top of page

Why Medical Devices Demand for Clean Rooms

Plastic Molding Manufacturing works with some of the world's leading companies in the medical market. Our team applies its vast experience and proficiency to meet the critical demands of this market. We are highly responsive and dedicated to supporting the continually evolving needs and time-to-market for medical products. We are equipped with horizontal and rotary injection molding machines to better serve our medical customers.

Molded plastic can be manufactured for many different industrial applications; automotive, industrial, connectors, electronics, consumer, defense and transportation. However, medical device demand and require 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
  • Critical Patient Care

  • Diagnostic Equipment

  • Drug Filtration

  • High Volume Disposable Products

  • Housings and Components

Cleanroom Expertise:

  • ​Single Use Medical Disposables

  • Surgical Instruments

  • Orthopedic Products

  • Cardiac Products

  • Eye Treatment Devices

  • Healthcare Components and Device

The molded plastic parts for medical devices are highly specialized, carrying precise, detailed requirements for sterility and regulatory accountability that go above and beyond what’s called for in other industries. The controlled environment of a clean room can help ensure particulate matter i.e., dust, airborne organisms, or vaporized particles do not contaminate plastic that will form parts of medical devices. Regulations require a monitoring system for environmental conditions in the clean room, which must be a separate, appropriately sized room that has equipment to adequately control humidity, dust, air pressure, temperature and microorganisms.

Plastic Molding Manufacturing’s clean room is equipped with air changing equipment which provides continuous clean air pressure with use of HEPA filters which are used to control clean room particle levels. The required cleanliness level is determined by the classification of the medical device in question. Plastic Molding Manufacturing operates an ISO class 8 clean room: 100,000 particles/cu. Ft. at 0.5 microns.

bottom of page