CLEANROOM MANUFACTURING​

For over 25 years, AIM has been a trusted partner for the medical device manufacturing industry.

Cleanroom Medical Manufacturing

OUR ISO 14644 CERTIFIED CLASS 7 CLEANROOM IS READY TO PRODUCE

Our 6,000 square-foot, Class 7 cleanroom has the capacity to deliver on your most challenging medical manufacturing projects. We make components and sub-assemblies for nationally-recognized medical device manufacturers. Partnering with AIM offers access to our team of expert consultants who can assist medical device engineers in translating technical specifications into a component that meets regulatory requirements, while also ensuring a cost-effective and efficient production process.

Whether you need rapid prototyping for short-run manufacturing or you are seeking a long-term partner for high-volume manufacturing projects, AIM is the preferred choice for medical device component manufacturing and light assembly.

Advanced Medical Device Cleanroom Manufacturing Capabilities

PRECISION MOLDING, INSERT MOLDING, OVERMOLDING AND TWO-SHOT MOLDING

What sets AIM apart from other cleanroom manufacturers is the variety of manufacturing processes we are able to support in our ISO 14644 Certified Class 7 cleanroom. AIM’s capabilities include a vertical molding machine with a rotary platen for continuous cycle overmolding and a rotary two-shot molding machine that allows us to mold two different resins in one molding cycle, as well as a standard array of horizontal molding machines.

AIM has the capacity to produce a diverse array of components using the following processes in our Class 7 cleanroom:

We also offer value-added services, such as multi-color pad printing of supplied artwork and logos onto components as well as small-batch assembly. We are a highly-valued partner for medical device companies with unique or complex manufacturing needs.

Above and Beyond Regulatory Standards

AIM is committed to maintaining the integrity of our ISO 14644 Certified Class 7 cleanroom. Our 6,000 square-foot cleanroom has 66 HEPA filters that provide a 10% ceiling coverage. This constant air supply also provides the required pressurization for the cleanroom. The air within the cleanroom is consistently recirculated and is completely changed out at a rate of 27 air changes per hour. The temperature and humidity within the cleanroom are continuously monitored.

In addition to the annual certification, AIM goes above and beyond, performing additional testing to ensure the quality of the environment:

  • Particle Count Testing

    AIM performs monthly particle count monitoring using the Airy P311 handheld laser particle counter.

  • Viable Organism Sampling

    AIM performs annual viable organism sampling that includes viable room air sampling, viable surface contact sampling, and viable sampling of our supplied compressed air system. Samples are sent to an independent lab for testing.

Compressed air particle, oil, and water content sampling is also performed annually. AIM believes in complete transparency with our customers regarding the results of this testing.

Strategic Partnering with Medical Device Manufacturers

AIM is more than just a medical component manufacturer. We are a strategic partner that can help our customers achieve their business goals related to cost savings and efficiency.

AIM has the capacity in our ISO 14644 Certified Class 7 cleanroom to take over existing manufacturing programs from other cleanroom vendors through a proven validation process that will ensure a high-quality product. When taking over an existing cleanroom production program, AIM will:

  • Obtain the existing tooling.
  • Perform a small test run to check for production quality.
  • Make any necessary adjustments if the product does not meet our quality standards.
  • Perform a complete validation prior to starting full production.

Outsourcing is very common in the medical device industry. Many customers are seeking short-term start-up production runs that can eventually be transferred offshore. AIM has the expertise and capacity in our certified Class 7 cleanroom to take on these short-term production projects and seamlessly transition the tooling and equipment to the contracted offshore vendor. For start-up transfer projects in our cleanroom, AIM will:

  • Manufacture all tooling.
  • Acquire the necessary machines and equipment.
  • Perform the testing and validation needed for our customers to obtain FDA approval.
  • Perform the initial production run, typically for one year.
  • Transfer all of the existing tooling, equipment and machines to the offshore vendor.

AIM understands the business needs and interests of medical device manufacturers. Our ISO 14644 Certified, Class 7 cleanroom is ready and waiting to meet your manufacturing challenges.