Competition and regulation for medical device OEMs require them to work with injection molders who can bring the right environment, equipment, engineering materials, and employees to their designs and manufactures. These "Four E's" contain important evaluation criteria by which medical molding equipment manufacturers identify and measure who they work with among molders and other plastic processors. The definitions under each standard are as follows:
1. Environment: Includes clean and non-clean rooms, as well as quality and regulatory requirements such as cGMP, ISO 13485, ISO 9001 and batch traceability.
2. Equipment: covering injection molding machinery, molds, robots and assembly automation.
3. Engineering materials: including non-commercial plastics with challenging process requirements. Includes supply lot control, USP Class VI, BSE/TSE and 10993 compliance.
4. Employees: Includes highly skilled personnel who support complex tooling and assembly verification using technologically advanced tooling, equipment and processes.
The four E's not only represent the evaluation criteria for medical mold manufacturers. In many ways, they define the higher performance standards that differentiate these molders and qualify them to meet the rigorous demands of medical molding device manufacturing.
Like the industries they serve, medical moldmakers operate in highly regulated, quality-intensive environments that often involve manufacturing products in cleanrooms that require special air filtration systems. The decision to use a cleanroom depends on the air cleanliness required in the manufacturing process - a function of the size and amount of particles in the air.
To ensure clean air, cleanrooms rely on ceiling-mounted HEPA filters through which air enters the room and sweeps down to the bottom of the walls to exit ducts near the floor. The airflow is laminar, from top to bottom, preventing particles from floating in the air and causing pollution.
Not surprisingly, medical molding equipment must go through a rigorous installation certification process. Confirming the correct setup is critical for compliance, quality, safety and cost control. Most injection molding machines are fully installed in ISO 8 cleanrooms. Medical mold makers must also identify and document their equipment to support daily process audits.
Most printing presses are equipped with robots that automatically remove finished parts to ensure they remain clean and undamaged. Robots mounted on the machine also provide mold protection by confirming part removal and preventing molds from closing parts.
Many medical molding applications use highly engineered materials to enhance the performance of medical devices. These materials may contain special additives such as PTFE (fluoropolymer) or silicone to achieve low coefficient of friction and low sliding force properties.
Engineered materials are more difficult to process and have a narrower processing window than commodity materials. Validation requires recording the material melt flow index (MFI) and ensuring it is within the specified range.
Highly skilled employees are one of the "Four E's" that a medical mold maker must have to succeed. Managers, engineers, technicians, inspectors and operators must know and understand current Good Manufacturing Practices (cGMPs) for medical molding and assembly and work with care and diligence to ensure high quality and compliance.
The complexity and extensive validation of medical molds requires a high skill level. Generally speaking, medical molding employees are paid more than traditional/industrial molding staff.
Molders wishing to engage in medical device manufacturing must recognize the challenges and costs inherent in the industry. Without investing in the proper environment, equipment, engineering materials processing knowledge, and highly skilled employees, equipment manufacturers may find that a particular molder cannot meet their needs. These key fundamentals of medical molding can make or break medical device manufacturing and unlock new opportunities.
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