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The business of manufacturing plastic molded parts stretches across the globe and spans multiple industries. But the molded plastic parts market for medical devices is highly specialized, carrying specific requirements for sterility and regulatory accountability that go above and beyond what’s called for in other industries. As medical devices become more detailed and more specialized, many medical device manufacturers require clean room manufacturing for their molded plastic parts.

Why Medical Devices Call for Clean Rooms

Molded plastic can be manufactured for many different industrial applications; automotive production stands as an example of a global industry that incorporates various molded plastic parts. However, medical device parts fall under greater scrutiny for cleanliness, and in some cases, sterility. The controlled environment of a clean room can help ensure that dust and other particulate matter do not contaminate plastic that will form parts of medical devices. Medical Device and Diagnostics Industry magazine notes that Food and Drug Administration (FDA) requirements say that where environmental conditions could affect product quality, “the manufacturer shall establish and maintain procedures to adequately control these environmental conditions.” Clean room manufacturing can establish this control.

Clean rooms are classified under a number of different standards that account for permissible particle limits and sterility requirements, Medical Device and Diagnostics explains. The International Standards Organization (ISO) classifies clean rooms according to airborne particulate cleanliness per cubic meter, ranging from class 9 to class 1. Ordinary room air corresponds to an ISO class 9 room. To put things in perspective, MDI operates an ISO class 7 clean room.

Particles found in the clean room include those created by the manufacturing equipment, as well as particles already in the room. Air changing equipment can be used to control clean room particle levels. The required cleanliness level is determined by the classification of the medical device in question. A Class III device calls for greater clean room particle control than a Class I device requires, Medical Device and Diagnostics explains.

ISO 13485 Certified

Molded Devices’ four United States-based manufacturing facilities offer clean room manufacturing that meets ISO 13485 certification standards. This manufacturing standard was designed for and is followed by many medical device makers as part of their quality management systems. ISO 13485 requires manufacturers to have formal written policies regarding control on documents and records, internal auditing procedures, controls for non-conformance, corrective and preventative actions, process and design controls, record retention, and accountability and traceability.

Although ISO 13485 is a voluntary standard, many OEMs require that their suppliers, such as plastics parts makers, hold the certification. Though there are many companies providing plastics manufacturing services, not all meet ISO 13485 certification. With a clean room environment, MDI can take a molded plastic part to the next step of the medical device manufacturing process, without compromising cleanliness levels.

MDI’s ISO 13485 certification means it can serve medical device manufacturers around the world. ISO 13485, in particular, was created to meet the quality system requirements in Australia, Japan, and Canada. In Europe, it is the de facto standard. Companies that meet this certification have also laid the groundwork to serve some additional markets. For example, the ISO 13485 standards are also the basis for quality requirements in markets such as South Korea and Brazil, according to consulting firm Emerge Group.

While the Food and Drug Administration does not formally recognize ISO 13485 certification, these certification requirements overlap many of the standards observed in current good manufacturing practices (CGMP), a U.S. standard that the FDA does observe, notes Emerge Group.

MDI’s clean room molding capabilities and ISO certification ensures that the company can meet the manufacturing requirements that many medical device companies seek in their plastics suppliers. To learn more about how MDI can meet your molded plastic parts needs, contact us today.