Process Validation as defined by the FDA is “The collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.”

The injection molding process generates minimal material waste compared to other manufacturing methods. This not only contributes to cost savings but also aligns with the increasing focus on sustainable and environmentally friendly manufacturing practices.

At PTI, we have over 16,000 square feet of ISO Class 8 cleanroom space that we utilize in our injection molding process to ensure as little contamination as possible.  We adhere to strict protocols that meet the demands the medical industry requiring ISO 14644 Cleanroom specifications, including bioburden and electrostatic discharge (ESD).

Injection molding offers unmatched precision and consistency in the production of medical device components. The process allows for intricate designs and tight tolerances, ensuring that each part is identical to the next. This uniformity is crucial in the medical field, where reliability and precision are paramount.

Injection molding is scalable, which means it can cater to a variety of production volumes, from small-scale prototypes to mass production. This scalability offers manufacturers the flexibility to meet different market demands.

We have been serving the medical industry for nearly 40 years, specializing in handling complex, multi-part programs and medical device molding for a variety of customers. Our direct contact with doctors and other medical professionals gives us insight into their needs and helps define and assist with final product solutions.

Furthermore, we have over 5,000 square feet of controlled environment space.  This segregated area is temperature controlled and pressurized, and can accommodate part decorating, assembly and packaging needs.

At PTI, we collaborate with you to achieve the best possible design for manufacturability.  In fact, we have a FREE guide to help you with this.

One of the most significant advantages of injection molding is its design flexibility. Engineers can create complex, customized components with minimal tooling changes. This adaptability is essential in a field where the demand for innovative and unique medical devices is ever-expanding.

Every plastic part starts in a mold.   Molds are classified into two main types, cold runner and hot runner.  Each has its advantages and disadvantages.   Your plastic injection molder will be able to give you the costs and benefits of using these different systems.  However, by understanding the key differences of these technologies, you can have a more educated discussion on the type of mold that would best fit your project.

Having served the medical industry for nearly 40 years, we understand medical device manufacturing.   Plastic Injection Molding remains one of the best manufacturing methods for achieving precision and cost-efficiency as well as maintaining patient safety.

Posted by Paula Hynes | 10 / 23 / 14 0 Comments

Many medical devices must be in direct contact with the human body. Injection molding allows manufacturers to choose biocompatible materials, ensuring patient safety. These materials can be sterilized without affecting their properties, making them suitable for a wide range of medical applications.

Meeting stringent regulatory requirements is a non-negotiable in the medical device industry. Injection molding excels in this regard. The ability to use FDA-approved materials and consistently produce parts that meet these standards ensures compliance from the outset.

Professionals in the field of plastic injection molding should be your primary resource for determining the best injection molding system for your project.  Look for injection molders who are familiar with all types of plastics processing.  They will be able to provide you with a cost/benefit analysis of the various systems available based on the part and the material used. At The Rodon Group, we can help you navigate the plastics manufacturing process to insure the highest level of quality and efficiency.

In many cases, our medical device customers look to process validation to ensure quality parts.  After all, patients lives depend on PTI to deliver high quality parts each and every time.

Process validation is the best way to ensure the production of safe parts, to reduce rejection rates, to prevent part failures in the field and to ensure the part meets with application, specification and regulatory obligations.

Mold Design is a crucial step in the injection molding process.  Once you’ve finalized your part in CAD software for fit and function, it must then be transformed into a design for molding to ensure the capture of all the specified details.  In some cases, certain features of the part design may not be manufacturable via the injection molding process.

The plastic is injected into the mold via the sprue and fills the runners which lead to the parts in the cavity.  In 2 plate molds, the runner system and parts are attached, and an ejection system is used to separate the pair from the mold.  For those of you who assembled a model car at some point in your youth, the runners and the parts were not separated.  The child assembling the model was responsible for that final part of the process. In 3 plate molds, the runner is contained on a separate plate, leaving the parts to be ejected alone.  In both systems, the runner is re-cycled and reground, reducing plastic waste.  However, these processes can increase cycle time.

Injection molding produces parts with a high level of structural integrity, ensuring they can withstand the rigors of their intended application. These parts are less prone to defects and offer superior performance over their lifecycle.

Injection molding allows medical design engineers the freedom to design complex or intricate parts, a vast selection of suitable materials and the consistency to produce both low and high volumes of devices.

The high initial tooling costs can be a barrier to entry for some manufacturers. However, once the molds are in place, injection molding is incredibly cost-effective for large production runs. The ability to produce a large number of parts in a short time reduces unit costs significantly, making it an ideal choice for mass production.

Careful selection of materials is extremely important within the medical industry. Materials must meet FDA and other regulatory standards, ensuring patient safety, biocompatibility, sterilizability and durability.  As Injection molding allows for a vast selection of both thermoplastic and thermoset materials to choose from, there is certain to be a material suitable for just about any application.

Some of the most common materials used in medical devices are: Polypropylene, ABS, Polyurethane, Polyvinylchloride, Polycarbonate, Polystyrene, Polysulfone, Acetal and Polyethylene.

Hot runner molds consist of 2 plates that are heated with a manifold system.   The manifold sends the melted plastic to nozzles which fill the part cavities.  There are several types of hot runner systems, however, in general, they fall into two main categories; externally heated and internally heated.  The externally heated systems are well suited to polymers that are sensitive to thermal variations.  Internally heated systems offer better flow control.  The hot runner process eliminates runners entirely, so recycling and regrind (which can only be done with virgin plastics) do not impact cycle times.  A variation of this system is called an insulated runner.  The insulation, rather than heat, keeps the plastic in a molten state.  This system can only accommodate a few types of plastics, specifically semi-crystalline polymers which have a low thermal conductivity.

Injection molded parts can undergo a variety of post-processing operations, such as assembly, machining, laser marking, pad printing or surface finishing, to meet the exact requirements of the medical device.

With streamlined production processes, injection molding can significantly reduce time-to-market for medical devices. This is crucial in a rapidly evolving industry where innovations can make a significant impact on patient care and outcomes.

PTI Engineered Plastics provides medical device manufacturers with full-service advanced product development delivered in a compressed timeframe. With superior design for manufacturability, tooling, and molding capabilities, PTI turns product visions into reality and gets your product to market first.

Injection molding for medical devices represents the perfect synergy of precision engineering and advanced manufacturing technology. Its benefits, from precision and consistency to cost-efficiency and regulatory compliance, make it a top choice for design engineers and medical device manufacturers. The process empowers engineers to innovate, create intricate components, and bring lifesaving devices to market faster than ever before. The future of medical device manufacturing is being molded with precision, and injection molding is at the forefront of this revolution.