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The Critical Role of Cleanrooms in Medical Device Manufacturing

Plastic Molding Manufacturing (PMM) collaborates with some of the world's leading companies in the medical industry. Recognizing the critical role of cleanrooms in medical device manufacturing, our team applies its vast experience and proficiency to meet the demanding standards of this sector. We are highly responsive and dedicated to supporting the continually evolving needs and time-to-market for medical products. Equipped with horizontal and rotary injection molding machines, PMM is better positioned to serve our medical customers.

Molded plastic can serve various industrial applications, including automotive, industrial, connectors, electronics, consumer goods, defense, and transportation. However, the medical device industry demands and requires greater scrutiny for cleanliness and, in some cases, sterility.

Medical Applications:

Medical devices being manufactured in an ISO Class 8 Cleanroom
PMM's ISO Class 8 Cleanroom, equipped with a two-shot molding injection machine
  • Critical Patient Care

  • Diagnostic Equipment

  • Drug Filtration

  • High-Volume Disposables Products

  • Housings and Components

Cleanroom Expertise:

  • ​Single-Use Medical Disposables

  • Surgical Instruments

  • Orthopedic Products

  • Cardiac Products

  • Eye Treatment Devices

  • Healthcare Components and Devices

Molded plastic parts for medical devices are highly specialized, with precise and detailed requirements for sterility and regulatory compliance that exceed those of other industries. The controlled environment of a cleanroom helps ensure that particulate matter such as dust, airborne organisms, or vaporized particles do not contaminate the plastic used in medical device components. Regulations require a monitoring system for environmental conditions in the cleanroom, which must be a separate, appropriately sized facility equipment to control humidity, dust, air pressure, temperature, and microorganisms.

PMM’s cleanroom is equipped with air changing equipment that provides continuous clean air pressure using HEPA filters to control particle levels. The required cleanliness level is determined by the classification of the medical device being manufactured. PMM operates an ISO class 8 clean room, maintaining 100,000 particles/cu. ft. at 0.5 microns.

ISO 13485 Medical Devices Certification Logo

Within the medical devices industry, safety and quality are non-negotiable. That's why each year, PMM's ISO Class 8 Cleanroom undergoes a quality inspection to ensure our cleanroom is up to standard. This allows PMM to demonstrate our quality management processes and ensure best practice in everything we do.


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