Full Assembly Bowls resized 600During the past - injection molding companies both large and small were subject to rapidly changing business climates.

The economic effect of changing auto markets, electronics movement overseas and continued cost reduction pressure from current industries connected to medical injection molding all serve to support looking at ways for improving operations.

Understanding Current ISO Standards

Medical Injection Molding is a lot more than just a plastics process. The molding process goes beyond machines, molds and materials. The most important factors include quality operational controls. High-quality full-system compliance is a primary requirement for medical molding.

Most molders use a version of ISO systems. The ISO standards focus on quality by documenting how to develop controls from incoming through shipping.

Once a medical injection molding specialist determines which levels of ISO standardization to achieve, certification is necessary. Experienced molders know they need top-of-the line quality systems in place.

Medical injection molding customers expect ISO-13485 certification –– the standard for on-going suppliers. The ISO-13485 standard is the norm for control and compliance.  Accomplishing this quality-control system of compliance greatly enhances your ability to attract potential customers.

Quality Control, Safety and Operating Compliance

Quality control systems required for medical device manufactures will achieve ISO 13485:2003 certification standards. This is the medical injection molding device manufacturers’ standard for quality.

ISO 13485 achieves regulatory purposes and ISO 13485 mandates that you maintain quality procedures. System ISO 13485 emphasizes documentation to verify procedures that provide controlled conditions. These are for the activities and processes required to be performed.

ISO 13485 is a reference. 21CFR80 Quality system regulation is for medical devices. This serves as the guidance document for regulatory requirements.

ISO 13485 implementation requirements involve work environment controls needed to ensure medical injection molding product safety. Risk management activities are required during product development and special inspection.  Traceability requirements for implantable products are required as well.

Quality control and regulatory compliance garners serious consideration by suppliers of injection molded projects. 

Environmental and Material Controls

Other key variables include:

  • raw material and lot number control
  • process parameter controls
  • mold control and record keeping
  • environmental compliance

Medical injection molders need systems of control for their materials, molds and processes.  

Testing and verification for your process and material control also need more consideration. Once raw materials and/or formulations are approved by medical injection molding customers, no other changes are allowed without approval.

The levels of control require all elements of the formulation, including:

  • base material
  • colorants
  • processing aides
  • stabilizers, etc.

When materials control is crucial, your medical injection molder needs a vigorous system for lot number control and record keeping. Specific material grades and formula ingredients require maintenance and control while linking with shipment information.

Environmental control means having a certified clean room. This is designed to have a space with air control meeting a particulate count and a minimum air volume turnover for even better control. 

Adding Value to your Services

Design services are a major factor because your injection molder should be able to contribute to helping to modify designs for manufacture-ability of the completed part. 

Your injection molder needs to help the customers’ engineers with a variety of needs. These needs include part design expertise, design materials expertise, mold design expertise, prototyping generation - even assembly assistance. 

Evaluation of Strategies

The following should be considered when considering a medical injection molding company.

Consider the following:

  • Design,
  • Materials expertise,
  • Mold design and building,
  • Machine diversity (e.g., barrel size, small tonnage versus large tonnage, secondary operations, etc.).
  • What can be outsourced?

As standards and expectations change and expand in the medical industry, the ability of your injection molder to maintain and grow with you will be an expectation.

If you find yourself needing a medical injection molder,  Crescent Industries is ISO 13485:2003 certification that operates a Class 100K clean room for injection molding and a Class 10K for assembly and packaging operations, click here to learn more about Crescent Industries medical molding capabilities.