Clean Room Injection Molding
A clean room is a controlled environment where technicians use equipment and gear to minimize and eliminate pollutants such as dust, microbes, and other airborne particles.
Clean rooms are used in manufacturing to varying degrees based on many factors, such as:
With our vast experience, Spectrum can manage the complexity of different clean room applications.
Many medical devices come into contact with or are inserted into the human body. Therefore, manufacturers must utilize the highest standards of precision and cleanliness when producing medical device products to ensure the safety of patients.
Additionally, federal standards significantly drive the clean room technology and processes needed in medical device manufacturing. Most medical device manufacturing must be conducted in a clean room between Class 100,000 (ISO 8) and Class 100 (ISO 5).
Here are some of the key reasons why clean room molding is important:
Clean rooms are classified into different levels, depending on the “allowable” amount of particles (contaminants) in the space. This is conveyed as the number of particles per cubic meter.
Medical injection molding is typically conducted in an ISO Class 8 clean room. An ISO 8 clean room provides air quality levels with an allowable maximum of 100,000 particles (≥0.5 um) per cubic foot of interior air with a minimum of 20 air exchanges per hour.
The clean room facility in Minneapolis is an ISO Class 8 room with 10,000 square feet of controlled environment.
Spectrum designed the clean room to manage the unique challenges of clean room molding and workflow. Real-time data capture, process quality monitoring, and in-cavity pressure monitoring are components of this clean room’s ultra-modern digital technology framework.
Other features in our clean room include:
Our clean room facilities are ideal for testing, developing, and assembling highly sensitive parts and products. These parts are made from materials engineered to deliver very specific physical and chemical characteristics.
The work area and personnel within the Minneapolis clean room conform to environmental control standards through the use of:
Keeping the clean room environment free from contaminants requires precise control of the area's airflow, temperature, and humidity and strict cleaning procedures for the people, equipment, and materials that pass in and out of the clean room.
Other advantages of our clean room include:
We fully understand the specifications of each part and the standard of excellence our customers require.
We subject our clean room to regular external and internal audits to ensure quality control.
Our external audits have always confirmed our high-quality standards. An external certified professional verifies our airflow, filter flow, and bioburdens. We are ISO 14644 certified, and our clean rooms are suited for manufacturing various types of medical devices.
Experienced members of our team perform our internal audits.
Clean room molding is vital for industries where precision, cleanliness, and contamination control are paramount. It helps companies meet regulatory standards, produce high-quality, reliable products, and maintain the integrity of sensitive materials. This specialized manufacturing process plays a crucial role in ensuring the safety, functionality, and quality of products in various high-stakes industries.
Customers’ expectations for even higher quality cleanliness increase with the production of medical molding products.
At Spectrum, we have anticipated continued growth of key markets and can expand our clean rooms as demand changes.
Not all parts require clean room injection molding. We also offer injection molding services for lower-risk applications that require a controlled environment but no certification.
Do you have any questions about our clean room and injection molding services? Contact us for more information.