When evaluating an injection molding partner for your medical device or components, finding a manufacturer that has the necessary process, certifications and equipment is critical. If you are working in the medical realm, having a scientific molder that can provide a controlled environment to produce, assemble and package your medical device in an FDA-registered facility that conforms to all ISO-13485 standards is key.
Consider further the benefits of partnering with an injection molder that goes beyond meeting the standards. Does your molding partner focus on quality control systems, procedure documentation, material traceability, machine and operational maintenance and training, regulated cleanroom protocols, all while striving to reach the highest levels of customer satisfaction and support?
Forum Plastics does this and more as they focus on all of these aspects, insuring the necessary checkpoints are in place to support these lifesaving and quality of life enhancing medical devices and components.
What are specific assembly services offered in the cleanroom?
Forum announced the addition of a Class 7 Cleanroom in October 2020 and has been providing world-class services to the medical industry through the leveraging and continued expansion of our services. Now that we have become an FDA-certified facility, we can provide more fully comprehensive assembly services up to a finished or semi-finished part.
Some of the services we currently provide include:
- Manual and semi-automated assembly of components and subassemblies
- Mechanical assembly
- Automated trimming/cutting/slitting
- Adhesive processes; gluing and bonding
- UV curing
- Ultrasonic welding
- Ultrasonic insert installation
- Heat insert installation
- Friction fit assembly (press fits)
- Hot stamping
- Tooling and fixture development
- Lean manufacturing principles
- Program management
- Heat staking
What determines which applications or products can be performed inside the cleanroom?
This is mainly determined by customer needs and the product or component classification requirements. Forum has the experience and knowledge to help to support regulatory compliance and identification of need basis. To maintain the highest level of cleanliness and lowest particulation risk, Forum avoids having any parts in the cleanroom that require secondary operations that would impact the sterility requirement. Because of this, Forum avoids any milling or non-contained cutting operations in the cleanroom environment. Additionally, we control in room packaging by utilizing non-cardboard or non-particulate producing options.
Focusing on Process
It’s not enough to simply have a Class 7 cleanroom. A scientific molder must have a process in place to keep those parts made on the shop clean before being assembled in the cleanroom.
Some examples of the processes we follow include:
- All our parts are double bagged on the shop floor. We transfer only the inner bag when parts are transitioned to our cleanroom. Parts are generally inspected and given an additional cleaning if any post-mold trimming is required prior to cleanroom assembly.
- Material traceability:
- All parts are fully certified to ISO 13485 standards and all products are shipped with a “document package.” As part of Forum’s ISO 140001, we have largely transitioned to digital files from paper copies. This includes the packing slip, certificate of compliance, inspection report, and commercial invoice (if required).
- The materials listed on the CoC can be traced back to the material certs stored on our system when the materials are received.
Forum maintains full traceability throughout the system from the starting material lots through to the finished components. All materials, equipment, tooling and operators are logged through our MRP system, and we maintain internally and externally supported operating system data. At any point, we can trace all relevant inputs to the parts they produced, and all component lots (by lot number) back to the input factors.
The Benefit to You
Forum is transitioning their focus in broadening the breadth of products and services offered to the medical device industry. Today, Forum has the inhouse capabilities and expertise to offer injection molding, 3D printing, metrology and cleanroom assembly, thus affording device companies a vertically integrated partner who can assist in process development and optimization, as well as ensuring the highest levels of quality, product consistency and on-time delivery possible.
As part of Forum’s strategic plan for continued advancements in their products and services, they will shortly be offering mobile and modular cleanroom capabilities. With the recognition that certain devices and device componentry require cleanroom processing through the entire development and manufacturing cycle, Forum is investing in this capability to continue to support evolving industry and growing customer-based needs. Additionally, this provides a higher level of low particulate protection and assuredness for the molded parts which will transition to the cleanroom for assembly.
From prototype to production, we’re committed to helping you get there faster.
Contact the Forum Team to learn more about their ISO Class 7 Cleanroom assembly services.