right packaging solution is critical to protect your medical product through sterilization, shipping and final delivery to the end patient.
Pro-Tech Design & Manufacturing, Inc. has over 40 years of experience creating packaging that meets the unique requirements of our customers.
We provide medical device contract manufacturing and packaging services and have the expertise and market understanding to design solutions that balance quality, Food and Drug Administration (FDA) requirements, and cost.
CUSTOMER-DRIVEN APPROACH
Packaging development starts with understanding the needs of the customer. From the largest medical device companies in the healthcare industry to small startups, we seek to understand the unique requirements of each customer so that we can create a tailored packaging solution.
The process begins with a Packaging Consult where our experienced sales engineers determine the key aspects of a customer’s situation.
This is usually a combination of the device itself (size, materials, complexity, design), quality considerations, sterilization requirements, specific needs for the packaging, and cost. Because this is what we focus on every day, we leverage all these elements to develop secure packaging solutions specifically designed for you.
CONTRACT PACKAGING SERVICES
For most medical device companies, packaging is not a core capability. At Pro-Tech Design & Manufacturing, Inc., we can fill that gap.
We are solely focused on providing packaging and assembly services for the medical device market. And because we work with a broad range of customers and packaging, we bring detailed knowledge of the medical device industry, packaging requirements, a diverse range of components, and cost-effective solutions.
We take the burden of this specialized area off our customer’s plates so that they can focus on what they do best – designing great medical devices.
OUR STRENGTHS
Custom & Pre-Validated Packaging
One important decision early on in the packaging consult is whether to design fully custom packaging or to use our portfolio of pre-validated packages.
We determine cost and timing considerations and provide customers with a recommendation on how best to solve their requirements. Pre-Validated packaging has been pre-tested and qualified to meet regulatory requirements and aging studies for up to 5 years.
Often pre-validated pouches and trays can get to market more quickly and cost effectively with no sacrifice in quality.
PACKAGING DESIGN
Our team of engineers uses the latest design software to create packaging designs that blend technical and regulatory requirements with cost-effective designs.
They are experienced at developing custom packaging solutions that not only provide quality and critical sterile protection, but also take into account important production and cost elements.
Understanding the link between initial design to full-scale production is a valuable part of the services that we provide.
MATERIAL EXPERTISE
We processed over 8,000 orders last year and work with packaging products for nearly all sectors of the medical device market. We are experienced in a wide range of packaging materials and configurations, including pouches, form-fill-seal trays, and even sewn items.
Production runs ranging from a few to thousands are routinely managed through our dedicated ISO 13485 registered facilities and our production equipment can be set up to handle unique sizes and quantities.
Medical Device Packaging Capabilities & Services
Pro-Tech Design & Manufacturing, Inc. provides full-service medical device packaging solutions.
- Pouching – 6 High-Speed Pouching Lines
- Trays – 5 Rigid Tray Lines
- Vacuum/Inert Packaging
- Liquid Filling – Syringes, Vials, and Tubes
- Chemical Compounding and QC Services
- Custom Boxes, Foam, and Inserts
- Cartoning/Multi-Packs
- Heat-Sealed Carding
- Automated Bagging
- Shrink Wrapping
Frequently Asked Questions
What medical device contract packaging services do you offer?
PRO-TECH Design & Manufacturing provides a wide range of services, including medical device contract packaging, contract assembly, custom and pre-validated packaging, and sterilization management. Our solutions cover the full packaging process, from initial concept to packaging development and sterilization process requirements. We specialize in blister packaging, pouches, trays, and even sewn wearable products to meet the rigorous needs of the medical industry.
How do you ensure regulatory compliance during the packaging process?
We adhere to strict regulatory standards, including FDA and ISO 13485 standards , to ensure compliance throughout the packaging process. Our cleanroom facilities are Class 10,000/ISO 7-rated and, provide the ideal environment for medical packaging and assembly. Our Quality System is designed to meet and exceed regulatory requirements, ensuring the highest level of quality control for our clients.
What are your core competencies in medical device packaging?
Our core competencies include contract manufacturing services, product assembly, medical device packaging services, and custom-sewn products. We provide advanced equipment and innovative solutions to meet the specific product requirements of our clients. Additionally, our team is experienced in developing packaging solutions for sterile medical devices and managing the necessary sterilization approaches to deliver safe, quality products to market.
Can you handle the sterilization process for medical devices?
Yes, PRO-TECH offers in-house steam sterilization services and is ISO 17665 certified. We also manage Ethylene Oxide (EO) and Gamma sterilization through licensed third-party sterilizers. We typically manage the entire sterilization process for our customers, ensuring your products meet all necessary regulatory requirements, and that the sterilization method is optimal for your type of product.
What makes PRO-TECH stand out in medical device contract manufacturing?
With over 40 years of experience, PRO-TECH Design & Manufacturing has developed a reputation for delivering high-quality medical device packaging and assembly services to our customers. We provide an array of packaging options tailored to each client’s needs. Our commitment to utilizing the latest technology, custom packaging design, and validation ensures that your device is protected and meets all industry and regulatory standards.
How do you support medical companies in getting their products to market?
PRO-TECH is a full-service partner that is invested in the success of our customers. We have a deep understanding of the medical device market and the intricate regulations surrounding packaging and sterilization. As such, we can provide end-to-end solutions, from initial packaging design to cleanroom assembly to sterilization to delivery. Our packaging solutions are designed to expedite time-to-market while ensuring that all packaging and assembly processes meet the specific needs of the medical device manufacturers we serve.
What are the benefits of using PRO-TECH's packaging validation services?
Our ISO 17025-accredited laboratory provides thorough testing and validation of the packaging, including Accelerated and Real-time Aging, Distribution Simulation, Package Seal Strength, and Integrity testing. By utilizing our in-house validation services, you are benefiting from our years of experience, speed to market, and cost savings.
What types of packaging technology do you utilize?
PRO-TECH utilizes form-fill-seal automation, vacuum/inert packaging, liquid filling, automated package sealing, as well as custom manual assembly. We also offer manual and automated sewing for custom-sewn medical products. These allow us to provide maximum flexibility and innovative packaging solutions to meet the needs of any customer.